Analysis of the clinical characteristics and prognostic influencing factors of toxic epidermal necrolysis: A report of 52 cases

Analysis of the clinical characteristics and prognostic influencing factors of toxic epidermal necrolysis: A report of 52 cases | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Analysis of the clinical characteristics and prognostic influencing factors of toxic epidermal necrolysis: A report of 52 cases Zheng-xiang Hu, Hui-ning Bian, Hong-min Luo, Wen Lai, Xin Chu, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7263673/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background Toxic epidermal necrolysis (TEN) and Stevens–Johnson syndrome (SJS) are rare, acute, predominantly drug-induced, life-threatening type IV hypersensitivity reaction characterized by severe skin and mucosae involvement. Objective To investigate the clinical features and explore the prognostic factors of TEN. Methods A retrospective study was conducted to select 52 TEN patients who met the inclusion criteria and were admitted to Guangdong Provincial People's Hospital from January 2008 to January 2024. The data of gender, age, admission diagnosis, department category, history of ICU or burn department treatment, cause of death, suspected allergens, comorbidities, and SCORTEN were collected. Data were statistically analyzed with chi-square test, Fisher's exact probability test, and Mann-Whitney U test. The risk factors affecting the prognosis of TEN patients were screened. Results There were 33 males(63.46%) and 19 females(36.54%), aged from 8 months to 92 years. There were 11 cases (21.15%) of epidermolysis bullosa, 10 cases (19.23%) of exfoliative dermatitis, 12 cases (23.08%) of TEN, 7 cases (13.46%) of epidermolysis bullosa, 7 cases (13.46%) of Stevens-Johnson syndrome, and 5 cases (9.62%) of severe drug eruption diagnosed on admission. The patients were admitted to 11 departments, and the mortality rate of patients with treatment history in ICU or burn department was similar to that of patients without such department treatment history (P > 0.05). All the dead patients were complicated with sepsis. The suspected pathogens of TEN patients were allopurinol (21.15%) and antibiotics (13.46%). The proportion of patients with comorbidities and the SCORTEN of patients in sepsis group were significantly higher than those in non-sepsis group (P < 0.05). The age and SCORTEN of patients in death group were significantly higher than those in survival group (P < 0.05). The SCORTEN was an independent risk factor affecting the death of TEN patients (P < 0.05). Conclusions It is difficult to diagnose TEN on admission. Male is the susceptible population and allopurinol is the most common causative agent. The proportion of patients with sepsis combined with comorbidities and SCORTEN were higher, the age of death patients was higher than that of survival patients, and the main cause of death was sepsis. The SCORTEN is an independent risk factor for mortality in TEN patients. Epidermal necrolysis toxic Sepsis Prognosis Related factor 1. Introduction Toxic epidermal necrolysis (TEN) and Stevens–Johnson syndrome (SJS) are rare, acute, predominantly drug-induced, life-threatening a type IV hypersensitivity reaction characterized by severe skin and mucosae involvement[1]. SJS and TEN are nowadays considered variants of one disease entity with varying degrees of severity called epidermal necrolysis(EN). Below 10% of the body surface area the condition is referred to as SJS, between 10 and 30% as SJS/TEN overlap, and above 30% as TEN. TEN is the most severe type. The incidence of TEN is 0.4–1.45 per million, and mortality rate can reach 51%[2]. Sepsis is the main cause of death in TEN[3]. Because it is rare and a rapidly progressing, there is still a lack of standard treatment programs supported by evidence-based evidence[4]. Therefore, it is necessary to strengthen the collection of evidence-based evidence for the disease in clinical practice, so as to provide effective basis for the formulation of clinical treatment programs. The aim of our study is to summarize the clinical characteristics of 52 TEN patients, and explore the related factors that may affect their prognosis. 2. Methods 2.1. Patients A total of 52 patients from the Guangdong Provincial People's Hospital were included in this study. All patients were diagnosed for TEN between January 2008 and January 2024. The inclusion criteria were as follows:(1)All patients had a primary discharge diagnosis of TEN.༈2༉Medical records of allthe patients were integrated. Exclusion criteria included:༈1༉TEN was not treated after admission. (2) The patient who was treated in another hospital was admitted after being in stable condition. 2.2. Data collection and grouping Detailed medical information, including gender, age, diagnosis on admission, department category, history of treatment in intensive care unit(ICU) or burn department, cause of death of all patients, suspected drug allergy history, total body surface area(TBSA) of lesion, vital signs, medical comorbidities, physical examination, laboratory data, associated complications, treatments, duration of hospital stay, was extracted from the medical record. According to whether complicated with sepsis, the patients were divided into sepsis group (33 cases) and non-sepsis group (19 cases). According to whether they died, the patients were divided into death group (9 cases) and survival group (43 cases). The collection of clinical data about the patients were approved by the Ethics Committee of Guangdong Provincial People's Hospital. 2.3. Evaluation of the SCORTEN The severity-of-illness scoring system for TEN (SCORTEN) consists of seven clinical parameters with in the first 24h of admission:(1) age ≥ 40 years, (2) skin detachment ≥ 10% TBSA, (3) heart rate ≥ 120 bpm, (4) serum blood urea nitrogen > 10mmol/L, (5) serum bicarbonate 14mmol/L, and (7) malignancy present. Each variable had an equal weight in the score. 2.4. The diagnostic criteria for sepsis For patients with infection or suspected infection, sepsis can be diagnosed when the sequential (sepsis-related) organ failure assessment (SOFA) score increases by more than 2 points compared to the baseline. 2.5. Analysis of sepsis-related and death-related factors Data including gender, age, TBSA, SCORTEN, comorbidities, positive blood microbial culture in the course of the disease, applying corticosteroid(CS) and immunoglobulins(IVIG) therapy or not, had a history of admission to ICU or burn department or not after admission were collected for the analysis of sepsis-related and death-related factors. All variables significantly associated with sepsis and death with a significance level of P-value were included as candidates in the multivariable model. 2.6. Statistical analysis All statistical analyses were performed using SPSS 22.0. Quantitative data did not conform to the normal distribution and were expressed as M ( min , max ). Count data were expressed as frequency (percentage), and comparison between groups was analyzed by chi-square test or Fisher's exact probability test. Ordinal data were expressed as frequency, and comparison between groups was analyzed by Mann-Whitney U test. Univariate analysis was performed on the comparison of related factors of patients between sepsis group and non-sepsis group, death group and survival group, respectively. Logistic regression (backward LR) was used to determine the risk factors of sepsis and death inpatients with TEN. The odds ratio (OR) at 95% CI was calculated. A P-value of < 0.05 was considered to indicate a statistically significant difference. 3. Results A total of 52 patients were included in this study. Patients with TEN, comprising 33 males (63.5%) and 19 females(36.5%), were aged between 8 months and 92 years (the median age was 55.5years). There were 11 cases (21.15%) of epidermolysis bullosa, 10 cases (19.23%) of exfoliative dermatitis, 12 cases (23.08%) of TEN, 7 cases (13.46%) of epidermolysis bullosa, 7 cases (13.46%) of Stevens-Johnson syndrome, and 5 cases (9.62%) of severe drug eruption diagnosed on admission. The patients were admitted to the departments of infection, endocrinology, rheumatology, nephrology, stomatology, dermatology, ICU, burn department, Emergency department, cardiac surgery, and health care department. 16 patients had a history of treatment in ICU or burn department, and 5 of them died. 36 patients had no ICU or burn department treatment history, and 4 patients died, and the difference was not statistically significant (x 2 =3.139, P=0.077). 24 patients in the survival group were complicated with sepsis, and all patients in the death group were complicated with sepsis. The proportion of patients complicated with sepsis in the death group was higher than that in the survival group (x 2 =6.266, P=0.018). The causes of death were sepsis (n = 6), respiratory failure (n = 2) and acute renal failure (n = 1). 3.1. Suspected allergens and comorbidities in TEN patients There are many types of suspected allergens in patients with TEN, including allopurinol (21.15%), antibiotics (13.46%) , non-steroidal anti-inflammatory drugs(NSAIDs, 11.54%), chinese patent medicine(9.62%), psychotropic medicine(7.69%), thalidomide(1.92%), hydrochlorothiazide(1.92%), monoclonal antibody drugs(1.92%), unidentified medication(21.15%) and non-medicine(virus infection, barbecue, conditioner, lychee and dog meat, 9.62%).The comorbidities that the TEN patients have include malignant tumor(15.38%), kidney disease(13.46%), hypertension(11.54%), heart disease(7.69%), systemic lupus erythematosus(5.77%), rheumatoid arthritis combined with Sjögren's syndrome(1.92%), ankylosing spondylitis(1.92%). 3.2. Detection of pathogenic microorganisms and drug resistance There were 22 cases in sepsis group and 8 cases in non-sepsis group with positive pathogenic microorganisms. The samples of sepsis group included 7 cases of blood, 10 cases of respiratory secretion, and 12 cases of skin secretion, and the samples of non-sepsis group included 4 cases of blood, 1 case of respiratory secretion, and 4 cases of skin secretion. The detection of pathogenic microorganisms and drug resistance in each specimen of patients in sepsis group and non-sepsis group are shown in Tables 1. There were 15 cases of drug-resistant bacteria infection in sepsis group, of which 5 cases were combined with multiple drug-resistant bacteria. Among the detected strains, 9 strains were methicillin-resistant (MRS) strains, 12 strains were lactamase-resistant bacteria, 4 strains were extended-spectrum β-lactamase (ESBL) -resistant bacteria, 2 strains were multi-drug resistant bacteria, and 4 strains were all-drug resistant bacteria. A total of 9 strains of pathogenic bacteria were cultured from blood samples of patients in this group, including 8 strains of drug-resistant bacteria and 6 strains of Gram-positive bacteria. Among the patients in non-sepsis group, 6 cases were infected with drug-resistant bacteria, of which 1 case was complicated with multiple drug-resistant bacteria. Among the detected strains, 3 strains were MRS Strains, 5 strains were lactamase-producing drug-resistant bacteria, 1 strain was ESBL-producing bacteria, and 1 strain was multidrug-resistant bacteria. 3.3. Univariate analysis of factors influencing sepsis and death in TEN patients There were more males than females in the sepsis group and the non-sepsis group, but the difference was not statistically significant (P>0.05). There were no significant differences in age, skin lesion area, blood microbial culture positive rate, CS use rate, and IVIG use rate between the two groups (P>0.05). The proportion of patients with comorbidities, SCORTEN score, and proportion of patients admitted to ICU or burn department in sepsis group were significantly higher than those in non-sepsis group (P<0.05), as shown in Table 2. The gender, underlying disease, lesion area, positive rate of blood microbial culture, use of CS, use of IVIG , and proportion of admission to ICU or burn department of patients were similar between survival group and death group (P>0.05). The age and SCORTEN score of the death group were significantly higher than those of the survival group (P<0.05), as shown in Table 3. 3.4. Multivariate logistic regression analysis was used to analyze the influencing factors of sepsis and death in TEN patients The factors with statistically significant differences in univariate analysis between sepsis group and non-sepsis group were combined with comorbidities and SCORTEN score. The assignment of combined with comorbidities was no =0, yes =1, the assignment of SCORTEN score was 1-3 =0, 4-6 =1, the assignment of whether to stay in ICU or burn department was no =0, yes =1. The results of binary multivariate logistic regression analysis showed that none of the three factors were independent risk factors for sepsis in TEN patients (P>0.05), as shown in Table 4. The statistically significant factors in the univariate analysis between the survival group and the death group were age and SCORTEN score. The age was assigned, <60 years =0, ≥60 years =1, and the SCORTEN score was assigned, 1-3 =0, 4-6 =1. The results showed that SCORTEN score was an independent risk factor for death in TEN patients (P<0.05), as shown in Table 5. 4. Discussion The first symptoms of TEN are typically non-specifc and precede cutaneous symptoms by a few days in up to one third of cases[4]. Early symptoms may include headache, rhinitis, cough, sore throat, or myalgias. The clinical picture is characterized by extensive exanthema consisting of macules and/or target-like individual lesions without trizonal structure (atypical target lesions), followed by the formation of skin blisters (positive Nissl's sign), mucosal ulceration(oral and genital mucosa, conjunctiva, nasal mucosa, less often tracheal or bronchial mucosa), epidermal exfoliation, with or without organ function damage[5]. The clinical features of TEN can mimic other dermatologic diseases, including erythema multiforme, generalized bullous fxed drug eruption, staphylococcal scalded skin syndrome, pemphigus vulgaris, among others. It is important to differentiate between these conditions, as they have diferent treatments and prognoses. TEN is rare in clinical practice, and non-specialists lack of understanding of the disease, which is easy to lead to misdiagnosis or non-standard diagnosis. Less than 1/4 (23.08%) of the cases in this study were diagnosed as TEN on admission. SJS is defined in Japan as detachment covering < 10% TBSA, whereas TEN involves 10% detachment[6]. The aim is to reinforce the important role that clinical specialists have during the diagnosis of SJS/TEN. Many studies have shown that women are more than men in TEN patients [7–9], but this study showed that men are more than women (1.74∶1.00), which is consistent with the survey results of Yang et al. [10] and Yoo et al. [11].The possible reason is that with the improvement of living standards in China, the proportion of TEN patients induced by taking uric acid-lowering drugs due to high uric acid is increasing. Men had a higher risk of hyperuricemia. With the increasing number of patients with hyperuricemia, allopurinol has been widely used. It has been suggested that allopurinol should be regarded as the most common drug associated with the development of SJS/TEN[12]. A meta-analysis showed that the main pathogenic drugs of TEN were antibiotics (25.4%), anticonvulsants (22.0%) and antipyretic analgesics (18.3%) [13]. However, another international multi-center study showed that allopurinol was the most common drug inducing TEN [14], which was consistent with the results of this study. The factors leading to this difference may be living habits, dietary habits or regional differences. For patients with exfoliative dermatitis or vesicular skin lesions with progressive aggravation after a suspicious history of drug use, the diagnosis should be confirmed as soon as possible, and the relevant drugs should be discontinued[15]. Studies have shown that the factors affecting the mortality of TEN patients include age, SCORTEN score > 3 points, > 5 days from onset to transfer to burn center, complicated with comorbidities and malignant tumors[16–17]. Early diagnosis, early withdrawal of allergenic drugs, and early transfer to ICU or burn center are considered to effectively improve the prognosis of TEN patients [18]. In this study, the mortality rate of patients with treatment history of ICU/ burn department was higher than that of patients without treatment history of ICU/ burn department, but the difference was not statistically significant (P > 0.05). The reason may be that patients with treatment history of ICU or burn department were not transferred to this department for treatment at early stage, and their condition was critical when transferred. The results of this study showed that patients with a history of treatment in ICU or burn department had a higher proportion of patients complicated with sepsis (χ2 = 4.896, P = 0.027 < 0.05), which may also be caused by the above reasons, or patients were considered to transfer to other departments after they were complicated with sepsis. Therefore, early multidisciplinary cooperation to confirm the diagnosis and start active and standardized treatment as soon as possible are of great significance to the prognosis of patients [19–21]. The main cause of death in TEN patients was MODS caused by sepsis. In this study, 100% of the dead cases were complicated with sepsis, which was significantly higher than 55.81% of the survival group (χ2 = 6.266, P = 0.018). Therefore, in order to reduce the mortality of patients, we should prevent the occurrence of sepsis as much as possible. The SCORTEN score is a good indicator to evaluate the severity of SJS/TEN and predict the mortality (the predicted mortality of 0–1 score is 3.2%, the predicted mortality of 2 score is 12.1%, the predicted mortality of 3 score is 32.3%, the predicted mortality of 4 score is 58.3%, and the predicted mortality of more than 5 score is 90%) [22]. Univariate analysis of this study showed that combined comorbidities, SCORTEN score > 3 points, and admission to ICU or burn department may be the influencing factors of sepsis in TEN patients. Multivariate logistic regression analysis showed that none of the three factors was the independent risk factor affecting sepsis in TEN patients. In order to reduce the incidence of sepsis, the risk factors that may affect the complication of sepsis should be controlled, that is, the patients should be scored in the early stage. For patients with comorbidities, SCORTEN score > 3 points, and those admitted to ICU or burn department, we should intervene as soon as possible, focusing on preventing sepsis to improve the prognosis. Univariate analysis showed that age and SCORTEN score may be the factors affecting the death of TEN patients, and multivariate logistic regression analysis showed that SCORTEN score was an independent risk factor affecting the death of TEN patients. Therefore, patients with age ≥ 60 years and higher SCORTEN score should be treated as early as possible and comprehensively to reduce the mortality. However, there were no statistically significant differences in gender, lesion area, combined comorbidities, positive blood microbial culture, use of IVIG and hormone, and whether they were admitted to ICU or burn department after death between the death group and the survival group (P > 0.05). The possible reason was that this study was a single-center study with small number of cases and there was sampling bias. The study had other limitations. For example, there were 5 patients who were discharged automatically, among whom there may have been dead cases and were not included in the death group. The lesion area was estimated. The long time span of the cases and the many confounding factors may have a certain impact on the results. The main treatments for TEN include supportive therapy and systemic therapy. Supportive treatment is the key to TEN patient[23], including the wound care, protection of organ function, prevention and treatment of infection, and treatment of comorbidities. If necessary, alternative treatments such as plasma exchange, hemodialysis, and extracorporeal membrane oxygenation are needed. The skin lesions of TEN are similar to uniform superficial partial thickness burns[24], which usually do not require surgical treatment. The wounds are generally self-healing after regular debridement and dressing change to keep them clean[25]. Other antibacterial dressings or biological dressings can also be appropriately applied[26–27]. Surgical debridement is only applicable to patients with skin infection and necrosis or deepened wounds[28]. Progressive increase in surface lesion area often indicates disease progression. In this study, there was no clear correlation between wound area and prognosis, which was consistent with the results of McCullough et al.[25]. However, fluid loss should be considered, the balance of water and electrolyte should be actively corrected, and wound infection should be prevented. In this study, 88.89% of the blood microbial cultures of sepsis patients were resistant bacteria, and 66.67% were Gram-positive bacteria. Therefore, antibiotics against drug-resistant Gram-positive bacteria should be used during empirical anti-infection treatment. ICU can provide effective life support and organ protection strategies for patients, while burn centers can not only provide active wound treatment, but also provide important guarantee for the comprehensive prevention and treatment of sepsis. This may be one of the important reasons why many scholars and guidelines recommend to transfer to ICU or burn department for specialized treatment as soon as possible[14, 29]. The drugs for systemic treatment include CS, IVIG, cyclosporine A, etanercept, thalidomide and adalimumab[30]. Among them, CS and IVIG are the most widely used. Different scholars have different views on the systemic treatment of TEN. Because the disease is a delayed hypersensitivity reaction, CS has a strong anti-allergic effect, and IVIG can block the death receptor pathway and prevent the apoptosis of killer cells [31], so most scholars recommend CS combined with IVIG treatment[29, 32–33]. Due to the low incidence and severe condition of TEN, it is impossible to conduct prospective randomized controlled studies with large samples, and there is no evidence-based evidence that the use of CS and IVIG can improve the prognosis[34–36]. Therefore, systemic therapy should only be administered, if progression of the erythema has occurred in the last 24 hours[29]. This study showed that there was no significant correlation between the use of IVIG or CS and the prognosis of TEN patients (P > 0.05), which was consistent with the results of most studies[14, 29]. However, this study was not a randomized controlled study, and the sample size was small, so it cannot be concluded that patients did not benefit from the use of CS or IVIG. 5. Conclusions TEN has a low incidence but a high mortality rate and is easy to be misdiagnosed in the early stage, which should be paid attention to by clinicians. For high frequency pathogenic drugs, clinical use should be cautious, and the presence of related susceptibility genes should be detected to reduce the risk of disease. Sepsis is the main cause of death in TEN patients. In order to improve the survival rate of patients, we should focus on the prevention and treatment of sepsis. The patients should be transferred to qualified treatment departments such as ICU and burn center in time, so that the wound can be treated and the primary disease and its related complications can be treated at the same time. The drug treatment of TEN still needs more randomized controlled trials with more samples to provide a reliable "standard" scheme for clinical treatment. Declarations Author Contribution Hu: Writing- Original draft preparation. Ma: Data curation. Bian: Conceptualization, Methodology .Luo: Visualization, Investigation.Chu: Software, Validation.Liu: Writing- Reviewing and Editing, Lai: Supervision.All authors reviewed the manuscript. References Hasegawa A, Abe R. Stevens-Johnson syndrome and toxic epidermal necrolysis: Updates in pathophysiology and management. Chin Med J (Engl). 2024;137(19):2294-2307. doi: 10.1097/CM9.0000000000003250. Breidung D, Delavari S, Megas IF, Geierlehner A, Hitzl W, Bodenschatz KJ, et al. Epidemiological Characteristics and Prognostic Scoring in Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome: Insights from a 17-Year Burn Center Experience. Medicina (Kaunas). 2025;61(1):66. doi: 10.3390/medicina61010066. 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Cureus. 2024;16(3):e55350. doi: 10.7759/cureus.55350. Heuer R, Paulmann M, Annecke T, Behr B, Boch K, Boos AM, et al. S3 guideline: Diagnosis and treatment of epidermal necrolysis (Stevens-Johnson syndrome and toxic epidermal necrolysis) - Part 1: Diagnosis, initial management, and immunomodulating systemic therapy. J Dtsch Dermatol Ges. 2024;22(10):1448-1466. doi: 10.1111/ddg.15515. Lin M, Gong T, Ruan S, Lv X, Chen R, Su X, et al. Emerging Insights into Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Induced by Immune Checkpoint Inhibitor and Tumor-Targeted Therapy. J Inflamm Res. 2024;17:2337-2351. doi: 10.2147/JIR.S454673. Barron SJ, Del Vecchio MT, Aronoff SC. Intravenous immunoglobulin in the treatment of Stevens-Johnson syndrome and toxic epidermal necrolysis: a meta-analysis with meta-regression of observational studies[J]. Int J Dermatol, 2015;54(1):108-115. Yang L, Shou YH, Li F, Zhu XH, Yang YS, Xu JH. Intravenous Immunoglobulin Combined With Corticosteroids for the Treatment of Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis: A Propensity-Matched Retrospective Study in China. Front Pharmacol. 2022;12:750173. doi: 10.3389/fphar.2021.750173. Jagadeesan S, Sobhanakumari K, Sadanandan SM, Ravindran S, Divakaran MV, Skaria L, et al. Low dose intravenous immunoglobulins and steroids in toxic epidermal necrolysis: a prospective comparative open-labelled study of 36 cases. Indian J Dermatol Venereol Leprol. 2013;79(4):506-11. doi: 10.4103/0378-6323.113080. Lin CC, Chen CB, Wang CW, et al. Stevens-Johnson syndrome and toxic epidermal necrolysis: risk factors, causality assessment and potential prevention strategies[J]. Expert Rev Clin Immunol, 2020;16(4) : 373-387. doi: 10.1080/1744666X.2020.1740591. Zimmermann S, Sekula P, Venhoff M, Motschall E, Knaus J, Schumacher M, et al. Systemic Immunomodulating Therapies for Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis: A Systematic Review and Meta-analysis. JAMA Dermatol. 2017;153(6):514-522. doi: 10.1001/jamadermatol.2016.5668. Marchitto MC, Sung S, Doong J, Chien AL. Toxic epidermal necrolysis: a review of 20 years of data. J Eur Acad Dermatol Venereol. 2018;32(7):e263-e264. doi: 10.1111/jdv.14786. Tables Tables 1 to 5 are available in the Supplementary Files section. Additional Declarations No competing interests reported. Supplementary Files Table1.docx Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7263673","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":505455334,"identity":"39da9386-c594-4608-9605-9045b7b38184","order_by":0,"name":"Zheng-xiang Hu","email":"","orcid":"","institution":"Guangdong Provincial People’s Hospital Zhuhai Hospital","correspondingAuthor":false,"prefix":"","firstName":"Zheng-xiang","middleName":"","lastName":"Hu","suffix":""},{"id":505455336,"identity":"99f2fef4-fa26-4cbe-a56c-8f400a9e0b70","order_by":1,"name":"Hui-ning Bian","email":"","orcid":"","institution":"Guangdong Provincial People's Hospital","correspondingAuthor":false,"prefix":"","firstName":"Hui-ning","middleName":"","lastName":"Bian","suffix":""},{"id":505455339,"identity":"344e5098-a0a2-4823-a369-c42066c2ce60","order_by":2,"name":"Hong-min Luo","email":"","orcid":"","institution":"Guangdong Provincial People's Hospital","correspondingAuthor":false,"prefix":"","firstName":"Hong-min","middleName":"","lastName":"Luo","suffix":""},{"id":505455340,"identity":"1348f9c8-d2df-43b5-9c22-d3f511d14e6c","order_by":3,"name":"Wen Lai","email":"","orcid":"","institution":"Guangdong Provincial People's Hospital","correspondingAuthor":false,"prefix":"","firstName":"Wen","middleName":"","lastName":"Lai","suffix":""},{"id":505455342,"identity":"6d741236-febf-47ee-9148-3ce5f2a5bb53","order_by":4,"name":"Xin Chu","email":"","orcid":"","institution":"Guangdong Provincial People’s Hospital Zhuhai Hospital","correspondingAuthor":false,"prefix":"","firstName":"Xin","middleName":"","lastName":"Chu","suffix":""},{"id":505455345,"identity":"e90ad7de-1d42-486d-8712-00238c56fb78","order_by":5,"name":"Yi-xing Liu","email":"","orcid":"","institution":"Guangdong Provincial People’s Hospital Zhuhai Hospital","correspondingAuthor":false,"prefix":"","firstName":"Yi-xing","middleName":"","lastName":"Liu","suffix":""},{"id":505455349,"identity":"8cb1fff4-7e5e-40f4-9849-e9d99e921f1b","order_by":6,"name":"Dan Ma","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAy0lEQVRIiWNgGAWjYBACfvbmgw8SDGyY+dkbiNQi2XMs2eBBRRq7ZM8BIrUY3MhRk3xw5jC/wY0EYl12I4dNIrEtTdrg5uONNxhqbKIJ6mDseXvYIrHNxljydlqxBcOxtNwGQlqY2fMSbwBtSea7nWMmwdhwmLAWNoYcA6DDDtc33DxDpBYejhwjiYQzh5kFbvAQqUWCBxjICRVpzJI9QL8kEOMX++PNBx/+AEfl4Y03PtTYENaCDAwkEkhRDtFCqo5RMApGwSgYGQAAKOZD7WjmbRgAAAAASUVORK5CYII=","orcid":"","institution":"Zhuhai Center for Disease Control and Prevention","correspondingAuthor":true,"prefix":"","firstName":"Dan","middleName":"","lastName":"Ma","suffix":""}],"badges":[],"createdAt":"2025-07-31 15:08:34","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-7263673/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-7263673/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":92191946,"identity":"14b9b36f-3086-4b20-8640-3a59ef28d528","added_by":"auto","created_at":"2025-09-25 15:14:09","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":447099,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7263673/v1/23137a7a-ac71-492c-a095-d07f5745f078.pdf"},{"id":89950200,"identity":"6b01836b-11ff-4a09-b536-a42f65e2c010","added_by":"auto","created_at":"2025-08-26 18:53:59","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":21812,"visible":true,"origin":"","legend":"","description":"","filename":"Table1.docx","url":"https://assets-eu.researchsquare.com/files/rs-7263673/v1/2e51ae4e81b4127d4f6b0fa5.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Analysis of the clinical characteristics and prognostic influencing factors of toxic epidermal necrolysis: A report of 52 cases","fulltext":[{"header":"1. Introduction","content":"\u003cp\u003eToxic epidermal necrolysis (TEN) and Stevens\u0026ndash;Johnson syndrome (SJS) are rare, acute, predominantly drug-induced, life-threatening a type IV hypersensitivity reaction characterized by severe skin and mucosae involvement[1]. SJS and TEN are nowadays considered variants of one disease entity with varying degrees of severity called epidermal necrolysis(EN). Below 10% of the body surface area the condition is referred to as SJS, between 10 and 30% as SJS/TEN overlap, and above 30% as TEN. TEN is the most severe type. The incidence of TEN is 0.4\u0026ndash;1.45 per million, and mortality rate can reach 51%[2]. Sepsis is the main cause of death in TEN[3]. Because it is rare and a rapidly progressing, there is still a lack of standard treatment programs supported by evidence-based evidence[4]. Therefore, it is necessary to strengthen the collection of evidence-based evidence for the disease in clinical practice, so as to provide effective basis for the formulation of clinical treatment programs. The aim of our study is to summarize the clinical characteristics of 52 TEN patients, and explore the related factors that may affect their prognosis.\u003c/p\u003e"},{"header":"2. Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u003ch2\u003e2.1. Patients\u003c/h2\u003e\u003cp\u003eA total of 52 patients from the Guangdong Provincial People's Hospital were included in this study. All patients were diagnosed for TEN between January 2008 and January 2024. The inclusion criteria were as follows:(1)All patients had a primary discharge diagnosis of TEN.༈2༉Medical records of allthe patients were integrated. Exclusion criteria included:༈1༉TEN was not treated after admission. (2) The patient who was treated in another hospital was admitted after being in stable condition.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec4\" class=\"Section2\"\u003e\u003ch2\u003e2.2. Data collection and grouping\u003c/h2\u003e\u003cp\u003eDetailed medical information, including gender, age, diagnosis on admission, department category, history of treatment in intensive care unit(ICU) or burn department, cause of death of all patients, suspected drug allergy history, total body surface area(TBSA) of lesion, vital signs, medical comorbidities, physical examination, laboratory data, associated complications, treatments, duration of hospital stay, was extracted from the medical record.\u003c/p\u003e\u003cp\u003eAccording to whether complicated with sepsis, the patients were divided into sepsis group (33 cases) and non-sepsis group (19 cases). According to whether they died, the patients were divided into death group (9 cases) and survival group (43 cases). The collection of clinical data about the patients were approved by the Ethics Committee of Guangdong Provincial People's Hospital.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec5\" class=\"Section2\"\u003e\u003ch2\u003e2.3. Evaluation of the SCORTEN\u003c/h2\u003e\u003cp\u003eThe severity-of-illness scoring system for TEN (SCORTEN) consists of seven clinical parameters with in the first 24h of admission:(1) age\u0026thinsp;\u0026ge;\u0026thinsp;40 years, (2) skin detachment\u0026thinsp;\u0026ge;\u0026thinsp;10% TBSA, (3) heart rate\u0026thinsp;\u0026ge;\u0026thinsp;120 bpm, (4) serum blood urea nitrogen\u0026thinsp;\u0026gt;\u0026thinsp;10mmol/L, (5) serum bicarbonate\u0026thinsp;\u0026lt;\u0026thinsp;20mmol/L, (6) serum glucose\u0026thinsp;\u0026gt;\u0026thinsp;14mmol/L, and (7) malignancy present. Each variable had an equal weight in the score.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec6\" class=\"Section2\"\u003e\u003ch2\u003e2.4. The diagnostic criteria for sepsis\u003c/h2\u003e\u003cp\u003eFor patients with infection or suspected infection, sepsis can be diagnosed when the sequential (sepsis-related) organ failure assessment (SOFA) score increases by more than 2 points compared to the baseline.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec7\" class=\"Section2\"\u003e\u003ch2\u003e2.5. Analysis of sepsis-related and death-related factors\u003c/h2\u003e\u003cp\u003eData including gender, age, TBSA, SCORTEN, comorbidities, positive blood microbial culture in the course of the disease, applying corticosteroid(CS) and immunoglobulins(IVIG) therapy or not, had a history of admission to ICU or burn department or not after admission were collected for the analysis of sepsis-related and death-related factors. All variables significantly associated with sepsis and death with a significance level of P-value were included as candidates in the multivariable model.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e\u003ch2\u003e2.6. Statistical analysis\u003c/h2\u003e\u003cp\u003eAll statistical analyses were performed using SPSS 22.0. Quantitative data did not conform to the normal distribution and were expressed as \u003cem\u003eM\u003c/em\u003e (\u003cem\u003emin\u003c/em\u003e, \u003cem\u003emax\u003c/em\u003e). Count data were expressed as frequency (percentage), and comparison between groups was analyzed by chi-square test or Fisher's exact probability test. Ordinal data were expressed as frequency, and comparison between groups was analyzed by Mann-Whitney U test. Univariate analysis was performed on the comparison of related factors of patients between sepsis group and non-sepsis group, death group and survival group, respectively. Logistic regression (backward LR) was used to determine the risk factors of sepsis and death inpatients with TEN. The odds ratio (OR) at 95% CI was calculated. A P-value of \u0026lt;\u0026thinsp;0.05 was considered to indicate a statistically significant difference.\u003c/p\u003e\u003c/div\u003e"},{"header":"3. Results","content":"\u003cp\u003eA total of 52 patients were included in this study. Patients with TEN, comprising 33 males (63.5%) and 19 females(36.5%), were aged between 8 months and 92 years (the median age was 55.5years). There were 11 cases (21.15%) of epidermolysis bullosa, 10 cases (19.23%) of exfoliative dermatitis, 12 cases (23.08%) of TEN, 7 cases (13.46%) of epidermolysis bullosa, 7 cases (13.46%) of Stevens-Johnson syndrome, and 5 cases (9.62%) of severe drug eruption diagnosed on admission.\u003c/p\u003e\n\u003cp\u003eThe patients were admitted to the departments of infection, endocrinology, rheumatology, nephrology, stomatology, dermatology, ICU, burn department, Emergency department, cardiac surgery, and health care department. 16 patients had a history of treatment in ICU or burn department, and 5 of them died. 36 patients had no ICU or burn department treatment history, and 4 patients died, and the difference was not statistically significant (x\u003csup\u003e2\u003c/sup\u003e=3.139, P=0.077).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e24 patients in the survival group were complicated with sepsis, and all patients in the death group were complicated with sepsis. The proportion of patients complicated with sepsis in the death group was higher than that in the survival group (x\u003csup\u003e2\u003c/sup\u003e=6.266, P=0.018). The causes of death were sepsis (n = 6), respiratory failure (n = 2) and acute renal failure (n = 1).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e3.1. Suspected allergens and comorbidities in TEN patients\u003c/p\u003e\n\u003cp\u003eThere are many types of suspected allergens in patients with TEN, including allopurinol (21.15%), antibiotics (13.46%) , non-steroidal anti-inflammatory drugs(NSAIDs, 11.54%), \u0026nbsp;chinese patent medicine(9.62%), psychotropic medicine(7.69%), thalidomide(1.92%), hydrochlorothiazide(1.92%), monoclonal antibody drugs(1.92%), unidentified medication(21.15%) and non-medicine(virus infection, barbecue, conditioner, lychee and dog meat, 9.62%).The comorbidities that the TEN patients have include malignant tumor(15.38%), \u0026nbsp;kidney disease(13.46%), hypertension(11.54%), heart disease(7.69%), systemic lupus erythematosus(5.77%), rheumatoid arthritis combined with Sj\u0026ouml;gren\u0026apos;s syndrome(1.92%), \u0026nbsp;ankylosing spondylitis(1.92%).\u003c/p\u003e\n\u003cp\u003e3.2.\u0026nbsp;Detection of pathogenic microorganisms and drug resistance\u003c/p\u003e\n\u003cp\u003eThere were 22 cases in sepsis group and 8 cases in non-sepsis group with positive pathogenic microorganisms. The samples of sepsis group included 7 cases of blood, 10 cases of respiratory secretion, and 12 cases of skin secretion, and the samples of non-sepsis group included 4 cases of blood, 1 case of respiratory secretion, and 4 cases of skin secretion. The detection of pathogenic microorganisms and drug resistance in each specimen of patients in sepsis group and non-sepsis group are shown in Tables 1. There were 15 cases of drug-resistant bacteria infection in sepsis group, of which 5 cases were combined with multiple drug-resistant bacteria. Among the detected strains, 9 strains were methicillin-resistant (MRS) strains, 12 strains were lactamase-resistant bacteria, 4 strains were extended-spectrum \u0026beta;-lactamase (ESBL) -resistant bacteria, 2 strains were multi-drug resistant bacteria, and 4 strains were all-drug resistant bacteria. A total of 9 strains of pathogenic bacteria were cultured from blood samples of patients in this group, including 8 strains of drug-resistant bacteria and 6 strains of Gram-positive bacteria. Among the patients in non-sepsis group, 6 cases were infected with drug-resistant bacteria, of which 1 case was complicated with multiple drug-resistant bacteria. Among the detected strains, 3 strains were MRS Strains, 5 strains were lactamase-producing drug-resistant bacteria, 1 strain was ESBL-producing bacteria, and 1 strain was multidrug-resistant bacteria.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e3.3. Univariate analysis of factors influencing sepsis and death in TEN patients\u003c/p\u003e\n\u003cp\u003eThere were more males than females in the sepsis group and the non-sepsis group, but the difference was not statistically significant (P\u0026gt;0.05). There were no significant differences in age, skin lesion area, blood microbial culture positive rate, CS use rate, and IVIG use rate between the two groups (P\u0026gt;0.05). The proportion of patients with comorbidities, SCORTEN score, and proportion of patients admitted to ICU or burn department in sepsis group were significantly higher than those in non-sepsis group (P\u0026lt;0.05), as shown in Table 2.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe gender, underlying disease, lesion area, positive rate of blood microbial culture, use of CS, use of IVIG , and proportion of admission to ICU or burn department of patients were similar between survival group and death group (P\u0026gt;0.05). The age and SCORTEN score of the death group were significantly higher than those of the survival group (P\u0026lt;0.05), as shown in Table 3.\u003c/p\u003e\n\u003cp\u003e3.4. Multivariate logistic regression analysis was used to analyze the influencing factors of sepsis and death in TEN patients\u003c/p\u003e\n\u003cp\u003eThe factors with statistically significant differences in univariate analysis between sepsis group and non-sepsis group were combined with comorbidities and SCORTEN score. The assignment of combined with comorbidities was no =0, yes =1, the assignment of SCORTEN score was 1-3 =0, 4-6 =1, the assignment of whether to stay in ICU or burn department was no =0, yes =1. The results of binary multivariate logistic regression analysis showed that none of the three factors were independent risk factors for sepsis in TEN patients (P\u0026gt;0.05), as shown in Table 4.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe statistically significant factors in the univariate analysis between the survival group and the death group were age and SCORTEN score. The age was assigned, \u0026lt;60 years =0, \u0026ge;60 years =1, and the SCORTEN score was assigned, 1-3 =0, 4-6 =1. The results showed that SCORTEN score was an independent risk factor for death in TEN patients (P\u0026lt;0.05), as shown in Table 5.\u003c/p\u003e"},{"header":"4. Discussion","content":"\u003cp\u003eThe first symptoms of TEN are typically non-specifc and precede cutaneous symptoms by a few days in up to one third of cases[4]. Early symptoms may include headache, rhinitis, cough, sore throat, or myalgias. The clinical picture is characterized by extensive exanthema consisting of macules and/or target-like individual lesions without trizonal structure (atypical target lesions), followed by the formation of skin blisters (positive Nissl's sign), mucosal ulceration(oral and genital mucosa, conjunctiva, nasal mucosa, less often tracheal or bronchial mucosa), epidermal exfoliation, with or without organ function damage[5]. The clinical features of TEN can mimic other dermatologic diseases, including erythema multiforme, generalized bullous fxed drug eruption, staphylococcal scalded skin syndrome, pemphigus vulgaris, among others. It is important to differentiate between these conditions, as they have diferent treatments and prognoses. TEN is rare in clinical practice, and non-specialists lack of understanding of the disease, which is easy to lead to misdiagnosis or non-standard diagnosis. Less than 1/4 (23.08%) of the cases in this study were diagnosed as TEN on admission. SJS is defined in Japan as detachment covering\u0026thinsp;\u0026lt;\u0026thinsp;10% TBSA, whereas TEN involves 10% detachment[6]. The aim is to reinforce the important role that clinical specialists have during the diagnosis of SJS/TEN.\u003c/p\u003e\u003cp\u003eMany studies have shown that women are more than men in TEN patients [7\u0026ndash;9], but this study showed that men are more than women (1.74∶1.00), which is consistent with the survey results of Yang et al. [10] and Yoo et al. [11].The possible reason is that with the improvement of living standards in China, the proportion of TEN patients induced by taking uric acid-lowering drugs due to high uric acid is increasing. Men had a higher risk of hyperuricemia.\u003c/p\u003e\u003cp\u003eWith the increasing number of patients with hyperuricemia, allopurinol has been widely used. It has been suggested that allopurinol should be regarded as the most common drug associated with the development of SJS/TEN[12]. A meta-analysis showed that the main pathogenic drugs of TEN were antibiotics (25.4%), anticonvulsants (22.0%) and antipyretic analgesics (18.3%) [13]. However, another international multi-center study showed that allopurinol was the most common drug inducing TEN [14], which was consistent with the results of this study. The factors leading to this difference may be living habits, dietary habits or regional differences.\u003c/p\u003e\u003cp\u003eFor patients with exfoliative dermatitis or vesicular skin lesions with progressive aggravation after a suspicious history of drug use, the diagnosis should be confirmed as soon as possible, and the relevant drugs should be discontinued[15].\u003c/p\u003e\u003cp\u003eStudies have shown that the factors affecting the mortality of TEN patients include age, SCORTEN score\u0026thinsp;\u0026gt;\u0026thinsp;3 points, \u0026gt;\u0026thinsp;5 days from onset to transfer to burn center, complicated with comorbidities and malignant tumors[16\u0026ndash;17]. Early diagnosis, early withdrawal of allergenic drugs, and early transfer to ICU or burn center are considered to effectively improve the prognosis of TEN patients [18]. In this study, the mortality rate of patients with treatment history of ICU/ burn department was higher than that of patients without treatment history of ICU/ burn department, but the difference was not statistically significant (P\u0026thinsp;\u0026gt;\u0026thinsp;0.05). The reason may be that patients with treatment history of ICU or burn department were not transferred to this department for treatment at early stage, and their condition was critical when transferred. The results of this study showed that patients with a history of treatment in ICU or burn department had a higher proportion of patients complicated with sepsis (χ2\u0026thinsp;=\u0026thinsp;4.896, P\u0026thinsp;=\u0026thinsp;0.027\u0026thinsp;\u0026lt;\u0026thinsp;0.05), which may also be caused by the above reasons, or patients were considered to transfer to other departments after they were complicated with sepsis. Therefore, early multidisciplinary cooperation to confirm the diagnosis and start active and standardized treatment as soon as possible are of great significance to the prognosis of patients [19\u0026ndash;21].\u003c/p\u003e\u003cp\u003eThe main cause of death in TEN patients was MODS caused by sepsis. In this study, 100% of the dead cases were complicated with sepsis, which was significantly higher than 55.81% of the survival group (χ2\u0026thinsp;=\u0026thinsp;6.266, P\u0026thinsp;=\u0026thinsp;0.018). Therefore, in order to reduce the mortality of patients, we should prevent the occurrence of sepsis as much as possible.\u003c/p\u003e\u003cp\u003eThe SCORTEN score is a good indicator to evaluate the severity of SJS/TEN and predict the mortality (the predicted mortality of 0\u0026ndash;1 score is 3.2%, the predicted mortality of 2 score is 12.1%, the predicted mortality of 3 score is 32.3%, the predicted mortality of 4 score is 58.3%, and the predicted mortality of more than 5 score is 90%) [22]. Univariate analysis of this study showed that combined comorbidities, SCORTEN score\u0026thinsp;\u0026gt;\u0026thinsp;3 points, and admission to ICU or burn department may be the influencing factors of sepsis in TEN patients. Multivariate logistic regression analysis showed that none of the three factors was the independent risk factor affecting sepsis in TEN patients. In order to reduce the incidence of sepsis, the risk factors that may affect the complication of sepsis should be controlled, that is, the patients should be scored in the early stage. For patients with comorbidities, SCORTEN score\u0026thinsp;\u0026gt;\u0026thinsp;3 points, and those admitted to ICU or burn department, we should intervene as soon as possible, focusing on preventing sepsis to improve the prognosis.\u003c/p\u003e\u003cp\u003eUnivariate analysis showed that age and SCORTEN score may be the factors affecting the death of TEN patients, and multivariate logistic regression analysis showed that SCORTEN score was an independent risk factor affecting the death of TEN patients. Therefore, patients with age\u0026thinsp;\u0026ge;\u0026thinsp;60 years and higher SCORTEN score should be treated as early as possible and comprehensively to reduce the mortality. However, there were no statistically significant differences in gender, lesion area, combined comorbidities, positive blood microbial culture, use of IVIG and hormone, and whether they were admitted to ICU or burn department after death between the death group and the survival group (P\u0026thinsp;\u0026gt;\u0026thinsp;0.05). The possible reason was that this study was a single-center study with small number of cases and there was sampling bias. The study had other limitations. For example, there were 5 patients who were discharged automatically, among whom there may have been dead cases and were not included in the death group. The lesion area was estimated. The long time span of the cases and the many confounding factors may have a certain impact on the results.\u003c/p\u003e\u003cp\u003eThe main treatments for TEN include supportive therapy and systemic therapy. Supportive treatment is the key to TEN patient[23], including the wound care, protection of organ function, prevention and treatment of infection, and treatment of comorbidities. If necessary, alternative treatments such as plasma exchange, hemodialysis, and extracorporeal membrane oxygenation are needed. The skin lesions of TEN are similar to uniform superficial partial thickness burns[24], which usually do not require surgical treatment. The wounds are generally self-healing after regular debridement and dressing change to keep them clean[25]. Other antibacterial dressings or biological dressings can also be appropriately applied[26\u0026ndash;27]. Surgical debridement is only applicable to patients with skin infection and necrosis or deepened wounds[28]. Progressive increase in surface lesion area often indicates disease progression. In this study, there was no clear correlation between wound area and prognosis, which was consistent with the results of McCullough et al.[25]. However, fluid loss should be considered, the balance of water and electrolyte should be actively corrected, and wound infection should be prevented. In this study, 88.89% of the blood microbial cultures of sepsis patients were resistant bacteria, and 66.67% were Gram-positive bacteria. Therefore, antibiotics against drug-resistant Gram-positive bacteria should be used during empirical anti-infection treatment. ICU can provide effective life support and organ protection strategies for patients, while burn centers can not only provide active wound treatment, but also provide important guarantee for the comprehensive prevention and treatment of sepsis. This may be one of the important reasons why many scholars and guidelines recommend to transfer to ICU or burn department for specialized treatment as soon as possible[14, 29]. The drugs for systemic treatment include CS, IVIG, cyclosporine A, etanercept, thalidomide and adalimumab[30]. Among them, CS and IVIG are the most widely used. Different scholars have different views on the systemic treatment of TEN. Because the disease is a delayed hypersensitivity reaction, CS has a strong anti-allergic effect, and IVIG can block the death receptor pathway and prevent the apoptosis of killer cells [31], so most scholars recommend CS combined with IVIG treatment[29, 32\u0026ndash;33]. Due to the low incidence and severe condition of TEN, it is impossible to conduct prospective randomized controlled studies with large samples, and there is no evidence-based evidence that the use of CS and IVIG can improve the prognosis[34\u0026ndash;36]. Therefore, systemic therapy should only be administered, if progression of the erythema has occurred in the last 24 hours[29]. This study showed that there was no significant correlation between the use of IVIG or CS and the prognosis of TEN patients (P\u0026thinsp;\u0026gt;\u0026thinsp;0.05), which was consistent with the results of most studies[14, 29]. However, this study was not a randomized controlled study, and the sample size was small, so it cannot be concluded that patients did not benefit from the use of CS or IVIG.\u003c/p\u003e"},{"header":"5. Conclusions","content":"\u003cp\u003eTEN has a low incidence but a high mortality rate and is easy to be misdiagnosed in the early stage, which should be paid attention to by clinicians. For high frequency pathogenic drugs, clinical use should be cautious, and the presence of related susceptibility genes should be detected to reduce the risk of disease. Sepsis is the main cause of death in TEN patients. In order to improve the survival rate of patients, we should focus on the prevention and treatment of sepsis. The patients should be transferred to qualified treatment departments such as ICU and burn center in time, so that the wound can be treated and the primary disease and its related complications can be treated at the same time. The drug treatment of TEN still needs more randomized controlled trials with more samples to provide a reliable \u0026quot;standard\u0026quot; scheme for clinical treatment.\u003c/p\u003e"},{"header":"Declarations","content":"\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eHu: Writing- Original draft preparation. Ma: Data curation. Bian: Conceptualization, Methodology .Luo: Visualization, Investigation.Chu: Software, Validation.Liu: Writing- Reviewing and Editing, Lai: Supervision.All authors reviewed the manuscript.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eHasegawa A, Abe R. Stevens-Johnson syndrome and toxic epidermal necrolysis: Updates in pathophysiology and management. Chin Med J (Engl). 2024;137(19):2294-2307. doi: 10.1097/CM9.0000000000003250. \u003c/li\u003e\n\u003cli\u003eBreidung D, Delavari S, Megas IF, Geierlehner A, Hitzl W, Bodenschatz KJ, et al. 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Toxic epidermal necrolysis - clinicopathological aspects and therapeutic management. Rom J Morphol Embryol. 2024,65(4):765-773. doi: 10.47162/RJME.65.4.23. \u003c/li\u003e\n\u003cli\u003eSunaga Y, Kurosawa M, Ochiai H, Watanabe H, Sueki H, Azukizawa H, et al. The nationwide epidemiological survey of Stevens-Johnson syndrome and toxic epidermal necrolysis in Japan, 2016-2018. J Dermatol Sci. 2020;100(3):175-182. doi: 10.1016/j.jdermsci.2020.09.009. \u003c/li\u003e\n\u003cli\u003eSunaga, Y, Kurosawa, M, Ochiai, H, et al. The nationwide epidemiological survey of Stevens-Johnson syndrome and toxic epidermal necrolysis in Japan, 2016-2018. J DERMATOL SCI. 2020; 100 J DERMATOL SCI. doi: 10.1016/j.jdermsci.2020.09.009.\u003c/li\u003e\n\u003cli\u003eFakoya AOJ, Omenyi P, Anthony P, Anthony F, Etti P, Otohinoyi DA, et al. Stevens - Johnson Syndrome and Toxic Epidermal Necrolysis; Extensive Review of Reports of Drug-Induced Etiologies, and Possible Therapeutic Modalities. Open Access Maced J Med Sci. 2018;6(4):730-738. doi: 10.3889/oamjms.2018.148. \u003c/li\u003e\n\u003cli\u003eFakoya AOJ, Omenyi P, Anthony P, et al. Stevens - Johnson Syndrome and Toxic Epidermal Necrolysis; Extensive Review of Reports of Drug-Induced Etiologies, and Possible Therapeutic Modalities[J]. Open Access Maced J Med Sci, 2018,6(4):730-738.DOI:10.3889/oamjms.2018.148.\u003c/li\u003e\n\u003cli\u003eArantes LB, Reis CS, Novaes AG, Carvalho MR, G\u0026ouml;ttems LBD, Novaes MRCG. Stevens-Johnson syndrome and toxic epidermal necrolysis: epidemiological and clinical outcomes analysis in public hospitals. An Bras Dermatol. 2017;92(5):661-667. doi: 10.1590/abd1806-4841.20176610. \u003c/li\u003e\n\u003cli\u003eSekula P, Dunant A, Mockenhaupt M, Naldi L, Bouwes Bavinck JN, Halevy S, et al. Comprehensive survival analysis of a cohort of patients with Stevens-Johnson syndrome and toxic epidermal necrolysis. 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Allopurinol: Clinical Considerations in the Development and Treatment of Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, and Other Associated Drug Reactions. Cureus. 2024;16(7):e64654. doi: 10.7759/cureus.64654. \u003c/li\u003e\n\u003cli\u003eDeng Q, Fang X, Zeng Q, Lu J, Jing C, Huang J. Severe cutaneous adverse drug reactions of Chinese inpatients: a meta-analysis. An Bras Dermatol. 2017;92(3):345-349. doi: 10.1590/abd1806-4841.20175171. \u003c/li\u003e\n\u003cli\u003eSchwartz RA, McDonough PH, Lee BW. Toxic epidermal necrolysis: Part II. Prognosis, sequelae, diagnosis,differential diagnosis,prevention,and treatment[J].J Am Acad Dermatol. 2013; 69(2):187.e1-204. doi: 10.1016/j.jaad.2013.05.002.\u003c/li\u003e\n\u003cli\u003eAbulatan IT, Ben-David SG, Morales-Colon LA, Beason E, Fakoya AO. A Compilation of Drug Etiologies of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis. Cureus. 2023;15(11):e48728. doi: 10.7759/cureus.48728. \u003c/li\u003e\n\u003cli\u003eLerch M, Mainetti C, Terziroli Beretta-Piccoli B, Harr T. Current Perspectives on Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis. Clin Rev Allergy Immunol. 2018;54(1):147-176. doi: 10.1007/s12016-017-8654-z. \u003c/li\u003e\n\u003cli\u003eSchwartz RA, McDonough PH, Lee BW. Toxic epidermal necrolysis: Part II. Prognosis, sequelae, diagnosis,differential diagnosis,prevention,and treatment[J].J Am Acad Dermatol. 2013; 69(2):187.e1-204. doi:10.1016/j.jaad.2013.05.002.\u003c/li\u003e\n\u003cli\u003eCartotto R. Burn Center Care of Patients with Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis[J].Clin Plast Surg, 2017; 44(3):583-595. doi:10.1016/j.cps.2017.02.016.\u003c/li\u003e\n\u003cli\u003eCharlton OA, Harris V, Phan K, Mewton E, Jackson C, Cooper A. Toxic Epidermal Necrolysis and Steven-Johnson Syndrome: A Comprehensive Review. Adv Wound Care (New Rochelle). 2020;9(7):426-439. doi: 10.1089/wound.2019.0977. \u003c/li\u003e\n\u003cli\u003eWhite KD, Abe R, Ardern-Jones M, Beachkofsky T, Bouchard C, Carleton B, et al. SJS/TEN 2017: Building Multidisciplinary Networks to Drive Science and Translation. J Allergy Clin Immunol Pract. 2018;6(1):38-69. doi: 10.1016/j.jaip.2017.11.023. \u003c/li\u003e\n\u003cli\u003eSurowiecka A, Barańska-Rybak W, Strużyna J. Multidisciplinary Treatment in Toxic Epidermal Necrolysis. Int J Environ Res Public Health. 2023 Jan 26;20(3):2217. doi: 10.3390/ijerph20032217. \u003c/li\u003e\n\u003cli\u003eBastuji-Garin S, Fouchard N, Bertocchi M, Roujeau JC, Revuz J, Wolkenstein P. SCORTEN: a severity-of-illness score for toxic epidermal necrolysis. J Invest Dermatol. 2000;115(2):149-53. doi: 10.1046/j.1523-1747.\u003c/li\u003e\n\u003cli\u003eSchneider JA, Cohen PR. Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis: A Concise Review with a Comprehensive Summary of Therapeutic Interventions Emphasizing Supportive Measures[J]. Adv Ther, 2017,34(6):1235-1244. doi:10.1007/s12325-017-0530-y.\u003c/li\u003e\n\u003cli\u003eRahesh J, Al-Sukhni L, Griswold J. Stevens-Johnson syndrome/toxic epidermal necrolysis management in the burn intensive care unit: A case series The Chronicles. 2022; 10 (44): 40-44. doi: 10.12746/swrccc.v10i44.1023\u003c/li\u003e\n\u003cli\u003eMcCullough M, Burg M, Lin E, Peng D, Garner W. Steven Johnson Syndrome and Toxic Epidermal Necrolysis in a burn unit: A 15-year experience[J]. Burns, 2017;43(1):200-205. DOI:10.1016/j.burns.2016.07.026.\u003c/li\u003e\n\u003cli\u003eCastillo B, Vera N, ortega-Loayza AG, et al. Wound care for Stevens-Johnson syndrome and toxic epidermal necrolysis[J]. J Am Acad Dermatol, 2018;79(4):764-767.e1. DOI:10.1016/j.jaad. 2018.03.032.\u003c/li\u003e\n\u003cli\u003eRogers AD, Blackport E, Cartotto R. The use of Biobrane\u003csup\u003e\u0026reg;\u003c/sup\u003e for wound coverage in Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis[J]. Burns, 2017;43(7):1464-1472. DOI:10.1016/j.burns.2017.03.016. \u003c/li\u003e\n\u003cli\u003eEnescu CD, Elder AJ, Deirawan H, Moossavi M. To Debride or Not to Debride: A Review of Wound Management for Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis. Cureus. 2024;16(3):e55350. doi: 10.7759/cureus.55350. \u003c/li\u003e\n\u003cli\u003eHeuer R, Paulmann M, Annecke T, Behr B, Boch K, Boos AM, et al. S3 guideline: Diagnosis and treatment of epidermal necrolysis (Stevens-Johnson syndrome and toxic epidermal necrolysis) - Part 1: Diagnosis, initial management, and immunomodulating systemic therapy. J Dtsch Dermatol Ges. 2024;22(10):1448-1466. doi: 10.1111/ddg.15515. \u003c/li\u003e\n\u003cli\u003eLin M, Gong T, Ruan S, Lv X, Chen R, Su X, et al. Emerging Insights into Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Induced by Immune Checkpoint Inhibitor and Tumor-Targeted Therapy. J Inflamm Res. 2024;17:2337-2351. doi: 10.2147/JIR.S454673. \u003c/li\u003e\n\u003cli\u003eBarron SJ, Del Vecchio MT, Aronoff SC. Intravenous immunoglobulin in the treatment of Stevens-Johnson syndrome and toxic epidermal necrolysis: a meta-analysis with meta-regression of observational studies[J]. Int J Dermatol, 2015;54(1):108-115.\u003c/li\u003e\n\u003cli\u003eYang L, Shou YH, Li F, Zhu XH, Yang YS, Xu JH. Intravenous Immunoglobulin Combined With Corticosteroids for the Treatment of Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis: A Propensity-Matched Retrospective Study in China. Front Pharmacol. 2022;12:750173. doi: 10.3389/fphar.2021.750173. \u003c/li\u003e\n\u003cli\u003eJagadeesan S, Sobhanakumari K, Sadanandan SM, Ravindran S, Divakaran MV, Skaria L, et al. Low dose intravenous immunoglobulins and steroids in toxic epidermal necrolysis: a prospective comparative open-labelled study of 36 cases. Indian J Dermatol Venereol Leprol. 2013;79(4):506-11. doi: 10.4103/0378-6323.113080. \u003c/li\u003e\n\u003cli\u003eLin CC, Chen CB, Wang CW, et al. Stevens-Johnson syndrome and toxic epidermal necrolysis: risk factors, causality assessment and potential prevention strategies[J]. Expert Rev Clin Immunol, 2020;16(4) : 373-387. doi: 10.1080/1744666X.2020.1740591.\u003c/li\u003e\n\u003cli\u003eZimmermann S, Sekula P, Venhoff M, Motschall E, Knaus J, Schumacher M, et al. Systemic Immunomodulating Therapies for Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis: A Systematic Review and Meta-analysis. JAMA Dermatol. 2017;153(6):514-522. doi: 10.1001/jamadermatol.2016.5668. \u003c/li\u003e\n\u003cli\u003eMarchitto MC, Sung S, Doong J, Chien AL. Toxic epidermal necrolysis: a review of 20 years of data. J Eur Acad Dermatol Venereol. 2018;32(7):e263-e264. doi: 10.1111/jdv.14786.\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTables 1 to 5 are available in the Supplementary Files section.\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Epidermal necrolysis, toxic, Sepsis, Prognosis, Related factor","lastPublishedDoi":"10.21203/rs.3.rs-7263673/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7263673/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e\u003cp\u003eToxic epidermal necrolysis (TEN) and Stevens\u0026ndash;Johnson syndrome (SJS) are rare, acute, predominantly drug-induced, life-threatening type IV hypersensitivity reaction characterized by severe skin and mucosae involvement.\u003c/p\u003e\u003ch2\u003eObjective\u003c/h2\u003e\u003cp\u003eTo investigate the clinical features and explore the prognostic factors of TEN.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e\u003cp\u003eA retrospective study was conducted to select 52 TEN patients who met the inclusion criteria and were admitted to Guangdong Provincial People's Hospital from January 2008 to January 2024. The data of gender, age, admission diagnosis, department category, history of ICU or burn department treatment, cause of death, suspected allergens, comorbidities, and SCORTEN were collected. Data were statistically analyzed with chi-square test, Fisher's exact probability test, and Mann-Whitney U test. The risk factors affecting the prognosis of TEN patients were screened.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e\u003cp\u003eThere were 33 males(63.46%) and 19 females(36.54%), aged from 8 months to 92 years. There were 11 cases (21.15%) of epidermolysis bullosa, 10 cases (19.23%) of exfoliative dermatitis, 12 cases (23.08%) of TEN, 7 cases (13.46%) of epidermolysis bullosa, 7 cases (13.46%) of Stevens-Johnson syndrome, and 5 cases (9.62%) of severe drug eruption diagnosed on admission. The patients were admitted to 11 departments, and the mortality rate of patients with treatment history in ICU or burn department was similar to that of patients without such department treatment history (P\u0026thinsp;\u0026gt;\u0026thinsp;0.05). All the dead patients were complicated with sepsis. The suspected pathogens of TEN patients were allopurinol (21.15%) and antibiotics (13.46%). The proportion of patients with comorbidities and the SCORTEN of patients in sepsis group were significantly higher than those in non-sepsis group (P\u0026thinsp;\u0026lt;\u0026thinsp;0.05). The age and SCORTEN of patients in death group were significantly higher than those in survival group (P\u0026thinsp;\u0026lt;\u0026thinsp;0.05). The SCORTEN was an independent risk factor affecting the death of TEN patients (P\u0026thinsp;\u0026lt;\u0026thinsp;0.05).\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e\u003cp\u003eIt is difficult to diagnose TEN on admission. Male is the susceptible population and allopurinol is the most common causative agent. The proportion of patients with sepsis combined with comorbidities and SCORTEN were higher, the age of death patients was higher than that of survival patients, and the main cause of death was sepsis. The SCORTEN is an independent risk factor for mortality in TEN patients.\u003c/p\u003e","manuscriptTitle":"Analysis of the clinical characteristics and prognostic influencing factors of toxic epidermal necrolysis: A report of 52 cases","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-08-26 18:45:54","doi":"10.21203/rs.3.rs-7263673/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"5459698d-17e9-4545-b4fc-511cdfed5156","owner":[],"postedDate":"August 26th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-09-25T15:12:36+00:00","versionOfRecord":[],"versionCreatedAt":"2025-08-26 18:45:54","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7263673","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7263673","identity":"rs-7263673","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}