Abstract
Background Calcium-modulated inhibitors are commonly used after allogeneic haematopoietic stem cell transplantation (allo-HSCT), and the risk factors for the development of acute graft-versus-host disease (aGVHD) may differ among immunosuppressive regimens, presenting a challenge for clinical prediction. Cyclosporine (CsA) is a frequently used immunosuppressant in the postoperative period. By investigating the clinical characteristics and risk factors of aGVHD in allo-HSCT treated with the CsA regimen, we aspire to furnish evidence-based proof for patients applying CsA after allo-HSCT.
Methods
This retrospective study based on the clinical data of patients who received allo-HSCT and used CsA in the First Affiliated Hospital of Guangxi Medical University from June 2020 to July 2023, calculated the incidence rate of aGVHD, and analyzed the risk factors of poor prognosis through logical regression. Simultaneously perform ROC curve analysis.
Results
A total of 129 subjects were enrolled in this study, among whom 19 patients developed aGVHD. The sites of aGVHD involvement were skin in 11 cases (57.9%) and intestine in 8 cases (42.1%). Univariate analysis results showed that CsA concentration on days 15 ~ 21 after transplantation, bacterial infection before transplantation, fungal infection before transplantation, and pretreatment programme were the associated factors with aGVHD. Multifactorial analysis revealed that CsA concentration on days 15~21 after transplantation (OR=0.987, 95% CI=0.978~0.997, P=0.011), CsA dose-normalized concentration on days 15 ~ 21 after transplantation (OR=1.015, 95% CI=1.001 ~ 1.029, P=0.035), bacterial infection before transplantation (OR=0.255, 95%CI=0.079 ~ 0.823, P=0.022), and pretreatment programme (OR=0.488, 95% CI=0.252 ~ 0.944, P=0.033) were independent risk factors for aGVHD. After transplantation, the ideal threshold of CsA concentration is 136.45 ng/ml.
Conclusion
This study highlights the necessity for patients undergoing allo-HSCT and receiving CsA regimens to be particularly vigilant about the pretreatment programme, the monitoring of CsA or CsA dose-normalized concentration on days 15 ~ 21 after transplantation, and to avoid bacterial infections before surgery.
Competing Interest Statement
The authors have declared no competing interest.
Funding Statement
Yes
Author Declarations
I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Not Applicable
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
This study was approved by the Ethics Committee of the First Affiliated Hospital of GuangXi Medical University(NO. 2024-E748-01), and conducted in accordance with the principles outlined in the tenets of the Declaration of Helsinki.
I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.
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I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
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