[Research of gestrinone-related abnormal uterine bleeding and the intervention in the treatment: a multi-center, randomized, controlled clinical trial]

孕三烯酮使用中不规则子宫出血干预的多中心、随机、平行对照研究 Research of gestrinone-related abnormal uterine bleeding and the intervention in the treatment:a multi-center, randomized, controlled clinical trial 摘要目的：探讨孕三烯酮不同剂量服药时不规则子宫出血的发生率、影响因素及干预措施。方法采用多中心、随机、平行对照临床研究方法，选择2012年6月至2013年11月，将确诊的195例子宫内膜异位症或子宫腺肌病患者随机分为3组，各组均于月经第1～5天开始服药，2.5 mg/次。每周2次组：67例，每周给药2次，连用3个月；首月加倍组：67例，每周给药3次，连用1个月，后改为每周给药2次，连用2个月；每周3次组：61例，每周给药3次，连用3个月。观察阴道流血情况，以及雌二醇水平、肝功能和凝血功能指标等的变化，同时进行盆腔B超检查，测量子宫内膜厚度、子宫和卵巢体积；分析不规则子宫出血的影响因素。结果（1）服药3个月后，每周2次组患者不规则子宫出血的发生率为30%（20/67），首月加倍组和每周3次组分别为7%（5/67）和16%（10/61），3组比较，差异有统计学意义（P0.05）。logistic多因素回归分析显示，每周2次组不规则子宫出血的风险是首月加倍组的5倍（OR=0.211，P=0.011），用药前卵巢体积正常的患者不规则子宫出血发生率是卵巢体积增大者的3倍（OR=0.304，P=0.018）。（3）服药3个月后，仅有8%（15/195）的患者40 U/L<丙氨酸转氨酶（ALT）<100 U/L，其余患者ALT<40 U/L。3组患者的体质指数服药3个月后均有增加，分别与服药前比较，差异均有统计学意义（P0.05）。3组患者凝血功能指标均降低，但3组间各指标分别比较，差异均无统计学意义（P>0.05）。结论孕三烯酮首月剂量加倍能够显著降低不规则子宫出血发生率，无严重不良反应发生，是该药治疗子宫内膜异位症中更为优化的给药方案。临床试验注册中国临床试验注册中心，注册号ChiCTR-TRC-12002327 更多相关知识 abstractsObjective To investigate the incidence, influencing factors and intervention of gestrinone-related abnormal uterine bleeding at different dosage of gestrinone in the clinical treatment. Methods This was a multicenter, randomized, control study of 195 Chinese women with endometriosis or adenomyosis from June 2011 to November 2013. The subjects were randomized into three groups with oral administration of gestrinone, 2.5 mg dose at one time;twice a week group:67 cases with oral administration twice a week last three months;double dose first month group:67 cases with oral administration triple times a week at first month, then twice a week for two months; three times a week group: 61 cases with oral administration three times a week last three months. The improvement of the abnormal uterine bleeding, the changes in estrogen, liver function and blood coagulation were evaluated. At the same time, B-ultrasound examination evaluation were performed. Results (1) Three months later, the incidence of abnormal uterine bleeding in twice a week group was 30%(20/67), in double dose first month group and three times a week group were 7%(5/67) and 16%(10/61) respectively, there were significant difference between three groups (P<0.05). The incidence in double dose first month group was the most lower. (2) Univariate analysis showed that the dosage and ovarian size were the significant factors for abnormal uterine bleeding (OR=0.461, P=0.003; OR=0.303, P=0.016); logistic regression analysis demonstrated that the risk of abnormal uterine bleeding in double dose first month group was the lowest when compared with twice a week group and three times a week group, the risk in twice a week group was 5-fold higher than that in double dose first month group (OR=0.211,P=0.011). The incidence of abnormal uterine bleeding in participants with abnormal ovarian volume results from ovarian cyst or ovarian surgery was significantly lower than those with normal ovarian volume (OR=0.304, P=0.018). (3) After the treatment of three months, there were no significant difference in alanine transaminase level between the groups (P>0.05). The body mass index significantly increased in three group (P0.05). As for blood coagulation, there were also no significant differences between the groups (P>0.05). Conclusions Double dose of gestrinone in the first month could significantly decrease the incidence of gestrinone-related abnormal uterine bleeding. It is a more optimied dosage of gestrinone and without severe side effects. Clinical trial registration Chinese Clinical Trial Registry, registration number: ChiCTR- TRC-12002327. More相关知识 - 浏览839 - 被引15 - 下载384 相似文献 - 中文期刊 - 外文期刊 - 学位论文 - 会议论文