两种地诺孕素治疗子宫内膜异位症的临床疗效及不良反应对比OA北大核心CSTPCD
Comparison of clinical effectiveness and safety between generic and branded dienogest tablets in the treatment of endometriosis
目的:评价地诺孕素仿制药和原研药在治疗子宫内膜异位症中的临床疗效和安全性,为地诺孕素临床用药提供依据.方法:收集我院2022年8月至2023年8月地诺孕素治疗子宫内膜异位症的患者资料,分为两组,分别给予地诺孕素仿制药或原研药地诺孕素2 mg/d,口服,连续治疗6个月.分别在3个月和6个月对两组患者进行随访调查,比较仿制药和原研药治疗子宫内膜异位症相关疼痛的临床疗效和不良反应发生情况.结果:仿制药组和原研药组患者的盆腔相关疼痛均明显降低(P<0.05),仿制药组下降了(34.0±3.0)mm,原研药组下降了(34.5±3.9)mm.最常见的异常出血情况,仿制药组、原研药组患者的发生率分别为 93%和90%,无统计学差异.结论:地诺孕素国产仿制药和原研药在临床疗效相似,安全性一致.
AIM:To evaluate the clinical effective-ness and safety of generic and branded dienogest in the treatment of endometriosis.so as to provide the basis for clinical use of dienogest.MEHTODS:The data of patients admitted to Third Affiliated Hospital of Zhengzhou University from August 2022 to August 2023 who received dienogest(2 mg/d,orally,for 6 months)for treatment of endometrio-sis were collected.The clinical efficacy and adverse reactions of generic drugs and original drugs in the treatment of endometriosis-related pain were com-pared through follow-up surveys of the two groups of patients at 3 months and 6 months respectively.RESULTS:There was highly significant reduction in pelvic pain in both groups with mean of similar in generic group(34.0±3.0)mm and branded group(34.5±3.9)mm.The most frequent drug-related ad-verse effects in generic dienogest was vaginal bleeding(93%)which was no statistical difference with branded dienogest(90%).CONCLUSION:The generic and branded dienogest have the same clini-cal effectiveness and similar safety.
刘倩;张家宁;张双;刘青蓝;张保寅;孙楠
郑州大学第三附属医院药学部,郑州 450052,河南
临床医学
地诺孕素仿制药原研药子宫内膜异位症
dienogestgeneric drugsbranded drugsendometriosis
《中国临床药理学与治疗学》 2024 (005)
527-534 / 8
河南省医学科技攻关计划(联合共建)项目(LHGJ20190402)
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