地屈孕酮治疗痛经有效性及安全性的前瞻性、随机对照、开放标签、多中心临床研究  

Effectiveness and safety of dydrogesterone in the treatment of dysmenorrhea:a prospective,randomcontrolled,open-label and multicenter clinical study

作　　者：李碧钦 张颖[1] 周祖妹 金文艳 李荔[1] 周嘉禾 张小伟 许秋仪 池瑞招 李金艳 马娟 LI Biqin;ZHANG Ying;ZHOU Zumei;JIN Wenyan;LI Li;ZHOU Jiahe;ZHANG Xiaowei;XU Qiuyi;CHI Ruizhao;LI Jinyan;MA Juan(Dept.of Gynaecology,Guangdong Maternal and Child Health Hospital Affiliated to Guangzhou Medical University,Guangzhou 511442,China;Dept.of Gynaecology,Shenzhen Longgang District Seventh People’s Hospital,Guangdong Shenzhen 518114,China;Dept.of Gynaecology,Shenzhen Longgang District Second People’s Hospital,Guangdong Shenzhen 518112,China;Dept.of Gynaecology,Yangjiang Maternal and Child Health Hospital,Guangdong Yangjiang 529599,China)

机构地区：[1]广州医科大学附属广东省妇幼保健院妇科,广州511442 [2]深圳市龙岗区第七人民医院妇科,广东深圳518114 [3]深圳市龙岗区第二人民医院妇科,广东深圳518112 [4]阳江市妇幼保健院妇科,广东阳江529599

出　　处：《中国药房》2022年第3期344-351,共8页China Pharmacy

基　　金：广东省基础与应用研究基金自然科学基金项目(No.2021A1515010763);广东省中医药局科研项目(重点项目)(No.20184005);广州市科学研究计划项目(No.2060404)。

摘　　要：目的评估地屈孕酮治疗痛经的有效性及安全性。方法采用前瞻性、随机对照、开放标签、多中心临床研究。108例痛经患者按1∶1比例随机分配到地屈孕酮组和对照组,每组54例。地屈孕酮组于月经周期第5~25天,口服地屈孕酮10 mg,每天2次,治疗3个月经周期。对照组于月经干净开始持续至下次月经第3天,口服桂枝茯苓胶囊0.93 g,每天3次,治疗3个月经周期。主要研究结果为治疗3个月经周期后两组视觉模拟评分量表(VAS)评分的变化,次要研究结果为治疗3个月经周期后COX痛经症状评分(CMSS)、生活质量健康调查简表(SF-36)评分和糖类抗原125(CA125)、白细胞介素6(IL-6)水平的变化,其他研究结果包括额外获益和药物安全性。结果意向性分析与遵循研究方案分析数据集结果均显示,两组治疗痛经1、2、3个月经周期后的VAS评分均较治疗前下降,治疗时间越长VAS评分下降越明显(P<0.05),且地屈孕酮组VAS评分下降优于对照组(P<0.05)。治疗3个月经周期后,两组患者CMSS的严重程度、持续时间评分均较治疗前显著下降(P<0.05),且地屈孕酮组CMSS的严重程度、持续时间评分下降优于对照组(P<0.05)。治疗3个月经周期后,生活质量SF-36量表的8个维度中,地屈孕酮组在生理机能、生理职能、躯体疼痛、情感职能、社会功能、一般健康状况、精力7个维度的评分较治疗前显著升高(P<0.05),且躯体疼痛、社会功能、一般健康状况、精力4个维度评分升高优于对照组(P<0.05)。两组CA125、IL-6水平治疗前后差异均无统计学意义(P>0.05)。治疗3个月经周期后,地屈孕酮组月经周期、经期较治疗前缩短,经量显著下降(P<0.05),对照组上述指标则无明显改变(P>0.05)。治疗3个月经周期后,地屈孕酮组药物不良事件和不良反应发生率分别为32.69%(17/52)、28.85%(15/52),两组均未发生血栓等严重药物不良事件或不良反应。结论地屈孕�OBJECTIVE To evaluate the efficacy and safety of dydrogesterone in the treatment of dysmenorrhea.METHODS The prospective, random-controlled, open-label and multicenter clinical study was adopted. A total of 108 women with dysmenorrhea were randomly assigned into dydrogesterone group and control group according to the ratio of 1 ∶ 1,with 54 patients in each group. Dydrogesterone group was treated with dydrogesterone 10 mg orally,twice a day,on the5 th-25 th day of menstrual cycle,for 3 menstrual cycles. Control group received Guizhi fuling capsule 0.93 g orally,three times a day,since the end of menstrual bleeding to the third day of the next menstruation,for 3 menstrual cycles. Main results were the changes of visual analogue scale(VAS)scores in 2 groups after 3 menstrual cycles;secondary results were the changes of COX menstrual symptom scale(CMSS),quality life of 36-item short form(SF-36),levels of carbohydrate antigen 125(CA125)and interleukin 6(IL-6)after 3 menstrual cycles;other findings included additional benefits and drug safety. RESULTS The results of intention to analysis data set and the follow-up study protocol analysis data set showed that VAS scores of 2 groups after treatment of dysmenorrhea for 1,2 and 3 menstrual cycles were lower than those before treatment,the longer the treatment time,the more obvious the decrease of VAS score(P<0.05),and VAS score decline of dydrogesterone group was better than that of control group(P<0.05). After 3 menstrual cycles,both the two group showed significant reduction in the severity and duration scores of CMSS(P<0.05);and the decrease of the above scores in the dydrogesterone group was superior than in the control group(P<0.05). After 3 menstrual cycles,among 8 dimensions of SF-36 scale,the scores of 7 dimensions in dydrogesterone group were significantly higher than those before treatment, such as the scores of physiological function, physical role, physical pain,emotional function,social function,general health status and energy(P<0.05);the increase of the sc

关 键 词：地屈孕酮 痛经 有效性 安全性 视觉模拟评分 COX痛经症状评分 

分 类 号：R711[医药卫生—妇产科学] R979.9[医药卫生—临床医学]