宫血宁胶囊减少人工流产术后出血的有效性与安全性的多中心随机双盲研究  

A multicenter,randomized,double-blind clinical trial on the efficacy and safety of Gongxuening Capsule in reducing postoperative bleeding after induced abortion

作　　者：滕莉荣 李春颖 彭萍 赵淑萍[2] 顾向应[3] 郑晓霞[4] 江静[5] 倪亚莉[6] 王敏 汪邦兰 任琛琛[9] 单莉 林青[11] 刘欣燕 Teng Lirong;Li Chunying;Peng Ping;Zhao Shuping;Gu Xiangying;Zheng Xiaoxia;Jiang Jing;Ni Yali;Wang Min;Wang Banglan;Ren Chenchen;Shan Li;Lin Qing;Liu Xinyan(Obstetrics Center,Department of Obstetrics and Gynecology,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences,Beijing100730,China;Gynecology,Women and Children's Hospital,Qingdao University,Qingdao266034,China;Department of Gynecology and Obstetrics,Tianjin Medical University General Hospital,Tianjin300052,China;Department of Gynecology,Jinan Maternity and Child Care Hospital,Jinan250001,China;Department of Gynecology and Obstetrics,the Second Hospital of Hebei Medical University,Shijiazhuang050000,China;Reproductive Medicine Center,Gansu Provincial Maternity and Child-care Hospital,Lanzhou730050,China;Family Planning Department,Dalian Women and Children's Medical Group,Dalian116011,China;Outpatient Operating Room,Anhui Women and Children's Medical Center,Hefei230001,China;Department of Gynecology,the Third Affiliated Hospital of Zhengzhou University,Zhengzhou450052,China;Department of Gynecology,Northwest Women's and Children's Hospital,Xi'an710061,China;Department of Obstetrics and Gynecology,Beijing Friendship Hospital,Capital Medical University,Beijing100050,China)

机构地区：[1]中国医学科学院北京协和医院妇产科学系产科中心,北京100730 [2]青岛大学附属妇女儿童医院妇科,青岛266034 [3]天津医科大学总医院妇产科,天津300052 [4]济南市妇幼保健院妇科,济南250001 [5]河北医科大学第二医院妇产科,石家庄050000 [6]甘肃省妇幼保健院生殖医学中心,兰州730050 [7]大连市妇女儿童医疗中心(集团)计划生育科,大连116011 [8]安徽省妇女儿童医学中心门诊手术室,合肥230001 [9]郑州大学第三附属医院妇科,郑州450052 [10]西北妇女儿童医院妇科,西安710061 [11]首都医科大学附属北京友谊医院妇产科,北京100050

出　　处：《中华生殖与避孕杂志》2025年第1期39-44,共6页Chinese Journal of Reproduction and Contraception

基　　金：北京协和医院基金(FW-HXKT2022011800064)。

摘　　要：目的评价宫血宁胶囊在减少人工流产术后出血的有效性和安全性。方法采用多中心随机双盲研究。11家分中心于2022年5月31日至2023年3月31日期间纳入484例宫内早孕接受负压电吸人工流产术的患者,1∶1按照中心区组随机方式分配到对照组和研究组。对照组术后口服安慰剂9 d,研究组术后口服宫血宁胶囊9 d,观察比较两组术后受试者阴道出血量、阴道出血时间、子宫内膜厚度、月经复潮时间及并发症等情况。结果①研究入组受试者484例,完成研究472例。450例受试者纳入有效性分析集,对照组224例,研究组226例;468例受试者纳入安全性分析集,对照组236例,研究组232例,两组受试者一般资料具有可比性(均P>0.05)。②研究组阴道出血量为(13.30±12.14)mL,对照组阴道出血量为(19.00±17.67)mL,组间差异有统计学意义(P<0.001)。研究组出血天数小于4 d的受试者比例[29.65%(67/226)]高于对照组[19.20%(43/224),P=0.010]。③月经复潮时间、子宫内膜厚度两组间差异均无统计学意义(均P>0.05)。④研究组有3例受试者发生非疗效相关并发症,对照组有11例受试者发生,研究组非疗效相关并发症发生率[1.29%(3/232)]低于对照组[4.66%(11/236)],差异有统计学意义(P=0.033)。结论人工流产术后女性使用宫血宁胶囊治疗,可明显减少阴道出血量,且安全性良好,易为受试者接受。Objective To assess the efficacy and safety of Gongxuening Capsules in reducing post-abortion bleeding following artificial abortion.MethodsA multicenter,randomized,double-blind study was conducted.From May 31,2022 to March 31,2023,484 women who underwent vacuum aspiration abortion for early intrauterine pregnancy were enrolled in 11 centers and randomly assigned to control group and the study group at a 1∶1 ratio using a center-block randomization method.Control group were administered a placebo of Gongxuening Capsules for 9 d,while the study group received the actual Gongxuening Capsules for the same duration.The outcomes measured included vaginal bleeding volume,duration of vaginal bleeding,endometrial thickness,time to menstrual recovery,and complications.Results1)A total of 484 subjects were enrolled,and 472 completed the study.Totally 450 subjects were included in the efficacy analysis set,with 224 in control group and 226 in the study group;468 subjects were included in the safety analysis set,with 236 in control group and 232 in the study group.The baseline characteristics of the two groups were comparable(all P>0.05).2)The vaginal bleeding volume was lower in the study group[(13.30±12.14)mL]than in control group[(19.00±17.67)mL,P<0.001].The proportion of subjects in the study group with bleeding days less than 4 d[29.65%(67/226)]was higher than that in control group[19.20%(43/224),P=0.010].3)No significant differences were observed between the two groups in terms of time to menstrual recovery and endometrial thickness(all P>0.05).4)In the study group,3 subjects experienced non-therapeutic-related complications,while 11 subjects in control group.The incidence of complications was lower in the study group[1.29%(3/232)]than in control group[4.66%(11/236),P=0.033].ConclusionThe administration of Gongxuening Capsules to women following artificial abortion significantly reduced vaginal bleeding volume and was associated with good safety,with the treatment being well-tolerated by the subjects.

关 键 词：流产 人工 多中心研究 随机对照试验 宫血宁胶囊 双盲 

分 类 号：R169.42[医药卫生—公共卫生与预防医学]