益妇宁胶囊治疗药物流产后阴道出血的多中心临床研究  

Multi-center clinical trial of Yifuning capsule in the treatment of vaginal bleeding patients after medical abortion

作　　者：连凤梅[1] 赵瑞华[2] 姜羡华[2] 艾莉[2] 王燕[2] 陈瑞雪[2] 江建南[2] 蔡玉华[2] 

机构地区：[1]中国中医科学院广安门医院药物临床试验机构办公室,北京100053 [2]中国中医科学院广安门医院,北京100053

出　　处：《中国新药杂志》2009年第20期1958-1962,共5页Chinese Journal of New Drugs

摘　　要：目的:评价益妇宁胶囊治疗药物流产后阴道出血的临床疗效和不良反应。方法:采用随机、双盲、安慰剂平行对照、多中心临床研究方法。选择药物流产后(瘀血内阻证)患者420例,试验组(n=315)口服益妇宁胶囊680mg;对照组(n=105)口服安慰剂;bid。胎囊排出即开始服药,服药疗程7d,随访至药流后第一次月经来潮。以药物流产后阴道出血时间、出血量为主要评价指标,中医证候积分及疗效、血红蛋白、下次月经情况、完全流产率为次要评价指标,评价患者的疗效。以不良事件、实验室检查等评价安全性。结果:FAS中,益妇宁胶囊组平均出血时间229.10h(9.54d),安慰剂组平均出血时间331.39h(13.81d)。PPS中,益妇宁胶囊组平均出血时间222.18h(9.26d),安慰剂组平均出血时间327.32h(13.64d)。出血时间、总出血量、中医证候疗效,两组比较,差异有统计学意义。结论:益妇宁胶囊治疗药物流产后出血(瘀血内阻证)安全、有效。[Abstract~ Objective：To evaluate the efficacy and safety of Yifuning capsule in the treatment of vaginal bleeding patients after medical abortion. Patients who had vaginal bleeding after medical abortion with blood stasis syndrome （ n = 420） were recruited in a randomized, double-blind, placebo-paralleled control, multicenter clinical trial. The patients were randomly divided into 2 groups, and received a 7-day （ twice a day） treatment of Yifuning capsules or placebo from the moment of foetal sac outing. The efficacy was evaluated 7 days after treatment by the vaginal bleeding time,vaginal bleeding loss,syndrome, Hb,the first time menstrual after medical abortion and full-abortion rate. The safety was evaluated based on the incidences of adverse events and laboratory examination. Patients were followed up until the first time of menstrual onset after medical abortion. Results ： In FAS, the mean vaginal bleeding time was 229.10 h （9.54 days） in Yifuning group,and 331.39 h （ 13.81 days） in placebo group. In PPS, the mean vaginal bleeding time was 222.18 h （9.26 days） in Yifuning group, and 327.32 h （ 13.64 days） in placebo group. The differences between two groups were significant in the vaginal bleeding time,the vaginal bleeding loss and curative effect on syndrome. Conclusion：Yifuning capsule provides an effective and safe therapeutic option for vaginal bleeding after medical abortion in patients with blood stasis syndrome.

关 键 词：药物流产 安慰剂 中医药疗法 益妇宁胶囊 

分 类 号：R271.11[医药卫生—中医妇科学]