摘要
目的:评价益妇宁胶囊治疗药物流产后子宫出血的临床效果和安全性。方法:采用随机、双盲、剂量平行对照、多中心临床研究方法。选择药物流产后(瘀血内阻证)妇女240例,高剂量组(80例)口服益妇宁胶囊680mg;低剂量组(80例)口服益妇宁胶囊340mg;对照组(80例)口服安慰剂。胎囊排出即开始服药,2次/d,共7d,随访至药物流产后第1次月经来潮。以药物流产后出血时间、出血量为主要评价指标,以中医证候积分、血红蛋白、凝血3项、下次月经情况、完全流产率为次要评价指标,评价益妇宁胶囊疗效;以不良事件、实验室检查等评价其安全性。结果:全数据集中,益妇宁胶囊高剂量组平均出血时间216.68h(9.03d),低剂量组平均出血时间267.09h(11.13d),对照组平均出血时间355.76h(14.82d)。符合方案集中,高剂量组平均出血时间215.08h(8.96d),低剂量组平均出血时间262.43h(10.93d),对照组平均出血时间340.32h(14.18d)。出血时间、出血量、中医证候,3组比较差异具有统计学意义(P<0.01)。结论:益妇宁胶囊治疗药物流产后子宫出血(瘀血内阻证)安全、有效,高剂量组疗效优于低剂量组。
Objective ： To evaluate the effects and safety of Yifuning capsule on the treatment of uterine bleeding after medical abortion. Methods ： Randomized, double - blind, paralleled - dose control, and multi - center clinical trial method was adopted. 240 cases with uterine bleeding after medical abortion （blood stasis syndrome） were recruited and divided into 3 groups, the high - dose group （80 cases, with oral Yifuning capsule 680 mg）, low - dose group （80 cases, with oral Yifuning capsule 340 mg） and the control group （80 cases, with oral placebo）. All cases were administered Yffuning for 7 days after fetal sac discharge, and the follow- up survey was operated until the first menstrual onset after medical abortion. The effects of Yifuning were evaluated by the main evaluation indexes （the time and volume of uterine bleeding after medical abortion）, and the secondary evaluation indexes （ the integral of traditional Chinese medicine syndromes, effects, hemoglobin, three indexes of coagulation, next menstrual situation, and the complete abortion rate）. The safety of Yifuning was evaluated by the incidences of adverse events and laboratory examination. Results： The FAS showed that the mean times of uterine bleeding were 216.68h （9.03d） in 680mg Yifuning group, 267.09h （11.13d） in 340mg Yifuninggroup, and 355.76h （14.82d） in the placebo group, respectively. And in PPS, the mean times of uterine bleeding were 215.08h （8.96d） in 680mg Yifuning group, 262.43h （10.93d） in 340mg Yifuning group, and 340.32h （14.18d） in the placebo group, respectively. The differences of uterine bleeding time, bleeding volume, and traditional Chinese medicine syndromes in the 3 groups were statistically significant （P 〈 0.01 ）. Conclusion： Yifuning capsule provides an effective and safe therapeutic option for uterine bleeding after medical abortion （blood stasis syndrome）, and the effects of 680mg are better than 340mg.
出处
《中国计划生育学杂志》
北大核心
2009年第9期551-554,共4页
Chinese Journal of Family Planning
关键词
药物流产
安慰剂
中医药疗法
益妇宁胶囊
Medical abortion
Placebo
Traditional Chinese medication
Yifuning capsule
