目的:评价桂枝茯苓胶囊改善药物流产效果的有效性。方法:计算机检索CBM(1979—2013)、CNKI(1979—2013)、VIP(1989—2013)和WF(1998—2013)。辅以手工检索天津中医药大学图书馆过刊资料库。收集桂枝茯苓胶囊对照空白组或安慰剂干预药物流产的临床随机对照试验,由两名评价者独立提取资料并按照Cochrane Review Handbook5.1进行质量评估。统计学分析采用RevMan5.1.4软件。结果:共纳入21篇临床随机对照试验,共有4502例。Meta分析结果显示:1阴道出血时间(天):[WMD=-5.29,95%CI(-6.66,-3.91)],P〈0.00001有差别。2完全流产率:[RR=1.10,95%CI(1.06,1.14)],P〈0.00001,有差别。3阴道出血量正常率(≤月经量):[RR=1.26,95%CI(1.12,1.41)],P〈0.0001,有差别。4阴道出血时间正常率(≤7 d):[RR=2.18,95%CI(1.76,2.71)],P〈0.00001,有差别。结论:桂枝茯苓胶囊能够改善药物流产的效果,如缩短出血时间、减少出血量、提高完全流产率等。希望有更高质量,方法学更加完备的多中心大样本的随机对照试验来进一步验证本方在改善药物流产效果的干预作用。
Objective:To assess the improvement of Guizhi Fuling Capsule in medical abortion. Methods: Randomized controlled trials (RCTs) involving Guizhi Fuling Capsule versus placebo or blank control group in medical abortion were identified from CBM ( 1978 to 2013 ), VIP ( 1989 to 2013 ), WANFANG Database ( 1998 to 2013 ), CNKI ( 1979 to 2013 ). We also searched relevant journals from Tianjin University of TCM. Data was extracted and evaluated by two reviewers independently with a specially designed extraction form. The Cochrane Collaboration's RevManS. 1.4 software was used for data analyses. Results : A total of 21 trials involving 4502 patients were included. Meta - analyses showed that the time of Vaginal bleeding(d) in the experimental group was different when compared with blank control group (WMD = -5.29,95 % CI -6. 66 to -3.91 ), P 〈 0. 00001. As for the complete abortion rate, significant difference was noted between experimental group and blank control group ( RR = 1.10,95% CI 1.06 to 1.14), P 〈0. 00001. Also in the normal vaginal bleeding rate ( ≤ menstrual flow), significant difference was noted ( RR = 1. 26,95% CI 1.12 to 1.41 ) ,P 〈0. 00001. Meta - analyses showed that the vaginal bleeding time normal rate ( ≤7 d) in the experimental group was different when compared with that of blank control group (RR = 2. 18,95% CI 1.76 to 2. 71 ) ,P 〈 0. 00001. Conclusion:The profit treated by Guizhi Fuling Capsule can improve the effectiveness of medical abortion in reducing the time and the volume of vaginal bleeding and it also can reduce the proportion of curettage of uterine cavity. Further large - scale trials are required to define the role of Guizhi Fuling Capsule in the improvement of medical abortion.