系统评价宫血宁胶囊治疗药物流产后异常阴道出血的疗效和安全性。CNKI,万方,SinoMed,VIP,PubMed,检索CochraneLibrary和EMBase数据库,全面收集从数据库建立到2020年10月10日,宫血宁胶囊治疗药物流产后异常阴道出血的临床随机对照试验(RCT)。文学筛选,根据纳入和排除标准,由两名系统审评员独立进行数据提取和质量评价.使用Cochrane手册偏差风险评估工具进行文献方法论质量评估,采用RevMan5.3软件进行Meta分析,并通过证据质量分级系统(GRADE)评估结果的证据质量。共包括16个RCT。Meta分析结果显示,与单纯西药治疗相比,西药治疗中加用宫血宁胶囊可减少阴道出血量(RR=1.23,95CI[1.19,1.27],P<0.00001),缩短阴道出血时间(RR_(≤15d人数)=1.39,95CI[1.31,1.48],P&lt;0.00001;MD_(天数)=-1.20,95CI[-1.66,-0.74],P<0.00001)。然而,流产效果无明显优势(RR=1.02,95CI[0.99,1.06],P=0.14)和月经恢复(MD=-0.35,95CI[-0.96,0.25],P=0.25)。GRADE结果显示,阴道出血量和阴道出血时间的分级水平较低,流产效果和男性康复极低。在安全方面,16项研究报告了不良事件。只有一项研究显示无不良事件,其余研究显示一过性恶心,呕吐,胃灼热,上腹部不适等胃肠道症状。结果表明,在西药治疗药物流产的同时加用宫血宁胶囊可减少阴道出血量,缩短阴道出血时间,但流产效果和月经恢复没有明显优势。使用功血宁胶囊有助于达到不良反应少、安全性高的目的。由于纳入研究样本量小,方法学质量问题多,无法得出具有临床指导价值的结论。大样本,高质量的随机对照试验仍需要进一步验证.
To systematically evaluate the efficacy and safety of Gongxuening Capsules in the treatment of abnormal vaginal bleeding after medical abortion. CNKI, Wanfang, SinoMed, VIP, PubMed, Cochrane Library and EMbase databases were retrieved to comprehensively collect the clinical randomized controlled trials(RCTs) of Gongxuening Capsules for treatment of abnormal vaginal bleeding after medical abortion from the establishment of the databases to October 10, 2020. Literature screening, data extraction and quality evaluation were conducted independently by two system reviewers according to the inclusion and exclusion criteria. Cochrane Handbook bias risk assessment tool was used for the literature methodology quality evaluation, RevMan 5.3 software was used for Meta-analysis, and the evidence quality of outcomes was evaluated by the evidence quality grading system(GRADE). A total of 16 RCTs were inclu-ded. The results of Meta-analysis showed that as compared with the western medicine treatment alone, the addition of Gongxuening Capsules to the western medicine treatment can reduce the amount of vaginal bleeding(RR=1.23, 95%CI[1.19, 1.27], P<0.000 01), shorten vaginal bleeding time(RR_(≤15 d number of people)=1.39, 95%CI[1.31, 1.48], P<0.000 01; MD_(number ofdays)=-1.20, 95%CI[-1.66,-0.74],P<0.000 01). However, there was no obvious advantage in abortion effect(RR=1.02, 95%CI[0.99, 1.06], P=0.14) and menstrual recovery(MD=-0.35, 95%CI[-0.96, 0.25], P=0.25). The results of GRADE showed that the grading level was low for vaginal bleeding volume and vaginal bleeding time, and extremely low for abortion effect and mens-trual recovery. In terms of safety, 16 studies reported adverse events. Only one study showed no adverse events and the rest showed transient nausea, vomiting, stomach burning, upper abdominal discomfort and other gastrointestinal symptoms. The results show that the addition of Gongxuening Capsules to the application of western medicine in treatment of drug abortion can reduce the amount of vaginal bleeding and shorten vaginal bleeding time, but the abortion effect and menstrual recovery have no obvious advantages. The use of Gongxuening Capsules helps to achieve less adverse reactions and higher safety. Due to the small sample size of the included studies and many methodological quality problems, no conclusions with clinical guidance value can be obtained. Large sample-zise, high-qua-lity randomized controlled trials are still needed for further verification.