宫血宁胶囊治疗药物流产后阴道异常出血疗效和安全性的系统评价与Meta分析  

Systematic review and Meta-analysis on efficacy and safety of Gongxuening Capsules in treatment of abnormal vaginal bleeding after medical abortion

作　　者：牛柏寒 张明妍[1,2] 张婷 蔡慧姿[1,2] 李凯 王辉 NIU Bo-han;ZHANG Ming-yan;ZHANG Ting;CAI Hui-zi;LI Kai;WANG Hui(Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China;Evidence-based Medicine Center,Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China)

机构地区：[1]天津中医药大学,天津301617 [2]天津中医药大学循证医学中心,天津301617

出　　处：《中国中药杂志》2021年第15期3990-3997,共8页China Journal of Chinese Materia Medica

基　　金：国家自然科学基金青年基金项目(81904056)。

摘　　要：系统评价宫血宁胶囊治疗药物流产后阴道异常出血的疗效及安全性。计算机检索中国知网(CNKI)、万方(Wanfang)、中国生物医学文献服务系统(SinoMed)、维普(VIP)、PubMed、Cochrane Library和EMbase数据库,全面收集宫血宁胶囊治疗药物流产后阴道异常出血的临床随机对照试验(randomized controlled trial,RCT),检索时限为建库至2020年10月10日。由2名系统评价员按照纳入与排除标准独立进行文献筛选、资料提取和质量评价,文献方法学质量评价采用Cochrane Handbook偏倚风险评估工具,采用RevMan 5.3软件进行Meta分析并用证据质量分级系统GRADE评价结局指标证据质量,共纳入16个RCTs。Meta分析结果显示,与单纯西药治疗相比,在常规西药治疗基础上加用宫血宁胶囊,可以减少阴道出血量(RR=1.23,95%CI[1.19,1.27],P<0.000 01),缩短阴道出血时间(RR≤15 d人数=1.39,95%CI[1.31,1.48],P<0.000 01;MD天数=-1.20,95%CI[-1.66,-0.74],P<0.000 01),但流产效果(RR=1.02,95%CI[0.99,1.06],P=0.14)及月经恢复情况(MD=-0.35,95%CI[-0.96,0.25],P=0.25)无明显优势。GRADE证据分级结果显示,阴道出血量、阴道出血时间等级为低级,流产效果、月经恢复情况等级为极低级。安全性方面,16项研究报告不良事件,其中1项研究无不良事件的发生,其余研究均为一过性恶心、呕吐、胃部烧灼感、上腹部不适等胃肠道症状。结果表明,在应用常规西药治疗药物流产的基础上加用宫血宁胶囊,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情况无明显优势。使用宫血宁胶囊,发生不良反应低,具有一定安全性。但由于纳入研究样本量少,且存在较多方法学质量问题,还不能得到有临床指导价值的结论,需要开展大样本、高质量随机对照试验进一步证实。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;MDnumber 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 shorte

关 键 词：宫血宁胶囊 药物流产 阴道出血 随机对照试验 系统评价 META分析 

分 类 号：R714.461[医药卫生—妇产科学]