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宫血宁胶囊治疗药物流产后异常阴道出血疗效与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].

作者信息

Niu Bo-Han, Zhang Ming-Yan, Zhang Ting, Cai Hui-Zi, Li Kai, Wang Hui

机构信息

Tianjin University of Traditional Chinese Medicine Tianjin 301617, China Evidence-based Medicine Center,Tianjin University of Traditional Chinese Medicine Tianjin 301617, China.

出版信息

Zhongguo Zhong Yao Za Zhi. 2021 Aug;46(15):3990-3997. doi: 10.19540/j.cnki.cjcmm.20210201.502.

Abstract

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.

摘要

系统评价宫血宁胶囊治疗药物流产后阴道出血异常的有效性和安全性。检索中国知网、万方、中国生物医学文献数据库、维普、PubMed、Cochrane图书馆和EMbase数据库,全面收集自建库至2020年10月10日关于宫血宁胶囊治疗药物流产后阴道出血异常的临床随机对照试验(RCT)。由两名系统评价员根据纳入和排除标准独立进行文献筛选、数据提取和质量评价。采用Cochrane手册偏倚风险评估工具进行文献方法学质量评价,RevMan 5.3软件进行Meta分析,结局证据质量采用证据质量分级系统(GRADE)进行评价。共纳入16项RCT。Meta分析结果显示,与单纯西药治疗相比,西药治疗基础上加用宫血宁胶囊可减少阴道出血量(RR=1.23,95%CI[1.19,1.27],P<0.000 01),缩短阴道出血时间(RR(≤15天人数)=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)。然而,在流产效果(RR=1.02,95%CI[0.99,1.06],P=0.14)和月经恢复方面(MD=-0.35,95%CI[-0.96,0.25],P=0.25)无明显优势。GRADE结果显示,阴道出血量和阴道出血时间的分级水平为低,流产效果和月经恢复的分级水平为极低。在安全性方面,16项研究报告了不良事件。仅1项研究未显示不良事件,其余研究显示有短暂恶心、呕吐、胃烧灼感、上腹部不适等胃肠道症状。结果表明,西药治疗药物流产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无明显优势。使用宫血宁胶囊有助于减少不良反应,安全性较高。由于纳入研究样本量小,存在较多方法学质量问题,无法得出具有临床指导价值的结论。仍需要大样本、高质量的随机对照试验进一步验证。

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