摘要
目的:系统评价新生化颗粒对米非司酮联合米索前列醇用于早期妊娠药物流产的干预效果,为临床早期药物流产提供循证参考。方法:计算机检索Cochrane图书馆、PubMed、EMBase、中国知网、中国生物医学文献数据库、万方数据库和维普数据库等,收集新生化颗粒(研究组)对比空白组(对照组)干预米非司酮联合米索前列醇用于早期妊娠药物流产的随机对照试验,检索时限均为建库至2020年3月。使用Cochrane手册指南中的标准评价纳入文献的质量,同时对纳入文献采用RevMan 5.3软件进行荟萃分析(Meta分析)。结果:最终纳入15项研究,共2513例患者(研究组患者1272例,对照组患者1241例)。Meta分析结果显示,与对照组比较,研究组治疗方案可显著提高患者的完全流产率(RR=1.14,95%CI=1.11~1.18,P<0.00001)、阴道出血持续时间正常率(≤7 d)(RR=2.19,95%CI=1.34~3.56,P=0.002)和阴道出血量正常率(≤平素月经量)(RR=1.37,95%CI=1.30~1.44,P<0.00001),缩短患者的阴道出血持续时间(WMD=-4.24,95%CI=-4.48~-4.00,P<0.00001)、月经复潮时间(WMD=-3.44,95%CI=-4.22~-2.65,P<0.00001)和孕囊排出时间(WMD=-2.48,95%CI=-2.70~-2.25,P<0.00001),差异均有统计学意义。结论:新生化颗粒能有效改善米非司酮联合米索前列醇用于早期妊娠药物流产的效果,提高完全流产率,缩短阴道出血持续时间、月经复潮时间及孕囊排出时间,减少阴道出血量。未来需要质量更高、方法学更完备的多中心、大样本的随机对照试验,进一步验证新生化颗粒对早期药物流产效果的干预作用。
OBJECTIVE:To systematically evaluate the intervention effects of Xinshenghua granules on mifepristone combined with misoprostol for early medical abortion,so as to provide evidence-based reference for clinical early medical abortion.METHODS:The Cochrane Library,PubMed,EMBase,CNKI,CBM,Wanfang database and VIP database were retrieved to collect the randomized controlled trial of Xinshenghua granules(study group)and blank group(control group)on intervention of mifepristone combined with misoprostol in early medical abortion,the retrieval time was from the establishment of the database to Mar.2020.Quality of the included literature was evaluated by using the criteria in the Cochrane Handbook guidelines,while Meta-analysis was performed on the included literature by using RevMan 5.3 software.RESULTS:Totally 15 literature were collected,including 2513 patients(1272 patients in the study group and 1241 patients in the control group).Meta-analysis showed that,compared with the control group,the treatment regimen in the study group significantly increased patients’complete abortion rate(RR=1.14,95%CI=1.11-1.18,P<0.00001),the normal rate of vaginal bleeding time(≤7 d)(RR=2.19,95%CI=1.34-3.56,P=0.002)and normal rate of vaginal bleeding volume(less than or equal to normal menstrual volume)(RR=1.37,95%CI=1.30-1.44,P<0.00001),shortened the duration of vaginal bleeding(WMD=-4.24,95%CI=-4.48--4.00,P<0.00001),menstrual rehydration time(WMD=-3.44,95%CI=-4.22--2.65,P<0.00001)and the expulsion time of gestational sac(WMD=-2.48,95%CI=-2.70--2.25,P<0.00001),the differences were statistically significant.CONCLUSIONS:Xinshenghua granules can effectively improve the effect of early medical abortion of mifepristone combined with misoprostol,increase the rate of complete abortion,shorten the vaginal bleeding time,the menstrual rehydration time and the expulsion time of gestational sac,and reduce the amount of vaginal bleeding.In the future,multi-center,large-sample randomized controlled trials with higher quality and more complete methodology are needed to further verify the intervention effect of Xinshenghua granules on early medical abortion.
作者
胡霓霓
吴燕燕
秦露露
陈琳
HU Nini;WU Yanyan;QIN Lulu;CHEN Lin(Dept.of Pharmacy,Chongqing Health Center for Women and Children,Chongqing 400021,China)
出处
《中国医院用药评价与分析》
2021年第7期848-852,857,共6页
Evaluation and Analysis of Drug-use in Hospitals of China
基金
重庆市科委基金项目(No.cstc2018jscx-msybX0101)。
