益母草注射液安全性研究文献评价

Literature Evaluation on Safety of Yimucao Injection

目的:从既往文献报道,总结益母草注射液使用情况及不良反应特点。方法:以"益母草注射液""不良反应"或"安全性"为关键词,对中国知网(CNKI)、万方医学(Wan Fang Data)、维普(VIP)、中国生物医学文献服务(Sino Med)、Pub Med、EMbase数据库进行检索,截止发表时间为2020年1月31日。纳入所有研究设计类型,并对多中心临床研究、病例报道及随机对照临床研究进行文献计量学分析。结果:共查阅到225篇关于益母草注射液安全性研究文献。文献计量学分析22 911例使用益母草注射液的患者及ADR表现显示:年龄主要在21~44岁之间,提及妊娠时间主要为37~44周,初产妇有3 481例,经产妇2 044例,原患疾病主要为剖宫产妇产后出血、产后出血及自然分娩产妇产后出血,合并疾病主要为妊娠巨大儿、羊水异常、妊娠糖尿病等;使用的益母草注射液涉及不同产家,未具体提及编号及厂家的占大多数,单次使用剂量(mL)主要为2 mL,给药途径主要为肌内注射液、宫体和肌内注射液、宫体注射,疗程主要为2~3 d;合并用药主要为缩宫素、卡前列素氨丁三醇、米索前列醇注射液等;使用不同厂家益母草注射均发生ADR的表现为:面部潮红、恶心呕吐等。结论:临床上使用益母草注射液相对安全,其不良反应多为轻度。

Objective:The usage and adverse reaction characteristics of Yimucao Injection were summarized from previous literature and research. Methods:CNKI, Wan Fang Data, VIP, SinoMed, PubMed and EMbase databases were searched. The deadline for publication was January 31 st, 2020. All study design types were included, and multicenter clinical studies, case reports and randomized controlled clinical studies were analyzed by bibliometrics. Results:A total of 225 literature on the safety of Yimucao Injection were reviewed. Bibliometric analysis of 22 911 patients using Yimucao Injection and ADR showed: the age were mainly from 21 to 44, the time of pregnancy was mainly from 37 to 44 weeks, and there were 3 481 cases of primipara and 2 044 cases of transpara;the main diseases of the patients were postpartum hemorrhage in caesarean section, postpartum hemorrhage and natural postpartum hemorrhage, and the main combined diseases were large gestational children, abnormal amniotic fluid, and gestational diabetes etc;the use of Yimucao Injection involved in different producers, the majority did not specifically mention the number and the manufacturer, and the single dose(ml) was mainly 2 mL, and the main route of administration was intramuscular injection, intrauterine injection and intramuscular injection, and intrauterine injection. The course of treatment was 2 to 3 days;combined drug use was mainly oxytocin, carbendazim aminobutanol, and misoprostol injection;the manifestation of ADR by using Yimucao Injection from different manufacturers were: facial flushing, nausea and vomiting etc. Conclusion:Clinical use of Yimucao Injection is relatively safe, and its adverse reactions are mostly mild.