银杏叶提取物注射液不良事件发生率的Meta分析

Incidence of Adverse Drug Events on Extract of Ginkgo Biloba Leaves Injection:A Meta-analysis

目的:了解银杏叶提取物注射液不良事件(adverse drug events,ADE)的发生情况。方法:2016年9月采用银杏叶提取物注射液、金纳多等检索词系统检索中国生物医学文献数据库、中国知网、万方数据库、维普数据库、PubMed、EMBASE、Clinical Trials.gov、Cochrane Library等多个数据库。对符合纳入标准的文献,提取基本信息、方法学特征、干预特征和ADE发生情况等信息,采用率的Meta分析对各个ADE发生率进行加权合并。结果:最终纳入607篇文献,共包括716个银杏叶提取物注射液组。总的ADE发生率为2.6%(95%CI:2.4%~2.9%)。ADE发生率最多的类型是输液/注射部位疼痛,为7.9%(95%CI:4.9%~12.6%);其次是腹胀7.5%(95%CI:1.2%~36.4%);潮红5.7%(95%CI:3.5%~9.4%)。纳入的21个个案报道共计报道ADE 53例,无死亡或后遗症病例,经停药或对症治疗均症状缓解或恢复正常。结论:银杏叶提取物注射液ADE发生类型较多,涉及全身多系统,应重视对其ADE的防治。由于文献质量及发表偏倚等问题,所得结论在推广时需谨慎。

Objective：To analyze the incidence of adverse drug events （ADE） on extract of ginkgo biloba leaves injection. Methods：The CBMDisc, CNKI, VIP, WanFang, PubMed, EMBASE, ClinicalTrials. gov and Cochrane Library were searched using ＂Extract of Ginkgo Biloba Leaves Injection＂ or ＂ginaton＂ as keywords in September 2016. For studies which met the inclusion criteria, the general and methodology characteristics, intervention information and ADE information were extracted. The ADE incidence of each study was merged using the rate meta analysis. Results： A total of 607 articles were included in the analysis, which includes 716 groups of extract of ginkgo biloba leaves injection. The overall incidence of all ADE was 2.6% （95% CI：2.4% -2.9% ）. The most common reported ADE was pain at the injection site, the inci- Q dence was 7.9% （95% CI：4.9%-12.6% ）, followed by abdominal distension [7.5% （95% CI： 1.2%-36.4% ） ] and flushing [ 5.7 % （95 % CI： 3.5 % -9.4% ） ]. 21 ADE case reports including 53 ADEs were analyzed, no patient died or had sequela, all patients recovered completely after drug withdrawal or symptomatic treatment. Conclusion： Many kinds of extract of ginkgo biloba leaves injection ADE were observed, involving multiple body systems, so we should pay more attention to the prevention and treatment of those ADE. Because of the low quality and publication bias of included studies, the findings of our study should be interpreted with caution.