基于296200例的中药注射剂临床安全性集中监测研究的系统评价

Clinical surveillance cases of clinical safety in 296200 cases of traditional Chinese medicine injection: a systematic review

目的系统评价目前已开展上市后临床集中监测研究中药注射剂的安全性,分析中药注射剂不良反应(ADR)发生情况,探讨相关危险因素,为指导临床安全用药、优化集中监测方案提供依据。方法计算机检索CFDA、CNKI、VIP、WanFang Data、Sinomed、PubMed和The Cochrane Library数据库,搜集中药注射剂相关集中监测研究,检索时限均从建库至2018年2月。由2名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用Excel软件进行统计分析。结果共纳入14篇文献,涉及14个品种,296 200例被监测对象。ADR总发生率为1.58‰。其中,血必净注射液不良反应发生率最高(2.54%)。ADR相关因素为:年龄、性别、合并用药、距给药时间、过敏史、用药天数、适应症、剂量和冲管的分布情况。结论中药注射剂安全性普遍较高。中高龄是ADR发生的重要因素,ADR发生集中在最初用药6天内,临床不合理用药更易导致ADR发生,过敏史可能与ADR发生有关。受纳入研究数量和质量的限制,上述结论尚待更多高质量研究予以验证。

Objectives To systematically review the safety of traditional Chinese medicine injection based on clinical centralized monitoring studies that have been carried out and listed so far, to understand basic situation of adverse reactions and explore the risk factors of traditional Chinese medicine injections and to provide evidence for clinical rational use of drugs and optimizing centralized monitoring methods. Methods CFDA, CNKI, VIP, WanFang Data,Sinomed, PubMed and The Cochrane Library databases were electronically searched to collect studies on safety monitoring of listed traditional Chinese medicine injections from inception to February, 2018. Two reviewersindependently screened literature, extracted data and assessed the risk of bias of included studies. Meta-analysis was then performed by using Excel software. Results A total of 14 studies involving 14 varieties of injections, 296 200 cases were included. The highest incidence rate of adverse reactions was found in the XueBiJing injection(2.54%). The related factorsof ADR extraction were age, sex, drug combined usage, time from administration, allergic history, administration days,indication, dose and distribution of the tube. Conclusions The safety of traditional Chinese medicine injection isgenerally high. Middle and old age is an important factor in the occurrence of ADR. The incidence of ADR is relatively high in the first 6 days of drug use, and the incidence of ADR is more likely to be caused by irrational use of drugs in clinic,and the history of allergy may be related to the occurrence of ADR. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusion.