葛根素注射液临床使用安全性的评价研究

Evaluation on safety of puerarin injection in clinical use

葛根素注射液临床常用于辅助治疗冠心病、各型心绞痛,视网膜动、静脉阻塞,突发性耳聋等疾病,评价葛根素注射液在临床使用的安全性,挖掘可能造成葛根素注射液不良反应(ADRs)的相关因素,以便及时发现安全性用药警示信号,提出预警,做到早判断,早处理,确保用药安全。通过加强监控,确立最佳用药方案,预防葛根素注射剂不良反应的发生,提高人们对使用葛根素注射剂临床使用安全性的重视。计算机全面检索与葛根素注射液不良反应相关的一次文献,排除一次信息缺失较多的文献,最终筛选纳入文献62篇,共涉及129个案例。从中提取相关资料并通过Treeage软件进行决策树分析,χ^2检验对数据进行验证。葛根素ADRs多发生于50~79岁患者,以免疫系统和血液系统占多数(88.3%),用药48 h后发生ADR最多(61.1%),发生不良反应的严重程度与葛根素的使用剂量无关,但与滴注溶媒的选择相关,葛根素注射剂中、重度不良反应居多(64.3%),129例病案中死亡病例13例(10.1%)。葛根素注射液可致严重ADRs发生,因此,临床使用时应严格把握适应症及使用方法,用药前仔细询问患者过敏史,加强用药监测。

Puerarin injection is commonly used in clinical treatment of coronary heart disease, angina pectoris, retinal artery, vein occlusion, sudden deafness and so on. This paper is aimed to evaluate the safety of puerarin injection in clinical use and explore the related factors that may cause its adverse reactions(ADRs), so as to find the warning signal of safety medication in time, put forward early warning, make early judgment and treatment, and ensure the safety of drug use. By strengthening surveillance, the best medication plan was established to prevent the occurrence of adverse reactions of puerarin injection and enhance people′s awareness on the safety of puerarin injection. Database were searched to collect literature related to ADRs of puerarin injection. The data were extracted and analyzed by decision tree with treeage software and χ^2 test was used to verify the data. A total of 62 papers involving 129 cases were included. The results showed that ADRs occurred mostly in patients aged 50-79 years, with the immune system and blood system accounting for the majority(88.3%), and ADRs occurred mostly 48 h after drug administration(61.1%). The severity of ADRs was not related to the dosage of puerarin, but it was related to the choice of the infusion solvent. In puerarin injection, most of the ADRs were moderate or severe(64.3%), 13 out of 129 cases were of death. Therefore, the indications and methods of use should be strictly controlled, and the allergic history of patients should be carefully questioned before medication to strengthen the monitoring of drug use.