944篇521例刺五加注射液不良反应文献分析

521 Cases of Adverse Drug Reactions of Ciwujia Injection based on 944 Studies

目的全面了解刺五加注射液不良反应(adverse drug reactions,ADR)发生情况及其相关因素。方法检索中国知网(CNKI)关于刺五加注射液的临床研究及不良反应报告。提取纳入文献中ADR病例原患疾病,刺五加注射液用药剂量、溶媒及配伍用药情况,ADR病例的性别、年龄及有无过敏史情况,ADR出现时间、类型、处理及转归等。结果800篇临床研究中有97篇(12.1%)共报道285例ADR病例;144篇ADR报告共包括236例ADR病例。ADR病例中女性高于男性,主要集中于40～69岁年龄段;不良反应报告的ADR主要集中于过敏性休克,临床研究的ADR主要集中于注射局部疼痛;72.3%的ADR病例严重程度为Ⅲ～Ⅳ级,4例死亡;ADR病例原患疾病最主要为冠心病和脑梗死;27例(11.4%)ADR病例有过敏史;刺五加注射液ADR病例所用溶媒主要为5%葡萄糖液、生理盐水和10%葡萄糖液,共36例ADR病例为刺五加注射液和其他药物配伍使用;刺五加注射液常用剂量为20～60ml;首次用药者ADR病例占总ADR的83.0%。结论①刺五加注射液的ADR报告和临床研究均存在ADR/AE(不良事件)概念模糊,关键信息不完整,缺乏总处方量/用药人数,及不能计算发生率的缺陷,报告质量尚待提高。②刺五加注射液的基础研究有待深入,特别是剂量探索研究,以支持临床应用。③刺五加作为ADR报告最多的中药注射剂品种之一,统一规划下的高质量ADR监测、规范报告和及时析因、指导改进迫在眉睫。

Objective To analyze the adverse drug reactions（ADR） of Ciwujia injection and the relative in uence factors.Methods We searched all clinical studies and ADR reports of Ciwujia injection from the China National Knowledge Infrastructure（CNKI） database.The relevant information such as the diseases for treatment;menstruum,dosage and compatibility of Ciwujia injection;the age,gender and allergic history of patients;and the category,treatment and prognosis of ADR were collected and analyzed.Results In the 800 clinical studies,only 97（12.1%） reported 285 ADR cases,144 ADR reports including 236 ADR cases.Of the ADR cases,the male to female ratio was 1：1.34,mainly in 40 to 69 years group;The ADR cases mainly including anaphylactic shock and local pain in ADR reports and clinical studies,respectively;72.3 percent ADR cases were Ⅲ to Ⅳ class,4 anaphylactic shock cases died;the diseases for treatment of ADR cases mainly were coronary artery heart disease and cerebral infarction;27（11.4%） ADR cases had allergic history;The menstruum of Ciwujia injection mainly were 5% glucose,0.9% NaCl and 10% glucose,drug incompatibility in 36 ADR cases;The usual dosage of Ciwujia injection was 20-60 ml;196（83.0%） ADR cases occurred in rst time medication,mainly in the early 30 minutes of medication used.Conclusion（1） In both ADR reports and clinical studies of Ciwujia injection,there are some problems of ADR and adverse drug events（AE） were not easily distinguishable,key information of total prescriptions divided by drug persons were lacking,so we can＇t calculate the ADR rate,the reporting quality remained to be improved.（2） To support the rational drug use,the basic researches of Ciwujia injection remains to be further studied,especially the dose-nding studies.（3） As one of the most frequently reported ADR of traditional Chinese medicine（TCM） injection,high quality ADR monitoring,normative ADR reporting and timely analyzing the ADR reason of Ciwujia injection is extremely urgent.