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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 comprehensively understand the incidence of adverse drug reactions (ADR) in Acanthopanax senticosus and its related factors. Methods To search CNKI for the clinical research and adverse reactions of Acanthopanax senticosus injection. The ADR patients were included in the literature for the original disease, acanthopanax injection dosage, drug and compatibility of drug use, ADR cases of gender, age and presence of allergy history, ADR appearance, type, treatment and outcome. Results A total of 800 ADR cases were reported in 97 of 800 clinical trials (12.1%). A total of 144 ADR cases were reported in 236 ADR cases. ADR cases in women than men, mainly in the 40 to 69 age group; ADR reported adverse reactions mainly in anaphylactic shock, clinical research ADR focused on injection of local pain; 72.3% of the severity of ADR cases for the Ⅲ ~ Ⅳ, and 4 died. The predominant disease in ADR cases was coronary heart disease and cerebral infarction. 27 cases (11.4%) had allergy history. The drug used in ADR cases of Acanthopanax injection was mainly 5% glucose solution, Saline and 10% glucose solution. A total of 36 ADR cases were used with Acanthopanax senticosus injection and other drugs. Acanthopanax senticosus injection was used in a dose of 20 ~ 60ml. ADR was 83.0% of the first-time ADR patients. Conclusion ① Acanthopanax senticosus ADR reports and clinical studies both have the concept of ADR / AE (adverse events) fuzzy, the key information is not complete, the lack of total prescription / drug users, and can not calculate the incidence of defects, the quality of the report yet to be improve. ② acanthopanax injection of basic research needs further study, in particular, to explore the dose to support clinical applications. ③ Acanthopanax as one of the most reported traditional Chinese medicine injections in ADR, under the unified planning of high quality ADR monitoring, standardized reporting and timely analysis, guiding improvement is imminent.