以英文发表的口服中药随机对照试验中不良事件及其影响因素的分析

为评价英文发表的口服中药随机对照试验(randomized controlled trials,RCTs)中不良事件(adverse event, AE)的发生情况及其相关影响因素,全面检索Medline,EMbase和Cochrane Central Register of Controlled Trials (CENTRAL)数据库。收集2009年1月至2018年7月以英文发表的口服中药RCTs,提取基本信息、研究人群、干预特征和AE发生情况等信息,采用Meta分析对各个AE发生率进行加权合并。最终纳入218个RCTs,其中28.4%没有对AE进行任何报告。103个口服中药研究组共发生1 634例次AE,总AE的发生率11.2%(95%CI10.7%, 11.7%])。AE发生率最高的是血常规实验室异常,为8.0%(95%CI6.6%, 9.7%]),其次是神经、精神系统,为7.9%(95%CI6.6%, 9.5%]),胃肠道反应为7.8%(95%CI6.8%, 8.9%]),和肝功能异常为7.6%(95%CI6.4%, 8.9%])。口服中药剂型中,片剂和颗粒剂的AE发生率最高,汤药和口服液的AE发生率最低。口服中药和西药对照组合用的AE发生率最高。随着用药疗程增加,AE发生率也相应增加。儿童患者的AE发生率高于成人患者。基于现有数据及分析结果,口服中药AE发生率较高的部位集中在神经精神系统、胃肠道系统和肝功能异常。AE发生率与剂型、药物联用、用药疗程和患者年龄有关。应对中药现代剂型、中西药联用、用药疗程长以及儿童患者引起的AE予以重视。

Analysis of adverse events and influencing factors in randomized controlled trials of oral Chinese medicine published in English

In order to analyze the incidence of adverse events(AE) and evaluate the related influencing factors in randomized controlled trials(RCTs) of oral Chinese medicine which published in English, Medline, EMbase, and the Cochrane Central Register of Controlled Trials(CENTRAL) database were searched. Oral Chinese medicine RCTs published in English from January 2009 to July 2018 were collected to extract the basic characteristics, subjects, intervention characteristics and AE information. The AE incidence of each study was merged by using Meta analysis. Finally, 218 RCTs were included, of which 28.4% did not report any AE. A total of 1 634 AE occurred in 103 oral Chinese medicine groups, and the total incidence of AE was 11.2%(95%CI10.7%, 11.7%]). The highest incidence of AE came to blood routine laboratory abnormalities, 8.0%(95%CI6.6%, 9.7%]), followed by neurological and psychiatric systems 7.9%(95%CI6.6%, 9.5%]), digestive system 7.8%(95%CI6.8%, 8.9%]) and liver function abnormalities 7.6%(95%CI6.4%, 8.9%]). Among the oral dosage forms, tablets and granules had the highest incidence of AEs, while decoction and oral liquids had the lowest incidence. The combination of oral Chinese medicine and Western medicine had the highest incidence of AE. As the medication course increased, the incidence of AE increased accordingly. The incidence of AE in children was higher than that in adults. Based on the analysis results, the higher AE incidence of oral Chinese medicine was in the neuropsychiatric system, gastrointestinal system and liver function abnormalities. The incidence of AE was related to the dosage form, drug combination, medication duration, and patient age. We should pay attention to the AE in children due to modern dosage forms of traditional Chinese medicine, combination of Chinese and Western medicine, and long course of medication.