奇正消痛贴膏安全性评价研究

Evaluation on Safety of Qizheng Xiaotong Plaster

目的旨在通过文献计量分析与循证评价相结合的方法,对奇正消痛贴膏的安全性进行评价。方法系统全面地检索的中文数据库包括中国知网数据库(CNKI)、万方数据库、重庆维普中文科技期刊数据库(VIP)、中国生物医学文献数据库(CBM)和英文数据库包括美国国立医学图书馆(PubMed)、Cochrane图书馆(Cochrane Library),以及国家食品药品监督管理总局药品不良反应监测中心数据库(检索时间为各数据库建库至2019年4月),纳入奇正消痛贴膏的所有临床研究。对纳入的研究采用R 3.5.3软件对纳入研究不良反应/事件的发生率进行Meta分析,并通过亚组分析探讨影响奇正消痛贴膏不良反应/事件发生的因素,对不能进行Meta分析的研究进行描述性分析。结果共纳入随机对照试验(RCT)62项,非随机对照试验(CCT)9项,病例系列15项,和病例报告8项。86项RCT/CCT/病例系列研究中使用奇正消痛贴膏者8111例,累计出现不良反应/事件579例,Meta结果显示:奇正消痛贴膏不良反应/事件发生率为3.73%(95%CI[2.57%,5.10%])。奇正消痛贴膏不良反应/事件主要是接触性皮炎,其发生率与疾病类型、是否联合用药、用药方式、用药时间长短及疗程均无显著关联。结论文献分析数据表明奇正消痛贴膏不良反应/事件主要表现为皮肤过敏,其发生率与疾病类型、是否联合用药、用药方式、用药时间长短及疗程长短均无显著关联。

Objective To conduct an evidence-based evaluation on the safety of Qizheng Xiaotong Plaster(QZXTP)by combining bibliometrics analysis and evidence-based evaluation.MethodsChinese databases(CNKI,VIP,WanFang,CBM)and English databases(PubMed,Cochrane Library)and the State Food and Drug Administration Adverse Drug Reactions Monitoring Center database were retrieved from the establishment of each database to April 2019.All the clinical trials of QZXTP were included.Meta-analysis was performed on the incidence of adverse reactions/events using R3.5.3 Software.The factors affecting adverse reactions/events of QZXTP were discussed through subgroup analysis,and descriptive analysis was performed on the studies that could not be Meta-analyzed.Results A total of 62 randomized controlled trials(RCTs),9 non-randomized controlled clinical trials(CCTs),15 case series,and 8 case reports were included.Among 8111 patients using QZXTP in 86 RCT/CCT/case series studies,adverse reactions/events occurred in 579 cases.Meta-analysis results showed that the incidence of adverse reactions/events of QZXTP was 3.73%(95%CI[2.57%,5.10%]).Subgroup analysis showed that there was no significant association between the incidence of adverse reactions/events of QZXTP with the type of disease/whether it was combined/the mode of administration/the length of medication/duration of treatment.Contact dermatitis was the main adverse reactions/events of QZXTP.Conclusions The adverse reactions/events of QZXTP was mainly manifested as skin allergies.There was no significant association between the incidence of adverse reactions/events of QZXTP with the type of disease/whether it was combined/the mode of administration/the length of medication/duration of treatment.