蒲地蓝消炎口服液不良反应报告率的Meta分析  

Meta-Analysis on Incidence of ADR Induced by Pudilan Xiaoyan Oral Liquid

作　　者：戎萍[1] 潘桂赟 王昕[1] 张喜莲[1] 马融[1] Rong Ping;Pan Guiyun;Wang Xin;Zhang Xilian;Ma Rong(Dept of Pediatric,First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300381)

机构地区：[1]天津中医药大学第一附属医院儿科,天津300381

出　　处：《中药药理与临床》2020年第2期206-214,共9页Pharmacology and Clinics of Chinese Materia Medica

基　　金：天津市重点研发计划科技支撑重点项目(编号:18YFZCSY00540);天津市卫生计生行业"青年医学新锐"(2018);第六批全国老中医药专家学术经验继承人(2017)。

摘　　要：目的:系统评价蒲地蓝消炎口服液的用药安全性,为临床提供循证参考。方法:计算机检索知网、万方、CBM、Cochrane Library、PubMed,检索时限均为建库至2019年05月,收集单用或联用蒲地蓝消炎口服液(试验组)对比基础治疗或其他药物(对照组)治疗各类疾病致不良反应(胃肠道反应、皮疹等)的随机对照试验(RCT),提取资料并采用Cochrane风险偏倚评估工具进行质量评价后,采用RevMan5.2软件进行Meta分析。结果:共纳入88篇RCT,合计9735例患者。Meta分析结果显示,蒲地蓝消炎口服液不良反应报告率[RR=0.50,95%CI(0.42,0.60)]明显低于对照组(P<0.05)。亚组分析中,适应证为手足口病[RR=0.31,95%CI(0.18,0.53)]、疱疹性咽峡炎[RR=0.51,95%CI(0.35,0.74)]、上呼吸道感染[RR=0.54,95%CI(0.34,0.86)]、支原体肺炎[RR=0.52,95%CI(0.29,0.93)]和幽门螺旋杆菌感染[RR=0.43,95%CI(0.20,0.90)]中试验组的不良反应报告率明显低于对照组(P<0.05);儿童组[RR=0.46,95%CI(0.38,0.57)]和成人组[RR=0.61,95%CI(0.43,0.86)]中试验组的不良反应报告率明显低于对照组(P<0.05);疗程≤7 d组[RR=0.49,95%CI(0.39,0.61)]和>7 d组[RR=0.54,95%CI(0.37,0.77)]中试验组的不良反应报告率明显低于对照组(P<0.05);消化系统[RR=0.60,95%CI(0.48,0.75)]、血液系统[RR=0.49,95%CI(0.26,0.92)]和皮肤及黏膜亚组[RR=0.41,95%CI(0.27,0.62)]中试验组的不良反应报告率明显低于对照组(P<0.05)。结论:蒲地蓝消炎口服液安全性较高,不良反应发生的影响因素与适应证、适应人群和疗程存在关联性,且不同损害类型之间的不良反应报告率存在差异。Objective:This paper systematically evaluated the safety of Pudilan Xiaoyan Oral Liquid and provided evidence-based reference for clinical practice.Methods:Information(up to May 2019)was searched in CNKI,Wanfang,CBM,Cochrane Library and PubMed,to collect randomized controlled trials(RCT)of Pudilan Xiaoyan Oral Liquid(experimental group)singly or unitedly basic therapy or other drugs(control group)in the treatment of adverse reactions(gastrointestinal reactions,rashes,etc.)caused by various diseases.Meta-analysis was performed using RevMan 5.2 after the data extraction and quality evaluation by the Cochrane risk bias assessment tool.Results:88 RCTs were employed which included 9735 patients.Meta-analysis showed that the incidence of adverse reactions of Pudilan Xiaoyan Oral Liquid[RR=0.50,95%CI(0.42,0.60)]was significantly lower than that of the control group(P<0.05).In the subgroup analysis,the incidence of adverse reactions in the hand-foot-mouth disease subgroup[RR=0.31,95%CI(0.18,0.53)],herpangina[RR=0.51,95%CI(0.35,0.74)],upper respiratory tract infection[RR=0.54,95%CI(0.34,0.86)],mycoplasma pneumonia[RR=0.52,95%CI(0.29,0.93)]and Hp infection[RR=0.43,95%CI(0.20,0.90)]was significantly lower than that in the control group(P<0.05).In the children subgroup[RR=0.46,95%CI(0.38,0.57)]and the adult subgroup[RR=0.61,95%CI(0.43,0.86)],the incidence of adverse reactions in the test group was significantly lower than that in the control group(P<0.05).The incidence of adverse reactions in the test group was significantly lower than that of the control group in the subgroup≤7 d[RR=0.49,95%CI(0.39,0.61)]and>7 d[RR=0.54,95%CI(0.37,0.77)](P<0.05).The incidence of adverse reactions in the digestive system response subgroup[RR=0.60,95%CI(0.48,0.75)],the blood system[RR=0.49,95%CI(0.26,0.92)]and the skin and mucosal subgroup[RR=0.41,95%CI(0.27,0.62)]was significantly lower than that of the control group(P<0.05).Conclusions:Pudilan Xiaoyan Oral Liquid has high safety.Influencing factors of adverse reactions is associated with

关 键 词：蒲地蓝消炎口服液 不良反应 META分析 亚组分析 

分 类 号：R285.6[医药卫生—中药学]