热毒宁注射液不良反应的Meta分析  

Meta-analysis of Adverse Reaction of Reduning Injection

作　　者：王永静[1] 赵晓娟[1] 吴瑕[1] 孙倩[1] 刘秀菊[1] WANG Yongjing;ZHAO Xiaojuan;WU Xia;SUN Qian;LIU Xiuju(The Second Hosipital of Hebei Medical University,Shijiazhuang 050000,China)

机构地区：[1]河北医科大学第二医院,石家庄050000

出　　处：《世界中医药》2022年第9期1297-1303,共7页World Chinese Medicine

基　　金：河北省中医药管理局科研计划项目(2021143)。

摘　　要：目的:采用Meta分析的方法对热毒宁注射液不良反应进行统计分析,评价其临床安全性。方法:检索国家知识基础设施数据库(CNKI)、中国学术期刊数据库(CSPD)、中文科技期刊数据库(CCD),以及PubMed、Cochrane Library、Web of Science,检索公开发表的有关热毒宁注射液的临床随机对照试验,时间从建库至2020年4月。由2名研究人员分别独立检索并根据纳入及排除标准筛选文献、提取信息、进行质量评价,采用RevMan 5.3统计软件进行数据分析。同时对不同对照药品、不同用药天数、不同年龄人群的不良反应发生率进行分析。结果:最终符合纳入标准的文献共36篇(37项对照研究),总样本量3917例。Meta分析显示,热毒宁注射液不良反应发生率(3.50%)低于对照组(11.84%),差异有统计学意义(RR=0.31,95%CI为0.24~0.40,Z=9.07,P<0.00001)。亚组分析显示,在利巴韦林亚组(P<0.00001)、用药天数≤5 d亚组(P<0.0001)和>5 d亚组(P=0.0005)以及儿童亚组(P<0.00001)中,热毒宁注射液不良反应发生率均显著低于对照组。与利巴韦林(P<0.00001)、炎琥宁(P=0.01)、痰热清(P=0.02)、双黄连(P=0.001)、头孢曲松(P=0.01)比较,热毒宁注射液有效率均显著高于对照组。结论:热毒宁注射液与利巴韦林比较,不良反应发生率低,疗效好;与炎琥宁、痰热清比较,有较好的临床疗效,但安全性方面没有显著优势。Objective:To evaluate the adverse reactions of Reduning Injection in clinical application and to analyze its clinical safety.Methods:The commonly used Chinese databases for computer retrieval were:China China National Knowledge Infrastructure(CNKI),China Science Periodical Database(CSPD),Chinese Citation Database(CCD),and common English databases:PubMed,Cochrane Library,Web of Science.We searched for publicly published hot topics:the clinical randomized controlled trial of Reduning Injection,from the establishment of the database to April 2020.A total of 2 researchers independently searched and screened the literature according to the inclusion and exclusion criteria,extracted information,and evaluated the quality.RevMan 5.3 software was used for statistical analysis.Meanwhile,the incidence of adverse reactions of different control drugs,different medication days,and different age groups was analyzed in subgroups.Results:In the end,a total of 36 papers(37 studies)met the inclusion criteria,with a total sample size of 3917 cases.Meta-analysis showed that the incidence of adverse reactions of Reduning Injection(3.50%)was lower than that of the control group(11.84%).The difference was statistically significant(RR=0.31,95%CI 0.24 to 0.40,Z=9.07,P<0.00001).Subgroup analysis showed that in the ribavirin subgroup(P<0.00001),the duration of treatment≤5 d subgroup(P<0.0001)and>5 d subgroup(P=0.0005),and the child subgroup(P<0.00001),the incidence of adverse reactions of Reduning Injection was significantly lower than that of the control group.The effectiveness analysis showed that,compared with ribavirin(P<0.00001),Yanhuning(P=0.01),Tanreqing(P=0.02),Shuanghuanglian(P=0.001),ceftriaxone(P=0.01),the effective rate of Reduning Injection was significantly higher than that of the control group.Conclusion:Compared with ribavirin,Reduning Injection has a lower incidence of clinical adverse reactions and better efficacy;compared with Yanhuning and Tanreqing,it has better clinical efficacy but no significant advantage in safety

关 键 词：热毒宁注射液 中药注射剂 清热解毒 中成药 不良反应 临床安全性 META分析 随机对照试验 

分 类 号：R289.5[医药卫生—方剂学] R242[医药卫生—中药学]