热毒宁注射液治疗≤14岁儿童急性呼吸道感染不良反应的Meta分析  

Meta-analysis of adverse reactions of Reduning injection in the treatment of acute respiratory tract infection in children ≤14 years old

作　　者：张跃 杨婷婷[2] 凌建春 Zhang Yue;Yang Tingting;Ling Jianchun(The First Editorial Department,Shanxi Provincial Medical and Health Institutions Comprehensive Service Center(Shanxi Provincial Blood Center),Taiyuan 030006;Immunization Program Department,Shanxi Center for Disease Control and Prevention,Taiyuan 030012,China)

机构地区：[1]山西省医疗卫生机构综合服务中心(山西省血液中心)编辑一部,太原030006 [2]山西省疾病预防控制中心免疫规划科,太原030012

出　　处：《实用医技杂志》2024年第1期58-64,共7页Journal of Practical Medical Techniques

摘　　要：目的 分析≤14岁患儿热毒宁注射液治疗急性上呼吸道感染随机对照研究不良反应Meta评价。方法 采用计算机检索中国知网(CNKI)、万方数据库(Wanfang)、维普科技期刊全文数据库、中国生物医学文献服务系统(SinoMed)、PubMed、EMBASE、Cochrane Central Register of Controlled Trials、MEDLINE数据库,检索时间为建库至2022年4月,筛选热毒宁注射液治疗上呼吸道感染的临床研究。结果 纳入17篇随机对照试验(RCT)文献进行Meta分析,其中试验组(热毒宁注射液)1 043例,对照组(利巴韦林注射液)1 042例。14篇报告不良反应的文献Meta分析显示:2组总体还是以恶心呕吐、上腹部不适、腹泻、皮疹等不良反应为主,其中热毒宁注射液(试验组)引起恶心呕吐15例、上腹部不适6例、腹泻12例、皮疹3例;利巴韦林注射液(对照组)引起恶心呕吐38例、上腹部不适20例、腹泻10例、皮疹26例,此外利巴韦林注射液还引起患儿白细胞减少18例、其他不良反应6例。热毒宁注射液(试验组)引起的不良反应的危险度总体低于利巴韦林注射液(对照组)[OR值(95%CI)=0.27(0.19,0.40),Z=6.583,P<0.001];总体不良反应以恶心呕吐、上腹部不适、腹泻、皮疹等为主。研究还发现,热毒宁注射液(试验组)总体有效率高于利巴韦林注射液(对照组)[OR值(95%CI)=5.00(3.46,7.22),Z=8.582,P<0.001]。结论 热毒宁注射液总体不良反应以恶心呕吐、上腹部不适、腹泻、皮疹等为主,总体安全性较好、有效性较高,但需进一步纳入高质量随机对照研究为临床提供循证依据。Objective To analyze the adverse reactions in a randomized controlled study of Reduning Injection in the treatment of acute upper respiratory tract infection in children under 14 years old.Methods We searched China National Knowledge Infrastructure(CNKI),Wanfang Database(Wanfang),VIP Science and Technology Periodical Full-text Database,China Biomedical Literature Service System(SinoMed),PubMed,EMBASE,Cochrane Central Registe r of Controlled Trials,MEDLINE database for the clinical researches of Reduning injection in the treatment of upper respiratory tract infection published before April 2022.Results Seventeen RCT literatures were included for meta-analysis,including 1 043 cases in the experimental group(Reduning injection) and 1 042 cases in the control group(ribavirin injection).Meta-analysis of 14 literatures reporting adverse reactions showed that the two groups were still of main adverse reactions such as nausea and vomiting,epigastric discomfort,diarrhea,and rash.Among them,Reduning injection(test group) caused 15 cases of epigastric nausea and vomiting,6 cases of discomfort,12 cases of diarrhea,and 3 cases of rash;Ribavirin injection(control group) caused nausea and vomiting in 38 cases,epigastric discomfort in 20 cases,diarrhea in 10cases,and rash in 26 cases.Additionally,Ribavirin injection caused leukopenia in 18 cases and other adverse reactions in 6 cases.The risk of adverse reactions caused by Reduning injection(test group) was generally lower than that of ribavirin injection(control group) [OR(95% CI) =0.27(0.19,0.40),Z =6.583,P <0.001];the overall adverse reactions are mainly nausea and vomiting,epigastric discomfort,diarrhea,rash and so on.The study also found that the overall effective rate of Reduning Injection(test group) was higher than that of Ribavirin Injection(control group) [OR(95%CI)=5.00(3.46,7.22),Z =8.582,P <0.001].Conclusion The main adverse reactions of Reduning injection are nausea and vomiting,epigastric discomfort,diarrhea and rash,etc.The overall safety is good and the efficacy

关 键 词：热毒宁注射液 利巴韦林注射液 不良反应 有效率 META分析 

分 类 号：R725.6[医药卫生—儿科]