重组人干扰素α1b注射液雾化吸入辅助治疗婴幼儿毛细支气管炎疗效和安全性的系统评价  

Efficacy and Safety of Recombinant Human Interferon α1b Injection Inhaling as Adjuvant Therapy for Bronchiolitis in Infants:A Systematic Review and Meta-analysis

作　　者：陈灿[1,2] 马丽萍[3] 张蕾[2] 沈司京[2] 翟所迪[1] 

机构地区：[1]北京大学第三医院药剂科,北京100191 [2]北京大学药学院药事管理与临床药学系,北京100191 [3]北京大学首钢医院药剂科,北京100144

出　　处：《中国医院用药评价与分析》2016年第6期806-810,共5页Evaluation and Analysis of Drug-use in Hospitals of China

摘　　要：目的:系统评价重组人干扰素α1b注射液雾化吸入辅助治疗婴幼儿毛细支气管炎的有效性和安全性,为临床治疗提供循证医学参考。方法:计算机检索Pub Med、Medline、EMBase、Cochrane图书馆、维普中文科技期刊数据库、中国期刊全文数据库、万方数据库、中国生物医学文献数据库等,检索重组人干扰素α1b注射液雾化吸入治疗婴幼儿毛细支气管炎的随机对照试验(randomized controlled trial,RCT),提取数据并进行方法学质量评价后,采用Rev Man 5.3软件进行文献荟萃(Meta)分析。结果:共纳入24个RCT,合计2 961例患儿。Meta分析结果显示:观察组患儿的总有效率明显高于对照组(RR=1.20,95%CI=1.16~1.24,P<0.000 01),观察组患儿的治愈率明显高于对照组(RR=1.37,95%CI=1.27~1.46,P<0.000 01),观察组患儿的住院时间明显短于对照组(MD=-1.67,95%CI=-2.65^-0.69,P=0.000 8),观察组患儿的临床症状(如咳嗽,喘息等)和体征缓解或消失时间明显短于对照组,差异均有统计学意义(P<0.05);2组患儿药品不良反应发生情况的差异无统计学意义(P>0.05)。结论:在常规治疗的基础上使用重组人干扰素α1b注射液雾化吸入,有利于增强毛细支气管炎的治疗效果,可以显著缩短住院时间、提高治愈率,且未见严重不良反应。但受纳入研究质量的局限,该结论有待大样本、高质量、多中心的RCT进一步验证。OBJECTIVE：To systematically assess the efficacy and safety of recombinant human interferon α1 b injection inhaling as adjuvant therapy for bronchiolitis in infants , so as to provide reference of evidence-based medicine for the clinical treatment . METHODS： Randomized controlled trails （ RCTs ） of interferon α1 b inhaling for bronchiolitis in infants were searched through PubMed , Medline, EMBase, Cochrane library , VIP, CNKI, WanFang Database and CBM;RCTs were selected according to the inclusion and exclusion criteria .Related data were extracted and the meta-analysis was performed by using RevMan 5.3 software.RESULTS：24 RCTs were involved , including 2 961 patients.The meta-analysis revealed that the total effective rate of the observational group was higher than that of the control group（RR=1.20,95%CI=1.16-1.24,P〈0.000 01）,and the cure rate was also higher than that of the control group（RR =1.37,95%CI =1.27-1.46,P 〈0.000 01）; in addition, compared with control group, the observational group had a significantly shorter mean length of hospital stay （ MD=-1.67 ,95%CI=-2.65 --0.69 , P=0.000 8）;and the remission or disappearance time of clinical symptoms （such as cough, wheezing, etc.） and signs in the observational group were significantly shorter than that in the control group , with statistically significant difference（P〈0.05）.There was no significant difference in incidence of adverse drug reactions between two groups （P〉0.05）.CONCLUSIONS：On the basis of conventional treatment , the use of interferon α1b atomization inhalation is conducive to improve the treatment effects for bronchiolitis in infants , which can significantly shorten the length of hospital stay , improve the cure rate with no severe adverse drug reactions .However , by the limitations of the quality of studies, the conclusion remains to be further verified by high quality , large samples and multiple center RCTs .

关 键 词：干扰素Α1B 毛细支气管炎 婴幼儿 系统评价 Meta分析 

分 类 号：R977[医药卫生—药品]