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

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PubMed、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RevMan 5．3软件进行文献荟萃（ Meta）分析。结果：共纳入24个RCT，合计2961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＜0．00001），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＜0．00001），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＝0．0008），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 .6806-8101