沐舒坦预防早产儿呼吸窘迫综合征的Meta分析

Ambroxol for the prevention of respiratory distress syndrome in preterm infants:a Meta analysis

目的系统评价沐舒坦预防早产儿呼吸窘迫综合征(respiratory distress syndrome,RDS)的有效性及安全性。方法电子检索Cochrane图书馆、PubMED、EMBASE、中国生物医学文献数据库、中国期刊全文数据库、万方和维普数据库等,手工检索Pediatrics及Pediatric Research中刊载的会议论文。检索沐舒坦预防早产儿RDS的随机对照试验(randomized controlled trial,RCT)文献。应用Cochrane协作网推荐的方法评价文献质量,对同质研究采用RevMan5.0.17软件进行Meta分析。结果共纳入6个RCT,其中1篇质量评价为A级,1篇为B级,4篇为C级,包括823例早产儿。Meta分析结果显示,沐舒坦预防组与对照组比较,在RDS发病率(OR=0.24,95%CI[0.15,0.64],P<0.01)、支气管肺发育不良(BPD)发病率(OR=0.41,95%CI[0.23,0.75],P<0.01)、脑室内出血(IVH)发病率(OR=0.39,95%CI[0.24,0.64],P<0.01)、动脉导管未闭(PDA)发病率(OR=0.33,95%CI[0.17,0.67],P<0.01)及肺部感染发病率(OR=0.24,95%CI[0.14,0.38],P<0.01)差异均有统计学意义。所有研究均未报道不良反应的发生。结论现有证据表明,早产儿早期使用沐舒坦预防性治疗能有效减少RDS、BPD、IVH、PDA及肺部感染的发病率。

Objective To evaluate the efficacy and safety of ambroxol in the prevention of respiratory distress syndrome（RDS） in preterm infants.Methods Electronic searches were performed in the Cochrane Library,PubMED,EMBASE,Chinese CBM,Chinese VIP Database,Chinese Wanfang Database and Chinese CNKI Database up to the year of 2009 for randomized controlled trials（RCT） on ambroxol for the prevention of RDS in preterm infants.The meeting articles related to the RCT were manually searched in Pediatrics and Pediatric Research.Meta analysis was performed for the results of homogeneous studies by the Cochrane Collaboration′s software RevMan 5.0.17.Results Six RCTs involving 823 preterm infants were included,and the quality assessment for the trials demonstrated 1 article as A class,1 article as B class and 4 articles as C class.The Meta analysis showed that ambroxol administration significantly reduced the incidence of RDS（OR=0.24,95%CI：0.15-0.64,P0.01）,bronchopulmonary dysplasis（BPD,OR=0.41,95%CI：0.23-0.75,P0.01）,intraventricular hemorrhage（IVH,OR=0.39,95%CI：0.24-0.64,P0.01）,patent ductus arteriosus（PDA,OR=0.33,95%CI：0.17-0.67,P0.01） and pulmonary infection（OR=0.24,95%CI：0.14-0.38,P0.01）.No adverse events related to the ambroxol treatment were reported.Conclusions The current evidence shows that early use of ambroxol can reduce the risk of RDS,BPD,IVH,PDA and pulmonary infection in preterm infants.