沐舒坦预防早产儿呼吸窘迫综合征的Meta分析

张志群; 黄先玫; 芦惠

PDF(1328 KB)

中国当代儿科杂志 ›› 2010, Vol. 12 ›› Issue (11) : 858-863.

论著·临床研究

沐舒坦预防早产儿呼吸窘迫综合征的Meta分析

张志群，黄先玫，芦惠

作者信息 +

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

ZHANG Zhi-Qun, HUANG Xian-Mei, LU Hui

Author information +

文章历史 +

摘要

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RevMan 5.0.17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。［中国当代儿科杂志，2010，12（11）：858-863］

Abstract

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, P＜0.01), bronchopulmonary dysplasis (BPD, OR=0.41, 95%CI: 0.23 - 0.75, P＜0.01), intraventricular hemorrhage (IVH, OR=0.39, 95%CI:0.24 - 0.64, P＜0.01), patent ductus arteriosus (PDA, OR=0.33, 95%CI: 0.17 - 0.67, P＜0.01) and pulmonary infection (OR=0.24, 95%CI:0.14 - 0.38, P＜0.01). 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.［Chin J Contemp Pediatr, 2010, 12 (11):858-863］

导出引用

张志群, 黄先玫, 芦惠. 沐舒坦预防早产儿呼吸窘迫综合征的Meta分析[J]. 中国当代儿科杂志. 2010, 12(11): 858-863

ZHANG Zhi-Qun, HUANG Xian-Mei, LU Hui. Ambroxol for the prevention of respiratory distress syndrome in preterm infants: a Meta analysis[J]. Chinese Journal of Contemporary Pediatrics. 2010, 12(11): 858-863

中图分类号： R725.6

参考文献

［1］Miracle X, Di Renzo GC, Stark A, Fanaroff A, Carbonell-Estrany X, Saling E. Guideline for the use of antenatal corticosteroids for fetal maturation［J］.J Perinat Med, 2008, 36 (2):191-196.
［2］Jobe AH. Pulmonary surfactant therapy［J］. N Engl J Med, 1993, 328（8）:861-868.
［3］Henderson-Smart DJ, Wilkinson A, Raynes-Greenow CH. Mechanical ventilation for newborn infants with respiratory failure due to pulmonary disease［DB/OL］.Cochrane Database Syst Rev, 2002, (4):CD002770.
［4］Soll RF, Morley CJ. Prophylactic versus selective use of surfactant in preventing morbidity and mortality in preterm infants［DB/OL］.Cochrane Syst Rev, 2001, (2):CD00510.
［5］Disse BG, Ziegler HW. Pharmacodynamic mechanism and therapeutic activity of ambroxol in animal experiments［J］.Respiration, 1987, 51(Suppl 1):15-22.
［6］Allegra L, Bossi R, Braga P. Influence of surfactant on mucociliary transport［J］.Eur J Respir Dis, 1985, 67(Suppl 142):71-76.
［7］Robertson B. Pharmacological stimulation of surfactant secretion and surfactant replacement［J］. Eur J Respir Dis, 1985, 67(Suppl 142):63-70.
［8］Pfeifer S, Zissel G, Kienast K, Müller-Quernheim J. Reduction of cytokine release of blood and bronchoalveolar mononuclear cells by ambroxol［J］.Eur J Med Res, 1997, 2（3）:129-132.
［9］Weiser T, Wilson N. Inhibition of tetrodotoxin (TTX)-resistant and TTX-sensitive neuronal Na+ channels by the secretolytic ambroxol［J］. Mol Pharmacol, 2002, 62 (3):433-438.
［10］Weiser T.Comparison of the effects of four Na+ channel analgesics on TTX-resistant Na+ currents in rat sensory neurons and recombinant［J］. Neurosci Lett, 2006, 395（3）:179-184.
［11］Fabbri L, Pauwels RA, Hurd SS; GOLD Scientific Committee. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary updated 2003［J］.COPD, 2004, 1(1):105-141.
［12］Poole PJ, Black PN. Oral mucolytic drugs for exacerbations of chronic obstructive pulmonary diseases: systematic review［J］.BMJ, 2001, 322（7297）:1271-1274.
［13］Malerba M,Ponticiello A, Radaeli A, Bensi G, Grassi V. Effect of twelve-months therapy with oral ambroxol in preventing exacerbations in patients with COPD.Double-blind, randomized, multicenter,placebo-controlled study［J］.Pulm Pharmacol Ther, 2004, 17（1）:27-34.
［14］Luerti M, Lazzarin A, Corbella E, Zavattini G. An alternative to steroids for prevention of respiratory distress syndrome (RDS): Multicenter controlled study to compare ambroxol and betamethasone［J］.J Perinat Med, 1987, 15（3）:227-238.
［15］Wauer RR, Schmalisch G, B-hme B, Arand J, Lehmann D. Randomized double blind trial of ambroxol for the treatment of respiratory distress syndrome［J］.Eur J Pediatr, 1992, 151（5）:357-363.
［16］Fegiz G.Prevention by ambroxol of bronchopulmonary complications after upper abdominal surgery: double-blind Italian multicenter clinical study versus placebo［J］.Lung, 1991, 169（1）:69-76.
［17］Higgins JPT, Green S. Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.17［updated Dec 2008］［DB/OL］.The Cochrane Collaboration, 2008.Available at www.cochranehandbook.org.
［18］庄婉珠,陈冬梅,郭贞美,施燕禧.早产儿早期预防性应用盐酸氨溴索后肺氧合功能变化的随机对照研究［J］.福建医药杂志, 2004, 26（5）:3-5.
［19］李珊,陈晶,刘恒,盛红.沐舒坦在预防早产儿呼吸窘迫综合征中的疗效观察［J］.中国当代儿科杂志,2004, 6（5）:425-426.
［20］秦素芳,张红梅,方炜.沐舒坦预防早产儿呼吸窘迫综合征的临床疗效分析［J］.中国妇幼保健,2007, 22(35):5006-5007.
［21］胡琴,连金媚,李俭庆.沐舒坦不同给药方式预防早产儿呼吸窘迫综合证疗效观察［J］.中国当代儿科杂志,2006, 8（4）:301-303.
［22］蒋曙红,顾春艳,蒋惠芬,祁斌.沐舒坦预防早产儿肺透明膜病的疗效观察［J］.同济大学学报(医学版),2006, 27（5）:86-87.
［23］Marini A, Franzetti M, Gios G, Flauto U, Arosio A, Maccabruni M, et al. Ambroxol in the treatment of idiopathic respiratory distress syndrome. An interim report on a controlled double-blind multicenter study versus placebo［J］.Respiration, 1987, 51（Suppl 1）:60-67.
［24］Wauer RR, Schmalisch G, Hammer H, Buttenberg S, Weigel H, Huth M.Ambroxol for prevention and treatment of hyaline membrane disease［J］.Eur Respir J Suppl, 1989, 3（1）:57-65.
［25］Wauer RR, Schmalisch G, Kurze D, Rachmann B, Grauel EL.The use of ambroxol (bromhexine metabolite VIII) in the prevention and treatment of hyaline membrane disease (HMD)［J］.EJOG, 1983, 15（4）:421-424.