Evaluation Of The Clinical Efficacy And Safety Of Montelukast For Asthma Or Wheeze Infant In Aged 2 Years Or Younger

Objective:To evaluate the clinical therapeutic efficacy and safety of montelukast to asthma or wheeze infant in aged 2 years and younger.Methods:The database of PubMed(1966 to March 2010), Cochrane Library (Issue3, 2010), EMBASE(1974 to March 2010), VIP(1989 to March 2010), CNKI(1994 to March 2010), WANFANG Database(1978 to March 2010) and Databases of ongoing trials-Current Controlled Trials were used to search the target literature of asthma or wheeze infant in aged 2 years and younger treated by Montelukast. Meanwhile, the correlated academic meeting proceedings, documents of pharmaceutical factory and the reference of all searched literature acted as the information resource. According to the inclusion criteria of target randomized controlled trials (RCTs), the RCTs were collected to evaluate initially the quality of study methodology according to the Cochrane Handbook 5.0.2 for Systematic Reviews of Interventions, and the valid data were used to evaluate the clinical therapeutic efficacy and safety of montelukast for asthma or wheeze patients in aged 2 years or younger.Results:We searched 906 citations,6 RCTs including 1372 patients that corresponded to the inclusion criteria were enrolled. Two RCTs have high dropouts or withdrawals (21.7%,32.1% respectively). There were clinical heterogeneity in six included RCTs, we could not do Meta-analysis and only describe the results of every trial.â‘ No RCT reported the asthma-related mortality.â‘¡There was no significant difference between the montelukast and placebo in the score of clinical symptom and therapeutic dose of alleviating asthma (P>0.05).â‘¢There was no significant difference between the montelukast and placebo in the adverse effects such as diarrhea, fever, vomiting and increased alanine aminotransferase and so on (P>0.05). Conclusions:The results indicated that the strong evidence of curing asthma or wheeze patients with different doses of montelukast in aged 2 years or younger could be insufficiency, but the therapeutic doses of montelukast 4mg or 8mg and time of therapy could have favorable safety and tolerability.