孟鲁司特钠咀嚼片治疗小儿支气管哮喘的临床研究

Clinical study on Montelukast Sodium Chewable Tablets in treatment of infantile bronchial asthma

目的探讨孟鲁司特纳咀嚼片治疗小儿支气管哮喘的临床疗效。方法选取2013年1月—12月延安大学附属医院收治的小儿支气管哮喘患者97例,随机分为治疗组(49例)和对照组(48例),两组患儿均给予常规平喘、止咳治疗,治疗组给予孟鲁司特钠咀嚼片,5 mg/次,每晚一次。对照组给予富马酸酮替芬分散片,1 mg/次,2次/d。两组分别治疗1个月。观察两组的临床疗效,同时观察两组一秒钟用力呼气量(FEV1)/用力肺活量(FVC)、呼气高峰流量(PEFR)、肿瘤坏死因子(TNF-α)、白介素-5(IL-5)、生活质量评分的变化,比较两组患者临床症状、体征的消失时间和不良反应发生情况。结果治疗组和对照组的总有效率分别为91.84%、72.92%,两组比较差异有统计学意义(P<0.05)。治疗后,两组患儿的生活质量评分均较治疗前显著提高,同组治疗前后差异有统计学意义(P<0.05),治疗组明显高于对照组,两组比较差异有统计学意义(P<0.05)。治疗后,两组肺功能指标(FEV1/FVC、PEFR)较治疗前有显著提高,且治疗组明显高于对照组,两组比较差异有统计学意义(P<0.05)。治疗后,两组患儿气道炎症因子TNF-α、IL-5均显著降低,治疗组明显低于对照组,差异有统计学意义(P<0.05)。结论孟鲁司特钠咀嚼片对小儿支气管哮喘有较好的临床疗效,可显著改善患儿的临床症状,值得临床推广使用。

Objective To observe the clinical efficacy of Montelukast Sodium Chewable Tablets in the treatment of infantile bronchial asthma. Methods Infantile bronchial asthma patients （97 cases） in Affiliated Hospital of Yan＇an University from January to December, 2013 were randomly divided into treatment （49 cases）and control （48 cases）groups. The patients in both the groups received the conventional therapy such as antiasthmatic and antitussive therapy. Patients in the treatment group were given Montelukast Sodium Chewable Tablets, 5 mg/time, once every night. Patients in the control group were given Ketotifen Fumarate Dispersible Tablets, 1 mg/time, twice daily. All the patients were treated continuously for 1 month. The total clinical efficacy was observed, including the changes of FEV1/FVC, PEFR, TNF-α IL-5, and score of quality life. Disappeared time of clinical symptoms and signs and situation of adverse drug reactions in the two groups were compared. Results The total effective rates of the treatment and control groups were 91.84% and 72.92%, respectively, with the significant difference between the two groups （P 〈 0.05）. After the treatment, the score of quality life was higher than that before the treatment in the two groups, and the differences were statistically significant in the same group before and after the treatment （P 〈 0.05, 0.01）. The score in the treatment group was higher than that in the control group, with the significant difference between the two groups （P 〈 0.05）. After the treatment, the lung function indexes （FEV1/FVC, PEFR） were more significantly improved than before the treatment, and the indexes in the treatment group were higher than those in the control group, with significant difference between the two groups （P 〈 0.05）. After the treatment, the TNF-α and IL-5 were significantly lower than before the treatment, and the TNF-α and IL-5 in the treatment group was lower than those in the control group, with significant difference between the two groups （P 〈 0.05）. Conclusion Montelukast Sodium Chewable Tablets has a good clinical efficacy in the treatment of infantile bronchial asthma, and can significantly improve the clinical symptoms of children, which is worthy of clinical application.