孟鲁司特钠联合布地奈德治疗儿童哮喘的临床研究

Clinical trial of montelukast sodium combined with budesonide in the treatment of childhood asthma

目的观察孟鲁司特钠联合布地奈德治疗儿童哮喘的临床疗效及安全性。方法将84例哮喘患儿随机分为对照组42例和试验组42例。对照组予以布地奈德每次200μg,qd;试验组在对照组的基础上,加用孟鲁司特钠,3~6岁4mg·d^(-1),6~14岁5 mg·d^(-1),晚上顿服。2组患儿疗程均为3个月,并随访3个月。治疗期间,2组患儿若有哮喘急性发作,则加用复方异丙托溴铵吸入治疗,3~6岁每次50μL,每天4次;6~14岁每次100μL,每天4次,持续天数视病情而定。比较2组患儿的临床疗效、肺功能、血清总免疫球蛋白E(Ig E)水平变化情况、治疗期间哮喘急性发作情况和复方异丙托溴铵使用情况,以及不良反应发生情况。结果治疗后,试验组的总有效率为92.86%显著高于对照组的73.81%(P<0.05)。试验组的肺功能改善情况及血清总Ig E水平下降情况均显著优于对照组(P<0.05)。治疗期间,试验组哮喘急性发作次数及复方异丙托溴铵使用天数均显著少于对照组(P<0.05)。2组患儿不良反应发生率比较差异无统计学意义(P>0.05)。结论孟鲁司特钠联合布地奈德治疗能有效地缓解儿童哮喘的临床症状、改善肺功能、降低血清总Ig E,且不增加不良反应的发生率。

Objective To evaluate the clinical efficacy and safety of montelukast sodium combined with budesonide in the treatment of childhood asthma. Methods Eighty- four patients with childhood asthma were randomly divided into control group（ n = 42） and treatment group（ n = 42）. Control group was treated with budesonide 200 μg,qd.Treatment group was received budesonide 200 μg,qd and montelukast sodium 4 mg · d^-1（ 3- 6 years）,5 mg·d^-1（ 6- 14 years）,every night. The treatment of two groups was 3 months,and follow up for 3months. During the treatment, two groups were received compound ipratropium bromide 200 μL·d^-1（ 3- 6 years）,400 μL·d^-1（ 6- 14years） for acute asthma attack,continuous days depending on the severity of the disease. The clinical efficacy,lung function,levels of total serum immunoglobulin E（ Ig E）,acute attacks of asthma,the use of compound ipratropium bromide,and the incidence of adverse drug reactions were compared between two groups. Results After treatment, the total efficacy rates of treatment group was 92. 86%,which was significantly higher than 73. 81% in control group（ P〈0. 05）. The degrees of theimprovement of lung function and the decrease of the levels of total serum Ig E in treatment group were significantly better than those in control group（ P〈0. 05）. During the treatment,the acute attacks of asthma and the days of use compound ipratropium bromide in treatment group were significantly less than those in the control group（ P〈0. 05）. There was no significant difference with incidence of adverse drug reactions between two groups（ P〈0. 05）. Conclusion Montelukast sodium combined with budesonide have a definitive clinical efficacy for the treatment of childhood asthma,which may improve lung function and total serum Ig E,and without increasing the incidence of adverse drug reactions.