孟鲁司特钠联合布地奈德治疗小儿支气管哮喘的临床研究

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

目的 观察孟鲁司特钠颗粒联合布地奈德混悬液治疗小儿支气管哮喘的疗效及血清CD5抗原样蛋白(CD5L)、高迁移率族蛋白B1(HMGB1)水平变化。方法 将支气管哮喘患儿随机分为对照组及试验组,2组患儿均实施常规治疗,在上述基础上,对照组给予布地奈德混悬液雾化吸入治疗,1~2 mg,qd;试验组在对照组治疗的基础上联合孟鲁司特钠颗粒治疗,5 mg,qd。2组均连续治疗14 d。比较2组患儿临床疗效、气道炎症反应[呼出气一氧化氮(FeNO)、嗜酸粒细胞阳离子蛋白(ECP)、脂质过氧化物(LPO)]、肺功能[第1秒用力呼气容积(FEV1)、呼气峰流量(PEF)]以及血清CD5L、HMGB1水平,并统计药物不良反应发生情况。结果 对照组和试验组分别入组100例。治疗14 d后,对照组和试验组的总有效率分为72.00%和91.00%,差异有统计学意义(P<0.05)。治疗14 d后,对照组和试验组的血清FeNO表达水平分别为(23.51±3.02)和(15.41±1.68)ppb, ECP分别为(12.59±1.56)和(9.48±1.41)ng·L^(-1),LPO表达水平分别为(10.96±1.68)和(7.69±0.89)mmol·L^(-1),FEV1分别为(1.42±0.27)和(1.64±0.32)L,PEF分别为(3.52±0.41)和(3.89±0.56)L·s^(-1),血清CD5L表达水平分别为(175.23±22.72)和(196.45±25.38)ng·L^(-1),HMGB1表达水平分别为(6.37±0.89)和(4.41±0.62)ng·mL^(-1);试验组的上述指标与对照组比较,差异均有统计学意义(均P<0.05)。在治疗期间,对照组和试验组的药物不良反应总发生率分别为6.00%和7.00%,差异无统计学意义(P>0.05)。结论 支气管哮喘患儿应用孟鲁司特钠颗粒、布地奈德混悬液联合治疗,疗效确切,可改善气道炎症反应,调节血清CD5L、HMGB1水平,且安全性良好。

Objective To explore the efficacy of montelukast sodium granules combined with budesonide suspension in the treatment of children with bronchial asthma and the changes of serum cluster of differentiation 5 antigen-like(CD5L)and high mobility group box 1(HMGB1)levels.Methods Children with bronchial asthma were selected as the research subjects,and randomly divided into control group and treatment group.All patients were given conventional treatments.On this basis,the control group was given budesonide suspension atomization inhalation treatment,1-2 mg,qd.Patients in the treatment group were treated with montelukast sodium granules on the basis of the control group,5 mg,qd.All patients were treated for 14 d.The clinical efficacy,airway inflammation response[fractional exhaled nitric oxide(Fe NO),eosinophil cationic protein(ECP)and lipid peroxide(LPO)],lung function[forced expiratory volume in the first second(FEV1)and peak expiratory flow(PEF)],serum CD5L and HMGB1 levels and adverse drug reactions were compared between two groups.Results The control group and the treatment group were enrolled in 100 cases respectively.After treatment,the total clinical response rates of the control group and the treatment group were 72.00%and 91.00%;serum Fe NOlevels were(23.51±3.02)and(15.41±1.68)ppb;ECP levels were(12.59±1.56)and(9.48±1.41)ng·L^(-1);LPO levels were(10.96±1.68)and(7.69±0.89)mmol·L^(-1);FEV1 was(1.42±0.27)and(1.64±0.32)L;PEF was(3.52±0.41)and(3.89±0.56)L;serum CD5L levels were(175.23±22.72)and(196.45±25.38)ng·L^(-1);HMGB1 levels were(6.37±0.89)and(4.41±0.62)ng·mL^(-1).The above indexes were significantly different between the control group and the treatment group(all P<0.05).The incidence rates of total adverse drug reactions in the treatment group and the control group were 6.00%and 7.00%,without statistically significant differences between groups(P>0.05).Conclusion Montelukast sodium granules combined with budesonide suspension is effective in the treatment children with bronchial asthma,which can improve airway inflammation response,and regulate serum CD5L and HMGB1 levels,with good safety.