孟鲁司特钠片联合布地奈德福莫特罗粉吸入剂治疗支气管哮喘的临床研究

Clinical trial of montelukast sodium tablets combined with budesonide and formoterol fumarate powder for inhalation in the treatment of bronchial asthma

目的观察孟鲁司特钠片联合布地奈德福莫特罗粉吸入剂治疗支气管哮喘的临床疗效及安全性。方法将120例支气管哮喘患者随机分为对照组60例和试验组60例。对照组予以布地奈德福莫特罗粉吸入剂每次320μg/9μg,bid,经口吸入;试验组在对照组治疗的基础上,予以孟鲁司特钠每次10 mg,qd,睡前口服。2组患者均治疗12周。比较2组患者的临床疗效、肺功能,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为93.33%(56例/60例)和73.33%(44例/60例),差异有统计学意义(P<0.01)。治疗后,试验组和对照组的第1秒用力呼气容积分别为(3.05±0.76)和(2.54±0.81)L,用力肺活量分别为(4.34±0.92)和(3.59±0.99)L,呼气峰流速分别为(5.08±1.36)和(3.94±1.22)L,差异均有统计学意义(均P<0.01)。2组患者的药物不良反应以恶心口干、眩晕嗜睡和腹泻呕吐为主,试验组和对照组的总药物不良反应发生率分别为30.00%和21.67%,差异无统计学意义(P>0.05)。结论孟鲁司特钠片联合布地奈德福莫特罗粉吸入剂治疗支气管哮喘的临床疗效确切,其可显著提高患者的肺功能,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of mon- telukast sodium tablets combined with budesonide and formoterol fumarate powder for inhalation in the treatment of bronchial asthma. Methods A total of 120 bronchial asthma patients were randomly divided into control group and treatment group with 60 cases per group. Control group was given budesonide and formoterol fumarate powder for inhalation 320 μg/9μg every time, b/d, oral inhalation. Treatment group was given monte- lukast sodium 10 mg every night, orally. Two groups were treated for 12 weeks. The clinical efficacy, pulmonary function and adverse drug reactions were compared between two groups. Results After treatment, the total effective rate of treatment group and control group were 93.33% （56 cases/60 cases） and 73.33% （44 cases/60 cases） with significant difference （P 〈 0.01 ）. After treatment, the forced expiratory volume in 1 secOnd, forced vital capacity and peak expiratory flow in treatment and control groups were （3.05 ± 0.76） and （2.54 ± 0.81 ） L, （4.34±0.92） and （3.59 ±0.99） L, （5.08 ± 1.36） and （3.94 ± 1.22） L, with significant differences （ all P 〈 0. 01 ） . Theadverse drug reactions in two groups were mainly concentrated on nausea, dry mouth, dizziness, drowsiness, diarrhea, vomiting. The incidences of adverse drug reactions in treatment and control groups were 30. 00% and 21.67% without significant difference （P 〉 0. 05）. Conclusion Montelukast sodium tablets combined with budesonide and formoterol fumarate powder for inhalation have a definitive clinical efficacy in the treatment of bronchial asthma, which can significantly improve the lung function, without increasing the incidences of adverse drug reactions.