普鲁司特胶囊治疗支气管哮喘的临床疗效

Clinic Study of Pranlukast Capsule in Treating Bronchial Asthma

目的 比较国产普鲁司特胶囊与进口同类药物扎鲁司特 (安可来 )治疗支气管哮喘的临床疗效及其安全性。方法 采用双盲、随机、平行、对照方法观察 2 2 5例支气管哮喘患者用药前、后哮喘自觉症状、肺功能指标、实验室指标及不良反应。结果 两组患者治疗后第 1～ 4周的平均晨间呼气峰流速 (PEF值 )、平均夜间PEF值较治疗前均有显著性改变 (P <0 .0 0 1)。两组患者治疗后第 2、4周FEV1 值较治疗前有显著性改善 (P <0 .0 0 1)。治疗 4周后 ,两组患者的平均日间、夜间哮喘症状评分均减少明显 ,日间、夜间无症状天数的百分数增加明显。两组患者的全天无症状天数的百分数增加 ,日间、夜间两组患者使用喘乐宁气雾剂喷数减少 ;两组患者治疗期间全天未用喘乐宁气雾剂天数的百分数增加 ,两组治疗后各参数组间均无显著差异 (P >0 .0 5 )。结论 普鲁司特胶囊与安可来均能改善支气管哮喘患者的肺功能 ,减轻哮喘症状 ,不良反应轻微 。

Purpose: To compare the efficacy and safety of Pranlukast to Zafirlukast on asthmatic patients. Methods: To assess the asthmatic symptoms, pulmonary function, laboratory measurement and adverse effects of 225 patients after using study drug. Results: The average peak exporatory flow(PEF) in the morning and night improved significantly in two group patients after 1,2,3,4 weeks (P1) improved significant in two group patients after 2,4 weeks (P<0.001);average asthmatic symptoms score in the morning and night decreased significantly after 4 weeks, the percent of symptomless days in the morning and night increased significantly in two group patients, the percent of symptomless all-days increase in two group patients, the puff number of using ventolin decreased in the morning and night in two group patients. The percent of days of no using ventolin all-days increase in two group patients. Conclusions: Pranlukast could improve the pulmonary function andsymptoms in asthma patients, and its adverse effect is light, it posses satisfactory clinic effect and safety.