应用非氟里昂抛射剂的硫酸沙丁胺醇气雾剂治疗支气管哮喘的随机对照临床试验

发布时间：2018-11-10 17:01

【摘要】：目的评价应用非氟里昂抛射剂的国产硫酸沙丁胺醇气雾剂治疗支气管哮喘疗效与安全性。方法以进口硫酸沙丁胺醇气雾剂为阳性对照药,采用多中心、随机、双盲、阳性药物平行对照试验设计,试验组予以单次吸入国产硫酸沙丁胺醇气雾剂,对照组单次吸入进口硫酸沙丁胺醇气雾剂,观察给药后肺功能及症状评分改善情况。结果两组给药后15min,30min,120min,240min第一秒用力呼气容积(FEV1)较给药前均有改善,FEV1增加绝对值在给药后30min达到最大,各个时间点FEV1改善值和改善率组内比较差异有统计学意义(P0.05),组间比较均无统计学意义(P0.05);用力肺活量(FVC)、呼吸困难评分、咳嗽评分、呼气相干音评分等症状体征在用药后各个时间点较用药前均改善且差异有统计学意义(P0.05),组间比较差异无统计学意义(P0.05)。两组用药后不良反应率差异无统计学意义(P0.05),均表现出较好的安全性。结论应用非氟里昂抛射剂的国产硫酸沙丁胺醇气雾剂作为支气管哮喘缓解药物的疗效与安全性均较好。
[Abstract]:Objective to evaluate the efficacy and safety of domestic salbutamol sulfate aerosol in the treatment of bronchial asthma. Methods the imported salbutamol sulfate aerosol was used as a positive control drug. A multicenter, randomized, double-blind, parallel control trial was designed. The experimental group was given a single inhalation of domestic salbutamol sulfate aerosol. The control group inhaled the imported salbutamol sulfate aerosol and observed the improvement of pulmonary function and symptom score. Results the forced expiratory volume (FEV1) in the first second was improved in both groups 15 min after administration and 30 min after administration. The absolute value of FEV1 increased to the maximum after administration. There were significant differences in FEV1 improvement value and improvement rate between groups at each time point (P0.05), but there was no significant difference between groups (P0.05). The symptoms and signs of forced vital capacity (FVC),) dyspnea score, cough score, breath coherence score and so on were improved at each time point after treatment compared with those before medication (P0.05). There was no significant difference between the two groups (P0.05). There was no significant difference in adverse reaction rate between the two groups (P0.05), both showed good safety. Conclusion domestic salbutamol sulfate aerosol with non-Freon ejector is effective and safe for relieving bronchial asthma.
【作者单位】：四川大学华西医院GCP中心;四川大学华西医院呼吸内科;海南省人民医院呼吸科;河北省人民医院呼吸科;西安交通大学第二附属医院呼吸科;昆明医学院第一附属医院呼吸科;
【分类号】：R562.25

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