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

A Muti-center, Randomized, Double-blind, Positive Controlled Clinical Trial of Salbutamol Sulfate MDI without

中文关键词:  定量吸入气雾剂 抛射剂替代 硫酸沙丁胺醇 多中心临床试验 支气管哮喘

英文关键词:MDI Propellant replacement Salbutamol Sulfate Multi-center clinical trial Asthma

中文摘要:

      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15 min，30 min，120 min，240 min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30 min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(P<0.05)，组间比较均无统计学意义(P >0.05)；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(P <0.05)，组间比较差异无统计学意义(P>0.05)。两组用药后不良反应率差异无统计学意义(P>0.05)，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。

英文摘要:

      【Abstract】 Objective To evaluate the efficacy and safety of domestically produced Salbutamol Sulfate metered dose inhaler (MDI) without chloro-fluro-carbon (CFC) in the treatment of asthmatic patients. Methods A muti-center,randomized, double-blind, positive controlled clinical trial was conducted in asthmatic patients. The participants were randomized divided into trial group treated with domestically produced Salbutamol Sulfate Aerosol MDI (200 μg single-dose) and control group treated with imported Salbutamol Sulfate Aerosol MDI (200 μg single-dose). The lung function was measured by spirometry and a scoring questionaire before medications and 15, 30, 120 and 240 min post medications. Results A total of 238 patients were enrolled in the trial. Compared with baselines, the forced expiratory volume in 1 s (FEV₁) of the participants in both groups increased significantly 15, 30, 120 and 240 min after medications (P<0.05). There was no significant difference in the changes of FEV₁ between the two groups (P>0.05). Similarly, the forced vital capacity (FVC) and asthma symptomatic scores of the participants in both groups improved significantly after administration of medications (P<0.05). There was no significant difference in the ratio of adverse reactions between the two groups (P>0.05). In both groups, drugs were well tolerated. Conclusion The domestically produced Salbutamol Sulfate Aerosol MDI without CFC is effective and safe for treating asthma.