国产与进口含HFA-134A抛射剂的硫酸沙丁胺醇气雾剂对哮喘肺功能影响的比较

Pharmacodynamic evaluation of salbutamol sulfate metered-dose inhalers with HFA-134A propellant

目的：评价国产应用HFA-134A抛射剂的硫酸沙丁胺醇定量吸入气雾剂的药效学特征及安全性。方法：采用随机、双盲、阳性药物平行对照试验设计，以进口含HFA-134A抛射剂的硫酸沙丁胺醇定量吸入气雾剂为对照，试验组及予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，给药后不同时间点作肺功能检查。结果：两组给药后5，15，30min及1，2，4，6hFEV，较给药前均有改善，FEV。改善率曲线下面积（AFEV，％-AUC0-6h），组间比较差异无统计学意义；两组起效时间、药效维持时间、FEV，改善率平均值及最大值、FVC改善率平均值及最大值、PEF改善率平均值及最大值等药效学指标比较，差异均无统计学意义。两组均表现出较好的安全性且不良反应率无统计学差异。结论：国产应用HFA-134A抛射剂的硫酸沙丁胺醇定量吸入气雾剂药效学与参比进口制剂相当且安全性较好。

Objective： To evaluate the pharmacodynamic property and safety of domestic salbutamol sulfate MDI with HFA-134A in asthmatic patients. Methods： A randomized, double-blind, positive controlled clinical tri- al was conducted in asthmatic patients. They were randomized to inhale single dose of 200 μg domestic salbutamol sulfate MDI or same dose of imported salbutamol sulfate MDI. Lung function tests were conducted pre-doing and at 5, 15, 30 minutes and I, 2, 4, 6 hours post-dosing. Results： Totally 54 patients were enrolled into the trial. Both drugs showed equivalent time-dependent bronchodilator responses as measured by area under curve over 6 hours of percentage change in FEV1. Other pharmacodynamic parameters including time to onset of action, duration of bron- chodilation response, mean and maximum change rate of FEV1 , FVC and PEF values were similar between the two groups. Both drugs were well tolerated, with no significant difference in the incidence of adverse reactions between the two groups. Conclusion： The tested domestic salbutamol sulfate HFA-134A MDI produced similar bronchodila- tion response and safety as the imported product.