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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5,15,30 min及1,2,4,6 h FEV1较给药前均有改善,FEV1改善率曲线下面积(ΔFEV1%-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、FEV1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 characteristics and safety of domestic inhaled aerosol salbutamol using HFA-134A propellant. Methods: A randomized, double-blind, positive drug parallel controlled trial design was used to import inhalation of aerosol salbutamol sulfate-containing aerosol containing HFA-134A as a control. Patients in the experimental group and a single inhalation of domestic salbutaline sulphate aerosol, A single inhalation of imported salbutaline sulfate aerosol, administered at different time points for lung function tests. Results: The FEV1 at 5, 15, 30 min and 1, 2, 4, and 6 h after treatment were both improved compared with those before treatment, and the area under the curve of FEV1 improvement rate (ΔFEV1% -AUC0 ~ 6h) There was no significant difference between the two groups in the onset time, the efficacy of maintenance time, the average and maximum FEV1 improvement rate, the average and maximum FVC improvement rate, the mean and maximum PEF improvement rate and other pharmacodynamic indicators, the difference No statistical significance. Both groups showed good safety and no significant difference in adverse reaction rate. CONCLUSION: The domestic pharmacokinetics of inhaled aerosol salbutamol sulphate with HFA-134A propellant is comparable to that of imported imported formulations with good safety.