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

发布时间：2018-09-14 14:11

【摘要】：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。
[Abstract]:Aim: to evaluate the pharmacodynamics and safety of domestic salbutamol sulfate aerosol inhaled with HFA-134A ejector. Methods: a randomized, double-blind, positive drug parallel controlled design was used. The imported salbutamol sulfate aerosol was used as the control. The experimental group and single inhalation of domestic salbutamol sulfate aerosol were used as the control. In control group, salbutamol sulfate aerosol was inhaled once, and pulmonary function was examined at different time points after administration of salbutamol sulfate. Results: there was no significant difference in the area under the curve of FEV1 improvement rate (螖 FEV1%-AUC0~6h) between the two groups after 5: 1530 min and 1 1 + 2X 4h FEV1 before administration, and the onset time of the two groups was not statistically significant, and the effect time of the two groups was higher than that of the control group (P < 0. 05), but the difference was not significant between the two groups. There was no significant difference in the mean and maximum improvement rate of FEV1 and the average value of the improvement rate of FVC and the average and maximum value of PEF improvement rate between the two groups. Both groups showed good safety and no significant difference in adverse reaction rate. Conclusion: the pharmacodynamics of domestic salbutamol sulfate aerosol inhaled with HFA-134A ejector is comparable to that of reference preparation and the safety is good.
【作者单位】：四川大学华西医院国家药物临床试验机构/GCP中心;四川大学华西医院呼吸内科;
【分类号】：R562.25

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