【摘要】：目的:評價國產(chǎn)應(yīng)用HFA-134A拋射劑的硫酸沙丁胺醇定量吸入氣霧劑的藥效學(xué)特征及安全性。方法:采用隨機、雙盲、陽性藥物平行對照試驗設(shè)計,以進口含HFA-134A拋射劑的硫酸沙丁胺醇定量吸入氣霧劑為對照,試驗組及予單次吸入國產(chǎn)硫酸沙丁胺醇氣霧劑,對照組單次吸入進口硫酸沙丁胺醇氣霧劑,給藥后不同時間點作肺功能檢查。結(jié)果:兩組給藥后5,15,30 min及1,2,4,6 h FEV1較給藥前均有改善,FEV1改善率曲線下面積(ΔFEV1%-AUC0~6h),組間比較差異無統(tǒng)計學(xué)意義;兩組起效時間、藥效維持時間、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藥效學(xué)指標(biāo)比較,差異均無統(tǒng)計學(xué)意義。兩組均表現(xiàn)出較好的安全性且不良反應(yīng)率無統(tǒng)計學(xué)差異。結(jié)論:國產(chǎn)應(yīng)用HFA-134A拋射劑的硫酸沙丁胺醇定量吸入氣霧劑藥效學(xué)與參比進口制劑相當(dāng)且安全性較好。
[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.
【作者單位】： 四川大學(xué)華西醫(yī)院國家藥物臨床試驗機構(gòu)/GCP中心;四川大學(xué)華西醫(yī)院呼吸內(nèi)科;
【分類號】：R562.25

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