【摘要】：目的評價應(yīng)用非氟里昂拋射劑的國產(chǎn)硫酸沙丁胺醇氣霧劑治療支氣管哮喘療效與安全性。方法以進口硫酸沙丁胺醇氣霧劑為陽性對照藥,采用多中心、隨機、雙盲、陽性藥物平行對照試驗設(shè)計,試驗組予以單次吸入國產(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,觀察給藥后肺功能及癥狀評分改善情況。結(jié)果兩組給藥后15min,30min,120min,240min第一秒用力呼氣容積(FEV1)較給藥前均有改善,FEV1增加絕對值在給藥后30min達到最大,各個時間點FEV1改善值和改善率組內(nèi)比較差異有統(tǒng)計學(xué)意義(P0.05),組間比較均無統(tǒng)計學(xué)意義(P0.05);用力肺活量(FVC)、呼吸困難評分、咳嗽評分、呼氣相干音評分等癥狀體征在用藥后各個時間點較用藥前均改善且差異有統(tǒng)計學(xué)意義(P0.05),組間比較差異無統(tǒng)計學(xué)意義(P0.05)。兩組用藥后不良反應(yīng)率差異無統(tǒng)計學(xué)意義(P0.05),均表現(xiàn)出較好的安全性。結(jié)論應(yīng)用非氟里昂拋射劑的國產(chǎn)硫酸沙丁胺醇氣霧劑作為支氣管哮喘緩解藥物的療效與安全性均較好。
[Abstract]:Objective to evaluate the efficacy and safety of domestic salbutamol sulfate aerosol in the treatment of bronchial asthma. Methods the imported salbutamol sulfate aerosol was used as a positive control drug. A multicenter, randomized, double-blind, parallel control trial was designed. The experimental group was given a single inhalation of domestic salbutamol sulfate aerosol. The control group inhaled the imported salbutamol sulfate aerosol and observed the improvement of pulmonary function and symptom score. Results the forced expiratory volume (FEV1) in the first second was improved in both groups 15 min after administration and 30 min after administration. The absolute value of FEV1 increased to the maximum after administration. There were significant differences in FEV1 improvement value and improvement rate between groups at each time point (P0.05), but there was no significant difference between groups (P0.05). The symptoms and signs of forced vital capacity (FVC),) dyspnea score, cough score, breath coherence score and so on were improved at each time point after treatment compared with those before medication (P0.05). There was no significant difference between the two groups (P0.05). There was no significant difference in adverse reaction rate between the two groups (P0.05), both showed good safety. Conclusion domestic salbutamol sulfate aerosol with non-Freon ejector is effective and safe for relieving bronchial asthma.
【作者單位】： 四川大學(xué)華西醫(yī)院GCP中心;四川大學(xué)華西醫(yī)院呼吸內(nèi)科;海南省人民醫(yī)院呼吸科;河北省人民醫(yī)院呼吸科;西安交通大學(xué)第二附屬醫(yī)院呼吸科;昆明醫(yī)學(xué)院第一附屬醫(yī)院呼吸科;
【分類號】：R562.25

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