复方硫酸沙丁胺醇气雾剂治疗哮喘的多中心临床研究

Multicentre clinical study on indigenous compound salbutamol sulfate aerosol in treatment of patients with asthma

目的评价国产复方硫酸沙丁胺醇气雾剂与进口可必特气雾剂治疗轻、中度支气管哮喘患者的临床疗效和安全性及两者是否生物等效。方法在三所医院进行多中心、随机盲法、平行对照研究。完成实验的哮喘患者共72例,复方硫酸沙丁胺醇组(试验组)37例,可必特组(对照组)35例,两组均经气道喷雾吸入,每次2喷,1日3次,疗程1周。结果与治疗前比较,试验组和对照组肺功能和临床表现均明显改善。治疗3、7天的临床有效率分别为:试验组22/37(59.46%)和31/37(83.78%),对照组19/35(54.29%)与28/35(80.00%),治疗1周后,对照组的临床控制率(24.32%)和临床有效率(83.78%)略优于试验组(14.29%和80.00%),但两组差异无显著性(P>0.05)。试验组和对照组药物不良反应发生率分别为5.41%、8.57%,两组差异无显著性(P>0.05)。结论国产复方硫酸沙丁胺醇气雾剂能有效改善哮喘患者的症状,并且其疗效和安全性与进口可必特气雾剂相似,治疗轻、中度支气管哮喘安全有效。

Objective To compare the efficacy and safety of indigenous compound salbutamol sulfate aerosol and imported Combivent in the treatment of patients with asthma. Methods A multi-centre, randomized and parallel comparative study was conducted involving, 3 hospitals. A total of 72 patients with low- and middle-grade asthma were enrolled in this study. 37 patients were allocated to compound salbutarnol sulfate group （test group）, and 35 patients were in Combivent group （control group）. All patients in the two groups inhaled aerosol with two spurts each time and three times a day. The whole treatment lasted one week. Results The lung function and the clinical manifestations were significantly improved in both groups after the treatment. The clinical efficacy rates at 3-day and 7-day after treatment were 59.46% （22/37） and 83. 78% （31/37） in the test group, respectively. In the control group, they were 54. 29% （19/35） and 80. 00% （28/35）, respectively. Seven days after treatment, the clinical control rate （24. 32%） and the clinical efficacy rate （83. 78%） in control group was a little better than that in the test group （14. 29% and 80. 00%）, but there was no statistically significant deference between two groups （P〉0. 05）. The incidence of adverse reaction was 5. 41% and 8. 57 %, respectively in the test group and the control group, and they did not reach statistical significance （P〉0. 05）. Conclusion Compound salbutamol sulfate aerosol was able to improve the symptoms of patients with asthma, and the efficacy and safety of this drug are similar to that of Combivent. The results indicated that compound salbutamol sulfate aerosol may be a safe and effective drug in the treatment of asthma.