复方硫酸沙丁胺醇气雾剂治疗COPD的多中心临床研究

Multicentre clinical study on domestic compound salbutamol sulfate aerosol in treatment of patients with COPD

  • 摘要: 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慢性阻塞性肺病(COPD)患者的临床疗效和安全性及两者是否生物等效。方法: 在3所医院进行多中心、随机盲法、平行对照研究。复方硫酸沙丁胺醇组(试验组)30例,可必特组(对照组)31例,两组均经气道喷雾吸入,每次2喷,4/d,疗程2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1周,2周的临床有效率分别为试验组13.33%(4/30)与23.33%(7/30),对照组19.35%(6/31)与35.48%(11/31),治疗2周后,对照组的临床控制率(19.35%)和临床有效率(35.48%)略优于试验组(10.00%和23.33%),但两组差别无显著统计学差异(P>0.05)。试验组和对照组药物不良反应发生率分别为6.67%,3.33%,无显著性统计学差异(P>0.05)。结论: 国产复方硫酸沙丁胺醇气雾剂是治疗慢性阻塞性肺病(COPD)安全有效药物,其疗效和安全性与进口可必特气雾剂相似。

     

    Abstract: Objective: To compare the efficacy and safety of compound salbutamol sulfate aerosol and Combivent in treatment of patients with COPD. Methods: This multicentre,randomized and comparative study was completed in 3 hospitals. Compound salbutamol sulfate group(test group)has 30 patients,Combivent group(control group)has 31 patients.All patiens in the two groups inhale aerosol by airway,two spurts every time,treatmented 2 weeks,and four times a day. Results: The lung function and clinical manifestation were significantly improved in both groups after treatment.The clinical efficacy rate after 1-week treatment and 2-week treatment were 13.33%(4/30)and 23.33%(7/30)in test group,respectively.In the control group,there were (19.35%)(6/31)and 35.48%(11/31),respectively.After 2-week treatment,the clinical control rate(19.35%)and clinical(efficacy) rate(35.48%)of the control group was a litter better than that of the test group(10.00%and 23.33%),but there was no statistical deference between two groups(P>0.05).The incidences of adverse reaction were 6.67%and 3.23%,respectively in the test group and control group,and didn’t reach statistical significance(P>0.05). Conclusion: Compound salbutamol sulfate aerosol is a safe and effective drug in the treatment of COPD,and the efficacy and safety of compound salbutamol sulfate aerosol is similar to that of Combivent.

     

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