沙丁胺醇吸入粉雾剂与气雾剂治疗支气管哮喘的随机对照多中心研究

A randomized controlled, multicenter study of salbutamol inhalation power and aerosol in treatment of asthma

目的比较沙丁胺醇吸入粉雾剂与吸入气雾剂治疗中、重度支气管哮喘的临床疗效和安全性。方法采用随机、单盲、多中心阳性对照临床试验方法。共入选219例中、重度支气管哮喘患者,随机分为两组。试验组患者通过茜乐装置吸入沙丁胺醇吸入粉雾剂400μg(2吸),对照组通过储雾罐吸入沙丁胺醇气雾剂400μg(4吸)。检测两组吸药后15、30、45、60、120、180、240 min不同时间点第一秒用力呼气容积(FEV1)、用力肺活量(FVC)和最大呼气流速(PEF)值,计算FEV1、FVC和PEF曲线下面积,观察肺部症状及体征变化及不良事件发生情况。结果吸药后两组各时间点FEV1、FVC和PEF均较治疗前改善(P<0.05),作用均可持续4 h,组间无显著差异(P>0.05),两组FEV1、FVC和PEF曲线下面积亦无显著差异(P>0.05)。两组患者吸药后咳嗽、呼吸困难及肺部干啰音均有不同程度的改善,组间无显著差异(P>0.05)。两组不良事件的发生率相似,试验组为11.4%,对照组为13.4%,与药物相关不良事件的发生率分别为0.9%和对照组5.4%,组间差异均无显著意义(P>0.05)。整个研究过程两组均无严重不良事件发生。结论同等剂量沙丁胺醇吸入粉雾剂与气雾剂通过茜乐干粉吸入器和储雾罐吸入,均可明显改善中、重度支气管哮喘患者的肺功能和肺部症状,安全性较好。

AIM To observe the efficacy and safety of salbutamol inhalation power and aerosol on moderate-severe bronchial asthma. METHODS A multi-centre, randomize, mono-blind, positive comparative clinical study was performed in 219 patients with moderate- severe asthma. Patients were randomized to two groups. The patients in the trial group inhaled salbutamol inhalation power 400 μg （2 puff） via Easyhaler. The patients in the control group inhaled salbutamol aerosol 400 txg （4 puff） via spacer. The value of forced expiratory volume in one second （FEV1） , forced vital capacity （FVC）, peak expiratory flow （PEF） after inhalation 15, 30, 45, 60, 120, 180 and 240 min were tested and the area under curve of FEV1, FVC, PEF were computed. The changes of lung symptoms, signs and adverse events were also observed. RESULTS Compared with baseline, there were significantly improvements of FEV1, FVC and PEF after inhalation 15, 30, 45, 60, 120, 180 and 240 min in both groups （P 〈 0.05）, with no significant differences between two groups （P 〉 0.05）. The efficacy at least continued 4 hour. There was no difference in area under curve of FEVI, FVC, PEF between two groups （P 〉 0.05）. The lung symptoms and signs （including cough, dyspnoea and lung rales） were improved with some extent after inhalation study drugs in both groups, but there was no statistical differences between two groups （P 〉 0.05）. The rates of adverse events of the trial group and control group were 11.4% and 13.4% （P 〉 0.05）, and the drug-related adverse event rates were 0.9% and 5.4% （P 〉 0.05） . No severe adverse event occurred through the whole study. CONCLUSION Isodose salbutamol inhalation power via Easyhaler and aerosol via spacer both can improve significantly pulmonary function, lung symptoms and signs of patients with moderate-severe bronchial asthma and are safety.