布地奈德福莫特罗粉吸入治疗成人支气管哮喘的疗效观察

目的比较布地奈德福莫特罗粉复方制剂与沙丁胺醇气雾剂联合布地奈德气雾剂吸入治疗成人中重度持续性支气管哮喘的临床疗效和安全性。方法采用随机、开放、平行对照试验，80例18～70岁哮喘患者按随机数字表法分为试验组（43例，吸入布地奈德福莫特罗粉复方制剂每吸160μg／4．5彬吸，2吸，每天2次）和对照组（37例，吸入布地奈德200μg／吸，2吸，每天2次＋沙丁胺醇100μg／吸，2吸，每天4次），观察临床症状、肺功能变化和不良事件发生情况。结果两组药物都可改善患者的哮喘症状和减少按需使用缓解药物的情况，但试验组改善更快（P〈0．05）。肺功能方面，两组患者第1秒用力呼气量（FEV1）都有所提高，但两组间无显著差异；试验组对晨间呼气峰流速（PEFam）、夜间呼气峰流速（PEFpm）提高显著快于对照组（P〈0．05）。两组不良事件的发生率无显著差异（P〉0．05）。结论布地奈德福莫特罗粉复方制剂和沙丁胺醇气雾剂联合布地奈德气雾剂用于治疗持续性支气管哮喘都具有良好的疗效和安全性。但布地奈德福莫特罗粉复方制剂改善持续性支气管哮喘效果更快、使用更方便。

Efficacy of budesonide/formoterol dry powder inhaler in the management of adult asthma

Objective To compare the efficacy and safety of budesonide/formoterol dry powder inhaler （with aerosol combination therapy in the treatment of moderate - to - severe persistent asthma. Methods In this open, randomized, parallel - group trial, 80 patients with moderate -to -severe persistent asthma, aged from 18 to 70 years, were randomizely divided into study group and control group. The study group of43 patients received budesonide/formoterel （ symbicort turbuhaler） 160 μg/4.5 μg/per inhalation twice a day via inhaler. The control group of 37 patients received budesonide 200 μg/inhalation twice a day and salbutamol aerosol 100 μg/inhalation four times a day. Clinical symptoms, pulmonary function and adverse event profiles were examined. Results Relief in asthma symptoms and rescue medication use were observed in the two groups. Improvement in symbicort turbuhaler group occurred earlier than the control group （ P 〈0. 05 ）. Forced expiratory volume in 1 s （FEV1） increased in both groups, but there was no difference between the two groups. The morning peak expiratory flow （PE- Fain） and the evening peak expiratory flow （PEFpm） increased significantly in the symbicort turbuhaler as compared to the control group （ P 〈 0.05 ）. Conclusion Budesonide/formterel dry powder inhaler provides more rapid relief and convenience when compared to the combination use of pulmicort turbuhaler and salbutamol, although both groups have good efficacy and safety.