环索奈德气雾剂治疗成人支气管哮喘的有效性和安全性评价

目的:评价环索奈德气雾剂治疗成人支气管哮喘的临床疗效和安全性.方法:72例轻、中度支气管哮喘患者随机分成两组,进行单盲、平行、阳性药(布地奈德)对照试验,治疗12周,以晨间PEF值作为主要评价指标,辅以夜间PEF值、FEV1值、ACQ评分、哮喘症状评分、缓解症状所需的万托林剂量等评价环索奈德的有效性;通过心电图、口咽部检查、实验室检查及不良事件数据评价环索奈德的安全性.结果:治疗前、后试验组和对照组的晨间PEF值变化差异均有显著性(P ＜ 0.05),但组间差异无统计学意义(P ＞ 0.05);试验组和对照组夜间PEF、FEV1和ACQ数据有明显改善,所需万托林的剂量显著减少,哮喘症状评分明显好转,但组间差异无统计学意义(P ＞ 0.05).试验组不良事件发生率为16.67%,对照组为13.89%,组间比较无统计学意义(P ＞ 0.05).结论:本研究证实环索奈德气雾剂1次/d,2喷/次(200 μg)治疗成人哮喘有效而且安全.

Evaluation on the efficacy and safety of ciclesonide aerosols for bronchial asthma in adults

Objective To evaluate the clinical efficacy and safety of ciclesonide aerosols for bronchial asthma in adults. Method Seventy-two patients with mild or moderate bronchial asthma were randomly assigned to 2 groups (experimental group and control group). A single-blind, parallel, clinical study for 12 weeks was conducted, with budesonide aerosols as the positive control drug. For the efficacy evaluation, morning PEF value was the primary outcome, and the PEF in night, FEV1, ACQ scores, asthmatic symptom score...