环索奈德气雾剂治疗轻中度哮喘疗效观察

目的:评价环索奈德(CIC)气雾剂治疗轻中度哮喘的有效性和安全性。方法:采用多中心、随机、单盲、平行、阳性药物对照研究方法。将229例轻中度哮喘患者随机分为试验组与对照组,试验组给予国产CIC200μgqd治疗8周,对照组给予国产布地奈德(BUD)200μgbid治疗8周。观察治疗前、后晨间最大呼气流量(PEF)、夜间PEF、第1秒用力呼气容积(FEV1)、哮喘症状评分及缓解症状药物用量等指标。结果:经8周治疗后,2组晨间PEF、夜间PEF、FEV1、哮喘症状评分及缓解症状药物用量等指标较治疗前均有显著改善(P<0.05),但2组间的改善值差异无统计学意义(P>0.05)。主要不良反应是咽部发痒、疼痛和声音嘶哑,2组不良事件发生率差异无统计学意义(P>0.05)。结论:每天200μgCIC治疗轻中度哮喘与每天使用400μgBUD的疗效相当,且患者依从性更好。

Clinical Efficacy of Ciclesonide Aerosol in the Treatment of Mild-moderate Asthma

OBJECTIVE： To evaluate the efficacy and safety of ciclesonide（CIC） aerosol in the treatment of mild-moderate asthma. METHODS： A multi-centre, randomized, single-blinded, parallel method was applied for study with positive drugs as control. 229 patients with mild-moderate asthma were randomized into trial group and control group. Trial group were given 200 μg CIC once a day for 8 weeks and control group were given 200 μg BUD twice a day for 8 weeks. Peak expiratory flow（PEF） in the morning, PEF at night, forced expiratory volume at 1st second （FEV1） and symptom score were observed before and after treatment as well as drug dosage. RESULTS： After 8 weeks of treatment, PEF in the morning and the evening, FEV1 and symptom score in both groups were improved significantly（P0.05）. There was no statistical significance（P0.05）. Main manifestations of adverse reaction were scratchy sore throat and hoarseness of voice. There was no statistical significance（P0.05）.CONCLUSION： CIC daily dose of 200 μg and BUD daily dose of 400 μg have the same effect on mild-moderate asthma,and with better compliance.