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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。
PURPOSE: To evaluate the efficacy and safety of ciclesonide (CIC) aerosol in the treatment of mild to moderate asthma. Methods: Multi-center, randomized, single-blind, parallel, positive drug control study methods. 229 mild to moderate asthma patients were randomly divided into experimental group and control group. The experimental group was given domestic CIC200μgqd for 8 weeks, while the control group was given domestic budesonide (BUD) 200μgbid for 8 weeks. The maximum expiratory flow (PEF), nocturnal PEF, forced expiratory volume at 1 second (FEV1), asthma symptom scores and the dose of symptomatic drugs were observed before and after treatment. Results: After 8 weeks of treatment, the indexes of PEF, nocturnal PEF, FEV1, asthma symptoms and the dosage of relieving symptoms were significantly improved (P <0.05), but there was no significant difference between the two groups No statistical significance (P> 0.05). The main adverse reactions were itchy throat, pain and hoarseness. There was no significant difference in the incidence of adverse events between the two groups (P> 0.05). Conclusions: Daily treatment of 200 μg CIC with light and moderate asthma is equivalent to 400 μg budesonide daily, and patients are more compliant.