环索奈德粉吸入剂治疗轻中度支气管哮喘疗效与安全性

Efficacy and safety of cielesonide power inhaler in the treatment of mild-moderate bronchial asthma

目的评价环索奈德粉吸入剂治疗轻中度支气管哮喘（简称哮喘）的有效性及安全性。方法采用多中心、随机、双盲、安慰剂平行对照临床试验，将215例轻中度哮喘患者随机分为试验组与对照组，试验组给予国产环索奈德80μg，2次／d治疗84d，对照组给予安慰剂，用法、时间同前。观察指标包括：①主要指标：两组治疗前后FEV1；无效退出病例％。②次要指标：两组间哮喘症状积分的变化（哮喘症状积分为白天症状积分和晚上症状积分）；缓解药物使用量；PEF昼夜变异率。③不良反应。结果经过84d治疗：①试验组FEV1较治疗前无明显改善（P〉0．05），但安慰剂组较治疗前明显下降（P〈0．05），两组差异有统计学意义（P〈0．05）；②两组无效退出病例差异有统计学意义（P〈0．01），试验组无效退出病例低于对照组，且退出的时间也较晚；③试验组能明显减少哮喘患者的症状积分（P〈0．01），而对照组增加其积分，两组差异有统计学意义（P〈0．01）；④试验组虽能减少缓解药的使用量，但与对照组比较差异无统计学意义（P〉0．05）；⑤试验组能减少PEF的日变异率（P〈0．01），而对照组则增加（P〉0．05），两组差异有统计学意义（P〈0．01）；⑥两组不良事件发生率相似（P〉0．05），主要表现为咽部不适、声音嘶哑、咽痛等。结论每天2次80μg环索奈德干粉吸入剂治疗轻中度哮喘疗效显著，副作用小，使用方便，临床值得推广使用。

Objective To evaluate the efficacy and safety of ciclesonide （CIC） powder inhaler for the treatment of mild or moderate bronchial asthma （asthma）. Methods A multicenter, randomized, double-blind, placebo-controlled clinical trial was conducted. 215 patients with mild or moderate asthma were randomly divided into a test group or a control group. The test group received domestic CIC （80 μg bid） for 12 weeks while the control group was given a placebo. Outcome measures： ①The primary outcome：FEV1 before and after treatment. The dropout rate due to lack of efficacy. ②The secondary outcome：changes were related in asthma symptom score between the two groups （asthma symptom score includes scores during the day and in the evening）. Dose of rescue medicine use. The rate of diurnal variation of PEF. ③Adverse events. Results After 12 weeks of treatment：① FEV1 of the test group has no significant improvement （ P 〈0.05）, but FEV1 of the control group was decreased （ P 〈0.05）, two groups are significantly different（ P 〈0.05）. ②There was statistically significant difference between the two groups in the dropout rate due to lack of efficacy（ P 〈0.01） ,LOE of the test group was lower than the control group, and the dropout time of LOE in the test group was also late. ③Asthma symptom score was significantly reduced in the test group（ P 〈0.01）, while it was increased in control group, two groups are significantly different（ P 〈0.01）. ④The dose of rescue medicine use was reduced in the test group, but there was no statistically significant difference between the two groups（ P 〉0.05）. ⑤The day variation of PEF was reduced in the test group （ P 〈0.01）, while the control group was increased （ P 〉 0.05）, two groups are significantly different （ P 〈0.01）.⑥The adverse events were similar in the two groups （ P 〉0.05）, involving in throat discomfort, hoarseness, sore throat. Conclusions It tends to be modestly effective and safety to use CIC powder inhaler with 80 Fg twice a day for mild-moderate asthma, which is worthy to be popularized.