雾化吸入丙酸氟替卡松与口服泼尼松对儿童哮喘急性发作期有效性及安全性临床研究

发布时间：2018-05-29 23:10

本文选题：丙酸氟替卡松 + 泼尼松　；参考：《中国实用儿科杂志》2017年09期

【摘要】：目的观察比较4~16岁哮喘患儿急性发作期雾化吸入丙酸氟替卡松(FP)吸入溶液与口服泼尼松(PRE)的安全性和有效性。方法根据随机、双盲、双模拟、活性药物对照、平行分组、多中心等研究设计要求,于2012年12月至2016年6月,将11家医院收集到的261例4~16岁哮喘急性发作受试者随机分为2组。观察组130例给予雾化吸入FP 1 mg,每日2次;对照组131例给予口服PRE,每日1次[前4 d为2 mg/(kg·d),最多40 mg/d;后3 d为1 mg/(kg·d)或予1/2初始剂量,最多20 mg/d],治疗7 d,对比两组的肺功能等指标。结果平均最大呼气流量(PEF)在两组之间差异的95%可信区间下限为-9.64 L/min,大于事先规定的非劣效界值-12 L/min。在次要评估终点各项指标中FP组和PRE组差异无统计学意义。FP组发生的不良事件少于PRE组。结论雾化吸入FP对哮喘患儿急性发作期的疗效不差于口服PRE,且具有良好的安全性。
[Abstract]:Objective to observe the safety and efficacy of aerosol inhalation of fluticasone propionate (FPN) and oral prednisone (PRE) in asthmatic children aged 16 years. Methods according to the requirements of randomized, double-blind, double-simulated, active drug control, parallel grouping and multi-center design, 261 patients with acute asthma attack aged 4 to 16 years were randomly divided into two groups from December 2012 to June 2016 in 11 hospitals. One hundred and thirty patients in the observation group were given 1 mg of FP twice a day, while 131 cases in the control group were given oral pree once a day (2 mg/(kg / d for the first 4 days, up to 40 mg / d for the first 4 days and 1 mg/(kg / d for the latter 3 days) or 1 / 2 initial dose. At most 20 mg/d], 7 days after treatment, pulmonary function was compared between the two groups. Results the lower limit of 95% confidence interval of PEF between the two groups was -9.64 L / min, which was higher than the pre-determined non-inferior threshold of -12 L / min. There was no significant difference between FP group and PRE group. The adverse events in FP group were less than those in PRE group. Conclusion the efficacy of aerosol inhalation FP in acute attack of asthmatic children is not worse than that in oral pree, and it has good safety.
【作者单位】：中国医科大学附属盛京医院小儿呼吸内科;首都医科大学附属北京儿童医院;首都儿科研究所附属儿童医院;上海交通大学医学院附属新华医院;重庆医科大学附属儿童医院;吉林大学第一医院;温州医科大学附属第二医院;无锡市人民医院;北京大学第三医院;延边大学附属医院;湖南省人民医院;
【基金】：国家药监局批准临床药理项目(LOC114220)
【分类号】：R725.6

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