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
张晗;周薇;金正勇;钟礼立;尚云晓;申昆玲;曹玲;鲍一笑;刘恩梅;成焕吉;李昌崇;谢娟娟
【期刊名称】《中国实用儿科杂志》 【年(卷),期】2017(032)009
【摘要】Objective To investigate the efficacy and safety of fluticasone propionate (FP) inhalation solution compared with oral prednisone (PRE) in Chinese pediatric and adolescent subjects (aged 4 to 16 years) with an
acute
exacerbation
of
asthma.Methods
This
was
a
randomized,double-blind,double-dummy,active-controlled,parallelgroup,multi-center,non-inferiority
study
involving
subjects (aged 4 to 16 years old,inclusive) with an acute exacerbation of asthma [to compare the morning Peak expiratory flow (AM PEF).Oral PRE once daily 2 mg/(kg· d),up to 40 mg/ d for 4 d,then 1 mg/(kg· d) or half of the original dose,up to 20 mg/d for 3 d) for 7 d.The study comprised a 7-d treatment period and a 14-d follow-up period].Results In terms of the primary efficacy endpoint mean AM PEF,the low limit of 95％ CI was-9.64 L/min,which was above the pre-defined non-inferiority margin-12 L/min.Conclusion FP inhalation solution was shown to be non-inferior to oral PRE in the treatment of acute exacerbation of asthma in Chinese pediatric and adolescent patients.FP inhalation solution demonstrates good safety.%目的 观察比较4～16岁哮喘患儿急性
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
