摘要
目的探讨布地奈德/福莫特罗干粉吸入剂治疗儿童支气管哮喘的疗效、依从性和安全性。方法采用随机、开放、平行对照研究方法,44例支气管哮喘患儿分为A组(布地奈德/福莫特罗干粉吸入剂,30例)和B组(布地奈德干粉吸入剂加福莫特罗干粉吸入剂,14例)。A组使用单个吸入器吸入布地奈德/福莫特罗干粉吸入剂[80μg(布地奈德)/4.5μg(福莫特罗)/吸],1吸/次,2次/d,共12周;B组每天分别使用2个吸入器吸入布地奈德干粉吸入剂(100μg/吸)和福莫特罗干粉吸入剂(4.5μg/吸),1吸/次,2次/d,共12周。观察二组患儿每天症状评分、视觉近似评价量尺(VAS量尺)、最大呼气峰流速[最大呼气流量(PEF)占预计值%]、肺功能[一秒钟用力呼气量(FEV1)占预计值%]和不良事件发生情况。采用SPSS11.0软件进行统计学分析。结果用药后,二组哮喘患儿的临床症状均改善。治疗8、12周A组改善明显,与B组比较差异显著(Z=-2.223,-2.042 Pa<0.05);治疗8、12周VAS量尺评分A组降低较B组明显(Z=-3.877,-3.536 Pa<0.05);PEF占预计值%和FEV1占预计值%二组均有改善,A组在治疗4周PEF占预计值%改善快于B组(Z=-2.602P<0.05)。A组在治疗12周FEV1占预计值%改善优于B组(Z=-1.966 P<0.05),二组均无明显不良事件发生。结论布地奈德/福莫特罗干粉吸入剂和布地奈德干粉吸入剂加福莫特罗干粉吸入剂联合治疗哮喘患儿都具有良好的疗效和安全性,但布地奈德/福莫特罗干粉吸入剂起效更快,使用更方便,患儿依从性更好。
Objective To explore the efficacy, tolerability and safety of Budesonide and Formoterdol fumarate powder for inhalation in treatment of children with bronchial asthma. Methods In randomized, open,parallel - group trial ,44 cases of asthma were divided into group A and group B. All patients in group A inspired Budesonide Formoterol sing inspirator [ 80μg（Budesonide）/4.5μg（ Formoterol ）/snuff] 2 times/d, 12 weeks. All patients in group B inspired Budesonide （100μg/snuff） and Formoterol （4.5μg/snuff） , 1 snuff/time, respectively, 2 times/d, 12 weeks. Clinical symptom, visual analog scale （VAS） ,lung function as peak expiratory（ PEF ） and forced expiratory volume in one second（ FEV1 ）, adverse - events were investigated. Results Improvement in asthma symptoms were found in the 2 groups. Improvement in the group A was earlier than that in group B （Z = - 2. 223, - 2. 042 Pa 〈 0.05 ） after treatment for 8,12 weeks,VAS was lower in group A than that in group B （ Z = - 3. 877, - 3. 536 Pa 〈 0.05 ） after treatment for 8,12 weeks. Both groups got improvement in PEF predictive volue %. Improvement in group A was earlier than that in group B after 4 weeks （ Z = - 2. 602 P 〈 0.05 ）. Both groups got improvement in FEV1 predictive volue %. After 12 weeks, the symptoms made rapid improvement in group A compared to group B （ Z = - 1. 966 P 〈 0. 05 ）. No adverse - events were observed in both groups. Conclusions Budesonide and Formoterol fumarate powder for inhalation and Budesonide fumarate powder for inhalation plus Formoterol fumarate powder for inhalation have good efficacy and safety. But Budesonide and Formoterol fumarate powder for inhalation provide more rapid improvement and more convenience when compared to control treatment.
出处
《实用儿科临床杂志》
CAS
CSCD
北大核心
2008年第4期301-303,共3页
Journal of Applied Clinical Pediatrics
关键词
布地奈德/福莫特罗干粉吸入剂
哮喘
疗效
儿童
Budesonide and Formoterol fumarate powder for inhalation
asthma
efficacy
child
