摘要
目的观察不同起始剂量布地奈德混悬液雾化吸入（budesonide inhalation，BI）治疗婴幼儿中重度哮喘急性发作的疗效和安全性。方法2008年9月至2010年4月，上海交通大学附属第一人民医院儿内科、上海交通大学医学院附属新华医院儿内科及复旦大学附属儿科医院呼吸科共收集6个月～3岁的中重度哮喘急性发作的住院患儿150例，随机分为高起始剂量BI组和常规起始剂量BI组。高起始剂量BI组给予雾化吸入BI1mg／次，每8小时1次，连用2d。常规起始剂量BI组给予雾化吸入B10．5mg／次，每8小时1次，连用4d。两组均按需给予博利康尼雾化吸入2．5mg／次。主要疗效指标为入院时（0h）及入院后8、16、24、48、72h的临床症状评分；次要疗效指标为β2受体激动剂、全身糖皮质激素使用情况、住院总天数及医疗费用。结果采用SPSS13．0统计软件进行分析。结果（1）两组组内治疗后各时间点的临床症状评分与入院时比较均明显降低，差异有统计学意义（P〈0．05）；高起始剂量BI组较常规起始剂量BI组在治疗后8h、16h能更快地改善症状，提高临床症状评分（2．87±1．60VS4．48±2．24，2．48±1．56VS3．25±1．82）（P〈0．01）。（2）高起始剂量BI组特布他林的使用量、全身激素的累积使用量均明显减少[（16．27±12．99）mgVS（22．90±18．27）mg，（4．54±18．18）mgVS（11．16±21．34）mg]（P〈0．05）；而平均住院天数、住院总费用两组比较差异无统计学意义（P〉0．05）。（3）全部受试对象未见鹅口疮、声音嘶哑等与吸入激素相关的不良反应。结论对于中重度哮喘急性发作的婴幼儿，高起始剂量BI治疗能更快地控制症状，减少全身激素的使用量，具备较好的安全性，值得临床推广。
Objective To observe the efficacy and safety of different initial doses of nebulized budesonide inhalation （BI） in infants and young children with moderate to severe asthma exacerbations. Methods A multi-center, parallel controlled clinical trial was performed during Sep 2008 to Apr 2010 in three hospitals,which were Department of Pediatrics, Shanghai Jiaotong University Affiliated Shanghai First People＇s Hospital, Department of Pediatrics, Shanghai Jiaotong University School of Medicine Affiliated Xinhua Hospital, and Department of Respiratory, Fudan University Affiliated Children＇s Hospital. One hundred and fifty children aged 6 to 36 month with moderate to severe asthma exacerbations were randomly divided into two groups. The high-starting-dose group was treated with a dose of 1 mg nebulized BI every 8 h for 2 days,while the conventional-starting-dose group was treated with a dose of 0. 5 mg every 8 h for 4 days. The terbutaline sulfate aerosol liquid was administered with a dose of 2.5 mg each time as needed. The primary outcome measures were severity scores, which were assessed at admission （ 0 h）, and 8 h, 16 h,24 h,48 h, 72 h after treatment separately. The secondary outcome measures included the use of β2 receptor agonist,the systemic use of corticosteroids, average length of hospital stay and total cost. The data was analyzed with SPSS 13.0. Results （ 1 ） The clinical severity scores were significantly decreased at all time points after treatment in both groups （ P 〈 0. 05 ）. Compared with conventional starting-dose of BI, high starting-dose of BI improved symptoms more quickly at 8 h （2. 87 ± 1.60 vs 4.48 ±2. 24 ,P 〈0. 01 ） and 16 h（2. 48 ± 1.56 vs 3.25 ± 1.82 ,P 〈0. 01 ）. （2） The terbutaline doses and the systemic corticosteroids do-ses were significantly reduced in high-starting-dose group compared with conventional-starting-dose group [ （16. 27 ± 12. 99） mg vs （ 22. 90 ± 18. 27 ） mg, P 〈 0.05 ; （4. 54 ± 18. 18 ） mg vs （ 11.16 ±21.34 ） r
出处
《中国小儿急救医学》
CAS
2012年第5期477-480,共4页
Chinese Pediatric Emergency Medicine
基金
基金项目：中华医学会临床医学慢性呼吸道疾病科研专项资金（07010220030）
