A multi-center trial for the efficacy of nebulized budesonide inhalation in infants and young children with asthma exacerbations
10.3760/cma.j.issn.1673-4912.2012.05.010
- VernacularTitle:雾化吸入布地奈德治疗婴幼儿哮喘急性发作的多中心临床观察
- Author:
Jiao LU
;
Yixiao BAO
;
Libo WANG
;
Xiaojian ZHOU
;
Zhen LI
;
Xiaoyan DONG
;
Mingzhi ZHANG
;
Jianguo HONG
- Publication Type:Journal Article
- Keywords:
Asthma;
Budesonide;
Inhalation;
Infant
- From:Chinese Pediatric Emergency Medicine
2012;19(5):477-480
- CountryChina
- Language:Chinese
-
Abstract:
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 cvcry 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 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) mg,P ＜ 0.05).The average length of hospital stay and the total cost of the two groups showed no significant differences (P ＞ 0.05).(3) There were no side effects associated with BI.Conclusion Compared with conventional treatment,high-starting-dose of BI can control symptoms fast and reduce the use of systemic corticosteroid without any side effects.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
