Comparing the effects of two low-dose budesonide suspension nebulization treatments on asthma among young children: a multicenter study.

IF 1.3 4区 医学 Q3 ALLERGY
Pingbo Zhang, Yixiao Bao, Xiaojian Zhou, Yanming Lu, Bo Ding, Li Hua, Lili Zhong, Dan Liu, Jing Liu, Deyu Zhao, Zhongping Zhang, Lina Zhen, Suping Tang, Wenhui Jiang, Caifeng Zhang, Zhou Fu, Zehui Ye, Li Dong, Rongfang Zhang, Xuan Liang, Ning Wang, Long Zhao, Ya Luo, Zhaobo Shen, Ping Kang, Mengli Ren, Jie Shao
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引用次数: 0

Abstract

Objective: To evaluate the effects of treatment with nebulized budesonide inhalation suspension (BIS) at dosages of 500 µg/day and 250 µg/day on mild to moderate asthma in young children.

Methods: This was a randomized, parallel group, open-label study at 19 Chinese clinical sites. A total of 340 patients (4-7 years) with mild to moderate persistent pediatric asthma were randomly and evenly divided into the 500-µg group (BIS 500 µg/day) and the 250-µg group (BIS 250 µg/day); 323 patients completed the study. The Children-Asthma Control Test (C-ACT), asthma control, Pediatric Asthma Quality of Life Questionnaire (PAQLQ), pulmonary function tests (PFT), additional asthma-related therapy, and adverse effects (AEs) were compared after 1, 3, and 6 months of treatment between groups.

Results: There were no statistically significant differences in C-ACT scores, level of asthma control, PAQLQ scores, PFT parameters, additional medications and AE occurrences from baseline to 6 months post-treatment between the two groups (all p > 0.05). Compared with baseline values, both groups showed improvements in C-ACT and PAQLQ scores, the rate of well-controlled asthma, and PFT parameters (all p < 0.05). The cumulative number of unplanned outpatient visits (50 vs. 49) and hospitalizations (3 vs. 0) in the 250-µg group was higher than that in the 500-µg group (p < 0.05).

Conclusions: The lower dosage of 250 µg/day BIS was found to be as effective as 500 µg/day BIS. For young children with mild to moderate persistent asthma who have well-controlled, a lower dose of BIS treatment can be chosen.

比较两种低剂量布地奈德悬浮液雾化治疗幼儿哮喘的效果:一项多中心研究。
目的:评价布地奈德雾化吸入混悬液(BIS) 500µg/d和250µg/d对幼儿轻中度哮喘的治疗效果。方法:这是一项随机、平行组、开放标签的研究,在19个中国临床站点进行。将340例(4 ~ 7岁)轻中度持续性儿童哮喘患者随机均匀分为500µg组(BIS 500µg/d)和250µg组(BIS 250µg/d);323名患者完成了这项研究。比较两组治疗1、3、6个月后儿童哮喘控制测试(C-ACT)、哮喘控制、儿童哮喘生活质量问卷(PAQLQ)、肺功能测试(PFT)、额外哮喘相关治疗和不良反应(ae)。结果:两组患者C-ACT评分、哮喘控制水平、PAQLQ评分、PFT参数、额外用药及AE发生率从基线至治疗后6个月比较,差异均无统计学意义(p < 0.05)。与基线值相比,两组C-ACT和PAQLQ评分、哮喘控制良好率和PFT参数均有改善(均p < 0.05)。250µg组的累计计划外门诊次数(50次对49次)和住院次数(3次对0次)高于500µg组(p < 0.05)。结论:较低剂量250µg/天BIS与500µg/天BIS效果相同。对于患有轻度至中度持续性哮喘且控制良好的幼儿,可以选择较低剂量的BIS治疗。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Journal of Asthma
Journal of Asthma 医学-过敏
CiteScore
4.00
自引率
5.30%
发文量
158
审稿时长
3-8 weeks
期刊介绍: Providing an authoritative open forum on asthma and related conditions, Journal of Asthma publishes clinical research around such topics as asthma management, critical and long-term care, preventative measures, environmental counselling, and patient education.
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