Zhou Xiaojian, Hong Jianguo, Cheng Huanji, Xie Juanjuan, Yang Jianzhi, Chen Qiang, He Shaoru, Li Yun, Zhou Xiaoqin, Li Changchong
a Department of Pediatrics , Shanghai General Hospital, Shanghai Jiaotong University , Shanghai , P.R. China .
b Department of Pediatrics , First Affiliated People's Hospital, Shanghai Jiaotong University , Shanghai , P.R. China .
J Asthma. 2016 Jun;53(5):532-7. doi: 10.3109/02770903.2015.1111903. Epub 2016 Jan 20.
To describe the impact of nebulized budesonide inhalation suspension (BIS) on guardian-reported symptoms in Chinese pediatric patients with cough variant asthma (CVA).
This was a secondary analysis of a prospective, non-interventional study conducted at 39 Chinese sites. Patients with CVA aged ≤5 years were classified according to the severity of baseline symptoms: mild (symptom score ≤3) or severe (symptom score >3). Daytime and night-time symptom scores, disease control, use of bronchodilators, and improvements in symptoms control were compared after 1, 3, 5 and 7 weeks of treatment between groups.
Among 914 patients, 821 (89.8%) completed the 7-week treatment. Among all patients, 368 (40.3%) were classified as mild CVA and 529 (57.9%), as severe CVA. Symptom scores in the severe group were higher than those in the mild group at weeks 1, 3, and 5 (p < 0.05), but not at week 7 (p > 0.05). Further, more patients in the mild group achieved disease control at any time point (98.6% at 3 weeks and 99.7% at 7 weeks), compared with the patients in the severe group (p < 0.001). The proportion of patients requiring bronchodilators differed between the groups until week 5 (p < 0.001). No severe or drug-related adverse events were reported.
Individualized BIS treatment should be formulated according to the severity of baseline symptoms in CVA patients. Patients with mild CVA showed improvement after a shorter treatment time, while patients with severe CVA might require a longer time to respond to the treatment.
描述雾化吸入布地奈德混悬液（BIS）对中国咳嗽变异性哮喘（CVA）儿科患者监护人报告症状的影响。
这是一项对在中国39个地点进行的前瞻性非干预性研究的二次分析。年龄≤5岁的CVA患者根据基线症状的严重程度进行分类：轻度（症状评分≤3）或重度（症状评分>3）。比较两组在治疗1、3、5和7周后白天和夜间症状评分、疾病控制情况、支气管扩张剂的使用情况以及症状控制的改善情况。
在914例患者中，821例（89.8%）完成了7周的治疗。在所有患者中，368例（40.3%）被分类为轻度CVA，529例（57.9%）为重度CVA。重度组在第1、3和5周时的症状评分高于轻度组（p<0.05），但在第7周时无差异（p>0.05）。此外，与重度组患者相比，轻度组在任何时间点实现疾病控制的患者更多（3周时为98.6%，7周时为99.7%）（p<0.001）。直到第5周，两组中需要使用支气管扩张剂的患者比例存在差异（p<0.001）。未报告严重或与药物相关的不良事件。
应根据CVA患者基线症状的严重程度制定个体化的BIS治疗方案。轻度CVA患者在较短的治疗时间后症状有所改善，而重度CVA患者可能需要更长时间才能对治疗产生反应。
