阿奇霉素治疗因喘息到急诊科就诊的学龄前儿童:一项安慰剂对照随机试验。
Treatment of preschool children presenting to the emergency department with wheeze with azithromycin: A placebo-controlled randomized trial.
作者信息
Mandhane Piush J, Paredes Zambrano de Silbernagel Patricia, Aung Yin Nwe, Williamson Janie, Lee Bonita E, Spier Sheldon, Noseworthy Mary, Craig William R, Johnson David W
机构信息
Department of Pediatrics, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada.
Department of Community Medicine, Faculty of Medicine and Health Sciences, UCSI University, Kuala Lumpur, Malaysia.
出版信息
PLoS One. 2017 Aug 3;12(8):e0182411. doi: 10.1371/journal.pone.0182411. eCollection 2017.
BACKGROUND
Antibiotics are frequently used to treat wheezing children. Macrolides may be effective in treating bronchiolitis and asthma.
METHOD
We completed a prospective, double-blinded, randomized placebo-control trial of azithromycin among pre-school children (12 to 60 months of age) presenting to the emergency department with wheeze. Patients were randomized to receive either five days of azithromycin or placebo. Primary outcome was time to resolution of respiratory symptoms after treatment initiation. Secondary outcomes included the number of days children used a Short-Acting Beta-Agonists during the 21 day follow-up and time to disease exacerbation during the following six months (unscheduled health care visit or treatment with an oral corticosteroid for acute respiratory symptoms).
RESULTS
Of the 300 wheezing children recruited, 222 and 169 were analyzed for the primary and secondary outcomes, respectively. The treatment groups had similar demographics and clinical parameters at baseline. Median time to resolution of respiratory symptoms was four days for both treatment arms (interquartile range (IQR) 3,6; p = 0.28). Median number of days of Short-Acting Beta-Agonist use among those who received azithromycin was four and a half days (IQR 2, 7) and five days (IQR 2, 9; p = 0.22) among those who received placebo. Participants who received azithromycin had a 0.91 hazard ratio for time to six-month exacerbation compared to placebo (95% CI 0.61, 1.36, p = 0.65). A pre-determined subgroup analysis showed no differences in outcomes for children with their first or repeat episode of wheezing. There was no significant difference in the proportion of participants experiencing an adverse event.
CONCLUSION
Azithromycin neither reduced duration of respiratory symptoms nor time to respiratory exacerbation in the following six months after treatment among wheezing preschool children presenting to an emergency department. There was no significant effect among children with either first-time or prior wheezing.
背景
抗生素常用于治疗喘息儿童。大环内酯类药物可能对治疗细支气管炎和哮喘有效。
方法
我们对因喘息到急诊科就诊的学龄前儿童(12至60个月大)进行了一项阿奇霉素的前瞻性、双盲、随机安慰剂对照试验。患者被随机分为接受五天阿奇霉素治疗或安慰剂治疗。主要结局是治疗开始后呼吸道症状缓解的时间。次要结局包括儿童在21天随访期间使用短效β受体激动剂的天数以及接下来六个月内疾病加重的时间(因急性呼吸道症状进行的非计划医疗就诊或口服糖皮质激素治疗)。
结果
在招募的300名喘息儿童中,分别对222名和169名儿童进行了主要和次要结局分析。治疗组在基线时的人口统计学和临床参数相似。两个治疗组呼吸道症状缓解的中位时间均为四天(四分位间距(IQR)3,6;p = 0.28)。接受阿奇霉素治疗的儿童使用短效β受体激动剂的中位天数为四天半(IQR 2, 7),接受安慰剂治疗的儿童为五天(IQR 2, 9;p = 0.22)。与安慰剂相比,接受阿奇霉素治疗的参与者六个月内病情加重时间的风险比为0.91(95%置信区间0.61, 1.36,p = 0.65)。预先确定的亚组分析显示,首次或反复喘息儿童的结局无差异。经历不良事件的参与者比例无显著差异。
结论
对于到急诊科就诊的喘息学龄前儿童,阿奇霉素在治疗后六个月内既未缩短呼吸道症状的持续时间,也未缩短呼吸道病情加重的时间。首次喘息或既往有喘息的儿童均未出现显著效果。
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