Service d'accueil des urgences pédiatriques, Necker-Enfants Malades University Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France.
Epidémiologie Clinique et Évaluation Économique Appliquées aux Populations Vulnérables, INSERM, Unité Mixte de Recherche 1123, Paris, France.
JAMA Pediatr. 2017 Aug 7;171(8):e171333. doi: 10.1001/jamapediatrics.2017.1333.
Acute bronchiolitis is the leading cause of hospitalization among infants. Previous studies, underpowered to examine hospital admission, have found a limited benefit of nebulized hypertonic saline (HS) treatment in the pediatric emergency department (ED).
To examine whether HS nebulization treatment would decrease the hospital admission rate among infants with a first episode of acute bronchiolitis.
DESIGN, SETTING, AND PARTICIPANTS: The Efficacy of 3% Hypertonic Saline in Acute Viral Bronchiolitis (GUERANDE) study was a multicenter, double-blind randomized clinical trial on 2 parallel groups conducted during 2 bronchiolitis seasons (October through March) from October 15, 2012, through April 15, 2014, at 24 French pediatric EDs. Among the 2445 infants (6 weeks to 12 months of age) assessed for inclusion, 777 with a first episode of acute bronchiolitis with respiratory distress and no chronic medical condition were included.
Two 20-minute nebulization treatments of 4 mL of HS, 3%, or 4 mL of normal saline (NS), 0.9%, given 20 minutes apart.
Hospital admission rate in the 24 hours after enrollment.
Of the 777 infants included in the study (median age, 3 months; interquartile range, 2-5 months; 468 [60.2%] male), 385 (49.5%) were randomized to the HS group and 387 (49.8%) to the NS group (5 patients did not receive treatment). By 24 hours, 185 of 385 infants (48.1%) in the HS group were admitted compared with 202 of 387 infants (52.2%) in the NS group. The risk difference for hospitalizations was not significant according to the mixed-effects regression model (adjusted risk difference, -3.2%; 95% CI, -8.7% to 2.2%; P = .25). The mean (SD) Respiratory Distress Assessment Instrument score improvement was greater in the HS group (-3.1 [3.2]) than in the NS group (-2.4 [3.3]) (adjusted difference, -0.7; 95% CI, -1.2 to -0.2; P = .006) and similarly for the Respiratory Assessment Change Score. Mild adverse events, such as worsening of cough, occurred more frequently among children in the HS group (35 of 392 [8.9%]) than among those in the NS group (15 of 384 [3.9%]) (risk difference, 5.0%; 95% CI, 1.6%-8.4%; P = .005), with no serious adverse events.
Nebulized HS treatment did not significantly reduce the rate of hospital admissions among infants with a first episode of acute moderate to severe bronchiolitis who were admitted to the pediatric ED relative to NS, but mild adverse events were more frequent in the HS group.
clinicaltrials.gov Identifier: NCT01777347.
重要性：急性细支气管炎是婴儿住院的主要原因。以前的研究因缺乏检验住院的效力，发现儿科急诊室（ED）使用雾化高渗盐水（HS）治疗的益处有限。
目的：检验雾化 HS 治疗是否会降低首次发作急性细支气管炎婴儿的住院率。
设计、地点和参与者：Efficacy of 3% Hypertonic Saline in Acute Viral Bronchiolitis（GUERANDE）研究是一项多中心、双盲随机临床试验，在 2012 年 10 月 15 日至 2014 年 4 月 15 日期间的 2 个细支气管炎季节（10 月至 3 月），在 24 家法国儿科 ED 进行，共纳入了 2445 名（6 周到 12 个月）评估符合纳入标准的婴儿，其中 777 名患有首次发作的急性细支气管炎且有呼吸窘迫而无慢性疾病的婴儿被纳入。
干预措施：2 次 20 分钟的雾化治疗，分别给予 4 毫升 3%HS 或 4 毫升 0.9%生理盐水（NS），间隔 20 分钟。
主要结局和测量指标：纳入后 24 小时的住院率。
结果：在纳入的 777 名婴儿中（中位年龄 3 个月；四分位距 2-5 个月；468[60.2%]为男性），385 名（49.5%）随机分配到 HS 组，387 名（49.8%）分配到 NS 组（5 名患者未接受治疗）。到 24 小时时，HS 组 385 名婴儿中有 185 名（48.1%）住院，而 NS 组 387 名婴儿中有 202 名（52.2%）住院。混合效应回归模型显示，住院风险差异无统计学意义（调整风险差异，-3.2%；95%CI，-8.7%至 2.2%；P=0.25）。HS 组（-3.1[3.2]）的呼吸窘迫评估工具评分改善大于 NS 组（-2.4[3.3]）（调整差异，-0.7；95%CI，-1.2 至-0.2；P=0.006），呼吸评估变化评分也同样如此。在 HS 组（392 名中的 35 名[8.9%]）中，较 NS 组（384 名中的 15 名[3.9%]）更常见轻度不良事件，如咳嗽加重（风险差异，5.0%；95%CI，1.6%至 8.4%；P=0.005），但无严重不良事件。
结论和相关性：与 NS 相比，雾化 HS 治疗并不能显著降低首次发作急性中重度细支气管炎婴儿的住院率，这些婴儿被收入儿科 ED，但 HS 组的轻度不良事件更常见。
试验注册：clinicaltrials.gov 标识符：NCT01777347。
