Effect of Nebulized Hypertonic Saline Treatment in Emergency Departments on the Hospitalization Rate for Acute Bronchiolitis A Randomized Clinical Trial
Effect of Nebulized Hypertonic Saline Treatment in Emergency Departments on the Hospitalization Rate for Acute Bronchiolitis A Randomized Clinical Trial
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DOI：
10.1001/jamapediatrics.2017.1333
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发表时间：
2017-08-01
期刊：
影响因子：
26.1
通讯作者：
Gajdos, Vincent
中科院分区：
文献类型：
--
作者：
Angoulvant, Francois;Bellettre, Xavier;Gajdos, Vincent
急性毛细支气管炎是婴儿住院的主要原因。以前的研究在检查入院情况的能力不足的情况下，在儿科急诊科(ED)发现高渗盐水(HS)雾化治疗的益处有限。目的观察HS雾化治疗是否会降低首次发病的急性毛细支气管炎婴儿的住院率。设计、背景和参与者3%高渗盐水治疗急性病毒性毛细支气管炎(Guerande)的疗效是一项多中心、双盲随机临床试验，在2012年10月15日至2014年4月15日的两个毛细支气管炎季节(10月至2014年3月)在24个法国儿科急诊科进行。在2445名婴儿(6周到12个月大)中，777名首次出现急性毛细支气管炎并伴有呼吸窘迫，没有慢性疾病。干预措施两次20分钟雾化治疗，每次20分钟，雾化吸入HS 4毫升、3%或4毫升生理盐水(NS)，间隔20分钟。主要结果和测量登记后24小时内的住院率。结果纳入研究的777名婴儿(平均年龄3个月；四分位数范围2-5个月；随机分为HS组468例(60.2%)，NS组387例(49.8%)(5例未接受治疗)。到24小时时，HS组385名婴儿中有185名(48.1%)入院，而NS组387名婴儿中有202名(52.2%)入院。根据混合效应回归模型，住院的风险差异并不显著(调整后的风险差异，-3.2%；95%CI，-8.7%至2.2%；P=0.25)。HS组的平均(SD)呼吸窘迫评估工具得分改善幅度(-3.1[3.2])大于NS组(-2.4[3.3])(调整后差值为-0.7；95%可信区间为-1.2至-0.2；P=0.006)，呼吸评估改变得分也是如此。轻度不良事件，如咳嗽加重，在HS组儿童中发生的频率(35/392[8.9%])高于NS组(15/384[3.9%])(风险差异，5.0%；95%可信区间，1.6%-8.4%；结论与NS相比，HS雾化治疗并不能显著降低首次发病的急性中重度毛细支气管炎患儿的住院率，但HS组中轻度不良事件的发生率更高。
IMPORTANCE 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).OBJECTIVE 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.INTERVENTIONS Two 20-minute nebulization treatments of 4mL of HS, 3%, or 4 mL of normal saline (NS), 0.9%, given 20 minutes apart.MAIN OUTCOMES AND MEASURES Hospital admission rate in the 24 hours after enrollment.RESULTS 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.CONCLUSIONS AND RELEVANCE 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.