Beal Gaëlle, Barbier Catherine, Thoret Sophie, Rubio Amandine, Bonnet Mathilde, Mazet Roseline, Ego Anne, Pin Isabelle
Department of Pediatrics, Centre Hospitalier Métropole Savoie, FR-73000, Chambéry, France.
Department of Pediatrics, Centre Hospitalier Universitaire Grenoble Alpes, FR-38000, Grenoble, France.
BMC Pediatr. 2019 Nov 8;19(1):417. doi: 10.1186/s12887-019-1804-0.
The use and optimal duration of treatment with nebulized hypertonic saline (HS) in infants hospitalized for acute bronchiolitis is unclear. The objective was to compare the efficacy of 1 versus 3 days of nebulized 3% HS at 72 h of treatment. We conducted a blinded non-inferiority randomized controlled trial including infants aged less than 12 months old, hospitalized for a moderate bronchiolitis.
Nebulisations of 3% HS for 1 day were followed by either the continuation of 3% HS (HS3d group) or switched to 0.9% normal isotonic saline (HS1d group) for 2 days Randomization was performed according to a predefined list with a 1:1 ratio, obtained with a random generator number with blocks.. Main outcome was mean Wang clinical severity score (CSS) after 72 h of treatment.
One hundred sixteen infants (HS1d n = 59 and HS3d n = 57), were included over two epidemic seasons from 2014 to 2016, but recruitement did not reach the planned sample size. The difference for the Wang CSS score in the HS3d vs HS1d group was 0.71 [IC 90% 0.1; 1.3], above the precluded value of 0.4 set in the protocol defining the non-inferiority of shorter treatment duration. Clinical remission was more rapidly obtained in the HS3d than in HS1d (2.3 ± 1.6 vs 2.9 ± 1.4 days, p = 0.04), with a non-significant tendency for less need of nutritional support and supplemental oxygen in HS3d group. Clinical worsening and treatment intolerance were similar in the 2 groups.
Despite being underpowered, results seem not to be in favour of reducing the duration of nebulised HS treatment from 3 to 1 day in acute moderate bronchiolitis.
Clinical trials NCT02538458, October 2014.
雾化吸入高渗盐水（HS）治疗急性细支气管炎住院婴儿的使用情况及最佳疗程尚不清楚。目的是比较治疗72小时时1天与3天雾化吸入3% HS的疗效。我们进行了一项双盲非劣效随机对照试验，纳入年龄小于12个月、因中度细支气管炎住院的婴儿。
雾化吸入3% HS 1天，随后继续使用3% HS（HS3d组）或改用0.9%等渗生理盐水（HS1d组）2天。根据预定义列表以1:1比例进行随机分组，通过随机数字发生器生成区组。主要结局是治疗72小时后的平均王临床严重程度评分（CSS）。
2014年至2016年两个流行季节共纳入116例婴儿（HS1d组n = 59，HS3d组n = 57），但招募未达到计划样本量。HS3d组与HS1d组的王CSS评分差异为0.71[90%置信区间0.1；1.3]，高于方案中定义较短疗程非劣效性时设定的排除值0.4。HS3d组比HS1d组临床缓解更快（2.3±1.6天对2.9±1.4天，p = 0.04），HS3d组对营养支持和补充氧气的需求有减少趋势但无统计学意义。两组临床恶化和治疗不耐受情况相似。
尽管样本量不足，但结果似乎不支持将急性中度细支气管炎雾化吸入HS治疗疗程从3天减至1天。
临床试验NCT02538458，2014年10月。
