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高流量治疗与支气管肺炎中的高渗盐水:随机对照试验。

High flow therapy versus hypertonic saline in bronchiolitis: randomised controlled trial.

机构信息

Department of Pediatrics and Neonatology, Hospital Universitario Fundación Alcorcón, Alcorcón, Comunidad de Madrid, Madrid, Spain.

Department of Pediatrics and Neonatology, Hospital Universitario Severo Ochoa, Leganes, Comunidad de Madrid, Spain.

出版信息

Arch Dis Child. 2014 Jun;99(6):511-5. doi: 10.1136/archdischild-2013-305443. Epub 2014 Feb 12.

DOI:10.1136/archdischild-2013-305443
PMID:24521787
Abstract

OBJECTIVE

To demonstrate that heated humidified high-flow nasal cannula (HHHFNC) is superior to inhaled hypertonic saline solution (HSS) in improving respiratory distress in moderate bronchiolitis. In addition, it could improve comfort and reduce length of hospital stay (LOS) and admission to Paediatric Intensive Care Unit (PICU).

DESIGN

Randomised Clinical Trial from 1 October 2010 to 31 December 2012.

SETTING

Two urban secondary (no PICU available) paediatric hospitalisation units.

PATIENTS

Hospitalised children aged up to 6 months with moderate acute bronchiolitis (Respiratory Distress Assessment Instrument, RDAI ≥4).

INTERVENTION

Patients were randomised to HHHFNC or HSS. All of them received epinephrine as bronchodilator.

MAIN OUTCOMES

Primary outcome was difference in mean Respiratory Assessment Change Score (RACS) between both groups measured in six previously defined consecutive moments. Secondary outcomes were difference in mean comfort scores in this period, LOS and rate of PICU admission.

RESULTS

Seventy-five previously healthy patients were enrolled. Mean age was 2.4 months (95% CI 2.04 to 2.76). 43 were allocated to HSS group and 32 in HHHFNC. Data of 1 patient were lost, and 8 changed group over the study period. Intention-to-treat principle was applied. There were no significant differences in mean RACS and mean comfort scores between groups at the evaluation points. Median LOS or PICU admission rate were similar in both groups. No adverse events were observed.

CONCLUSIONS

HHHFNC was not superior to HSS in treatment of moderate acute bronchiolitis with respect to severity and comfort scores, LOS or PICU admission rate.

CLINICAL TRIAL REGISTRATION CLINICALTRIALSGOV IDENTIFIER

NCT01873144.

摘要

目的

证明加热湿化高流量鼻导管(HHHFNC)在改善中度毛细支气管炎的呼吸窘迫方面优于吸入高渗盐水溶液(HSS)。此外,它可以提高舒适度,缩短住院时间(LOS)和儿科重症监护病房(PICU)的入院率。

设计

2010 年 10 月 1 日至 2012 年 12 月 31 日的随机临床试验。

地点

两家城市二级(无 PICU)儿科住院病房。

患者

住院的 6 个月以下患有中度急性毛细支气管炎(呼吸窘迫评估工具,RDAI≥4)的儿童。

干预

患者随机分配到 HHHFNC 或 HSS 组。所有患者均接受肾上腺素作为支气管扩张剂。

主要结果

主要结局是在之前定义的六个连续时刻测量的两组之间平均呼吸评估变化评分(RACS)的差异。次要结局是这段时间内平均舒适度评分、LOS 和 PICU 入院率的差异。

结果

共纳入 75 名既往健康的患者。平均年龄为 2.4 个月(95%CI 2.04-2.76)。43 名患者分配到 HSS 组,32 名患者分配到 HHHFNC 组。1 名患者的数据丢失,8 名患者在研究期间改变了分组。采用意向治疗原则。在评估点,两组间的平均 RACS 和平均舒适度评分无显著差异。两组的 LOS 或 PICU 入院率相似。未观察到不良事件。

结论

在中度急性毛细支气管炎的治疗中,HHHFNC 与 HSS 相比,在严重程度和舒适度评分、LOS 或 PICU 入院率方面无优势。

临床试验注册号

NCT01873144。

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