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首页> 外文期刊>Pediatrics: Official Publication of the American Academy of Pediatrics >Heliox Therapy in Bronchiolitis: Phase III Multicenter Double-Blind Randomized Controlled Trial
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Heliox Therapy in Bronchiolitis: Phase III Multicenter Double-Blind Randomized Controlled Trial

机译：细支气管炎的Heliox治疗：III期多中心双盲随机对照试验

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BACKGROUND AND OBJECTIVE: Supportive care remains the mainstay of therapy in bronchiolitis. Earlier studies suggest that helium-oxygen therapy may be beneficial, but evidence is limited. We aimed to compare efficacy of 2 treatment gases, Heliox and Airox (21% oxygen + 79% helium or nitrogen, respectively), on length of hospital treatment for bronchiolitis. METHODS: This was a multicenter randomized blinded controlled trial of 319 bronchiolitic infant subjects randomly assigned to either gas; 281 subjects completed the study (140 Heliox, 141 Airox), whose data was analyzed. Treatment was delivered via facemask (nasal cannula, if the facemask intolerant) ± continuous positive airway pressure (CPAP). Severe bronchiolitics received CPAP from the start. Primary end point was length of treatment (LoT) required to alleviate hypoxia and respiratory distress. Secondary end-points were proportion of subjects needing CPAP; CPAP (LoT); and change in respiratory distress score. RESULTS: Analysis by intention to treat (all subjects); median LoT (interquartile range, days): Heliox 1.90 (1.08-3.17), Airox 1.87 (1.11-3.34), P = .41. Facemask tolerant subgroup: Heliox 1.46 (0.85-1.95), Airox 2.01 (0.93-2.86), P= .03. Nasal cannula subgroup: Heliox 2.51 (1.21-4.32), Airox 2.81 (1.45-4.78), P= .53. Subgroup started on CPAP: Heliox 1.55 (1.38-2.01), Airox 2.26 (1.84-2.73), P = .02. Proportion of subjects needing CPAP: Heliox 17%, Airox 19%, O.R. 0.87 (0.47-1.60), P= .76. Heliox reduced respiratory distress score after 8 hours (mixed models estimate, -0.1298; P < .001). The effect was greater for facemask compared with nasal cannula (mixed models estimate, 0.093; P= .04). CONCLUSIONS: Heliox therapy does not reduce LoT unless given via a tight-fitting facemask or CPAP. Nasal cannula heliox therapy is ineffective.
机译：背景与目的：支持性治疗仍是毛细支气管炎的主要治疗手段。较早的研究表明，氦氧疗法可能是有益的，但证据有限。我们的目的是比较两种治疗气体Heliox和Airox（分别为21％氧气+ 79％氦气或氮气）对毛细支气管炎的住院治疗时间的疗效。方法：这是一项对319名支气管石质婴儿受试者随机分配至任一气体的多中心随机盲对照试验。 281名受试者完成了研究（140 Heliox，141 Airox），并对其数据进行了分析。通过面罩（鼻管，如果面罩不耐受的话）±持续气道正压通气（CPAP）进行治疗。从一开始，严重的细支气管学就接受了CPAP。主要终点是缓解缺氧和呼吸窘迫所需的治疗时间（LoT）。次要终点是需要CPAP的受试者比例; CPAP（LoT）;并改变呼吸窘迫评分。结果：按治疗意图进行分析（所有受试者）; LoT中位数（四分位数间距，天）：Heliox 1.90（1.08-3.17），Airox 1.87（1.11-3.34），P = 0.41。耐口罩亚组：Heliox 1.46（0.85-1.95），Airox 2.01（0.93-2.86），P = .03。鼻插管亚组：Heliox 2.51（1.21-4.32），Airox 2.81（1.45-4.78），P = .53。分组开始于CPAP：Heliox 1.55（1.38-2.01），Airox 2.26（1.84-2.73），P = .02。需要CPAP的受试者比例：Heliox 17％，Airox 19％，O.R.。 0.87（0.47-1.60），P = 0.76。 Heliox在8小时后降低了呼吸窘迫评分（混合模型估计为-0.1298; P <.001）。与鼻插管相比，面罩的效果更好（混合模型估计为0.093; P = .04）。结论：Heliox疗法不会降低LoT，除非通过紧身口罩或CPAP给予。鼻插管日光疗法无效。

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