患有支气管炎 (BIDS) 的婴儿的氧和目标:双盲,随机,等效试验
Steve Cunningham1, Aryelly Rodriguez2, Tim Adams3
1Department of Child Life and Health, University of Edinburgh, Edinburgh, UK.
Lancet (London, England)
|September 19, 2015
概括
在患有支气管炎的婴儿中,低于90%的氧和值是安全和有效的94%. 这一发现支持当前治疗儿童下呼吸道感染的指南.
科学领域:
- 儿童重症监护医疗
- 呼吸系统药物
- 临床试验方法
背景情况:
- 目前的指导方针建议,在患有支气管炎的婴儿中,允许低血度达到90%的目标.
- 没有证据支持这一90%的门.
- 这项研究的目的是将90%或更高的目标与94%或更高的目标进行比较,用于治疗病毒性支气管炎的住院婴儿.
研究的目的:
- 为了确定90%或更高的氧和目标是否相当于94%或更高的目标在病毒性支气管炎住院的婴儿.
- 评估较低氧和值的安全性和临床有效性.
主要方法:
- 在英国的八个儿科医院进行了一项并行组,随机,受控等效性试验 (婴儿出院支气管炎研究 (BIDS)).
- 患有医生诊断的支气管炎的6周至12个月的婴儿被随机分配给标准氧计 (目标SpO2 < 94%) 或改性氧计 (目标SpO2 < 90%).
- 主要结局是咳消失的时间,相当性定义为±2天的差异.
主要成果:
- 共有615名婴儿被随机分类 (308名为标准,307名为修改).
- 在两组中,咳解决的中位时间为15. 0天,表明氧和目标之间的等价性.
- 严重的不良事件和临床结果 (例如,高依赖单位转移,再入院) 在两组之间没有显著差异.
结论:
- 使用90%或更高的氧和目标治疗支气管炎的婴儿在安全性和临床有效性上相当于94%或更高的目标.
- 建议进行进一步的研究,以探索患有急性呼吸道感染的老年儿童的最佳氧和目标,特别是在资源有限的环境中.
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