抗生素或白银与标准腹腔突变 (BASICS):多中心,单盲,随机试验和经济评估
Conor L Mallucci1, Michael D Jenkinson2, Elizabeth J Conroy3
1Department of Paediatric Neurosurgery, Alder Hey Children's Hospital, Liverpool, UK.
Lancet (London, England)
|September 17, 2019
概括
经过抗生素浸的分离器显著降低了为水脑病而进行腹腔皮质分离器插入的患者的感染率. 这种神经外科手术通过降低分流失败和后续并发症的风险来改善结果.
科学领域:
- 神经外科
- 传染性疾病
- 医疗设备技术
背景情况:
- 腹腔关节插入是常见的神经外科手术.
- 在多达15%的患者中发生了间接感染,导致显著的发病率,包括长期治疗,多次手术和降低生活质量.
研究的目的:
- 评估抗生素浸或银浸的分流器与标准分流器相比在减少腹腔膜分流器感染方面的临床和成本效益.
主要方法:
- 一个平行,多中心,单盲,随机对照试验 (BASICS试验) 涉及1605名在英国和爱尔兰的21个神经外科中心进行首次心室关节插入的患者.
- 患者被随机分配给接受标准的,用抗生素浸的 (利番素和克林达胺素) 或用银浸的分离疗法.
- 主要结局是因感染而导致的分流失效时间,使用Fine和Gray生存回归模型进行分析.
主要成果:
- 与标准分流组 (6%) 相比,抗生素分流组的患者发生了较少的感染分流修复 (2%) (csHR 0. 38, p=0. 0038).
- 与标准分离器相比,银分离器在感染率上没有显著差异 (6%对6%,p=0. 96).
- 不良事件在不同组中是可比的,通常不危及生命.
结论:
- 在英国,BASICS试验提供了强有力的证据支持首次腹腔关节插入的抗生素浸分离器.
- 建议所有年龄段的患者进行这种干预,以减少分流感染的发生率和影响.
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