预防性抗生素对与酒精有关的严重肝炎的死亡率的影响:随机临床试验
Alexandre Louvet1, Julien Labreuche2, Thong Dao3
1Université Lille, CHU de Lille, Service des maladies de l'appareil digestif, Hôpital Huriez, INFINITE-U1286, Lille, France.
JAMA
|May 9, 2023
概括
在严重的酒精性肝炎患者中,预防性阿莫西林- 克拉夫兰酸并没有改善存活率. 这项研究表明,抗生素不能提高这些住院患者的生存率.
科学领域:
- 肝病学
- 传染性疾病
- 临床药理学
背景情况:
- 严重的与酒精有关的肝炎带来严重的死亡风险.
- 预防性抗生素在治疗这种疾病中的作用仍然不确定.
- 目前的治疗指南并不一致地建议使用抗生素治疗严重的酒精性肝炎.
研究的目的:
- 评估阿莫西林- 克拉夫兰酸加普德尼索隆与安慰剂加普德尼索隆在患有严重酒精相关性肝炎的住院患者中降低死亡率的疗效.
- 评估预防性抗生素对该患者群体感染率和其他临床结果的影响.
主要方法:
- 一个多中心的,随机的,双盲的,安慰剂对照的试验,涉及292名生物检查证明严重的与酒精有关的肝炎患者.
- 在180天的随访期间,患者除了接受普雷尼索隆外,还接受了阿莫西林克拉夫兰酸或安慰剂.
- 主要结局是60天的所有原因死亡率;次要结局包括90天和180天的感染发病率和死亡率.
主要成果:
- 在阿莫西林- 克拉夫兰酸组 (17. 3%) 和安慰剂组 (21. 3%) 之间没有发现60天全因死亡率的显著差异.
- 然而,与安慰剂组 (41. 5%) 相比,阿莫西林- 克拉夫兰酸组60天感染的发生率明显较低.
- 对于其他次要结果,包括90日和180日死亡率或肝综合征发病率,没有发现显著差异.
结论:
- 艾莫西西林- 克拉夫兰酸在添加到普雷尼索隆时,不会改善住院患者的严重与酒精有关的肝炎的存活率.
- 这些发现不支持常规使用预防性抗生素以提高这一组患者的存活率.
- 虽然感染减少了,但并没有改善整体死亡率,强调需要仔细考虑抗生素的使用.
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