2天与5天的术后抗生素复杂尾炎:一个实用性的,开放的,多中心的,非劣势的随机试验
Elisabeth M L de Wijkerslooth1, Evert-Jan G Boerma2, Charles C van Rossem3
1Department of Surgery, Erasmus MC - University Medical Centre, Rotterdam, Netherlands.
两天的术后抗生素治疗复杂尾炎的效果与五天的效果相同, 这一发现支持治疗尾炎的抗生素持续时间较短.
科学领域:
- 外科瘤学
- 传染性疾病
- 临床药理学
背景情况:
- 术后抗生素治疗复杂尾炎的最佳持续时间尚不确定.
- 抗菌药物耐药性需要谨慎使用抗生素以尽量减少副作用,住院和医疗费用.
研究的目的:
- 要确定静脉注射抗生素的2天疗程是否与复杂尾炎的5天疗程不劣.
- 评估较短的抗生素对感染并发症,死亡率和不良事件的影响.
主要方法:
- 这是一项实用,开放的非劣势性试验,涉及15家荷兰医院的1066名复杂尾炎患者.
- 患者随机分组在尾切除后接受2天或5天的静脉注射抗生素.
- 主要终点是90天内感染并发症和死亡率的组合,非劣势率为7.5%.
主要成果:
- 两天的抗生素组与五天的抗生素组相比没有劣势,10%和8%的患者出现了初级终点 (调整后风险差异为2. 0%,95%CI为-1. 6至5. 6).
- 在两天治疗组中,抗生素不良反应显著降低 (9% vs 22%).
- 然而,在2天组中,再入院率较高 (12%与6%相比).
结论:
- 术后两天的抗生素治疗方案与复杂尾炎的五天治疗方案相比,特别是在资源充足的环境中进行腹腔镜手术.
- 缩短抗生素的持续时间可以减少副作用和潜在的住院时间.
- 可能需要进一步的研究来解决在较短时间内观察到的再入院率的增加.
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