塞法林与替代β-乳酸用于下肢骨折手术的预防:一个向试验仿真试验
Takaki Yoshiyama1, Toshiki Fukasawa2, Soichiro Masuda3
1Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Kyoto, Japan; Department of Orthopaedic Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Injury
|February 21, 2025
概括
在下肢骨折的手术预防中,用替代性β-乳替代塞法索林,在手术部位感染 (SSI) 的重新手术率上没有显著差异. 鉴于全球潜在的抗生素短缺,这一发现至关重要.
科学领域:
- 整形外科手术 整形外科手术
- 传染病流行病学 传染病流行病学
- 药理学 药理学是指药理学的学科.
背景情况:
- 塞法索林是用于骨科手术预防的标准抗生素.
- 日本的塞法林短缺促使人们评估替代性β-乳酸盐.
- 鉴于潜在的全球抗生素供应问题,确认替代品至关重要.
研究的目的:
- 为了比较塞法佐林和替代β-乳糖类药物之间的手术部位感染 (SSI) 重复手术的风险.
- 专注于接受下肢骨折手术的患者.
- 在塞法林供应中断期间评估替代抗生素的有效性.
主要方法:
- 使用日本医院管理数据库 (JMDC Inc.) 模拟了一个目标试验.
- 包括为下肢骨折进行开放式缩减和内部固定的患者 (2019年3月至2020年2月).
- 在30天内对SSI进行比较重新操作,使用反向概率权重和敏感性分析,长达365天.
主要成果:
- 在塞法佐林 (0.31%) 和替代β-乳酸药 (0.37%) 之间,对于SSI的30天重复手术风险没有实质性差异.
- 风险差异为-0.06% (95% CI, -0.33至0.14);风险比为0.82 (95% CI,0.50至1.52).风险比为0.82 (95% CI,0.50至1.52).
- 最长365天的敏感性分析也显示了可比的重新操作风险.
结论:
- 在下肢骨折手术中用替代性β-乳糖替代塞法索林,不会显著改变SSI重复手术的风险.
- 在塞法林短缺期间,替代性β-乳酸盐是手术预防的可行选择.
- 研究支持使用替代抗生素来确保外科治疗的连续性.
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