范科米辛和塞法索林作为关节塑性手术预防的试验
Trisha N Peel1, Sarah Astbury1, Allen C Cheng1
1From the Department of Infectious Diseases, Central Clinical School, Faculty of Medicine, Nursing, and Health Sciences (T.N.P., S. Astbury, J.W.), and the Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine (A.C.C.), Monash University, the Department of Infectious Diseases, Alfred Health (T.N.P., S. Astbury, A.C.C., J.R., J.W.), the Department of Infectious Diseases, Doherty Institute (K.L.B.), the Department of Surgery, St. Vincent's Hospital (T.S.), the Centre for Health Policy, Melbourne School of Population and Global Health (A.T.-D.), and the Department of Surgery, Epworth HealthCare (R.S.), University of Melbourne, the Victorian Infectious Diseases Service, Royal Melbourne Hospital (K.L.B.), and the Department of Health Services Research, Peter MacCallum Cancer Centre, and Burnet Institute (T.S.), Melbourne, VIC, the St. George and Sutherland Clinical Campuses, School of Clinical Medicine, University of New South Wales Medicine and Health, Sydney (S. Adie, R.M.), Bendigo Health, Bendigo, VIC (G.B.), the Department of Orthopaedics, Prince Charles Hospital, Metro North Hospital and Health Service (C.M., R.C.), the Department of Medicine (C.M.) and the Centre for Clinical Research (T.H.-B.), University of Queensland, and Queensland University of Technology (R.C.), Brisbane, the Department of Orthopaedics, Launceston General Hospital, Tasmanian Health Service, Launceston, TAS (J.M.), Gippsland Orthopaedic Group, Traralgon, VIC (P.R.), and Prince of Wales Hospital and Prince of Wales Private Hospital, Randwick, NSW (M.S.) - all in Australia; Advancing Clinical Evidence in Infectious Diseases, Saw Swee Hock School of Public Health, and the Infectious Diseases Translational Research Program, Yong Loo Lin School of Medicine, National University of Singapore, Singapore (D.L.P.); and the Department of Clinical Neuroscience, Karolinska Institute, Stockholm (T.S.).
在没有MRSA殖民的患者中,添加万科米辛到关节整形手术的标准抗生素预防中并没有减少手术部位感染. 该研究发现没有显著的益处,并指出过敏反应的潜在风险增加.
科学领域:
- 整形外科手术 整形外科手术
- 预防传染病 预防传染病
- 临床试验 临床试验
背景情况:
- 手术部位感染 (SSIs) 是关节整形手术后的一个严重并发症.
- 除了β-乳酸预防,除了β-乳酸预防,范科米在关节塑性手术中预防SSI的作用仍然不确定.
- 耐甲基西林黄金葡萄球菌 (MRSA) 殖民是SSI的已知风险因素.
研究的目的:
- 评价添加万科米辛到塞法林预防的有效性和安全性,以预防在没有已知的MRSA殖民化的关节塑造患者中SSI.
- 为了确定万科米辛是否与安慰剂相比提供更好的保护作用,当与标准塞法林预防药物相结合时.
主要方法:
- 进行了一项多中心,双盲,优越性,安慰剂受控试验.
- 在没有已知MRSA定居的成年患者接受关节塑造手术时,随机分配给除了塞法佐林外,接受万科米辛或正常盐水安慰剂.
- 测量的主要结果是手术后90天内手术部位感染的发生率.
主要成果:
- 香胺组SSI的总发病率为4.5%,而安慰剂组为3.5% (相对风险[RR]1.28,95%信心区间[CI]0.94-1.73,P=0.11).
- 在膝关节整形术患者中,SSIs发生在5.7%的范科米辛与3.7%的安慰剂 (RR 1.52,95% CI 1.04-2.23) 之间.
- 两组之间不良反应是相似的 (1.7%),但过敏反应更频繁地发生在万科米辛 (1.2%对0.5%),而急性损伤较少 (2.1%对3.6%).
结论:
- 在没有已知的MRSA殖民化的关节塑性患者中,添加范科米辛到塞法林预防并没有优于安慰剂来预防SSI.
- 这些发现不支持在这种患者群体中常规预防中常规添加万科米辛.
- 对于特定的子组或完全阐明急性损伤和过敏症的安全概况,可能需要进一步调查.
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