万古霉素和头孢唑林在关节置换术中作为预防用药的试验
Trial of Vancomycin and Cefazolin as Surgical Prophylaxis in Arthroplasty.
机构信息
From 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.).
出版信息
N Engl J Med. 2023 Oct 19;389(16):1488-1498. doi: 10.1056/NEJMoa2301401.
BACKGROUND
The addition of vancomycin to beta-lactam prophylaxis in arthroplasty may reduce surgical-site infections; however, the efficacy and safety are unclear.
METHODS
In this multicenter, double-blind, superiority, placebo-controlled trial, we randomly assigned adult patients without known methicillin-resistant (MRSA) colonization who were undergoing arthroplasty to receive 1.5 g of vancomycin or normal saline placebo, in addition to cefazolin prophylaxis. The primary outcome was surgical-site infection within 90 days after surgery.
RESULTS
A total of 4239 patients underwent randomization. Among 4113 patients in the modified intention-to-treat population (2233 undergoing knee arthroplasty, 1850 undergoing hip arthroplasty, and 30 undergoing shoulder arthroplasty), surgical-site infections occurred in 91 of 2044 patients (4.5%) in the vancomycin group and in 72 of 2069 patients (3.5%) in the placebo group (relative risk, 1.28; 95% confidence interval [CI], 0.94 to 1.73; P = 0.11). Among patients undergoing knee arthroplasty, surgical-site infections occurred in 63 of 1109 patients (5.7%) in the vancomyin group and in 42 of 1124 patients (3.7%) in the placebo group (relative risk, 1.52; 95% CI, 1.04 to 2.23). Among patients undergoing hip arthroplasty, surgical-site infections occurred in 28 of 920 patients (3.0%) in the vancomyin group and in 29 of 930 patients (3.1%) in the placebo group (relative risk, 0.98; 95% CI, 0.59 to 1.63). Adverse events occurred in 35 of 2010 patients (1.7%) in the vancomycin group and in 35 of 2030 patients (1.7%) in the placebo group, including hypersensitivity reactions in 24 of 2010 patients (1.2%) and 11 of 2030 patients (0.5%), respectively (relative risk, 2.20; 95% CI, 1.08 to 4.49), and acute kidney injury in 42 of 2010 patients (2.1%) and 74 of 2030 patients (3.6%), respectively (relative risk, 0.57; 95% CI, 0.39 to 0.83).
CONCLUSIONS
The addition of vancomycin to cefazolin prophylaxis was not superior to placebo for the prevention of surgical-site infections in arthroplasty among patients without known MRSA colonization. (Funded by the Australian National Health and Medical Research Council; Australian New Zealand Clinical Trials Registry number, ACTRN12618000642280.).
背景
在关节置换术中加用万古霉素预防β-内酰胺类药物可能会降低手术部位感染率；但疗效和安全性尚不清楚。
方法
在这项多中心、双盲、优效性、安慰剂对照试验中，我们将无已知耐甲氧西林金黄色葡萄球菌（MRSA）定植的成人关节置换术患者随机分为两组，分别接受万古霉素 1.5 g 或生理盐水安慰剂加头孢唑啉预防。主要结局为术后 90 天内的手术部位感染。
结果
共有 4239 例患者接受了随机分组。在改良意向治疗人群（2233 例膝关节置换术，1850 例髋关节置换术，30 例肩关节置换术）的 4113 例患者中，万古霉素组有 2044 例患者中的 91 例（4.5%）和安慰剂组有 2069 例患者中的 72 例（3.5%）发生手术部位感染（相对风险 1.28；95%置信区间 [CI]，0.94 至 1.73；P=0.11）。在膝关节置换术患者中，万古霉素组有 1109 例患者中的 63 例（5.7%）和安慰剂组有 1124 例患者中的 42 例（3.7%）发生手术部位感染（相对风险 1.52；95%CI，1.04 至 2.23）。在髋关节置换术患者中，万古霉素组有 920 例患者中的 28 例（3.0%）和安慰剂组有 930 例患者中的 29 例（3.1%）发生手术部位感染（相对风险 0.98；95%CI，0.59 至 1.63）。万古霉素组有 2010 例患者中的 35 例（1.7%）和安慰剂组有 2030 例患者中的 35 例（1.7%）发生不良事件，包括 24 例（1.2%）和 11 例（0.5%）的过敏反应（相对风险 2.20；95%CI，1.08 至 4.49）和 42 例（2.1%）和 74 例（3.6%）的急性肾损伤（相对风险 0.57；95%CI，0.39 至 0.83）。
结论
在无已知耐甲氧西林金黄色葡萄球菌定植的患者中，万古霉素加头孢唑啉预防并不优于安慰剂预防关节置换术的手术部位感染。（由澳大利亚国家卫生和医学研究委员会资助；澳大利亚新西兰临床试验注册中心编号：ACTRN12618000642280.）
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