[JAMA最新论文]:预防性抗生素对去除用于治疗足、踝及小腿骨科的骨科植入物后手术部位感染的影响 | 中国病理生理学会危重病医学专业委员会
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[JAMA最新论文]:预防性抗生素对去除用于治疗足、踝及小腿骨科的骨科植入物后手术部位感染的影响
2018年01月04日 时讯速递, 进展交流 暂无评论

Original Investigation

December 26, 2017

Effect of Antibiotic Prophylaxis on Surgical Site Infections Following Removal of Orthopedic Implants Used for Treatment of Foot, Ankle, and Lower Leg Fractures: A Randomized Clinical Trial

Manouk Backes, MD, Siem A. Dingemans, Marcel G. W. Dijkgraaf, et al

JAMA. 2017;318(24):2438-2445. doi:10.1001/jama.2017.19343

Abstract

Importance 背景

Following clean (class I, not contaminated) surgical procedures, the rate of surgical site infection (SSI) should be less than approximately 2%. However, an infection rate of 12.2% has been reported following removal of orthopedic implants used for treatment of fractures below the knee.

在清洁(I类,无污染)手术后,手术部位感染(SSI)发生率应不超过2%。然而,去除用于治疗膝关节以下部位骨折的骨科植入物后,感染率为12.2%。

Objective 目的

To evaluate the effect of a single dose of preoperative antibiotic prophylaxis on the incidence of SSIs following removal of orthopedic implants used for treatment of fractures below the knee.

评价术前单一剂量抗生素预防对去除用于治疗膝关节以下部位骨折的骨科植入物后SSI发生率的影响。

Design, Setting, and Participants 设计,场景及研究对象

Multicenter, double-blind, randomized clinical trial including 500 patients aged 18 to 75 years with previous surgical treatment for fractures below the knee who were undergoing removal of orthopedic implants from 19 hospitals (17 teaching and 2 academic) in the Netherlands (November 2014-September 2016), with a follow-up of 6 months (final follow-up, March 28, 2017). Exclusion criteria were an active infection or fistula, antibiotic treatment, reimplantation of osteosynthesis material in the same session, allergy for cephalosporins, known kidney disease, immunosuppressant use, or pregnancy.

2014年11月至2016年9月间,荷兰19所医院进行的多中心,双盲,随机临床试验,纳入500名年龄在18-75岁的患者,所有患者既往曾因膝关节以下骨折接受手术治疗,拟行手术去除骨科植入物,随访时间为6个月(最后随访时间2017年3月28日)。排除标准包括活动性感染或瘘,抗生素治疗,同期重新植入骨接合材料,头孢菌素过敏,已知肾脏疾病,使用免疫抑制剂或妊娠。

Interventions 干预措施

A single preoperative intravenous dose of 1000 mg of cefazolin (cefazolin group, n = 228) or sodium chloride (0.9%; saline group, n = 242).

术前静脉使用单一剂量头孢唑啉1000 mg(头孢唑啉组,n = 228)或氯化钠(0.9%生理盐水组,n = 242)。

Main Outcomes and Measures 主要预后指标

Primary outcome was SSI within 30 days as measured by the criteria from the US Centers for Disease Control and Prevention. Secondary outcome measures were functional outcome, health-related quality of life, and patient satisfaction.

主要预后指标为30天内SSI(根据美国CDC的诊断标准)发生率。次要预后指标为功能性预后,健康相关生活质量以及患者满意度。

Results 结果

Among 477 randomized patients (mean age, 44 years [SD, 15]; women, 274 [57%]; median time from orthopedic implant placement, 11 months [interquartile range, 7-16]), 470 patients completed the study. Sixty-six patients developed an SSI (14.0%): 30 patients (13.2%) in the cefazolin group vs 36 in the saline group (14.9%) (absolute risk difference, −1.7 [95% CI, −8.0 to 4.6], P = .60).

477名患者接受随机分组(平均年龄,44岁[SD, 15];女性,274 [57%];从留置骨科植入物至手术时间,11个月 [四分位区间。7-16]),其中470名患者完成试验。66名患者发生SSI (14.0%):头孢唑啉组30 名 (13.2%) ,生理盐水组36名 (14.9%)(绝对风险差异,−1.7 [95% CI, −8.0 to 4.6], P = .60)。

Conclusions and Relevance 结论与意义

Among patients undergoing surgery for removal of orthopedic implants used for treatment of fractures below the knee, a single preoperative dose of intravenous cefazolin compared with saline did not reduce the risk of surgical site infection within 30 days following implant removal.

对于接受手术去除用于治疗膝关节以下部位骨折的骨科植入物的患者,与盐水相比,术前静脉使用单一剂量头孢唑啉不能降低术后30天内手术部位感染风险。

Trial Registration 试验注册

clinicaltrials.gov Identifier: NCT02225821

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