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一项抗生素预防用药随机临床试验,旨在预防开放式网塞修补术后手术部位感染。

A randomized trial of antibiotic prophylaxis for the prevention of surgical site infection after open mesh-plug hernia repair.

机构信息

Department of Surgery, Nihon University School of Medicine, Tokyo, Japan.

Department of Surgery, Nihon University School of Medicine, Tokyo, Japan.

出版信息

Am J Surg. 2014 Apr;207(4):476-84. doi: 10.1016/j.amjsurg.2013.01.047.

Abstract

BACKGROUND

The efficacy of antibiotic prophylaxis for the prevention of surgical-site infection (SSI) after open tension-free inguinal hernia repair remains controversial.

METHODS

A double-blind, randomized, placebo-controlled trial was conducted. Patients who underwent elective open mesh-plug hernia repair were eligible for randomization. In the antibiotic prophylaxis group, 1.0 g cefazolin was intravenously administrated 30 minutes before the incision. In the placebo group, an equal volume of sterile saline was administered. The primary end point was the incidence of SSI.

RESULTS

A total of 200 patients were enrolled. SSI developed in 2 of 100 patients (2%) in the antibiotic prophylaxis group and 13 of 100 patients (13%) in the placebo group, indicating a significant difference between the 2 groups (relative risk ratio, 0.25; 95% confidence interval, 0.070 to 0.92; P = .003). Other complications occurred in 23 patients: 7 (7%) in the antibiotic prophylaxis group and 16 (16%) in the placebo group (P = .046).

CONCLUSIONS

This study indicates that antibiotic prophylaxis is effective for the prevention of SSI after open mesh-plug hernia repair.

摘要

背景

在开放式无张力腹股沟疝修补术后预防手术部位感染(SSI)方面,抗生素预防的疗效仍存在争议。

方法

进行了一项双盲、随机、安慰剂对照试验。接受择期开放式网塞疝修补术的患者有资格进行随机分组。在抗生素预防组中,在切开前 30 分钟静脉注射 1.0 g 头孢唑啉。在安慰剂组中,给予等量无菌生理盐水。主要终点是 SSI 的发生率。

结果

共纳入 200 例患者。抗生素预防组有 2 例(2%)患者发生 SSI,安慰剂组有 13 例(13%)患者发生 SSI,两组之间有显著差异(相对风险比,0.25;95%置信区间,0.070 至 0.92;P =.003)。其他并发症发生在 23 例患者中:抗生素预防组 7 例(7%),安慰剂组 16 例(16%)(P =.046)。

结论

本研究表明,抗生素预防可有效预防开放式网塞疝修补术后 SSI 的发生。

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