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一项在改良根治性乳房切除术常规应用术前抗生素预防的随机、双盲、安慰剂对照临床试验。

A randomized, double-blinded placebo-controlled clinical trial of the routine use of preoperative antibiotic prophylaxis in modified radical mastectomy.

机构信息

Department of Surgery, University of the Philippines Manila-Philippine General Hospital, Taft Avenue, 1000 Manila, Philippines.

出版信息

World J Surg. 2013 Jan;37(1):59-66. doi: 10.1007/s00268-012-1816-5.

DOI:10.1007/s00268-012-1816-5
PMID:23052809
Abstract

BACKGROUND

The effectiveness of antibiotic prophylaxis for prevention of surgical site infection (SSI) following specific types of breast cancer surgery remains uncertain. This study assessed the effectiveness of prophylaxis in modified radical mastectomy (MRM).

METHODS

Women undergoing MRM for breast cancer were recruited. Women were excluded who had diabetes mellitus, severe malnutrition or known allergy to cephalosporins; were receiving corticosteroid therapy or were treated with antibiotics within one week prior to surgery; were scheduled for simultaneous breast reconstruction or bilateral oophorectomy; had existing local infection. Participants were randomized to receive either intravenous cefazolin 1 g or placebo within 30 min prior to skin incision. Standard skin preparation and operative technique for MRM were carried out. Wounds were assessed for SSI and other complications weekly for 30 days.

RESULTS

A total of 254 women were recruited. Age, clinical stage, prior chemotherapy, and operative time were similar for antibiotic and placebo groups. The overall incidence of SSI was 14.2 %. There were no significant differences in the infection rate over the 30-day follow-up period between the placebo and antibiotic groups (15 % vs 13.4 %; p = 0.719) or at each week. The majority of SSI were either cellulitis or superficial infection for both groups. There were no significant differences between groups in treatments required for SSI, incidence of hematoma or seroma.

CONCLUSIONS

The findings of this study, alone and when meta-analyzed with data from studies in similar surgical populations, do not support the use of antibiotic prophylaxis in MRM.

摘要

背景

抗生素预防在特定类型乳腺癌手术后预防手术部位感染(SSI)的有效性仍不确定。本研究评估了预防方案在改良根治性乳房切除术(MRM)中的效果。

方法

招募接受 MRM 治疗乳腺癌的女性。排除患有糖尿病、严重营养不良或已知对头孢菌素过敏者;正在接受皮质类固醇治疗或在手术前一周内接受抗生素治疗者;计划同时进行乳房重建或双侧卵巢切除术者;有现有局部感染的患者。参与者被随机分为在皮肤切开前 30 分钟内接受静脉注射头孢唑林 1 g 或安慰剂。按照标准的皮肤准备和 MRM 手术技术进行操作。每周评估伤口 30 天,以评估 SSI 和其他并发症。

结果

共招募了 254 名女性。抗生素组和安慰剂组的年龄、临床分期、既往化疗和手术时间相似。SSI 的总发生率为 14.2%。在 30 天的随访期间,安慰剂组和抗生素组之间(15%比 13.4%;p=0.719)或每周的感染率均无显著差异。两组的大多数 SSI 均为蜂窝织炎或浅表感染。两组在 SSI 所需的治疗、血肿或血清肿的发生率方面无显著差异。

结论

本研究的结果,单独分析以及与类似手术人群研究的数据进行荟萃分析,均不支持在 MRM 中使用抗生素预防。

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