Ann Surg:肥胖乳腺癌患者术前应使用抗生素
2012-12-26 Ann Surg 网络 ecoliDh5
乳腺手术后手术部位感染发生率普遍高于预期。研究发现，肥胖是其风险因素之一。针对这种现状，美国外科医师学会会员、土耳其马尔马拉大学医学院Bahadir M. Gulluoglu博士等人进行了一项研究，该研究针对超重或肥胖的乳腺癌女性患者，旨在评价应用预防性抗生素对防止手术部位感染(SSI)的影响以及该预防手段的性价比。 该研究试验设计方案为，随机、对照、平行组临床I
乳腺手术后手术部位感染发生率普遍高于预期。研究发现，肥胖是其风险因素之一。针对这种现状，美国外科医师学会会员、土耳其马尔马拉大学医学院Bahadir M. Gulluoglu博士等人进行了一项研究，该研究针对超重或肥胖的乳腺癌女性患者，旨在评价应用预防性抗生素对防止手术部位感染(SSI)的影响以及该预防手段的性价比。
该研究试验设计方案为，随机、对照、平行组临床IV期有效性试验。该项试验于一所三级大学医院进行。试验合格人群为超重或肥胖的临床早期乳腺癌女性患者，这些患者均被应接受手术治疗。按照计算机生成的名单，研究人员将患者随机分入预防组或对照组。预防组患者在接受麻醉时，静脉注射1 g氨苄西林-舒巴坦钠。对照组患者则不进行任何干预措施。针对分配方案，采用患者盲法及观察者盲法。研究主要结果为比较两组患者手术部位感染发生率。患者监控时间为30天。
该研究的最终分析共包括369例患者，其中187例患者被随机分入预防组，182例患者被分入对照组。研究人员根据意向治疗原则完成分析。他们发现，与对照组患者 (13.7%)相比，通过预防措施可显著降低预防组患者的手术部位感染发生率[4.8%；风险比 (RR) 0.35; 95% CI: 0.17–0.73]。研究过程中，未发现不良反应。研究人员还发现，与预防组患者在手术部位感染方面的平均花费 (8.48 美元) 相比，对照组患者的平均花费明显较高(20.26 美元)。
该项研究表明，肥胖乳腺癌患者在选择性手术时，进行抗生素预防可显著减少后手术部位感染发生率，并且该方法性价比较高。
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Efficacy of Prophylactic Antibiotic Administration for Breast Cancer Surgery in Overweight or Obese Patients: A Randomized Controlled Trial
Abstract
Objective: To assess the impact of prophylactic antibiotics on the prevention of surgical site infection (SSI) and the cost-effectiveness of this prophylaxis for breast cancer surgery in overweight or obese women.
Background Data: SSI is higher than expected after breast surgery. Obesity was found to be one of the risk factors.
Methods: The trial was designed as a phase IV randomized, controlled, parallel-group efficacy trial. It was conducted at a tertiary university hospital. Overweight or obese women with clinically early-stage breast cancer who had been assigned to undergo surgery were eligible. Patients were randomly allocated to either a prophylaxis or a control group by using a computer-generated list. The prophylaxis group received 1 g ampicillin-sulbactam intravenously at anesthesia. The control group received no intervention. Patients and observers were blinded to the assignments. The primary outcome was the comparison of SSI incidences of the 2 groups. Patients were monitored for 30 days.
Results: A total of 369 patients were included in final analysis, out of which 187 were allocated for prophylaxis and 182 were randomly assigned to the control group. Analysis was done according to the intention-to-treat principle. Prophylaxis significantly reduced the SSI rate (4.8%) in the prophylaxis group when compared with that in the control group [13.7%; relative risk (RR) 0.35; 95% CI: 0.17–0.73]. No adverse reaction was observed. The mean SSI-related cost (20.26 USD) was found to be significantly higher in the control group when compared with that (8.48 USD) in the prophylaxis group.
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