骨科择期清洁切口手术3种头孢菌素预防性应用临床随机研究

Antibiotic prophylaxis of three cephalosporins in elective clean incision orthopedic surgery:a randomized clinical study

目的:评估骨科择期清洁切口手术预防性使用头孢硫脒、头孢唑林与头孢呋辛的有效性与安全性。方法:这项研究是我院2015年1月-2016年2月一项骨科择期清洁切口手术随机、开放性的临床对比研究。330名患者被纳入研究,随机分为头孢硫脒治疗组(A组)、头孢唑林治疗组(B组)和头孢呋辛治疗组(C组),术前、术后静脉滴注预防使用。三组均随访30d,使用手术部位感染的结果标准统计分析。结果:头孢硫脒治疗组(A组)浅表手术部位感染发生率为6.36%(1.73~10.9995%CI),头孢唑林治疗组(B组)浅表手术部位感染发生率为2.78%(0.32~5.88 95%CI)与头孢呋辛治疗组(C组)浅表手术部位感染发生率为3.57%(0.13~7.01 95%CI)。结论:骨科择期清洁切口手术预防手术部位的感染,头孢硫脒、头孢唑林、头孢呋辛之间的差异没有统计学意义(P=0.399)。

OBJECTIVE To evaluate the efficacy and safety of cefathiamidine, cefazolin and cefuroxime for peri-operative systemic antimicrobial prophylaxis in elective clean incision orthopedic surgery. METHODS A random, open label comparative design was used to enroll patients undergoing elective clean incision orthopedic procedures between January 2015 and February 2016 in our hospital. A total of 330 patients were enrolled in the study and randomly assigned into cefathiamidine regimen （group A）, cefazolin regimen （group B） and cefuroxime regimen （group C）, in which drugs were intravenously infused peri- operatively. The three groups were followed up for 30 days using superficial surgical site infection criterion for the outcome. RESULTS Of all 330 patients, 14 experienced superficial surgical site infections. Superficial surgical site infection rate was 6. 36% （1.73 - 10. 99 95%CI） in cefathiamidine regimen （group A）, 2. 78% （0. 32 - 5.88 95 %CI） in cefazolin regimen （group B） and 3.57%（0. 13 - 7. 01 95%CI） in cefuroxime regimen （group C）. CONCLUSION Cefathiamidine, cefazolin and cefu- roxime show no significant difference in preventing superficial surgical site infection following elective clean incision orthopedic surgery.