Marwa Joel M, Ngayomela Isidor H, Seni Jeremiah, Mshana Stephen E
Department of Surgery, Catholic University of Health and Allied Sciences, Box 1464, Mwanza, Tanzania.
Department of Trauma and Orthopedics, Bugando Medical Centre, Box 1370, Mwanza, Tanzania.
BMC Pharmacol Toxicol. 2015 Dec 23;16:42. doi: 10.1186/s40360-015-0039-4.
Antimicrobial prophylaxis reduces the incidence of postoperative wound infections especially among patients undergoing orthopedics surgery. However, there is dearth of information on the clinical effectiveness, spectrum limitations and practical contextual information on third and fourth generation cephalosporins. The aim of this study was to evaluate the efficacy and safety of cefepime and ceftriaxone as peri-operative systemic antimicrobial prophylaxis in elective orthopedic surgery in our center.
This study was a prospective, randomized, open label comparative clinical study of patients undergoing elective orthopedic procedures at the Bugando Medical Centre (BMC) between June 2014 and February 2015. Two hundred thirty participants were enrolled in the study and randomly assigned into Ceftriaxone regimen (group A) or Cefepime regimen (group B). Participants in ceftriaxone or cefepime group received 50 mg/kg up to 2 g single dose perioperative intravenous infusion at least 30 min before incision. Both groups were followed for 30 days using a Center for Disease Control superficial surgical site infection criterion for the outcome. A two-tailed margin of equivalence was set at 5% analyzed on the intent to treat.
All 230 participants were subjected to final analysis with no patient being lost to follow-up. Superficial surgical site infection occurred in 5 out of 117 (4.3%, 0.6 to 7.9 at 95% CI) patients receiving cefepime compared to 3 out of 113 (2.7%, 0.3 to 5.6 at 95% CI) among patients receiving ceftriaxone regimen. The absolute difference of 1.6% (95% Confidence Interval: -6.3 to 3.1), equivocally lies outside the 5% statistically significant margin of presumed clinical equivalence.
The difference between cefepime and ceftriaxone in preventing SSIs following elective clean orthopedic surgery was not statistically significant.
Pan African Clinical Trial Registry: PACTR201406000803420.
抗菌药物预防可降低术后伤口感染的发生率，尤其是在接受骨科手术的患者中。然而，关于第三代和第四代头孢菌素的临床疗效、抗菌谱局限性及实际背景信息却十分匮乏。本研究的目的是评估头孢吡肟和头孢曲松在我院择期骨科手术中作为围手术期全身抗菌药物预防用药的疗效和安全性。
本研究是一项前瞻性、随机、开放标签的对比临床研究，研究对象为2014年6月至2015年2月期间在布甘多医疗中心（BMC）接受择期骨科手术的患者。230名参与者被纳入研究，并随机分为头孢曲松组（A组）或头孢吡肟组（B组）。头孢曲松组或头孢吡肟组的参与者在手术切口前至少30分钟接受50mg/kg、最大剂量2g的单剂量围手术期静脉输注。两组均按照疾病控制中心的浅表手术部位感染标准随访30天以观察结局。设定双侧等效性界限为5%，按意向性治疗进行分析。
所有230名参与者均接受了最终分析，无患者失访。接受头孢吡肟治疗的117名患者中有5名（4.3%，95%CI为0.6至7.9）发生浅表手术部位感染，而接受头孢曲松治疗的113名患者中有3名（2.7%，95%CI为0.3至5.6）发生感染。1.6%的绝对差异（95%置信区间：-6.3至3.1）勉强超出了假定临床等效性的5%统计学显著界限。
在择期清洁骨科手术后预防手术部位感染方面，头孢吡肟和头孢曲松之间的差异无统计学意义。
泛非临床试验注册中心：PACTR201406000803420。
