Jewesson P J, Stiver G, Wai A, Frighetto L, Nickoloff D, Smith J, Schwartz L, Sleigh K, Danforth D, Scudamore C, Chow A
Department of Pharmacy, Vancouver Hospital and Health Sciences Centre, British Columbia, Canada.
Antimicrob Agents Chemother. 1996 Jan;40(1):70-4. doi: 10.1128/AAC.40.1.70.
Antibiotics have been shown to reduce the incidence of wound infections after elective biliary tract procedures. Cefazolin and cefoxitin are among the agents most commonly promoted for this purpose. Cefoxitin has been substituted with ceftizoxime in many institutions; however, the role of ceftizoxime as a prophylactic agent in this setting has not been determined. To assess the comparative prophylactic efficacies of cefazolin and ceftizoxime in biliary tract surgery, we conducted a double-blind, randomized prospective clinical trial in a tertiary-care teaching hospital. Adult patients were randomized to one of two treatment groups and received a 30-min preoperative dose of study drug and as many as two postoperative doses at 12 and 24 h, depending on hospitalization status. Cefazolin and ceftizoxime were given as 1,000-mg doses. Patients with infections, those receiving prior antibiotics, or those with beta-lactam allergies were excluded. Over the 19-month study tenure, 167 patients were enrolled. Seventeen patients were excluded from analysis because of protocol violations. Of the 150 evaluable patients (72 and 78 receiving cefazolin and ceftizoxime doses, respectively), there was no significant difference among groups regarding sex, age, weight, preoperative Apache II score, baseline chemistry, and hematological parameters. Groups were also equivalent regarding the surgeon, type of procedure, characteristics (blood loss, drains, organ injury, and complications), and duration of hospital stay (mean, 5.6 versus 4.3 days [P = 0.31]). No clinical evidence of infection (7-day hospital stay and 30-day follow-up) was identified in 93% of cefazolin and 92% of ceftizoxime patients (P = 1.0). Microbiological confirmation was found in only 18% of primary-site infections. In conclusion, cefazolin and ceftizoxime appear to be equivalent for the prevention of infection in biliary tract surgery with the dosage regimens studied.
抗生素已被证明可降低择期胆道手术后伤口感染的发生率。头孢唑林和头孢西丁是最常用于此目的的药物。在许多机构中，头孢西丁已被头孢唑肟取代；然而，头孢唑肟在这种情况下作为预防药物的作用尚未确定。为了评估头孢唑林和头孢唑肟在胆道手术中的相对预防效果，我们在一家三级护理教学医院进行了一项双盲、随机前瞻性临床试验。成年患者被随机分为两个治疗组之一，并在术前接受30分钟的研究药物剂量，根据住院情况在术后12小时和24小时最多接受两剂。头孢唑林和头孢唑肟均给予1000毫克剂量。排除有感染的患者、先前接受过抗生素治疗的患者或对β-内酰胺过敏的患者。在为期19个月的研究期间，共纳入167例患者。17例患者因违反方案被排除在分析之外。在150例可评估患者中（分别有72例和78例接受头孢唑林和头孢唑肟剂量），两组在性别、年龄、体重、术前急性生理与慢性健康状况评分系统II（Apache II）评分、基线化学指标和血液学参数方面无显著差异。两组在外科医生、手术类型、特征（失血量、引流、器官损伤和并发症）以及住院时间（平均分别为5.6天和4.3天[P = 0.31]）方面也相当。在接受头孢唑林治疗的患者中有93%以及接受头孢唑肟治疗的患者中有92%未发现感染的临床证据（7天住院和30天随访）（P = 1.0）。仅18%的原发部位感染得到微生物学确认。总之，在所研究的给药方案下，头孢唑林和头孢唑肟在预防胆道手术感染方面似乎等效。
