Gatell J M, Garcia S, Lozano L, Soriano E, Ramon R, SanMiguel J G
Department of Infectious Diseases, Hospital Clinic, Faculty of Medicine, Barcelona, Spain.
J Bone Joint Surg Am. 1987 Oct;69(8):1189-93.
Seven hundred and seventeen patients were included in a prospective randomized double-blind trial comparing the efficacy of five doses of cefamandole (group I, 335 patients) with that of a single preoperative dose (group II, 382 patients) for prophylaxis against sepsis in patients who had an operation using either a Moore prosthesis, Ender or Küntscher nails, a bone plate, or another internal-fixation device. Patients who had an open fracture or total joint replacement were not included in the study. The two groups were similar in terms of mean age, sex ratio, duration of preoperative hospital stay, underlying risk factors, and type of surgical procedure. A wound infection developed in none of the seventy-four patients in group I and in five (6.6 per cent) of the seventy-six in group II (p = 0.03) who required a Moore prosthesis. A wound infection developed in three patients (1 per cent) in group I and in fifteen (5 per cent) in group II (p = 0.006) who required an internal fixation device other than a Moore prosthesis. Staphylococcus aureus, Staphylococcus epidermidis, and gram-negative bacilli were the most common infecting organisms. The rate of mortality was similar in both groups, while the percentage of postoperative urinary-tract infections was lower in group I (p = 0.04). No adverse side effects of the drug were encountered.
717例患者纳入一项前瞻性随机双盲试验,比较五剂头孢孟多(I组,335例患者)与术前单剂(II组,382例患者)对使用Moore假体、Ender钉或Küntscher钉、接骨板或其他内固定装置进行手术的患者预防败血症的疗效。开放性骨折或全关节置换患者未纳入本研究。两组在平均年龄、性别比、术前住院时间、潜在危险因素和手术类型方面相似。I组74例使用Moore假体的患者中无一例发生伤口感染,II组76例使用Moore假体的患者中有5例(6.6%)发生伤口感染(p = 0.03)。I组3例(1%)使用Moore假体以外的内固定装置的患者发生伤口感染,II组15例(5%)使用Moore假体以外的内固定装置的患者发生伤口感染(p = 0.006)。金黄色葡萄球菌、表皮葡萄球菌和革兰氏阴性杆菌是最常见的感染病原体。两组死亡率相似,而I组术后尿路感染百分比更低(p = 0.04)。未发现该药物的不良副作用。