Barie P S, Vogel S B, Dellinger E P, Rotstein O D, Solomkin J S, Yang J Y, Baumgartner T F
Department of Surgery, Cornell University, New York, NY, USA.
Arch Surg. 1997 Dec;132(12):1294-302. doi: 10.1001/archsurg.1997.01430360040008.
To evaluate the safety and efficacy of cefepime hydrochloride plus metronidazole vs the combination of imipenem and cilastatin sodium in the treatment of complicated intra-abdominal infections in adult patients.
Prospective, randomized, double-blind multicenter study.
University-affiliated hospitals in the United States and Canada.
Three hundred twenty-three patients with complicated intra-abdominal infections in whom an operative procedure or percutaneous drainage was required for diagnosis and management.
Cefepime, 2 g, was administered intravenously every 12 hours (n= 164) in addition to metronidazole, 500 mg (or 7.5 mg/kg) intravenously every 6 hours. Imipenen-cilastatin sodium, 500 mg, was administered intravenously every 6 hours (n= 159). Surgical infection management was determined by the patients' surgeons. MAIN OUTCOME ASSESSMENTS: Clinical cure, defined as elimination of all signs and symptoms relevant to the original infection; and treatment failure, defined as persistence, increase or worsening of signs and symptoms resulting in an antibiotic change, requirement of an additional surgical procedure to cure the infection, or a wound infection with fever.
Of the initial isolates, 84% were susceptible to cefepime and 92% were susceptible to imipenem-cilastatin. Among the 217 protocol-valid patients, those treated with cefepime+metronidizole were deemed clinical cures (88%) more frequently than were imipenem-cilastatin-treated patients (76%) (P=.02). Using multivariate analysis to adjust for identified clinical risk factors for an adverse outcome (severity of presenting illness, isolation of enterococcus, type of infection, and duration of prestudy hospitalization), there was a trend (P=.06) toward a higher cure rate favoring cefepime+metronidazole. Pathogens were eradicated in significantly (P=.01) more patients treated with combined cefepime and metronidazole (89%) than with imipenem-cilastatin (76%).
The combination of cefepime plus metronidazole is safe and effective therapy for patients with severe intra-abdominal infections.
评估盐酸头孢吡肟联合甲硝唑与亚胺培南西司他丁钠治疗成年患者复杂性腹腔内感染的安全性和有效性。
前瞻性、随机、双盲多中心研究。
美国和加拿大的大学附属医院。
323例复杂性腹腔内感染患者，诊断和治疗需进行手术或经皮引流。
头孢吡肟2g，每12小时静脉注射一次（n = 164），加甲硝唑500mg（或7.5mg/kg），每6小时静脉注射一次。亚胺培南西司他丁钠500mg，每6小时静脉注射一次（n = 159）。手术感染管理由患者的外科医生决定。主要结局评估：临床治愈，定义为消除与原感染相关的所有体征和症状；治疗失败，定义为体征和症状持续、加重或恶化，导致更换抗生素、需要额外手术治疗感染或伤口感染伴发热。
在初始分离株中，84%对头孢吡肟敏感，92%对亚胺培南西司他丁敏感。在217例符合方案的患者中，接受头孢吡肟+甲硝唑治疗的患者临床治愈率（88%）高于接受亚胺培南西司他丁治疗的患者（76%）（P = 0.02）。使用多变量分析调整已确定的不良结局临床风险因素（疾病严重程度、肠球菌分离情况、感染类型和研究前住院时间），倾向于头孢吡肟+甲硝唑的治愈率更高（P = 0.06）。联合使用头孢吡肟和甲硝唑治疗的患者病原体清除率（89%）显著高于亚胺培南西司他丁治疗的患者（76%）（P = 0.01）。
头孢吡肟联合甲硝唑对严重腹腔内感染患者是安全有效的治疗方法。
