Walker A P, Nichols R L, Wilson R F, Bivens B A, Trunkey D D, Edmiston C E, Smith J W, Condon R E
Department of Surgery, Medical College of Wisconsin, Milwaukee 53226.
Ann Surg. 1993 Feb;217(2):115-21. doi: 10.1097/00000658-199302000-00004.
A double-blind trial was conducted in 385 patients with suspected bacterial intra-abdominal infections to compare the efficacy and safety of ampicillin-sulbactam with cefoxitin. Patients were randomized to receive either 3 g ampicillin-sulbactam (2 g ampicillin-1 g sulbactam), or 2 g cefoxitin, every 6 hours. To be evaluable, patients had to demonstrate positive culture evidence of peritoneal infection at the time of operation. A total of 197 patients were evaluable for clinical efficacy. The two treatment groups were comparable in demographic features and in the presence of risk factors for infection. Clinical success (absence of infection and of adverse drug reaction) was observed in 86% of patients in the ampicillin-sulbactam group and 78% in the cefoxitin group. Eradication of infection occurred in 88% of the ampicillin-sulbactam group and 79% of the cefoxitin group. There were no differences in the nature or frequency of side effects observed in the two groups. Ampicillin-sulbactam demonstrated no difference in safety or efficacy when compared with cefoxitin in the treatment of serious intra-abdominal infections of bacterial origin.
对385例疑似细菌性腹腔内感染患者进行了一项双盲试验，以比较氨苄西林-舒巴坦与头孢西丁的疗效和安全性。患者被随机分组，每6小时接受3克氨苄西林-舒巴坦（2克氨苄西林-1克舒巴坦）或2克头孢西丁治疗。为可评估，患者在手术时必须有腹膜感染的阳性培养证据。共有197例患者可评估临床疗效。两个治疗组在人口统计学特征和感染危险因素方面具有可比性。氨苄西林-舒巴坦组86%的患者和头孢西丁组78%的患者观察到临床成功（无感染和药物不良反应）。氨苄西林-舒巴坦组88%的患者和头孢西丁组79%的患者感染得到根除。两组观察到的副作用性质或频率没有差异。在治疗细菌性严重腹腔内感染时，氨苄西林-舒巴坦与头孢西丁相比在安全性或疗效方面无差异。
