Grayson M L, Gibbons G W, Habershaw G M, Freeman D V, Pomposelli F B, Rosenblum B I, Levin E, Karchmer A W
Division of Infectious Diseases (Department of Medicine), New England Deaconess Hospital, Boston, Massachusetts.
Clin Infect Dis. 1994 May;18(5):683-93. doi: 10.1093/clinids/18.5.683.
In a double-blind randomized trial, imipenem/cilastatin (I/C; 500 mg every 6 hours) and ampicillin/sulbactam (A/S; 3 g every 6 hours) were compared in regard to their efficacy for initial empirical and definitive parenteral treatment of limb-threatening pedal infection in diabetic patients. The major endpoints of treatment were cure (resolution of soft-tissue infection), failure (inadequate improvement, necessitating a change in antibiotic therapy), and eradication (clearance of all pathogens from the wound and any bone cultures). Patients in the two treatment groups were similar in regard to the severity of diabetes; presence of neuropathy and peripheral vascular disease; site and severity of infection; pathogen isolated; and frequency of osteomyelitis (associated with 68% of the 48 A/S-treated infections and 56% of the 48 I/C-treated infections). After 5 days of empirical treatment, improvement was noted in 94% of the A/S and 98% of the I/C recipients. At the end of definitive treatment (days' duration [mean +/- SD]: 13 +/- 6.5 [A/S], 14.8 +/- 8.6 [I/C]), outcomes were similar: cure, 81% (A/S) vs. 85% (I/C); failure, 17% (A/S) vs. 13% (I/C); and eradication, 67% (A/S) vs. 75% (I/C). Treatment failures were associated with the presence of antibiotic-resistant pathogens and possible nosocomial acquisition of infections. The number of adverse events among patients in the two treatment groups was similar: 7 in the A/S group (4 had diarrhea and 3 had rash) and 9 in the I/C group (5 had diarrhea, 2 had severe nausea, 1 had rash, and 1 had seizure). Efficacy of A/S and I/C is similar for initial empirical and definitive treatment of limb-threatening pedal infection in patients with diabetes.
在一项双盲随机试验中，比较了亚胺培南/西司他丁（I/C；每6小时500毫克）和氨苄西林/舒巴坦（A/S；每6小时3克）对糖尿病患者有肢体威胁的足部感染进行初始经验性和确定性肠外治疗的疗效。治疗的主要终点为治愈（软组织感染消退）、失败（改善不足，需要改变抗生素治疗）和根除（伤口及所有骨培养物中所有病原体清除）。两个治疗组的患者在糖尿病严重程度、神经病变和外周血管疾病的存在、感染部位和严重程度、分离出的病原体以及骨髓炎发生率（48例接受A/S治疗的感染中有68%、48例接受I/C治疗的感染中有56%伴有骨髓炎）方面相似。经验性治疗5天后，94%接受A/S治疗的患者和98%接受I/C治疗的患者病情有改善。在确定性治疗结束时（疗程天数[平均值±标准差]：A/S组为13±6.5天，I/C组为14.8±8.6天），结果相似：治愈，A/S组为81%，I/C组为85%；失败，A/S组为17%，I/C组为13%；根除，A/S组为67%，I/C组为75%。治疗失败与耐药病原体的存在以及可能的医院获得性感染有关。两个治疗组患者的不良事件数量相似：A/S组7例（4例腹泻，3例皮疹），I/C组9例（5例腹泻，2例严重恶心，1例皮疹，1例癫痫发作）。A/S和I/C对糖尿病患者有肢体威胁的足部感染进行初始经验性和确定性治疗的疗效相似。
