Winston D J, Bartoni K, Bruckner D A, Schiller G J, Territo M C
Department of Medicine, UCLA Center for the Health Sciences 90095, USA.
Clin Infect Dis. 1998 Mar;26(3):576-83. doi: 10.1086/514578.
In a prospective, randomized, controlled trial, we compared sulbactam/cefoperazone with imipenem as empirical monotherapy for febrile, granulocytopenic patients; 101 patients received sulbactam/cefoperazone (2 g/4 g every 12 hours) and 102 patients received imipenem (500 mg every 6 hours). Documented infections were present in 40% of patients treated with sulbactam/cefoperazone (40 of 101) and in 39% of patients receiving imipenem (40 of 102). The number of pretherapy gram-positive pathogens (52 isolates) was twice the number of pretherapy gram-negative pathogens (26 isolates). The overall favorable clinical response rates for sulbactam/cefoperazone (91 of 103 patients, or 88%) and imipenem (84 of 104 patients, or 81%) were similar. Both drugs were generally well tolerated. However, diarrhea occurred more often in patients treated with sulbactam/cefoperazone (31 of 101 patients, or 31%, vs. 15 of 102 patients, or 15%; P = .007), while seizures developed only in patients receiving imipenem (0 of 101 patients vs. 3 of 102 patients, or 3%). Superinfections developed in 16% of patients in both study groups but were infrequently caused by beta-lactam-resistant gram-negative bacilli (two cases with sulbactam/cefoperazone therapy and six cases with imipenem). These results support the efficacy and safety of either sulbactam/cefoperazone or imipenem as empirical monotherapy for febrile granulocytopenic patients.
在一项前瞻性、随机、对照试验中，我们比较了舒巴坦/头孢哌酮与亚胺培南作为发热性粒细胞减少患者经验性单一疗法的效果；101例患者接受舒巴坦/头孢哌酮治疗（每12小时2克/4克），102例患者接受亚胺培南治疗（每6小时500毫克）。接受舒巴坦/头孢哌酮治疗的患者中有40%（101例中的40例）记录有感染，接受亚胺培南治疗的患者中有39%（102例中的40例）记录有感染。治疗前革兰氏阳性病原体的数量（52株分离菌）是治疗前革兰氏阴性病原体数量（26株分离菌）的两倍。舒巴坦/头孢哌酮（103例患者中的91例，即88%）和亚胺培南（104例患者中的84例，即81%）的总体良好临床反应率相似。两种药物总体耐受性良好。然而，腹泻在接受舒巴坦/头孢哌酮治疗的患者中更常见（101例患者中的31例，即31%，而102例患者中的15例，即15%；P = 0.007），而癫痫仅在接受亚胺培南治疗的患者中出现（101例患者中0例，而102例患者中的3例，即3%）。两个研究组中均有16%的患者发生二重感染，但很少由对β-内酰胺耐药的革兰氏阴性杆菌引起（舒巴坦/头孢哌酮治疗2例，亚胺培南治疗6例）。这些结果支持了舒巴坦/头孢哌酮或亚胺培南作为发热性粒细胞减少患者经验性单一疗法的有效性和安全性。
