Greenberg R N, Cayavec P, Danko L S, Bowen K, Montazemi R, Kearney P A, Johnson S B, Strodel W E
Department of Medicine, University of Kentucky Medical Center, Lexington 40536-0083.
J Antimicrob Chemother. 1994 Sep;34(3):391-401. doi: 10.1093/jac/34.3.391.
This study compared the safety and efficacy of cefoperazone plus sulbactam with that of clindamycin plus gentamicin in the treatment of intra-abdominal infection. Seventy-six patients were included in the analysis of an open, randomized, comparative, single-site trial. Forty-seven patients received cefoperazone-sulbactam, and 29 patients received clindamycin plus gentamicin. Thirty-three patients (70%) who received cefoperazone-sulbactam and 15 patients (52%) who received clindamycin plus gentamicin were cured of infection, did not suffer a relapse within one month after the end of treatment, and did not receive any other antibiotics during the follow-up period (P = 0.17). In patients treated with cefoperazone-sulbactam there were four cases of superinfection, one patient had a prolonged prothrombin time, six patients had a poor response, two patients received antibiotics during follow-up, and one patient died during follow-up because of cancer. Treatment with clindamycin plus gentamicin was associated with five cases of superinfection, four patients had a poor response, four patients had a drug reaction, and one patient required antibiotics in the follow-up period. Serum levels of cefoperazone-sulbactam measured at one and three hours after dosing were consistent with earlier findings in normal volunteers. Two hundred and one pathogens were isolated, and 17 of 122 aerobic isolates (14%) were resistant to cefoperazone-sulbactam, and 17 of 122 (14%) were resistant to both clindamycin and gentamicin. Eleven of 79 (14%) anaerobic isolates were resistant to cefoperazone, none was resistant to cefoperazone-sulbactam, and 10 of 79 (13%) were resistant to clindamycin. The results of this study show that cefoperazone-sulbactam is an effective and safe alternative to clindamycin plus gentamicin in the treatment of intra-abdominal infections.
本研究比较了头孢哌酮加舒巴坦与克林霉素加庆大霉素治疗腹腔内感染的安全性和有效性。76例患者纳入一项开放、随机、对照、单中心试验的分析。47例患者接受头孢哌酮-舒巴坦治疗,29例患者接受克林霉素加庆大霉素治疗。接受头孢哌酮-舒巴坦治疗的33例患者(70%)和接受克林霉素加庆大霉素治疗的15例患者(52%)感染治愈,治疗结束后1个月内未复发,随访期间未接受任何其他抗生素治疗(P = 0.17)。接受头孢哌酮-舒巴坦治疗的患者中有4例发生二重感染,1例患者凝血酶原时间延长,6例患者反应不佳,2例患者在随访期间接受了抗生素治疗,1例患者在随访期间因癌症死亡。克林霉素加庆大霉素治疗与5例二重感染、4例患者反应不佳、4例患者出现药物反应以及1例患者在随访期间需要使用抗生素有关。给药后1小时和3小时测得的头孢哌酮-舒巴坦血清水平与正常志愿者早期研究结果一致。共分离出201株病原体,122株需氧菌中有17株(14%)对头孢哌酮-舒巴坦耐药,122株中有17株(14%)对克林霉素和庆大霉素均耐药。79株厌氧菌中有11株(14%)对头孢哌酮耐药,无1株对头孢哌酮-舒巴坦耐药,79株中有10株(13%)对克林霉素耐药。本研究结果表明,在治疗腹腔内感染方面,头孢哌酮-舒巴坦是克林霉素加庆大霉素的一种有效且安全的替代药物。