Bosseray A, Nicolini F, Brion J P, Michallet M, Hollard D, Stahl J P, Micoud M
Clinique Médicale et des Maladies Infectieuses, CHRU 38043, Grenoble, France.
Pathol Biol (Paris). 1992 Oct;40(8):797-804.
A three-arm prospective randomized trial was designed to compare the effectiveness of single drug therapy with imipenemcilastatin (IC), two-drug therapy with ceftazidime-vancomycin (CV), and three-drug therapy with ticarcillin-vancomycin-amikacin (TVA) for the empirical antimicrobial treatment of febrile neutropenia events. The objectives of the study were to determine whether IC monotherapy was as effective as combination drug therapy (CV or TVA) and to assess the value of adding vancomycin at initiation of treatment. One hundred eighty-three febrile neutropenia events were randomized and 125 were evaluable. Success rates were 73% with IC, 67% with CV, and 72% with TVA. There were no statistically significant differences between the three treatment groups, regardless of the duration and severity of neutropenia. Fifty-four bacterial isolates were recovered from 43 patients. Among recovered bacterial strains, 55% were Gram-negative and 45% were Gram-positive. Rates of bacteriologically documented failures (14/33) and superinfections (3/33) were similar in the three groups. Adverse events were rare but two patients given CV and three given TVA developed severe skin toxicity requiring modification of the antimicrobial regimen. IC alone showed similar effectiveness and less toxicity, as compared with CV or TVA. Vancomycin given initially increased toxicity but failed to improve the success rate. Vancomycin may be appropriate only in patients at high risk for infection with methicillin-resistant staphylococci.
一项三臂前瞻性随机试验旨在比较亚胺培南西司他丁(IC)单药治疗、头孢他啶 - 万古霉素(CV)两药治疗以及替卡西林 - 万古霉素 - 阿米卡星(TVA)三药治疗对发热性中性粒细胞减少事件进行经验性抗菌治疗的有效性。该研究的目的是确定IC单药治疗是否与联合药物治疗(CV或TVA)一样有效,并评估在治疗开始时添加万古霉素的价值。183例发热性中性粒细胞减少事件被随机分组,其中125例可进行评估。IC治疗的成功率为73%,CV为67%,TVA为72%。三个治疗组之间无统计学显著差异,无论中性粒细胞减少的持续时间和严重程度如何。从43例患者中分离出54株细菌。在分离出的细菌菌株中,55%为革兰氏阴性菌,45%为革兰氏阳性菌。三组中细菌学记录的治疗失败率(14/33)和二重感染率(3/33)相似。不良事件很少见,但接受CV治疗的2例患者和接受TVA治疗的3例患者出现严重皮肤毒性,需要调整抗菌治疗方案。与CV或TVA相比,单独使用IC显示出相似的有效性和更低的毒性。初始给予万古霉素增加了毒性,但未能提高成功率。万古霉素可能仅适用于有耐甲氧西林葡萄球菌感染高风险的患者。