Engervall P, Kalin M, Dornbusch K, Björkholm M
Department of Medicine, Karolinska Hospital, Stockholm, Sweden.
J Chemother. 1999 Aug;11(4):278-86. doi: 10.1179/joc.1999.11.4.278.
The purpose of this phase II trial was to evaluate the efficacy and safety of cefepime monotherapy in patients with neutropenia expected to last more than 7 days. Sixty-nine patients with neutropenia (<0.5 x 10(9)/1) were randomized during 94 episodes of fever to receive either cefepime monotherapy (n=76) or combination therapy with trimethoprim/sulfamethoxazole plus amikacin (TMP/SMZ plus AMI, n=18). A successful response to cefepime was seen in 31/76 (41%) episodes, with 10/36 (28%) in microbiologically documented infections, 3/4 (75%) in clinically documented infections and 18/36 (50%) in fever of unknown origin. No patient in either treatment group died due to the presenting infection. One patient in the cefepime group discontinued treatment due to a rash. Susceptibility testing of blood isolates by E-test strip showed low MIC values to cefepime for most isolates. It is concluded that cefepime monotherapy appeared both safe and effective as empirical therapy in patients with febrile neutropenia.
这项II期试验的目的是评估头孢吡肟单药治疗预计持续超过7天的中性粒细胞减少症患者的疗效和安全性。69例中性粒细胞减少症患者（<0.5×10⁹/L）在94次发热发作期间被随机分组，分别接受头孢吡肟单药治疗（n = 76）或甲氧苄啶/磺胺甲恶唑联合阿米卡星治疗（TMP/SMZ加AMI，n = 18）。在76次发作中有31次（41%）对头孢吡肟治疗反应成功，其中微生物学确诊感染患者中有10次（28%）、临床确诊感染患者中有3次（75%）、不明原因发热患者中有18次（50%）。两个治疗组中均无患者因当前感染死亡。头孢吡肟组有1例患者因皮疹而停止治疗。采用E-test试纸对血液分离株进行药敏试验显示，大多数分离株对头孢吡肟的最低抑菌浓度值较低。得出的结论是，在发热性中性粒细胞减少症患者中，头孢吡肟单药治疗作为经验性治疗似乎既安全又有效。
