Montalar J, Segura A, Bosch C, Galan A, Juan O, Molins C, Giner V, Aparicio J
Medical Oncology Unit, Hospital Universitario La Fe, Valencia, Spain.
Med Oncol. 2002;19(3):161-6. doi: 10.1385/MO:19:3:161.
Currently, monotherapy is considered a valid alternative to the combination antibiotic treatments used for initial, empirical management of febrile neutropenia. The advent of new cephalosporins warrants assessment. The aim of this study was to prospectively evaluate the effectiveness of cefepime monotherapy in the treatment of cancer patients with febrile granulocytopenia (< 1000 leukocytes/muL and/or < 500 neutrophils/muL). A prospective, multicenter, nonrandomized trial was conducted. Initial treatment consisted of iv cefepime, 2 g every 8 h. If the patient was still febrile after 72 h, amikacin, vancomycin/teicoplanin, and amphotericin B were added sequentially. Response was evaluated according to EORTC criteria. One hundred twenty episodes were analyzed in 81 males and 39 females (median age, 52 yr; range, 15-83). The median leukocyte count at the time of diagnosis was 781 microL(-1) (range, 100-2600) and the median neutrophil count was 173 microL(-1) (range 0-500). The median duration of neutropenia (< 1000 neutrophils/microL) was 4.8 d (range, 3-20). Fifty-two episodes (44%) were confirmed microbiologically (42 presented as bacteremia), 31 with Gram-positive bacteria and 21 with Gram-negative bacteria, 47 (39.3%) were confirmed clinically, 16 (13.3%) were considered as probable infections, and 5 (4.2%) as doubtful infections. Protocol success was achieved in 110 episodes (91.7%), 8 (6.6%) were treatment failures, and 2 (1.7%) were not evaluable. Ninety-nine episodes (83.3%) were controlled with cefepime monotherapy, with 19 other episodes requiring additional antibiotics: amikacin in 7 (5.8%), amikacin + vancomycin/teicoplanin in 12 (10.1%). Three patients (2,5%) died during an episode of neutropenic fever. Cefepime is effective as an initial, empirical treatment of febrile neutropenia. The early addition of amikacin and/or vancomycin resolves most of the monotherapy failures, which seem somewhat lower than with other monotherapies.
目前，单一疗法被认为是用于发热性中性粒细胞减少症初始经验性治疗的联合抗生素治疗的一种有效替代方法。新型头孢菌素的出现值得评估。本研究的目的是前瞻性评估头孢吡肟单一疗法治疗发热性粒细胞减少症（白细胞<1000/μL和/或中性粒细胞<500/μL）癌症患者的有效性。进行了一项前瞻性、多中心、非随机试验。初始治疗包括静脉注射头孢吡肟，每8小时2g。如果患者72小时后仍发热，则依次添加阿米卡星、万古霉素/替考拉宁和两性霉素B。根据欧洲癌症研究与治疗组织（EORTC）标准评估疗效。分析了81名男性和39名女性的120例病例（中位年龄52岁；范围15 - 83岁）。诊断时白细胞计数中位数为781/μL（范围100 - 2600），中性粒细胞计数中位数为173/μL（范围0 - 500）。中性粒细胞减少（<1000中性粒细胞/μL）的中位持续时间为4.8天（范围3 - 20天）。52例（44%）经微生物学确诊（42例为菌血症），其中31例为革兰氏阳性菌感染，21例为革兰氏阴性菌感染；47例（39.3%）经临床确诊，16例（13.3%）被视为可能感染，5例（4.2%）为可疑感染。110例（91.7%）达到方案成功标准，8例（6.6%）治疗失败，2例（1.7%）无法评估。99例（83.3%）仅用头孢吡肟单一疗法得到控制，另外19例需要加用其他抗生素：7例（5.8%）加用阿米卡星，12例（10.1%）加用阿米卡星 + 万古霉素/替考拉宁。3例患者（2.5%）在中性粒细胞减少性发热发作期间死亡。头孢吡肟作为发热性中性粒细胞减少症的初始经验性治疗有效。早期加用阿米卡星和/或万古霉素可解决大多数单一疗法失败的情况，单一疗法失败率似乎略低于其他单一疗法。
