Aparicio J, Oltra A, Llorca C, Montalar J, Herranz C, Gómez-Codina J, Pastor M, Munárriz B
Servicio de Oncología Médica, Hospital Universitario La Fe, Valencia, Spain.
Eur J Cancer. 1996 Sep;32A(10):1739-43. doi: 10.1016/0959-8049(96)00188-8.
With the availability of new, broad-spectrum antibiotics, initial therapy with a single agent has become an alternative to classic combinations in the management of febrile, neutropenic cancer patients. The aims of this study were to compare the efficacy of ceftazidime and imipenem as empirical monotherapy of febrile episodes in neutropenic patients, and to examine the frequency with which second-line antibiotics (amikacin, vancomycin, or both) were required. A prospective clinical trial was carried out in a single centre. Eligible patients with solid tumours or lymphoma were randomised to receive monotherapy with ceftazidime or imipenem. In the event of no response, amikacin and/or vancomycin were added in 48-72 h intervals (sequentially, or according to clinical or microbiological data). Efficacy was evaluable for 111 assessable episodes. Median neutrophil count at entry was 100 cells/microliters and median duration of neutropenia was 4 days. Febrile episodes were classified as microbiologically (34%) or clinically documented (42%), and fever of unknown origin (24%). Gram-negative infections (57%) predominated over gram-positive isolates (30%). The overall success rate with monotherapy (69% versus 70%), or with modification (20% versus 23%) were equivalent for ceftazidime and imipenem (P = 0.75). The mortality in this series was 5%. Single-agent therapy with either ceftazidime or imipenem is effective for the empirical treatment of febrile episodes in neutropenic patients with solid tumours. Early addition of amikacin and/or vancomycin resolves most failures of the first step.
随着新型广谱抗生素的出现，在发热性中性粒细胞减少的癌症患者管理中，单药初始治疗已成为经典联合治疗的替代方案。本研究的目的是比较头孢他啶和亚胺培南作为中性粒细胞减少患者发热发作经验性单药治疗的疗效，并检查需要二线抗生素（阿米卡星、万古霉素或两者）的频率。在单一中心进行了一项前瞻性临床试验。符合条件的实体瘤或淋巴瘤患者被随机分配接受头孢他啶或亚胺培南单药治疗。如果无反应，则每隔48 - 72小时添加阿米卡星和/或万古霉素（依次添加，或根据临床或微生物学数据添加）。对111次可评估发作的疗效进行了评估。入组时中性粒细胞计数中位数为100个细胞/微升，中性粒细胞减少的中位数持续时间为4天。发热发作分为微生物学确诊（34%）或临床确诊（42%），以及不明原因发热（24%）。革兰阴性菌感染（57%）多于革兰阳性菌分离株（30%）。头孢他啶和亚胺培南单药治疗的总体成功率（分别为69%和70%）或联合用药后的成功率（分别为20%和23%）相当（P = 0.75）。该系列的死亡率为5%。头孢他啶或亚胺培南单药治疗对实体瘤中性粒细胞减少患者发热发作的经验性治疗有效。早期添加阿米卡星和/或万古霉素可解决大多数第一步治疗失败的情况。
