Tamura K, Matsuoka H, Tsukada J, Masuda M, Ikeda S, Matsuishi E, Kawano F, Izumi Y, Uike N, Utsunomiya A, Saburi Y, Shibuya T, Imamura Y, Hanada S, Okamura S, Gondoh H
Fukuoka University Hospital, Fukuoka, Japan.
Am J Hematol. 2002 Dec;71(4):248-55. doi: 10.1002/ajh.10236.
1998, a consensus meeting was held in Miyazaki, Japan, to develop an approach to management of febrile neutropenia (FN). The K-HOT study group decided to examine whether this proposal was applicable to clinical practice in a multicenter study. Patients who developed fever with neutrophil counts <1,000/microL were randomized to receive either a single antibiotic, cefepime or one of the carbapenems, or a combination of cefepime and an aminoglycoside. Patients who became afebrile within the first 3 days were continued on the same treatment. Patients who remained febrile were switched to a combination regimen if they were randomized to receive a single agent, and patients on combination medication were changed from cefepime to another cephalosporin. A total of 165 patients were entered into the trial. One hundred fifty-three patients were evaluable for response. The average age was 52 years, and 70% of the patients had acute leukemia. Severe neutropenia, defined as <100/microL at the time of FN, was seen in 62% of the patients on entry and during the course of treatment 71% of patients experienced neutrophil counts of <100/microL. Microbiologically documented infection was seen in 6.5% for monotherapy, and 10.5% for a combination treatment, and fever of unknown origin occurred in 75.3% and 59.2% of the patients in each regimen, respectively. Excellent to good response was seen in two-thirds of the patients in all treatment groups. Adverse events were minimal, and three early deaths were observed at days 9, 16, and 16 among patients treated with a single antibiotic and three in the combination regimen group at days 14, 15, and 20. These results indicate that cefepime or a carbapenem alone is as effective as a combination of cefepime and an aminoglycoside for treating FN.
1998年，日本宫崎召开了一次共识会议，以制定发热性中性粒细胞减少症（FN）的管理方法。K-HOT研究小组决定在一项多中心研究中检验该提议是否适用于临床实践。中性粒细胞计数<1000/微升且出现发热的患者被随机分配接受单一抗生素（头孢吡肟或碳青霉烯类药物之一），或头孢吡肟与氨基糖苷类药物的联合治疗。在最初3天内退热的患者继续接受相同治疗。仍发热的患者若被随机分配接受单一药物治疗，则改为联合治疗方案；接受联合用药的患者则将头孢吡肟换为另一种头孢菌素。共有165例患者进入试验。153例患者可评估疗效。平均年龄为52岁，70%的患者患有急性白血病。FN发生时严重中性粒细胞减少（定义为<100/微升）的情况在62%的入组患者中出现，在治疗过程中，71%的患者中性粒细胞计数<100/微升。单药治疗中微生物学确诊感染的发生率为6.5%，联合治疗为10.5%，各治疗方案中不明原因发热分别发生在75.3%和59.2%的患者中。所有治疗组中三分之二的患者有良好至优秀的反应。不良事件极少，在接受单一抗生素治疗的患者中，第9天、16天和16天各有1例早期死亡，联合治疗组在第14天、15天和20天各有1例早期死亡。这些结果表明，单独使用头孢吡肟或碳青霉烯类药物治疗FN与头孢吡肟和氨基糖苷类药物联合治疗同样有效。
