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[采用每日一次新的头孢曲松给药方式治疗全身性血液系统疾病中的发热性中性粒细胞减少症发作]

[Therapy of febrile neutropenia episodes in systemic hematologic illnesses with new once daily ceftriaxone administration].

作者信息

Karthaus M, Südhoff T, Fenchel K, Egerer G, Kämpfe D, Ritter J, Franke A, Heil G, Peters G, Jürgens H

出版信息

Wien Med Wochenschr. 1998;148(21):481-7.

Abstract

In this open label prospective multicenter trial, 420 patients with neutropenia < 1000/microliter, fever > 38.5 degrees C and hematological malignancies were treated with ceftriaxone. Acute leukemia (n = 238) and high-grade lymphoma patients (n = 182) from 35 centers were enrolled. Between February 1992 and January 1996, patients were treated with 2 g ceftriaxone i.v. per day either as monotherapy (n = 135), or in combination with aminoglycosides (n = 235), glycopeptides (n = 37), or other antimicrobial agents (n = 13). Patients' median age was 54 years (range 15 to 97) with a median Karnofsky-performance-score of 6.0. The median neutrophil counts were 400/microliter. Fever was of unknown origin (FUO) in 268 (63.8%) of patients. Clinically defined infections (CDI) were diagnosed in 152 (36.2%) cases, including 74 (17.8%) episodes with pneumonia. Response to the initial approach with ceftriaxone was observed in 56.2% of febrile episodes, including 93 (68.8%) treatment courses with ceftriaxone alone. Concerning defervescence of fever ceftriaxone monotherapy was successful as compared to ceftriaxone in combination. Analysis revealed a low risk characterized by higher neutrophil counts (> or = 500/microliter; p < 0.0001), better Karnofsky-performance-score (> or = 7; p = 0.01), duration of neutropenia (< or = 5 days; p = 0.008) from start of antimicrobial treatment and duration of neutropenia per cycle (< or = 10 days; p = 0.0016). At the end of the observation, an overall response was obtained in 88.3% of the patients (n = 371) without statistical difference between patients treated with ceftriaxone alone or in combination. Once daily ceftriaxone either alone or in combination was effective in patients with hematological malignancies. Monotherapy was effective in a low risk group characterized by neutrophil counts (> or = 500/microliter), a Karnofsky-performance-score (> or = 7) and a duration of neutropenia (< or = 5 days) at the commencement of treatment.

摘要

在这项开放标签的前瞻性多中心试验中,420名中性粒细胞减少(<1000/微升)、发热(>38.5摄氏度)且患有血液系统恶性肿瘤的患者接受了头孢曲松治疗。来自35个中心的急性白血病患者(n = 238)和高级别淋巴瘤患者(n = 182)被纳入研究。在1992年2月至1996年1月期间,患者接受每日2克静脉注射头孢曲松治疗,治疗方式为单药治疗(n = 135),或与氨基糖苷类药物联合使用(n = 235)、糖肽类药物联合使用(n = 37),或与其他抗菌药物联合使用(n = 13)。患者的中位年龄为54岁(范围15至97岁),中位卡诺夫斯基性能评分6.0。中性粒细胞计数中位数为400/微升。268名(63.8%)患者的发热原因不明(不明原因发热)。临床诊断的感染(CDI)在152例(36.2%)病例中被诊断出来,其中包括74例(17.8%)肺炎发作。在56.2%的发热发作中观察到对初始头孢曲松治疗方案的反应,其中包括93例(68.8%)仅使用头孢曲松的治疗疗程。关于发热的退热情况,与联合使用头孢曲松相比,头孢曲松单药治疗是成功的。分析显示,风险较低的特征为中性粒细胞计数较高(≥500/微升;p < 0.0001)、卡诺夫斯基性能评分较好(≥7;p = 0.01)、从抗菌治疗开始的中性粒细胞减少持续时间(≤5天;p = 0.008)以及每个周期的中性粒细胞减少持续时间(≤10天;p = 0.0016)。在观察结束时,88.3%的患者(n = 371)获得了总体反应,单独使用或联合使用头孢曲松治疗的患者之间无统计学差异。每日一次的头孢曲松单独使用或联合使用对血液系统恶性肿瘤患者均有效。单药治疗在以中性粒细胞计数(≥500/微升)、卡诺夫斯基性能评分(≥7)和治疗开始时中性粒细胞减少持续时间(≤5天)为特征的低风险组中有效。

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