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头孢吡肟治疗肺癌伴发热性中性粒细胞减少症患者的临床疗效和安全性。

Clinical efficacy and safety of cefepime in febrile neutropenic patients with lung cancer.

机构信息

Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.

出版信息

J Infect Chemother. 2010 Apr;16(2):113-7. doi: 10.1007/s10156-010-0030-3. Epub 2010 Feb 4.

DOI:10.1007/s10156-010-0030-3
PMID:20130951
Abstract

Fever often occurs along with chemotherapy-induced neutropenia. This condition is referred to as febrile neutropenia (FN). Excellent guidelines for FN treatment have recently been published; however, there has so far been insufficient research concerning FN associated with solid tumors, especially in Japan. A multi-institution prospective study of cefepime for the treatment of FN in lung cancer patients was conducted. The objective of this study was to determine the efficacy and safety of cefepime for FN in lung cancer patients. Cefepime (2 g x 2/day) was administered to patients with FN after treatment for lung cancer. The therapeutic response rate, the effect of the drug on pathogen populations, and the incidence of adverse effects were statistically analyzed. Twenty-one patients with FN were registered for this study. One case was excluded because of protocol violation; therefore, a total of 20 cases were analyzed. Three days after the administration of cefepime, improvement was evident in 15 cases. The response rate was 75%, 95% CI: 53.1-88.8. After 7 days, 17 patients experienced improvement in their condition (85%, 95% CI: 64.0-94.8). Carbapenem was eventually substituted for cefepime in three cases, and all cases finally displayed improvement. There was no mortality. Pathogens for FN were detected in three cases and they disappeared in one case. Four patients experienced adverse side effects, including skin eruption, serum bilirubin elevation, neutrophil depletion, and anterior chest pain. There were no severe adverse events. In this study, cefepime demonstrated a high degree of clinical efficacy and safety in the treatment of FN. Empiric monotherapy using cefepime is a recommended regimen for FN in patients with lung cancer in Japan.

摘要

发热常伴有化疗引起的中性粒细胞减少症。这种情况被称为发热性中性粒细胞减少症(FN)。最近发布了优秀的 FN 治疗指南;然而,迄今为止,针对实体瘤相关 FN 的研究还不够充分,特别是在日本。一项针对肺癌患者使用头孢吡肟治疗 FN 的多机构前瞻性研究。本研究的目的是确定头孢吡肟治疗肺癌患者 FN 的疗效和安全性。在肺癌治疗后,对 FN 患者给予头孢吡肟(2 g x 2/天)。对治疗反应率、药物对病原体种群的影响以及不良反应发生率进行了统计学分析。这项研究共登记了 21 例 FN 患者。因违反方案,排除了 1 例,因此共分析了 20 例。头孢吡肟给药后 3 天,15 例患者病情明显改善。总有效率为 75%,95%可信区间:53.1-88.8。7 天后,17 例患者病情改善(85%,95%可信区间:64.0-94.8)。最终,3 例患者改用碳青霉烯类药物,所有患者最终均有所改善。无死亡病例。FN 的病原体在 3 例中被检出,1 例消失。4 例患者出现不良反应,包括皮疹、血清胆红素升高、中性粒细胞减少和前胸疼痛。无严重不良事件。在这项研究中,头孢吡肟在治疗 FN 方面表现出了高度的临床疗效和安全性。经验性单药治疗头孢吡肟是日本肺癌患者 FN 的推荐方案。

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