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一项关于氟康唑治疗血液系统恶性肿瘤患者播散性念珠菌感染的安全性和有效性的开放性研究。

An open study on the safety and efficacy of fluconazole in the treatment of disseminated Candida infections in patients treated for hematological malignancy.

作者信息

de Pauw B E, Raemaekers J M, Donnelly J P, Kullberg B J, Meis J F

机构信息

Department of Hematology, University Hospital St. Radboud, Nijmegen, The Netherlands.

出版信息

Ann Hematol. 1995 Feb;70(2):83-7. doi: 10.1007/BF01834385.

DOI:10.1007/BF01834385
PMID:7880929
Abstract

Disseminated candidiasis is a serious infectious complication with a mortality as high as 50%. Standard therapy consists of parenteral amphotericin B which is associated with major side effects and prolonged hospitalization. The aim of the study was to assess the efficacy and safety of fluconazole in an open, noncomparative study. Fluconazole, as a single agent, was given intravenously for the first 3 days at a dose of 200 mg twice daily, followed by 200 mg twice daily orally until resolution of signs and symptoms or evident treatment failure. The study group comprised 24 consecutive patients of whom nine had acute and 15 chronic disseminated candidiasis. A clinical response was achieved in 67% of cases of acute disseminated candidiasis and in 86% of cases of chronic disseminated candidiasis. The median duration of therapy was 15 days and 6 months, respectively. Superinfections with Aspergillus fumigatus developed in five patients who were persistently neutropenic. No drug-related toxicity was registered.

摘要

播散性念珠菌病是一种严重的感染性并发症,死亡率高达50%。标准治疗方法是胃肠外使用两性霉素B,但该药物会引发严重的副作用并导致住院时间延长。本研究的目的是在一项开放性、非对照研究中评估氟康唑的疗效和安全性。作为单一药物,氟康唑在最初3天静脉给药,剂量为每日2次,每次200毫克,之后改为每日口服2次,每次200毫克,直至症状体征消失或出现明显的治疗失败。研究组包括24例连续患者,其中9例为急性播散性念珠菌病,15例为慢性播散性念珠菌病。急性播散性念珠菌病患者中有67%取得了临床缓解,慢性播散性念珠菌病患者中有86%取得了临床缓解。治疗的中位持续时间分别为15天和6个月。5例持续性中性粒细胞减少的患者发生了烟曲霉二重感染。未记录到与药物相关的毒性反应。

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Fluconazole prophylaxis of fungal infections in patients with acute leukemia. Results of a randomized placebo-controlled, double-blind, multicenter trial.氟康唑预防急性白血病患者真菌感染。一项随机、安慰剂对照、双盲、多中心试验的结果
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