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氟康唑颗粒剂与注射剂在儿科患者中的应用经验

[Experience of fluconazole granules and injection in pediatric patients].

作者信息

Kamiya H, Ihara T, Yasuda N, Sakurai M, Ito M, Azuma E, Ido M, Nakano T

机构信息

Department of Pediatrics, National Sanatorium Mie Hospital.

出版信息

Jpn J Antibiot. 1994 Mar;47(3):280-8.

PMID:8182899
Abstract

Fluconazole (FLCZ) is an antifungal agent of triazole class and has been proven to be effective against deep-seated mycosis caused by Candida spp., Aspergillus spp. and Cryptococcus spp. This time, as we had an opportunity to use fluconazole granules, a new dosage form of the agent, we investigated its efficacy and safety in children with deep-seated mycosis together with the efficacy of the injectable form of the agent. FLCZ was administered to 6 patients with fungal infections for treatment and 5 compromised hosts with a high risk of fungal infections for evaluation of its prophylactic effect. The patients enrolled in the study were 11 in total, of whom 6 patients were evaluated for efficacy: fungal phlegmon in 2, esophageal candidiasis in 2, fungal bronchitis in 1 and oral mycosis in 1. Causative fungi for those infections were Candida albicans in 4 patients, Aspergillus, fumigatus in 1 and Aspergillus flavus in 1. The clinical efficacies were excellent in 3 patients and good in 3. The mycological efficacies were rated as eradicated in 5 patients and reduced in 1. In 5 patients to whom FLCZ was given prophylactically, development of neither fungal infection nor unknown fever was noted. No side effects nor clinical laboratory abnormalities were observed during treatment with either granules or injection, indicative of its safety in children.

摘要

氟康唑(FLCZ)是一种三唑类抗真菌药物,已被证明对由念珠菌属、曲霉属和隐球菌属引起的深部真菌病有效。此次,由于我们有机会使用该药物的新剂型氟康唑颗粒,我们研究了其在深部真菌病患儿中的疗效和安全性,以及该药物注射剂型的疗效。对6例真菌感染患者给予FLCZ进行治疗,并对5例有真菌感染高风险的免疫功能低下宿主给予FLCZ以评估其预防效果。参与研究的患者共有11例,其中6例患者接受了疗效评估:2例为真菌性蜂窝织炎,2例为食管念珠菌病,1例为真菌性支气管炎,1例为口腔真菌病。这些感染的致病真菌中,4例为白色念珠菌,1例为烟曲霉,1例为黄曲霉。临床疗效为3例优,3例良。真菌学疗效评定为5例根除,1例减轻。在5例接受FLCZ预防性给药的患者中,未观察到真菌感染或不明发热的发生。在使用颗粒剂或注射剂治疗期间,未观察到副作用或临床实验室异常,表明其在儿童中具有安全性。

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