Presterl E, Graninger W
Department of Medicine I, University of Vienna, Austria.
Eur J Clin Microbiol Infect Dis. 1994 Apr;13(4):347-51. doi: 10.1007/BF01974618.
In a non-comparative multicentre trial 51 patients aged 24 days to 17 years received treatment with intravenous or oral fluconazole for suspected systemic fungal infections. Twenty-seven patients had confirmed infections, 26 being confirmed mycologically and 1 histologically. All isolates were Candida species. Of the 43 clinically assessed patients, 30 were considered cured, 7 improved and 6 experienced failure of therapy. Of 27 patients with confirmed fungal infections, 25 were assessed mycologically and all but one were considered cured. Of the six patients experiencing clinical failure, two had a confirmed infection and only one of these experienced mycological failure. This patient had a primary diagnosis of candidemia with persistence of Candida albicans and Candida parapsilosis. All 51 patients were evaluable for safety. No treatment-related adverse events required termination of treatment. Treatment-related side effects (diarrhea, vomiting, deafness) were reported by three of 51 patients, three patients had laboratory test abnormalities possibly related to fluconazole treatment, including elevation of liver enzyme levels and of the eosinophil count. Results of this study confirm the efficacy and safety of fluconazole in the treatment of pediatric patients with severe fungal infection.
在一项非对照多中心试验中，51例年龄在24天至17岁的患者因疑似系统性真菌感染接受了静脉或口服氟康唑治疗。27例患者确诊感染，其中26例经真菌学确诊，1例经组织学确诊。所有分离株均为念珠菌属。在43例接受临床评估的患者中，30例被认为治愈，7例病情改善，6例治疗失败。在27例确诊真菌感染的患者中，25例接受了真菌学评估，除1例之外均被认为治愈。在6例临床治疗失败的患者中，2例确诊感染，其中只有1例出现真菌学治疗失败。该患者的初步诊断为念珠菌血症，白色念珠菌和近平滑念珠菌持续存在。所有51例患者均可进行安全性评估。没有与治疗相关的不良事件需要终止治疗。51例患者中有3例报告了与治疗相关的副作用（腹泻、呕吐、耳聋），3例患者出现了可能与氟康唑治疗相关的实验室检查异常，包括肝酶水平升高和嗜酸性粒细胞计数升高。本研究结果证实了氟康唑治疗小儿重症真菌感染的有效性和安全性。
