氟康唑长期治疗的安全性评估。泛美氟康唑研究小组。

Safety evaluation of chronic fluconazole therapy. Fluconazole Pan-American Study Group.

作者信息

Stevens D A, Diaz M, Negroni R, Montero-Gei F, Castro L G, Sampaio S A, Borelli D, Restrepo A, Franco L, Bran J L, Arathoon E G

机构信息

Santa Clara Valley Medical Center, Stanford University Medical School, San Jose, Calif 95128-2699, USA.

出版信息

Chemotherapy. 1997 Sep-Oct;43(5):371-7. doi: 10.1159/000239592.

DOI:10.1159/000239592

PMID:9309372

Abstract

The possible adverse effects of chronic, high-dose fluconazole therapy are detailed from analysis of a multicenter, dose-escalating study of the therapy of invasive mycoses. Ninety-three adult patients were studied, 48 of these received > or = 6 months therapy and 20 received > or = 1 year. Fifty-eight patients received > or = 300 mg/day, and 7 received > or = 600 mg/day. One patient received 1,997 g over 86 months. Twenty-seven percent experienced possible symptomatic side effects, which resulted in 2 patients discontinuing therapy, and 42% had asymptomatic laboratory abnormalities, none of which were progressive. Headache, hair loss and anorexia were the most common symptoms experienced (each by 3% of patients), and eosinophilia and aspartate aminotransferase increases were the most common laboratory findings (12 and 10%, respectively). Fluconazole appears well tolerated and safe in these doses and durations.

摘要

通过对一项治疗侵袭性真菌病的多中心、剂量递增研究的分析，详细阐述了长期大剂量氟康唑治疗可能产生的不良反应。研究了93例成年患者，其中48例接受了≥6个月的治疗，20例接受了≥1年的治疗。58例患者接受了≥300mg/天的治疗，7例接受了≥600mg/天的治疗。1例患者在86个月内接受了1997g的治疗。27%的患者出现了可能有症状的副作用，导致2例患者停止治疗，42%的患者有无症状的实验室异常，但均无进展。头痛、脱发和厌食是最常见的症状（各占患者的3%），嗜酸性粒细胞增多和天冬氨酸转氨酶升高是最常见的实验室检查结果（分别为12%和10%）。在这些剂量和疗程下，氟康唑似乎耐受性良好且安全。