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Comparison of oral fluconazole and itraconazole for progressive, nonmeningeal coccidioidomycosis. A randomized, double-blind trial. Mycoses Study Group.

Abstract：

BACKGROUND:In previous open-label noncomparative clinical trials, both fluconazole and itraconazole were effective therapy for progressive forms of coccidioidomycosis. OBJECTIVE:To determine whether fluconazole or itraconazole is superior for treatment of nonmeningeal progressive coccidioidal infections. DESIGN:Randomized, double-blind, placebo-controlled trial. SETTING:7 treatment centers in California, Arizona, and Texas. PATIENTS:198 patients with chronic pulmonary, soft tissue, or skeletal coccidioidal infections. INTERVENTION:Oral fluconazole, 400 mg/d, or itraconazole, 200 mg twice daily. MEASUREMENTS:After 4, 8, and 12 months, a predefined scoring system was used to assess severity of infection. Findings were compared with those at baseline. RESULTS:Overall, 50% of patients (47 of 94) and 63% of patients (61 of 97) responded to 8 months of treatment with fluconazole and itraconazole, respectively (difference, 13 percentage points [95% CI, -2 to 28 percentage points]; P = 0.08). Patients with skeletal infections responded twice as frequently to itraconazole as to fluconazole. By 12 months, 57% of patients had responded to fluconazole and 72% had responded to itraconazole (difference, 15 percentage points [CI, 0.003 to 30 percentage points]; P = 0.05). Soft tissue disease was associated with increased likelihood of response, as in previous studies. Azole drug was detected in serum specimens from all but 3 patients; however, drug concentrations were not helpful in predicting outcome. Relapse rates after discontinuation of therapy did not differ significantly between groups (28% after fluconazole treatment and 18% after itraconazole treatment). Both drugs were well tolerated. CONCLUSIONS:Neither fluconazole nor itraconazole showed statistically superior efficacy in nonmeningeal coccidioidomycosis, although there is a trend toward slightly greater efficacy with itraconazole at the doses studied.

journal_name

Ann Intern Med

journal_title

Annals of internal medicine

authors

Galgiani JN,Catanzaro A,Cloud GA,Johnson RH,Williams PL,Mirels LF,Nassar F,Lutz JE,Stevens DA,Sharkey PK,Singh VR,Larsen RA,Delgado KL,Flanigan C,Rinaldi MG

doi

10.7326/0003-4819-133-9-200011070-00009

subject

Has Abstract

pub_date

2000-11-07 00:00:00

pages

676-86

issue

eissn

0003-4819

issn

1539-3704

pii

200011070-00009

journal_volume

133

pub_type

临床试验,杂志文章,多中心研究,随机对照试验

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Comparison of oral fluconazole and itraconazole for progressive, nonmeningeal coccidioidomycosis. A randomized, double-blind trial. Mycoses Study Group.