       Document 0662
 DOCN  M9620662
 TI    Fluconazole vs. flucytosine in the treatment of esophageal candidiasis
       in AIDS patients: a double-blind, placebo-controlled study.
 DT    9602
 AU    Barbaro G; Barbarini G; Di Lorenzo G; Department of Emergency Medicine,
       La Sapienza University of Rome,; Italy.
 SO    Endoscopy. 1995 Jun;27(5):377-83. Unique Identifier : AIDSLINE
       MED/96026937
 AB    BACKGROUND AND STUDY AIMS: Contrasting opinions exist as to the
       pharmacological treatment of esophageal candidiasis in human
       immunodeficiency virus (HIV)-positive patients. The aim of this study
       has been to evaluate the role, therapeutic efficacy, and the
       cost-benefit ratio of two antifungal drugs, fluconazole and flucytosine,
       compared with a placebo, in the treatment of endoscopically-diagnosed
       esophageal candidiasis in patients with acquired immune deficiency
       syndrome (AIDS). PATIENTS AND METHODS: The study included 60
       HIV-positive patients (38 males and 22 females, mean age 27 +/- 2) with
       a first episode of esophageal candidiasis diagnosed by endoscopy (grades
       I-II of Kodsi's endoscopic classification, and grades I-IIa of Barbaro's
       clinical classification). No other opportunistic infection of the
       esophagus was detected. In a double-blind procedure, patients were
       randomized into three groups of 20 patients each, receiving either
       fluconazole (3 mg/kg/daily per os), flucytosine (100 mg/kg/daily per os)
       or placebo. After two weeks of treatment, the patients previously
       assigned to receive the placebo were double-blindly randomized to
       receive fluconazole (eight patients) or flucytosine (nine patients). In
       order to evaluate the efficacy of pharmacological therapy, clinical
       examination was performed at weeks 2 and 5, and then every week up to
       the end of follow-up (three months); endoscopic examination was
       performed at weeks 2 and 5, and at the end of follow-up. RESULTS: At
       week 2, endoscopic cure (grade 0) was observed in 13 patients (65%) of
       the fluconazole group and in three patients (15%) in the flucytosine
       group (relative risk ratio: 0.23; 95% C.I.: 0.10-0.48; p < 0.05), and a
       partial endoscopic response (grade I) was observed in two patients (10%)
       in the placebo group. Complete clinical remission (grade 0) was observed
       in 16 patients (80%) in the fluconazole group and 12 patients (60%) in
       the flucytosine group (relative risk ratio: 0.75; 95% C.I.: 0.42-0.89; p
       = n.s.), while six patients (30%) in the placebo group presented partial
       clinical remission (grade I). At the end of follow-up, endoscopic cure
       was observed in 19 patients (70%) in the fluconazole group and in nine
       patients (33%) in the flucytosine group (relative risk ratio: 0.47; 95%
       C.I.: 0.19-0.65; p < 0.05). Complete clinical remission was observed in
       21 patients (77.7%) in the fluconazole group and in 17 patients (63%) in
       the flucytosine group (relative risk ratio: 0.81; 95% C.I.: 0.53-0.92; p
       = n.s.). No noticeable side-effects were observed in the patients in
       either treatment group, without a statistically significant difference
       in comparison with the placebo. CONCLUSIONS: The results of this study
       have demonstrated that both fluconazole and flucytosine are safe and
       well tolerated in the treatment of esophageal candidiasis in AIDS
       patients. Fluconazole showed greater therapeutic efficacy than
       flucytosine, with a difference that was statistically significant in
       terms of the rate of endoscopic cure.
 DE    Acquired Immunodeficiency Syndrome/COMPLICATIONS  Adult  Antifungal
       Agents/*THERAPEUTIC USE  AIDS-Related Opportunistic Infections/*DRUG
       THERAPY/MICROBIOLOGY  Candidiasis/COMPLICATIONS/*DRUG THERAPY
       Comparative Study  Double-Blind Method  Esophagitis/COMPLICATIONS/*DRUG
       THERAPY/MICROBIOLOGY  Esophagoscopy  Female  Fluconazole/*THERAPEUTIC
       USE  Flucytosine/*THERAPEUTIC USE  Human  Male  CLINICAL TRIAL  JOURNAL
       ARTICLE  RANDOMIZED CONTROLLED TRIAL

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).

