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1996-02-27
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Document 0203
DOCN M9630203
TI Comparison of therapeutic activity of fluconazole and itraconazole in
the treatment of oesophageal candidiasis in AIDS patients: a
double-blind, randomized, controlled clinical study.
DT 9603
AU Barbaro G; Di Lorenzo G; Dipartimento di Medicina di Urgenza, Universita
degli Studi, La; Sapienza, Policlinico Umberto I, Roma, Italy.
SO Ital J Gastroenterol. 1995 May;27(4):175-80. Unique Identifier :
AIDSLINE MED/96010291
AB The aim of this study was to assess the role and therapeutic efficacy of
two azole antifungal drugs, fluconazole and itraconazole, in the
treatment of endoscopically-diagnosed Candida oesophagitis in patients
with Acquired Immunodeficiency Syndrome (AIDS). The study considered 120
Human Immunodeficiency Virus (HIV)-positive patients (67 males and 53
females, mean age 27 +/- 5) at their first episode of oesophageal
candidiasis diagnosed by endoscopy (Kodsi's grade II endoscopic
classification). The patients were double-blindly randomized into 2
groups of 60 patients each according to the pharmacological therapy
administered: a) the patients in the first group received fluconazole
(100 mg b.i.d. per os); b) the patients in the second group received
itraconazole (100 mg b.i.d. per os). In order to evaluate the efficacy
of the pharmacological therapy, a clinical examination was performed
every week up to the end of the follow-up period (2 months); endoscopic
examination was performed at the end of pharmacological treatment (3
weeks). All patients selected for the study gave their informed consent.
Complete remission of endoscopic lesions was observed in 45 patients
(75%) in the fluconazole group and in 23 patients (38%) in the
itraconazole group (p < 0.001); partial remission of endoscopic lesions
was observed in 15 patients (25%) in the fluconazole group and in 28
patients (47%) in the itraconazole group (p < 0.05). No response was
observed in 9 patients (15%) in the itraconazole group. Complete
clinical remission was observed in 47 patients (78%) in the fluconazole
group and in 44 patients (73%) in the itraconazole group (p = n.s.);
partial clinical remission was observed in 13 patients (22%) in the
fluconazole group and in 12 patients (20%) in the itraconazole group (p
=- m.s.). No clinical response was observed in 4 patients (7%) in the
itraconazole group. No side-effects worthy of note were observed in the
patients of either treatment group. The results of this study
demonstrated that fluconazole is associated with higher rates of
endoscopic and clinical cure than itraconazole, with a statistically
significant difference as regards endoscopic cure. Both drugs appear to
be safe and well tolerated. Nevertheless, further controlled clinical
investigations are needed to improve our knowledge of the therapeutic
action of antifungal drugs in the treatment of Candida oesophagitis in
HIV disease.
DE Acquired Immunodeficiency Syndrome/*COMPLICATIONS Adult Antifungal
Agents/*THERAPEUTIC USE AIDS-Related Opportunistic
Infections/COMPLICATIONS/*DRUG THERAPY Candidiasis/COMPLICATIONS/*DRUG
THERAPY Double-Blind Method Esophagitis/COMPLICATIONS/*MICROBIOLOGY
Female Fluconazole/*THERAPEUTIC USE Human Itraconazole/*THERAPEUTIC
USE 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).