Thalidomide as therapy for human immunodeficiency virus-related oral ulcers: a double-blind placebo-controlled clinical trial. NLM AIDSLINE Important note: Information in this article was accurate in 2000. The state of the art may have changed since the publication date.

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Thalidomide as therapy for human immunodeficiency virus-related oral ulcers: a double-blind placebo-controlled clinical trial.

Clin Infect Dis. 1999 Apr;28(4):892-4. Unique Identifier : AIDSLINE MED/20283202
Ramirez-Amador VA; Esquivel-Pedraza L; Ponce-de-Leon S; Reyes-Teran G; Gonzalez-Guevara M; Ponce-de-Leon S; Sierra-Madero JG; Universidad Autonoma Metropolitana-Xochimilco, Department of; Health Care, Villa Quietud, Consejo Nacional para la Prevencion; y Control del Sida, Toriello Guerra, Mexico.; rava1863@cueyatl.uam.mx

Abstract: A double-blind, randomized, placebo-controlled clinical trial was performed in Mexico City to evaluate the efficacy of thalidomide in treating oral recurrent aphthae in human immunodeficiency virus (HIV)-infected subjects. Sixteen HIV-infected patients with clinical and histological diagnosis of oral recurrent aphthous ulcerations received randomly an 8-week course of either thalidomide or placebo, with an initial oral dosage of 400 mg/d for 1 week, followed by 200 mg/d for 7 weeks. Ten subjects received thalidomide and six received placebo. At 8 weeks, nine subjects (90%) in the thalidomide group had complete healing of their ulcers, compared with two (33.3%) of the six patients in the placebo group (P = .03). There was a significant reduction in largest ulcer diameter in the thalidomide group. Rash was observed in 80% of the thalidomide patients. Although thalidomide demonstrated an unquestionable benefit in treatment of oral ulcers in HIV patients, caution must be taken given the frequent occurrence of side effects.
Keywords: CLINICAL TRIAL JOURNAL ARTICLE RANDOMIZED CONTROLLED TRIAL Adult Anti-HIV Agents/*THERAPEUTIC USE AIDS-Related Opportunistic Infections/*DRUG THERAPY Double-Blind Method Human Male Oral Ulcer/*DRUG THERAPY Thalidomide/*THERAPEUTIC USE

KWDclinicaltrialjournalarticlerandomizedcontrolledtrialadultanti-hivagents/KWDtherapeuticuseaids-relatedopportunisticinfections/KWDdrugtherapydouble-blindmethodhumanmaleoralulcer/KWDdrugtherapythalidomide/KWDtherapeuticuse
000930
A0091492

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