ABSTRACT
FUNDAMENTOS: A hanseníase persiste como problema de saúde pública, e episódios de ENH são eventos agudos que ocorrem antes, durante e após PQT. Na última década, o uso da talidomida como agente imunomodulador foi expandido a outras doenças. OBJETIVOS: realizar revisão sistemática dos ensaios clínicos publicados sobre a eficácia e efeitos colaterais da talidomida no ENH. Descrever metodologia e resultados da triagem para recrutamento de ensaio clínico visando avaliar dose-resposta da talidomida seguida de desmame no ENH moderado e grave, realizado no Brasil. MÉTODOS: Analisaram-se ensaios publicados sobre talidomida no ENH. Foi delineado um ensaio clínico duplo-cego randomizado para avaliar dose de 100 thalid 300mg/dia de talidomida durante fase aguda de ENH, seguida de desmame da talidomida, thalid placebo. Para este ensaio clínico descreve-se metodologia e dados de recrutamento de pacientes, com ênfase na gravidade dos episódios de ENH. RESULTADOS: Os seis ensaios clínicos publicados nas décadas de 1960 e 1970 apontam para o benefício da talidomida no ENH, embora diferenças metodológicas dificultem a comparação. Na fase de recrutamento do ensaio brasileiro, dos 143 pacientes de ENH triados, 65 por cento eram potencialmente elegíveis. A associação com neurite em 56,4 por cento dos ENH moderados e graves exigiu co-intervenção com corticosteróide. CONCLUSÃO: O padrão de recrutamento dos pacientes evidenciou alta freqüência de neurite nos episódios de ENH. O esquema de talidomida isolada no ENH foi avaliado como infreqüente na prática clínica brasileira. O desafio atual é acumular evidências sobre a eficácia e efeitos colaterais da talidomida em associação com corticosteróides.
Subject(s)
Erythema Nodosum , Neuritis , ThalidomideABSTRACT
From September to November 1994. 21 patients with active mucosal leishmaniasis were treated with aminosidine sulphate 16 mg/kg/day by intramuscular injection for 20 days. They were principally adult male agricultural workers. Thirteen patients had not received specific treatment and eight had failed to respond to Glucantime therapy. Diagnosis was based on clinical and epidemiological observations, a search for the parasite, leishmanin skin sensitivity and indirect fluorescent antibody serological tests. Sixty seven percent of patients had leishmania parasites isolated from inoculated hamsters or visualized in imprints or histopathological sections. The mean follow-up period was 12.6 months. All patients completed treatment. Side effects were pain at the injection site (86 per cent); mild proteinuria (24 per cent), elevated serum creatinine (.5 per cent) and subclinical bearing loss in one of two patients who did audiometric tests. Clinical cure was achieved in 48 per cent and the accumulated relapse rate was 29 per cent(4/14).
Subject(s)
Adult , Animals , Female , Cricetinae , Humans , Male , Antiprotozoal Agents/therapeutic use , Leishmania braziliensis , Leishmaniasis, Mucocutaneous/drug therapy , Paromomycin/therapeutic use , Organometallic Compounds/therapeutic use , Leishmaniasis, Mucocutaneous/diagnosis , Meglumine/therapeutic useABSTRACT
With the aim of comparing the therapeutic efficacy, tolerability and toxicity of meglumine antimoniate, aminosidine sulphate and pentamidine isethionate, a field study was conducted on randomized treatment of patients with primary cutaneous leishmaniasis due to Leishmania (Viannia) braziliensis (L(V)b), in Corte de Pedra, BA, from October 1992 up to January 1993. Forty six patients were treated and distributed into three groups, two with 15 and one with 16 subjects. All patients were submitted to clinical examination, histopathological and immunological investigations, as diagnostic criterium. All patients were treated by intramuscular route. Group 1 received pentamidine 4 mg/kg/every 2 days, for 8 applications; Group 2 received aminosidine 20 mg/kg/day, for 20 days, and Group 3 received meglumine 10 mg Sbv/kg/day, for 20 days. Failure of therapy was defined as ulceration of the skin lesion four months after treatment. Such failure occurred in five cases as follows: two cases in patients of group 1 one case in patients of group 2, and two cases in group 3, after the first year of follow up. In the evaluation after three years we reviewed fifteen patients, five in each group; except for one in Group 3, all of them were cured. Statistical significance of the results between the three schedules used was not verified.