bases para a avaliação do tratamento específico da doença de chagas humana segundo a parasitemia
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ID: 211938
1973
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Abstract
Os Autores propõem a padronização de métodos para se avaliarem os resultados de ensaios de terapêutica específica da doença de Chagas, a fim de se firmarem critérios seguros de interpretação. Discutem as experiências terapêuticas, com controle estatístico, no ser humano, sobretudo o problema ético, e concluem serem elas indispensáveis para se estabelecer a eficácia do medicamento, definir-lhe o modo de emprego, a posologia e os perigos, mas precisam reger-se por normas bem definidas. Relatam uma metodologia para o ensaio clínico na tripanossomíase americana, partindo do princípio de que só devem ser selecionados pacientes de "alta parasitemia". Submetendo chagásicos crônicos a xenodiagnósticos mensais consecutivos, por períodos até de três anos, verificaram ser variável a positividade: enquanto uns exibem todos os exames positivos (100%), outros mostram graus menores de positividade, havendo até os que nunca apresentam xeno positivo (0%). Explicam o fenômeno admitindo a existência de níveis diferentes de parasitemia e recomendam evitarem-se os pacientes de "baixa parasitemia", pela dificuldade de interpretação, ligada ao fato de eles apresentarem, espontâneamente, sem qualquer tratamento, xenodiagnósticos negativos durante anos. Descrevem os procedimentos correspondentes à fase pré-tratamento, para selecionar os pacientes que apresentem positivos pelo menos 60% de uma série de, no mínimo, seis xenodiagnósticos sêxtuplos quinzenais, cuja padronização é dada. Na fase de tratamento os doentes são internados no Hospital e examinados diariamente, para se verificar a tomada do medicamento e a tolerância, que também se aprecia por exames de laboratório prévios, e coincidentes com a última quinzena. A fase pós-tratamento, em regime ambulatório, é prevista para um ano, submetendo-se o paciente, de 15 em 15 dias, ao xenodiagnóstico e às reações imunológicas. Os Autores dão exemplos de casos retirados de um ensaio, ainda em desenvolvimento, com um nitrofurânico (Bayer 2502), no qual a avaliação da eficácia repousa no xenodiagnóstico e nas reações imunológicas quantitativas, de fixação do complemento (R.F.CJ, de hemoaglutinação (R.H.A.) e de imunofluorescência (T.I.F.). Finalmente, discutem e definem o eventual critério de cura da tripanossomiase americana humana.
After emphasizing the needs for standardization of processes for the clinicai trial of drugs in Cragas' disease, the Authors report a method based in the principie that only patients with "high parasitemia" should be selected for therapeutic trials. When patients with chronic Chagas' disease are monthly submitted to xenodiagnosis, the results are widely variable. While some patients show all the xenos to be positive (100%), others never have a positive xenodiagnosis (0%), even if the period of observation goes for three year (table III). Between these extremes a regular gradation of positivity is observed. It is necessary to establish, before treatment, the parasitoloficai behaviour of the patient as xenodiagnosis is concerned, and only those patients with a positivity of the xenodiagnosis of 60 per cent or higher should be selected for the study. The rules for the trial are presented, in relation to its three phases: pre-therapy, during the therapy (with the patients in the Hospital) and post-therapy. Three cases of a trial, still under way, with a derivative of nitrofurfurilidene (Bayer 2502) are shown, to exemplify the value of xenodiagnosis and sorological tests in the evaluation of efficacy of the drug (tables IV, V and VI). Finally the Authors discuss and define the criteria of cure of human Chagas' disease
After emphasizing the needs for standardization of processes for the clinicai trial of drugs in Cragas' disease, the Authors report a method based in the principie that only patients with "high parasitemia" should be selected for therapeutic trials. When patients with chronic Chagas' disease are monthly submitted to xenodiagnosis, the results are widely variable. While some patients show all the xenos to be positive (100%), others never have a positive xenodiagnosis (0%), even if the period of observation goes for three year (table III). Between these extremes a regular gradation of positivity is observed. It is necessary to establish, before treatment, the parasitoloficai behaviour of the patient as xenodiagnosis is concerned, and only those patients with a positivity of the xenodiagnosis of 60 per cent or higher should be selected for the study. The rules for the trial are presented, in relation to its three phases: pre-therapy, during the therapy (with the patients in the Hospital) and post-therapy. Three cases of a trial, still under way, with a derivative of nitrofurfurilidene (Bayer 2502) are shown, to exemplify the value of xenodiagnosis and sorological tests in the evaluation of efficacy of the drug (tables IV, V and VI). Finally the Authors discuss and define the criteria of cure of human Chagas' disease
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| Authors | ;J. Romeu Cançado;U. Duval Marra;O. G. Mourão;J. Mendes Álvares;J. P. Mendes de Oliveira;J. Raymundo Machado;A. Abreu Salgado |
| Journal | mobile information systems |
| Year | 1973 |
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