segunda-feira, 31 de agosto de 2009

Miltefosina: Estudos sobre o efeito da droga no tratamento da leishmaniose

 

Em 2005 a OMS aprovou o uso da Miltefosina no tratamento em humanos, o produto é mais barato e de fácil administração. As autoridades indianas acreditam que antes de 2010 a doença será erradicada (GONTIJO e MELO, 2004).

A Virbac já lançou a droga em outros países e muitos trabalhos tem sido publicados sobre ela. Abaixo deixo uma relação de textos para que o leitor se intere sobre a droga. Atualmente ela é proibida no Brasil. Vamos torcer para sua liberação.

Título:

Miltefosina – Ficha Técnica

Autor: Virbac Espanha
Fonte: Site Virbac
Resumo:

Milteforan - Control de la leishmaniosis canina. Inmediatamente después del inicio del tratamiento los signos clínicos de la enfermedad empiezan a disminuir marcadamente y dos semanas más tarde se reducen significativamente. La mejoría de los signos continúa al menos 4 semanas después de completar el tratamiento. La miltefosina tiene una marcada actividad directa antileishmanica in vitro y en modelos animales contra L. donovani (promastigotes y amastigotes) y L. infantum. Se piensa que la miltefosina inhibe la penetración de las especies de Leishmania en los macrófagos por su interacción con los anclajes de glicosomas y glucosilfosfatidilinositol (esencial para la supervivencia intracelular del Leishmania) e interfiere en la transducción de señales de la membrana del Leishmania inhibiendo la fosfolipasa C. (Ler textos completos: 01 02 03 04 05 06 07– pdf espanhol)

Título:

Oral miltefosine treatment in children with visceral leishmaniasis: a brief review

Autor: PALUMBO, Emilio.
Fonte:

Braz J Infect Dis [online]. 2008, vol.12, n.1 ISSN 1413-8670.

Resumo:  
Título:

 Miltefosina oral para el tratamiento de la leishmaniasis.

Autor: SOTO, Jaime  and  SOTO, Paula.
Fonte:

Biomédica [online]. 2006, vol.26 ISSN 0120-4157.

Resumo:  
Título:

New treatment for leishmaniasis is 95% effective

Autor:

World Health Organization

Fonte:

Bull World Health Organ vol.80 no.8 Genebra Aug. 2002

Resumo:

Miltefosine, a new drug against leishmaniasis, has cured 95% of the patients treated with it in clinical trials. About 60000 people a year die from this parasitic disease, which is also known as kala azar and black fever. Miltefosine, which is likely to cost less than current therapies as well as being more effective and easier to deliver, could save most of these lives. It is the first oral antileishmaniasis drug.

Miltefosine is the result of collaboration between the Government of India, the German biopharmaceutical company, Zentaris, and TDR (Tropical Disease Research), a programme sponsored by the World Bank, the United Nations Development Programme and WHO. The new drug has now been approved for use in India, where half the cases of visceral leishmaniasis in the world occur. By using this drug, the Government hopes to eliminate visceral leishmaniasis by 2010.

"The combined efforts of these partners have opened a new era in the fight against visceral leishmaniasis,'' said WHO's Director-General, Dr Gro Harlem Brundtland. "In doing so we can free the poor from one of their many burdens.''

Leishmaniasis is one of the "neglected diseases'' which afflict the world's poorest people. About 80% of its victims have less than US$ 2 a day to live on. It is transmitted by the bite of the sandfly. Attacking the liver and spleen, causing fever and weight loss, visceral leishmaniasis is fatal in those with compromised immune function and poor nutrition unless they obtain treatment.

Título:

Miltefosine, an Oral Agent, for the Treatment of Indian Visceral Leishmaniasis

Autor: T.K. Jha, M.D., Shyam Sundar, M.D., C.P. Thakur, M.D., Peter Bachmann, M.D., Juntra Karbwang, M.D., Ph.D., Christina Fischer, Dip., Andreas Voss, M.D., and Jonathan Berman, M.D., Ph.D.
Fonte:  
Resumo:

Background There is no effective orally administered medication for any leishmania infection. We investigated miltefosine, which can be taken orally, for the treatment of Indian visceral leishmaniasis. Miltefosine is a phosphocholine analogue that affects cell-signaling pathways and membrane synthesis.

Methods The study was an open-label, multicenter, phase 2 trial in which four 30-person cohorts received 50, 100, or 150 mg of miltefosine per day for four or six weeks. The 120 patients, who ranged in age from 12 to 50 years, had anorexia, fever, and splenomegaly with at least moderate (2+) leishmania in a splenic aspirate. A parasitologic cure was defined by the absence of parasites in a splenic aspirate obtained two weeks after completion of treatment. The clinical response was assessed at six months.

Results In all 120 patients there was an initial parasitologic cure. Six patients had clinical and parasitologic relapses; the remaining 114 patients had not relapsed by six months after treatment, for a cure rate of 95 percent (95 percent confidence interval, 89 to 98 percent). With the regimen of 100 mg of miltefosine per day (approximately 2.5 mg per kilogram of body weight per day) for four weeks, 29 of 30 patients (97 percent) were cured. Gastrointestinal side effects were frequent (occurring in 62 percent of patients) but mild to moderate in severity, and no patient discontinued therapy because of gastrointestinal side effects. In two patients, treatment was discontinued because of elevated levels of aspartate aminotransferase or creatinine;in both patients the levels rapidly returned to normal. In 12 other patients, the level of aspartate aminotransferase increased to 100 to 150 U per liter during treatment.

Conclusions Orally administered miltefosine appears to be an effective treatment for Indian visceral leishmaniasis.(Ler texto completo – inglês)

Título:

Clinical efficacy and tolerance of miltefosine in the treatment of canine leishmaniosis

Autor: Virginie Woerly1 , Laurence Maynard1, Annaële Sanquer1 and Hyone-Myong Eun
Fonte:

Journal
Parasitology Research,Volume 105, Number 2 / July, 2009

Resumo: The study was aimed to assess the efficacy and tolerance profiles of an oral administration miltefosine drug (Milteforan®, Virbac) in dogs with natural leishmaniosis. In this multicentric open trial, 96 dogs were treated with the drug administered orally at a dose of 2 mg/kg body weight once a day for 28 days. During the 56-day trial, clinical signs of the dogs were monitored every 2 weeks. On the first and the last visits, blood and bone marrow samples were collected for laboratory analyses. According to clinical scores, the treatment demonstrated a significant time-dependent therapeutic effect resulting in a 61.2% mean reduction on day 56. Hematologic and biochemical analyses showed improvements in most of the parameters examined, supporting the observed clinical efficacy of the drug. Overall, veterinarians estimated that 82.7% of the dogs treated with the miltefosine drug showed an equal or higher treatment efficacy than other antileishmanial drugs. During the trial, the adverse reactions probably associated with the drug treatment were observed in 11.7% of the dogs. However, they were not serious. The most frequent one was vomiting, which was transient, self-limiting, and reversible. These data demonstrate that the drug, at the recommended dose and treatment regime, was safe and efficacious for the treatment of canine leishmaniosis.(Ler texto completo – inglês)

Título:

Miltefosine: First Oral Drug for Treatment of Visceral Leishmaniasis

Autor:

Lt Col VK Agrawal*, Brig Zile Singh+

Fonte:

MJAFI 2006; 62 : 66-67

Resumo:

Miltefosine (1-O-hexadecylphosphocholine), an alkylphosphocholine and a membrane-active synthetic ether-lipid analogue was originally developed and tried
for the management of cancer patients. The dose required for such treatment had pronounced sideeffects, limiting its usefulness. Simultaneously, in vitro studies showed that it had striking activity against Leishmania donovani and L. infantum. The results of Phase III clinical trials of miltefosine in India have shown that this oral drug is effective for treating VL in both adults and children, and has limited side-effects. (Ler texto completo – inglês pdf)

POLÍTICA DO BLOG

>> Nada contido neste site deve ser usado como diagnóstico ou tratamento. O Blog não é responsável por qualquer tomada de decisão baseada nas informações publicadas neste. Quaisquer atitudes são de exclusiva responsabilidade do leitor.

>> Ratificamos que o Blog é um local onde a prioridade é ser uma de muitas fontes das fontes de referência para os internautas que buscam informação e novidades sobre Leishmaniose Canina, atuando de forma independente. O uso dessas informações para decisões sobre o procedimento com os cães só deverá ser feita por Médico Veterinário. Jamais utilize as informações para uso pessoal. A leishmaniose visceral é um grave problema de saúde pública e merece todo nosso cuidado e atenção.

>> Fica expressamente declarado que as informações, serviços, e outros materiais apresentados bem como os textos contidos no mesmo, são publicados a partir de fontes citadas e que os comentários são a interpretação pessoal, porém baseados na literatura disponível em jornais, revistas, prospectos, livros e enciclopédias.

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