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An open, randomized, phase III clinical trial of mefloquine and of quinine plus sulfadoxine-pyrimethamine in the treatment of symptomatic falciparum malaria in Brazil

de Souza, J M ; Sheth, U K ; de Oliveira, R M ; Roulet, H ; de Souza, S D

Bulletin of the World Health Organization, 1985, Vol.63 (3), p.603-609 [Periódico revisado por pares]

Switzerland

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  • Título:
    An open, randomized, phase III clinical trial of mefloquine and of quinine plus sulfadoxine-pyrimethamine in the treatment of symptomatic falciparum malaria in Brazil
  • Autor: de Souza, J M ; Sheth, U K ; de Oliveira, R M ; Roulet, H ; de Souza, S D
  • Assuntos: Adolescent ; Adult ; Brazil ; Clinical Trials as Topic ; Drug Combinations - therapeutic use ; Humans ; Malaria - drug therapy ; Male ; Mefloquine ; Middle Aged ; Plasmodium falciparum ; Pyrimethamine - therapeutic use ; Quinine - therapeutic use ; Quinolines - therapeutic use ; Random Allocation ; Sulfadoxine - therapeutic use ; Sulfanilamides - therapeutic use
  • É parte de: Bulletin of the World Health Organization, 1985, Vol.63 (3), p.603-609
  • Notas: ObjectType-Article-2
    SourceType-Scholarly Journals-1
    ObjectType-Feature-1
    ObjectType-News-3
    content type line 23
  • Descrição: The clinical and parasitological response of adult male patients to mefloquine and to a combination of quinine and sulfadoxine-pyrimethamine during the treatment of falciparum malaria was compared. These patients were from an area in Brazil where Plasmodium falciparum is showing increasing resistance to quinine and to sulfadoxine-pyrimethamine. The drugs were administered to 100 patients (50 in each group), based on a randomized study design.The rates of clearance of parasitaemia and fever were similar in both groups. However, the parasitological cure rate ("S" response) was 100% for mefloquine but only 92% for quinine plus sulfadoxine-pyrimethamine. Tolerance was good in both groups. The main side-effects (nausea, vomiting, abdominal pain, and dizziness) were mild, transient and required no specific treatment. Nausea and vomiting were more frequent in patients who received quinine plus sulfadoxine-pyrimethamine, while abdominal pain and loose stools or mild diarrhoea were more frequent in the mefloquine group. Tinnitus and hearing difficulty were observed following the administration of quinine plus sulfadoxine-pyrimethamine, but not after mefloquine treatment. Laboratory tests of various haematological and biochemical parameters were not adversely affected in either group after drug administration.It can be concluded that mefloquine, given in a single oral dose of 1000 mg, is highly effective, well tolerated, and safe for the treatment of falciparum malaria in adult males in Brazil.
  • Editor: Switzerland
  • Idioma: Inglês
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