RESUMEN
Fansimef is a combination of 250 mg mefloquine (base), 500 mg sulfadoxine, and 25 mg pyrimethamine per tablet. One hundred and fifty adult male Brazilian patients at Belém (Pará), who had peripheral blood smears positive for Plasmodium falciparum, with or without clinical symptoms of falciparum malaria, were treated in a double-blind randomized fashion with either one, two or three tablets of Fansimef. Of those receiving one tablet (48 patients), 81% were cured and 19% exhibited RI recrudescences. All the patients receiving two or three tablets of Fansimef (49 patients in each group) were cured. The rates of initial clearance of parasitaemia and fever were similar in all treatment groups. Tolerance was good at all dose levels. The main side-effects included nausea, vomiting, dizziness, diarrhoea and abdominal pain, but these were mild and transient and required no specific treatment. The incidence of vomiting and nausea was highest in patients given the three-tablet dose. The results of various haematological, biochemical and urine analyses were not adversely altered by the administration of Fansimef.
Asunto(s)
Antimaláricos/uso terapéutico , Malaria/tratamiento farmacológico , Mefloquina/análogos & derivados , Pirimetamina/uso terapéutico , Quinolinas/uso terapéutico , Sulfadoxina/uso terapéutico , Sulfanilamidas/uso terapéutico , Administración Oral , Adolescente , Adulto , Animales , Antimaláricos/administración & dosificación , Antimaláricos/efectos adversos , Brasil , Método Doble Ciego , Combinación de Medicamentos/administración & dosificación , Combinación de Medicamentos/efectos adversos , Combinación de Medicamentos/uso terapéutico , Evaluación de Medicamentos , Humanos , Masculino , Persona de Mediana Edad , Plasmodium falciparum , Pirimetamina/administración & dosificación , Pirimetamina/efectos adversos , Quinolinas/administración & dosificación , Quinolinas/efectos adversos , Distribución Aleatoria , Sulfadoxina/administración & dosificación , Sulfadoxina/efectos adversosRESUMEN
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.
Asunto(s)
Malaria/tratamiento farmacológico , Pirimetamina/uso terapéutico , Quinina/uso terapéutico , Quinolinas/uso terapéutico , Sulfadoxina/uso terapéutico , Sulfanilamidas/uso terapéutico , Adolescente , Adulto , Brasil , Ensayos Clínicos como Asunto , Combinación de Medicamentos/uso terapéutico , Humanos , Masculino , Mefloquina , Persona de Mediana Edad , Plasmodium falciparum , Distribución AleatoriaRESUMEN
A double-blind, randomized phase I clinical trial was carried out to compare Fansimef (a fixed-dose combination of mefloquine, sulfadoxine, and pyrimethamine) with sulfadoxine and pyrimethamine (Fansidar) for safety and tolerance. Twenty adult male Brazilian subjects from malaria endemic areas were studied for a period of 66 days, which included 2 days before and 63 days after drug administration.Both drugs were well tolerated and safe, as seen from the absence of drug-induced changes in the various laboratory, haematological, and biochemical parameters measured. Fansimef produced a complete clearance of parasites on day 3, with an "S" type response in one subject who had blood smears which were positive for Plasmodium falciparum on day 0. Two subjects in the sufladoxine-pyrimethamine group also had P. falciparum infections on day 0; the parasitaemia was cleared on day 2 in one of these subjects and on day 3 in the other, but an early RI response (recrudescence) was observed in the former case. Relapses due to P. vivax occurred in both groups.Side-effects due to Fansimef included mild dizziness, nausea, and vomiting. The incidence of dizziness and nausea was similar in the sulfadoxine-pyrimethamine group. In both groups, these side-effects were mild, short-lived and did not require specific treatment. Thus, Fansimef in an oral dose of three tablets (total of 750 mg mefloquine (base) plus 1500 mg sulfadoxine plus 75 mg pyrimethamine) was found to be well tolerated and safe.