A randomized clinical trial with high dose of chloroquine for treatment of Plasmodium falciparum malaria in Brazil Ensaio clínico aleatório duplo cego com cloroquina em dose alta para tratamento da malária por Plasmodium falciparum no Brasil

• Published in: Revista do Instituto de Medicina Tropical de São Paulo
• Main Authors: João Guimarães de Andrade, Ana Lúcia Sampaio Sgambatti de Andrade, Elisabeth S. O. Araujo, Renato Maurício Oliveira, Simonne Almeida Silva, Celina Maria Turchi Martelli, Fábio Zicker
• Format: Article in Journal/Newspaper
• Language: English
• Published: Universidade de São Paulo (USP) 1992
• Subjects: Malaria; Plasmodium falciparum; Chloroquine; Clinical trial; Arctic medicine. Tropical medicine; RC955-962; Infectious and parasitic diseases; RC109-216; Alta; Arctic
• Online Access: https://doi.org/10.1590/S0036-46651992000500015; https://doaj.org/article/4494fc391c0c4ac2bedfa998715a5f26

This clinical trial compared parasitological efficacy, levels of in vivo resistance and side effects of oral chloroquine 25 mg/Kg and 50 mg/Kg in 3 days treatment in Plasmodium falciparum malaria with an extended followed-up of 30 days. The study enroled 58 patients in the 25 mg/Kg group and 66 in the 50 mg/Kg group. All eligible subjects were over 14 years of age and came from Amazon Basin and Central Brazil during the period of August 1989 to April 1991. The cure rate in the 50 mg/Kg group was 89.4% on day 7 and 71.2% on day 14 compared to 44.8% and 24.1% in the 25 mg/Kg group. 74.1% of the patients in the 25 mg/Kg group and 48.4% of the patients in the 50 mg/Kg group had detectable parasitaemia at the day 30. However, there was a decrease of the geometric mean parasite density in both groups specially in the 50 mg/Kg group. There was 24.1% of RIII and 13.8% of RH in the 25 mg/Kg group. Side effects were found to be minimum in both groups. The present data support that there was a high level resistance to chloroquine in both groups, and the high dose regimen only delayed the development of resistance and its administration should not be recommended as first choice in malaria P. falciparum therapy in Brazil. Comparou-se a eficácia parasitológica, níveis de resistência "in vivo" e efeitos colaterais da cloroquina oral nas dosagens de 25 mg/kg e 50 mg/kg no tratamento da malária por Plasmodium falciparum com seguimento de 30 dias. O estudo foi conduzido de agosto de 1989 a abril de 1991 e incluiu 124 pacientes, selecionados aleatoriamente em blocos de 10 pacientes, do ambulatório da Fundação Nacional de Saúde-Goiânia, Brasil. Todos os pacientes eram procedentes da Bacia Amazônica e Brasil - Central, sendo 58 alocados no grupo de 25 mg/kg (C25) e 66 no grupo de 50 mg/kg (C50). Os efeitos colaterais foram mínimos em ambos os grupos. A taxa de cura no C50 foi 89,4% no dia 7 e 71,2% no dia 14 enquanto para o C25 as taxas foram de 44,8% e 24,1%, respectivamente. Setenta e quatro por cento dos pacientes do C25 e 48,4% ...