British journal of clinical pharmacology · 2021
Efficacy and safety of malarial prophylaxis with mefloquine during pregnancy in Kisangani, Democratic Republic of Congo: A randomized clinical trial.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Labama Otuli Noël, Marini Djang'eing'a Roland, Losimba Likwela Joris, Bosenge Nguma Jean-Didier, Maindo Alongo Mike-Antoine, Ahuka Ona Longombe Albert, Mbutu Mango Bernard, M N Bono Diane, L Mokili John, Manga Okenge Jean-Pascal
Аннотация
AIMS: Kisangani is an area with intense malaria transmission and sulfadoxine-pyrimethamine resistance. Alternative antimalaria prophylaxis medication and protocols are needed, particularly with pregnant individuals. In this study, we compare the tolerance and effectiveness of mefloquine regimen as a split dose with a meal vs. sulfadoxine-pyrimethamine for the intermittent preventive treatment in pregnant individuals in Kisangani.
METHODS: This study was conducted from 15 May to 30 November 2019 as a single-blind, randomized clinical trial comparing 2 regimens of intermittent preventive treatment during pregnancy. The first regimen consisted of 4 doses of sulfadoxine-pyrimethamine, and the second of 2 doses of mefloquine taken as a split dose with meal.
RESULTS: The occurrence of major or minor side-effects among patients treated with mefloquine and those treated with sulfadoxine-pyrimethamine were not statistically significant (major side effects: Fisher exact = 0.5014; minor side effects: P = .0961). Intermittent preventive treatment using mefloquine significantly reduced the risk of placental malaria (risk ratio [RR]: 0.4315, 95% confidence interval [CI]: 0.2201-0.8460), maternal peripheral parasitaemia (RR: 0.4397, 95% CI: 0.2377-0.8132) and low birth weight (RR: 0.4708, 95% CI: 0.2455-0.9029).
CONCLUSION: Splitting dose and intake with a meal increased mefloquine tolerability while keeping its efficacy higher compared to sulfadoxine-pyrimethamine. Intermittent preventive treatment during pregnancy using mefloquine reduces the risk of placental malaria, maternal peripheral parasitaemia and low birth weight, compared to sulfadoxine-pyrimethamine. Thus, mefloquine is a good alternative to intermittent preventive treatment in pregnancy.
METHODS: This study was conducted from 15 May to 30 November 2019 as a single-blind, randomized clinical trial comparing 2 regimens of intermittent preventive treatment during pregnancy. The first regimen consisted of 4 doses of sulfadoxine-pyrimethamine, and the second of 2 doses of mefloquine taken as a split dose with meal.
RESULTS: The occurrence of major or minor side-effects among patients treated with mefloquine and those treated with sulfadoxine-pyrimethamine were not statistically significant (major side effects: Fisher exact = 0.5014; minor side effects: P = .0961). Intermittent preventive treatment using mefloquine significantly reduced the risk of placental malaria (risk ratio [RR]: 0.4315, 95% confidence interval [CI]: 0.2201-0.8460), maternal peripheral parasitaemia (RR: 0.4397, 95% CI: 0.2377-0.8132) and low birth weight (RR: 0.4708, 95% CI: 0.2455-0.9029).
CONCLUSION: Splitting dose and intake with a meal increased mefloquine tolerability while keeping its efficacy higher compared to sulfadoxine-pyrimethamine. Intermittent preventive treatment during pregnancy using mefloquine reduces the risk of placental malaria, maternal peripheral parasitaemia and low birth weight, compared to sulfadoxine-pyrimethamine. Thus, mefloquine is a good alternative to intermittent preventive treatment in pregnancy.