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Publikasi Scopus 2010 s/d 2022
Publikasi Scopus 2010 s/d 2022
Safety of single-dose primaquine as a Plasmodium falciparum gametocytocide: a systematic review and meta-analysis of individual patient data
2022
BMC Medicine
20
1
350
3
https://www.scopus.com/inward/record.uri?eid=2-s2.0-85137936051&doi=10.1186%2fs12916-022-02504-z&partnerID=40&md5=6b5e9d82a690170aaa1e34c6e5cc6eb5
WorldWide Antimalarial Resistance Network, Oxford, United Kingdom; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom; Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa; Green Templeton College, University of Oxford, Oxford, United Kingdom; Malaria Elimination Initiative, Global Health Group, University of California San Francisco, San Francisco, United States; Jimma University Clinical Trial Unit, Department of Internal Medicine, Jimma University, Jimma, Ethiopia; Department of Infection and Immunity, London School of Hygiene and Tropical Medicine, London, United Kingdom; Department of Medical Microbiology, Radboud University Medical Center, Nijmegen, Netherlands; Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Global and Tropical Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, Australia; Parasitology Reference Laboratory, National Institute for Communicable Diseases, A Division of the National Health Laboratory Services, Johannesburg, South Africa; Wits Research Institute for Malaria, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa; Department of Women’s and Children’s Health, International Maternal and Child Health (IMCH), Uppsala University, Uppsala, Sweden; Department of Parasitology and Medical Entomology, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania; Department of Microbiology, Immunology and Parasitology, Hubert Kairuki Memorial University, Dar es Salaam, Tanzania; Shoklo Malaria Research Unit, Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot, Thailand; Laboratory of Medical Microbiology and Immunology, Rijnstate Hospital, Arnhem, Netherlands; Department of Microbiology Tumor and Cell Biology, Karolinska Institutet, Stockholm, Sweden; Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, United States; Medical Research Council Unit, London School of Hygiene and Tropical Medicine, Fajara, Gambia; Malaria Research and Training Centre, Faculty of Pharmacy and Faculty of Medicine and Dentistry, University of Science, Techniques and Technologies of Bamako, Bamako, Mali; Department of Epidemiology, Tropical Medicine Research Institute, National Centre for Research, Khartoum, Sudan; Department of Global Health and Infection, Brighton and Sussex Medical School, University of Sussex, Brighton, United Kingdom; Institute of Endemic Diseases, University of Khartoum, Khartoum, Sudan; Kenya Medical Research Institute (KEMRI), Kisian, Kenya; Infectious Disease Division, International Centre for Diarrheal Diseases Research, Dhaka, Bangladesh; Centers for Disease Control and Prevention, Department of Parasitic Diseases and Malaria, Kisumu, Kenya; Department of Women’s and Children’s Health, International Maternal and Child Health (IMCH), Uppsala University, Uppsala, Sweden; Disease Control & Elimination Theme, Medical Research Council Unit, Fajara, Gambia; Liverpool School of Tropical Medicine, Liverpool, United Kingdom; Department of Parasitology, Faculty of Medicine, University of Indonesia, Depok City, Indonesia; Department of Medical Parasitology, Faculty of Medicine, University Cheikh Anta Diop, Dakar, Senegal; Department of Biomedical Sciences, Centre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso; Department of Infection Biology, London School of Tropical Medicine and Hygiene, London, United Kingdom; Departments of Pharmacy & Global Health, Schools of Pharmacy and Public Health, University of Washington, Seattle, United States
Background: In 2012, the World Health Organization (WHO) recommended single low-dose (SLD, 0.25 mg/kg) primaquine to be added as a Plasmodium (P.) falciparum gametocytocide to artemisinin-based combination therapy (ACT) without glucose-6-phosphate dehydrogenase (G6PD) testing, to accelerate malaria elimination efforts and avoid the spread of artemisinin resistance. Uptake of this recommendation has been relatively slow primarily due to safety concerns. Methods: A systematic review and individual patient data (IPD) meta-analysis of single-dose (SD) primaquine studies for P. falciparum malaria were performed. Absolute and fractional changes in haemoglobin concentration within a week and adverse effects within 28 days of treatment initiation were characterised and compared between primaquine and no primaquine arms using random intercept models. Results: Data comprised 20 studies that enrolled 6406 participants, of whom 5129 (80.1%) had received a single target dose of primaquine ranging between 0.0625 and 0.75 mg/kg. There was no effect of primaquine in G6PD-normal participants on haemoglobin concentrations. However, among 194 G6PD-deficient African participants, a 0.25 mg/kg primaquine target dose resulted in an additional 0.53 g/dL (95% CI 0.17–0.89) reduction in haemoglobin concentration by day 7, with a 0.27 (95% CI 0.19–0.34) g/dL haemoglobin drop estimated for every 0.1 mg/kg increase in primaquine dose. Baseline haemoglobin, young age, and hyperparasitaemia were the main determinants of becoming anaemic (Hb < 10 g/dL), with the nadir observed on ACT day 2 or 3, regardless of G6PD status and exposure to primaquine. Time to recovery from anaemia took longer in young children and those with baseline anaemia or hyperparasitaemia. Serious adverse haematological events after primaquine were few (9/3, 113, 0.3%) and transitory. One blood transfusion was reported in the primaquine arms, and there were no primaquine-related deaths. In controlled studies, the proportions with either haematological or any serious adverse event were similar between primaquine and no primaquine arms. Conclusions: Our results support the WHO recommendation to use 0.25 mg/kg of primaquine as a P. falciparum gametocytocide, including in G6PD-deficient individuals. Although primaquine is associated with a transient reduction in haemoglobin levels in G6PD-deficient individuals, haemoglobin levels at clinical presentation are the major determinants of anaemia in these patients. Trial registration: PROSPERO, CRD42019128185. © 2022, The Author(s).
hemoglobin; primaquine; antimalarial agent; artemisinin derivative; glucose 6 phosphate dehydrogenase; hemoglobin; primaquine; age; anemia; Article; clinical effectiveness; clinical feature; drug effect; drug efficacy; drug exposure; drug response; glucose 6 phosphate dehydrogenase deficiency; hemoglobin blood level; hemoglobinuria; human; malaria falciparum; meta analysis; risk factor; single drug dose; systematic review; treatment outcome; child; complication; malaria; malaria falciparum; Plasmodium falciparum; preschool child; Antimalarials; Artemisinins; Child; Child, Preschool; Glucosephosphate Dehydrogenase; Hemoglobins; Humans; Malaria; Malaria, Falciparum; Plasmodium falciparum; Primaquine
Bill and Melinda Gates Foundation
This work was funded by the Bill and Melinda Gates Foundation as part of a grant to the Malaria Elimination Initiative, Global Health Group, University of California, San Francisco; to the WorldWide Antimalarial Resistance Network, Oxford University; and to the London School of Hygiene and Tropical medicine.
BioMed Central Ltd
17417015
36109733
Article
Q1
3405
478
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