Case Series of Primaquine-Induced Haemolytic Events in Controlled Trials with G6PD Screening.

Autor:	Kosasih A; Oxford University Clinical Research Unit Indonesia, Jakarta 10430, Indonesia., James R; Walter and Eliza Hall Institute of Medical Research, Melbourne, VIC 3052, Australia.; Department of Medical Biology, University of Melbourne, Melbourne, VIC 3010, Australia., Chau NH; Oxford University Clinical Research Unit, Hospital for Tropical Diseases, District 5, Ho Chi Minh City 749000, Vietnam., Karman MM; Oxford University Clinical Research Unit Indonesia, Jakarta 10430, Indonesia., Panggalo LV; Exeins Health Initiative, Jakarta 12870, Indonesia., Wini L; Vector-Borne Disease Control (VBDC) Division, Solomon Islands Ministry of Health and Medical Services, Honiara P.O. Box R113, Solomon Islands., Thanh NV; Oxford University Clinical Research Unit, Hospital for Tropical Diseases, District 5, Ho Chi Minh City 749000, Vietnam., Obadia T; Institut Pasteur, Université Paris Cité, Bioinformatics and Biostatistics Hub, F-75015 Paris, France.; Institut Pasteur, Université Paris Cité, G5 Infectious Diseases Epidemiology and Analytics, F-75015 Paris, France., Satyagraha AW; Exeins Health Initiative, Jakarta 12870, Indonesia.; Eijkman Research Center for Molecular Biology, National Research and Innovation Agency, Cibinong 16911, Indonesia., Asih PBS; Eijkman Research Center for Molecular Biology, National Research and Innovation Agency, Cibinong 16911, Indonesia., Syafruddin D; Eijkman Research Center for Molecular Biology, National Research and Innovation Agency, Cibinong 16911, Indonesia.; Department of Parasitology, Faculty of Medicine, Hasanuddin University, Makassar 90245, Indonesia.; Hasanuddin University Medical Research Center, Makassar 90245, Indonesia., Taylor WRJ; Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok 10400, Thailand.; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford OX3 7BN, UK., Mueller I; Walter and Eliza Hall Institute of Medical Research, Melbourne, VIC 3052, Australia., Sutanto I; Department of Parasitology, Faculty of Medicine, University of Indonesia, Jakarta 10430, Indonesia., Karunajeewa H; Department of Medicine, Western Health, The University of Melbourne, Melbourne, VIC 3010, Australia., Pasaribu AP; Department of Pediatrics, Medical Faculty, Universitas Sumatera Utara, Medan 20155, Indonesia., Baird JK; Oxford University Clinical Research Unit Indonesia, Jakarta 10430, Indonesia.; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford OX3 7BN, UK.
Jazyk:	angličtina
Zdroj:	Pathogens (Basel, Switzerland) [Pathogens] 2023 Sep 19; Vol. 12 (9). Date of Electronic Publication: 2023 Sep 19.
DOI:	10.3390/pathogens12091176
Abstrakt:	Primaquine for radical cure of Plasmodium vivax malaria poses a potentially life-threatening risk of haemolysis in G6PD-deficient patients. Herein, we review five events of acute haemolytic anaemia following the administration of primaquine in four malaria trials from Indonesia, the Solomon Islands, and Vietnam. Five males aged 9 to 48 years were improperly classified as G6PD-normal by various screening procedures and included as subjects in trials of anti-relapse therapy with daily primaquine. Routine safety monitoring by physical examination, urine inspection, and blood haemoglobin (Hb) assessment were performed in all those trials. Early signs of acute haemolysis, i.e., dark urine and haemoglobin drop >20%, occurred only after day 3 and as late as day 8 of primaquine dosing. All patients were hospitalized and fully recovered, all but one following blood transfusion rescue. Hb nadir was 4.7 to 7.9 g/dL. Hospitalization was for 1 to 7 days. Hb levels returned to baseline values 3 to 10 days after transfusion. Failed G6PD screening procedures in these trials led G6PD-deficient patients to suffer harmful exposures to primaquine. The safe application of primaquine anti-relapse therapy requires G6PD screening and anticipation of its failure with a means of prompt detection and rescue from the typically abrupt haemolytic crisis.
Databáze:	MEDLINE
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