Adverse Drug Reactions and Changes in Haematological and Clinical Chemistry to Two ACTs among Nigerian Children with Acute Uncomplicated Malaria.

Autor:	Anjorin OE; Department of Emergency Medicine, Obafemi Awolowo University Teaching Hospital, Ile Ife, Nigeria. E-mail: enitaanjorin@yahoo.com., Anjorin IA; Department of Family Medicine, University College Hospital, Ibadan, Nigeria., Falade CO; Department of Pharmacology and Therapeutics, University of Ibadan, Ibadan, Nigeria.
Jazyk:	angličtina
Zdroj:	West African journal of medicine [West Afr J Med] 2023 Dec 30; Vol. 40 (12), pp. 1332-1340.
Abstrakt:	Background: Adverse drug reaction (ADR) is a global and frequently occurring medical emergency with increased cases of mortality annually. ADRs can occur with the use of all drugs including artemisinin-based combination therapy (ACTs) which are currently the treatment of choice for acute uncomplicated malaria globally. Numerous doses of ACTs are administered daily in malaria endemic areas. Aims: This study determined the incidence, pattern of presentation and factors associated with ADRs to two ACTs- artemisinin piperaquine (AP) and artemether-lumefantrine (AL) among children with confirmed acute uncomplicated malaria in Ibadan, Nigeria. Methods: Children aged 2-10 years enrolled into a larger study evaluating the safety and efficacy of artemisinin /piperaquine (AP) and artemether /lumefantrine (AL) using the WHO 28-day protocol were studied. Monitoring for ADR was based on history from the parent and /or child (for occurrences of treatment emergent signs and symptoms), physical examinations and abnormalities in laboratory investigations- full blood count, blood chemistry and liver function tests. Causality assessment for the ADR was by the Naranjo algorithm scale. Result: 108 of 114 (94.7%) children completed the study. Over half [61(56.5%] were males. The mean age of enrollees was 65.1±30.0 months. Day 28 adequate clinical and parasitological response (ACPR) for AP was 96.1% and 90.4% for AL. Observed ADRs were cough, diarrhea, loss of appetite, abdominal pain, rash, irritability, insomnia and headache. The prevalence was similar in the two treatment groups (AL=14%, AP= 11%; ρ=1.000). The incidence of ADR to both ACTs was 12/1000 patients per day. All ADRs were mild and resolved spontaneously. No notable associated factor to ADR was detected in this study. Conclusion: Artemether-lumefantrine and Artemisinin piperaquine were found to be safe in the study population. Competing Interests: The Authors declare that no competing interest exists (Copyright © 2023 by West African Journal of Medicine.)
Databáze:	MEDLINE
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