Treatment outcomes in a safety observational study of dihydroartemisinin/piperaquine (Eurartesim®) in the treatment of uncomplicated malaria at public health facilities in four African countries

Malaria Journal

Research

Eusebio Macete¹  Esperance Sevene¹  Solomon Narh-Bana²  Margaret Gyapong²  Alberta Amu²  Vida Kukula²  Alexander Adjei²  Richard Afedi Nagai²  Rita Baiden³  Martin Adjuik³  Bernhards Ogutu³  Fred Binka⁴  Abdunoor Mulokozi⁵  Salim Abdulla⁵  Seth Owusu-Agyei⁶  Kwaku-Poku Asante⁶  Innocent Valea⁷  Tinto Halidou⁷  Abraham Oduro⁸  Isaac Osei⁸  Ali Sie⁹  Guillaume Compaore⁹ 

[1] Centro de Investigação em Saúde de Manhiça (CISM), Manhiça, Mozambique;Dodowa Health Research Centre, Dodowa, Ghana;INDEPTH-Network, Accra, Ghana;INDEPTH-Network, Accra, Ghana;University of Science and Allied Sciences, Ho, Ghana;Ifakara Health Institute, Ifakara, Tanzania;Kintampo Health Research Centre, Kintampo, Ghana;Nanoro Health Research Centre, Nanoro, Burkina Faso;Navrongo Health Research Centre, Navrongo, Ghana;Nouna Health Research Centre, Nouna, Burkina Faso;

关键词: Dihydroartemisinin-piperaquine;    Uncomplicated malaria;    Artemisinin-based combination therapy;    Treatment outcome;    Effectiveness;   

DOI  :  10.1186/s12936-016-1099-7

 received in 2015-07-09, accepted in 2016-01-12,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundDihydroartemisinin-piperaquine (DHA-PQ) is one of five WHO recommended artemisinin combination therapy (ACT) for the treatment of uncomplicated malaria. However, little was known on its post-registration safety and effectiveness in sub-Saharan Africa. DHA-PQ provides a long post-treatment prophylactic effect against re-infection; however, new infections have been reported within a few weeks of treatment, especially in children. This paper reports the clinical outcomes following administration of DHQ-PQ in real-life conditions in public health facilities in Burkina Faso, Ghana, Mozambique, and Tanzania for the treatment of confirmed uncomplicated malaria.MethodsAn observational, non-comparative, longitudinal study was conducted on 10,591 patients with confirmed uncomplicated malaria visiting public health facilities within seven health and demographic surveillance system sites in four African countries (Ghana, Tanzania, Burkina Faso, Mozambique) between September 2013 and April 2014. Patients were treated with DHA-PQ based on body weight and followed up for 28 days to assess the clinical outcome. A nested cohort of 1002 was intensely followed up. Clinical outcome was assessed using the proportion of patients who reported signs and symptoms of malaria after completing 3 days of treatment.ResultsA total of 11,097 patients were screened with 11,017 enrolled, 94 were lost to follow-up, 332 withdrew and 10,591 (96.1 %) patients aged 6 months–85 years met protocol requirements for analysis. Females were 52.8 and 48.5 % were <5 years of age. Malaria was diagnosed by microscopy and rapid diagnostic test in 69.8 % and 29.9 %, respectively. At day 28, the unadjusted risk of recurrent symptomatic parasitaemia was 0.5 % (51/10,591). Most of the recurrent symptomatic malaria patients (76 %) were children <5 years. The mean haemoglobin level decreased from 10.6 g/dl on day 1 to 10.2 g/dl on day 7. There was no significant renal impairment in the nested cohort during the first 7 days of follow-up with minimal non-clinically significant changes noted in the liver enzymes.ConclusionDHA-PQ was effective and well tolerated in the treatment of uncomplicated malaria and provides an excellent alternative first-line ACT in sub-Saharan Africa.

【 授权许可】

CC BY   
© Adjei et al. 2016