Abstract
BackgroundThe use of artemisinin derivatives has increased exponentially with the deployment of artemisinin combination therapy (ACT) in all malarious areas. They are highly effective and are considered safe, but in animal studies artemisinin derivatives produce neurotoxicity targeting mainly the auditory and vestibular pathways. The debate remains as to whether artemisinin derivatives induce similar toxicity in humans.MethodsThis prospective study assessed the effects on auditory function of a standard 3-day oral dose of artesunate (4 mg/kg/day) combined with mefloquine (25 mg/kg) in patients with acute uncomplicated falciparum malaria treated at the Shoklo Malaria Research Unit, on the Thai-Burmese border. A complete auditory evaluation with tympanometry, audiometry and auditory brainstem responses (ABR) was performed before the first dose and seven days after initiation of the antimalarial treatment.ResultsComplete auditory tests at day 0 (D0) and day 7 (D7) were obtained for 93 patients. Hearing loss (threshold > 25 dB) on admission was common (57%) and associated with age only. No patient had a threshold change exceeding 10 dB between D0 and D7 at any tested frequency. No patient showed a shift in Wave III peak latency of more than 0.30 msec between baseline and D7.ConclusionNeither audiometric or the ABR tests showed clinical evidence of auditory toxicity seven days after receiving oral artesunate and mefloquine.
Highlights
The use of artemisinin derivatives has increased exponentially with the deployment of artemisinin combination therapy (ACT) in all malarious areas
A negative change between the two audiograms was systematically seen among those having received artemether-lumefantrine, varying from -6.50 dBL to – 0.07 dBL. To further explore this issue the auditory function of 68 subjects treated with artemether-lumefantrine within the previous five years, and 68 age and sexmatched controls were assessed by the Shoklo Malaria Research Unit (SMRU), between October 2004 and March 2005
The present study aimed to evaluate prospectively the potential effects of artesunate in combination with mefloquine on the auditory function of patients with acute uncomplicated falciparum malaria treated in one of the SMRU clinic for migrant workers along the Thai-Burmese border
Summary
The use of artemisinin derivatives has increased exponentially with the deployment of artemisinin combination therapy (ACT) in all malarious areas. In 1997, retrospective studies in Thailand [17] and in Vietnam [18] have investigated the potential adverse effect on brainstem function in patients having been exposed to artemisinins Patients were, in both studies, compared to controls who had not been treated with an artemisinin and who were living in the same environment and they were matched by age and sex; audiology results were similar in both groups and no neurological anomalies were found. A negative change between the two audiograms was systematically seen among those having received artemether-lumefantrine, varying from -6.50 dBL to – 0.07 dBL To further explore this issue the auditory function of 68 subjects treated with artemether-lumefantrine within the previous five years, and 68 age and sexmatched controls were assessed by the Shoklo Malaria Research Unit (SMRU), between October 2004 and March 2005. Two prospective studies evaluated the potential audiotoxicity of a standard oral dose of artemether-lumefantrine; one in 15 healthy volunteers followed up 8 days after treatment [21] and one in Ethiopian patients followed up for a period of 90 days [22]; neither study found pathological changes in audiometric puretone thresholds or ABR peak latencies following artemether-lumefantrine
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