Y Birku1, E Makonnen, A Bjorkman. 1. Department of Pharmacology, Faculty of Medicine, Addis Ababa University, Ethiopia.
Abstract
OBJECTIVE: To compare the clinical efficacy and safety of artemisinin suppository with quinine injection. DESIGN: Comparative open randomised study. SETTING:A government regional referral hospital in Ethiopia. SUBJECTS:Sixty five adult patients of both sexes: 32 for artemisinin and 33 for quinine with complicated severe falciparum malaria. MAIN OUTCOME MEASURES: Therapeutic responses and adverse reactions. RESULTS: The clinical and laboratory data in both groups of patients on admission were comparable. The parasite clearance time (PCT), fever subsidence time (FST) and coma resolution time (CRT) were shorter in the artemisinin treated group. There was no significant different in the parasitological cure rates in both arms of treatment. No correlation was observed between the initial parasite density and PCT or FST in both groups of treatment. Mortality rates were similar both in the artemisinin and quinine groups. The common adverse effects observed in most patients receiving quinine, in an increasing order of occurrence were; vomiting, dizziness, hypoglycaemia and tinnitus, which were all relatively rare with artemisinin. Some patients treated with artemisinin showed tenesmus which was not observed in any patient treated with quinine. CONCLUSION: The rectal artemisinin is more efficacious and safer than the intravenous quinine. Thus, artemisinin may be considered a potential drug which can replace quinine in the treatment of severe malaria in Ethiopia provided it is made available at affordable prices.
RCT Entities:
OBJECTIVE: To compare the clinical efficacy and safety of artemisinin suppository with quinine injection. DESIGN: Comparative open randomised study. SETTING: A government regional referral hospital in Ethiopia. SUBJECTS: Sixty five adult patients of both sexes: 32 for artemisinin and 33 for quinine with complicated severe falciparum malaria. MAIN OUTCOME MEASURES: Therapeutic responses and adverse reactions. RESULTS: The clinical and laboratory data in both groups of patients on admission were comparable. The parasite clearance time (PCT), fever subsidence time (FST) and coma resolution time (CRT) were shorter in the artemisinin treated group. There was no significant different in the parasitological cure rates in both arms of treatment. No correlation was observed between the initial parasite density and PCT or FST in both groups of treatment. Mortality rates were similar both in the artemisinin and quinine groups. The common adverse effects observed in most patients receiving quinine, in an increasing order of occurrence were; vomiting, dizziness, hypoglycaemia and tinnitus, which were all relatively rare with artemisinin. Some patients treated with artemisinin showed tenesmus which was not observed in any patient treated with quinine. CONCLUSION: The rectal artemisinin is more efficacious and safer than the intravenous quinine. Thus, artemisinin may be considered a potential drug which can replace quinine in the treatment of severe malaria in Ethiopia provided it is made available at affordable prices.
Authors: Olakunle O Kassim; Mark Loyevsky; Biaffra Elliott; Andrew Geall; Henrietta Amonoo; Victor R Gordeuk Journal: Antimicrob Agents Chemother Date: 2005-01 Impact factor: 5.191