Saturday 8 February
No 8789
1992
ORIGINAL ARTICLES
Comparison of artemether and chloroquine for severe
malaria in Gambian children
Artemether is an oil-soluble methyl ether of artemesinin (qinghaosu). It has been studied extensively in China, where it has been shown to be rapidly effective in severe falciparum malaria. Nearly all the patients studied previously were adults. We have investigated the efficacy of artemether in children with moderate or severe falciparum malaria. In the preliminary study of moderately severe malaria, 30 Gambian children were randomised in pairs to receive either intramuscular artemether (4 mg/kg loading dose followed by 2 mg/kg daily) or intramuscular chloroquine (’Nivaquine’) 3·5 mg base/kg every 6 h. Both drugs were well tolerated and rapidly effective. The times to parasite clearance were significantly shorter in the artemether recipients (mean 36·7 [SD 11·3] vs 48·4 [16·8] h, p; to fall by 90% of the admission value (PC90); and to fall below the level of microscopic detection
I
drugs within the previous 4 h were excluded. On admission, a full clinical examination was done, the child’s weight and body length were recorded, and, when indicated, a nasogastric tube and intravenous infusion cannula were inserted. Lumbar puncture was done on all unconscious children. Baseline blood samples were taken for the same tests as in part 1 as well as for blood culture and measurement of lactate, pyruvate, cytokines, and glucose. This part of the study was also an open, randomised trial; children were allocated treatment with either artemether or chloroquine sulphate exactly as in part 1. All drugs were drawn up by the study team and administered by intramuscular injection to the anterior thigh. Vital signs and neurological observations were recorded every 15 min for 1 h, then every 30 min to 2 h, every 2 h to 12 h, and every 6 h until parasite and fever clearance. The indices of the therapeutic response were analysed in the same way as in part 1. A small catheter (22 G or 24 G) was inserted and blood was sampled at 0, 2, 4, 8, and 12 h, then every 6 h for measurement of glucose, pyruvate, lactate, cytokines, parasite counts, and drug concentrations. Reticulocyte counts were
TABLE II-RESPONSE TO TREATMENT IN PARTI
Part 2.’ severe malaria Children were included in part 2 if they had severe malana" "’’ that treatment. Children who had received
I
antimalarial
(PCT)."
required parenteral
I
*Tanner-Whitehouse scale (%) tp
No 8789
1992
ORIGINAL ARTICLES
Comparison of artemether and chloroquine for severe
malaria in Gambian children
Artemether is an oil-soluble methyl ether of artemesinin (qinghaosu). It has been studied extensively in China, where it has been shown to be rapidly effective in severe falciparum malaria. Nearly all the patients studied previously were adults. We have investigated the efficacy of artemether in children with moderate or severe falciparum malaria. In the preliminary study of moderately severe malaria, 30 Gambian children were randomised in pairs to receive either intramuscular artemether (4 mg/kg loading dose followed by 2 mg/kg daily) or intramuscular chloroquine (’Nivaquine’) 3·5 mg base/kg every 6 h. Both drugs were well tolerated and rapidly effective. The times to parasite clearance were significantly shorter in the artemether recipients (mean 36·7 [SD 11·3] vs 48·4 [16·8] h, p; to fall by 90% of the admission value (PC90); and to fall below the level of microscopic detection
I
drugs within the previous 4 h were excluded. On admission, a full clinical examination was done, the child’s weight and body length were recorded, and, when indicated, a nasogastric tube and intravenous infusion cannula were inserted. Lumbar puncture was done on all unconscious children. Baseline blood samples were taken for the same tests as in part 1 as well as for blood culture and measurement of lactate, pyruvate, cytokines, and glucose. This part of the study was also an open, randomised trial; children were allocated treatment with either artemether or chloroquine sulphate exactly as in part 1. All drugs were drawn up by the study team and administered by intramuscular injection to the anterior thigh. Vital signs and neurological observations were recorded every 15 min for 1 h, then every 30 min to 2 h, every 2 h to 12 h, and every 6 h until parasite and fever clearance. The indices of the therapeutic response were analysed in the same way as in part 1. A small catheter (22 G or 24 G) was inserted and blood was sampled at 0, 2, 4, 8, and 12 h, then every 6 h for measurement of glucose, pyruvate, lactate, cytokines, parasite counts, and drug concentrations. Reticulocyte counts were
TABLE II-RESPONSE TO TREATMENT IN PARTI
Part 2.’ severe malaria Children were included in part 2 if they had severe malana" "’’ that treatment. Children who had received
I
antimalarial
(PCT)."
required parenteral
I
*Tanner-Whitehouse scale (%) tp
