Abstract

To obtain an alternative drug regimen to reduce the complications and mortality of malaria, a comparative clinical trial of artemether and quinine in severe and complicated falciparum malaria patients was carried out at Balikpapan General Hospital, East Kalimantan, Indonesia, in 1993-1995. The objective of this study was to assess and compare the efficacy and safety of intramuscular artemether and intravenous quinine dihydrochloride in adult malaria patients. The sixty eligible severe and complicated falciparum malaria cases were randomized to receive either artemether intramusculary 1.6 mg/kg bw/dose bid on day ) and followed by a daily dose on day 104 or quinine dihydrochloride intravenously 20 mg salt/kg bw in 5 percent dextrose 10 ml/kg bw in 4 hours, followed by 10 mg/kg bw tid which was switched to oral quinine when the patient was able to swallow oral quinine, for a total of 21 doses. They were hospitalized for at least 14 days or longer. One, two, three and more than three complications were found in 47 percent, 28 percent, 17 percent and 8 percent of the 60 patients respectively. The most common complications were hyperbilirubinaemia (50 percent), hyperparasitaemia (28 percent) and cerebral malaria (25 percent). The highest fatality rates were associated with hypercreatininaemia, bleeding, pulmonary edema, acidosis and septic shock. The overall mortality rate was 18.3 percent (11/60). It was 13.3 percent (4/30) in the artemether group and 23.3 percent (7/30) in the quinine group, but this difference was not statistically significant. The case fatality rate of cerebral malaria cases was 53.3 percent (8/15). The risk of death increased with the number of complications. As assessed on day 14, there were no significant differences between the treatment groups in the survival rate (87 percent vs 77 percent), parasite clearance rate (100 percent vs 100 percent), mean fever clearance time (35.5 plus/minus 23.3 h vs 37.4 plus/minus 24.7 h), mean parasite clearance time (38.9 plus/minus 16.9 h vs 41.8 plus/minus 14.7 h and mean consciousness recovery time (32 plus/minus 14.1 h vs 62.8 plus/minus 19.2 h). Intramuscular artemether was well tolerated and as effective as intravenous quinine for the treatment of severe and complicated falciparum malaria. This drug is a good alternative to quinine, particularly in remote areas lacking hospitals and the capability for intravenous infusion.

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