OBJECTIVE: To assess the therapeutic efficacy of the combinations dihydroartemisinin-piperaquine and artemether-lumefantrine in treating uncomplicated falciparum malaria cases in an area with high level resistance of Plasmodium falciparum to chloroquine in Hainan Province. METHODS:Patients aged 1 to 60 with uncomplicated P. falciparum infection and parasite density 1,000 to 200,000 parasites/microl were enrolled following an informed consent. Eligible patients were randomly assigned to 2 groups for receiving either a 3-day course of dihydroartemisinin-piperaquine (40/320 mg, DP, group A) or 6-dose course of artemether/lumefantrine (20/120 mg tablets, AL, group B) over three days. They were followed up with clinical and laboratory examinations until day 28 using standard WHO in vivo antimalarial drug test protocol. RESULTS:Altogether 107 eligible patients were enrolled but 106 completed the study. Adequate clinical and parasitological response (ACPR) was observed in 51 (100%) and 55 (100%) cases in groups A and B respectively. The mean time of fever clearance and mean time of asexual parasite clearance were (20.99 +/- 11.38) h and (36.45 +/- 12.60) h in AL and (22.35 +/- 13.26)h and (34.99 +/- 12.28) h in DP, respectively. There was no statistical difference on the mean time of fever clearance and asexual parasite clearance between AL and DP (P > 0.05). None of the participants showed recrudescence and serious adverse effect. CONCLUSION: Both combinations artemether-lumefantrine and dihydroartemisinin-piperaquine show a high cure rate and proper tolerability among the patients with uncomplicated falciparum malaria in Hainan.
RCT Entities:
OBJECTIVE: To assess the therapeutic efficacy of the combinations dihydroartemisinin-piperaquine and artemether-lumefantrine in treating uncomplicated falciparum malaria cases in an area with high level resistance of Plasmodium falciparum to chloroquine in Hainan Province. METHODS:Patients aged 1 to 60 with uncomplicated P. falciparum infection and parasite density 1,000 to 200,000 parasites/microl were enrolled following an informed consent. Eligible patients were randomly assigned to 2 groups for receiving either a 3-day course of dihydroartemisinin-piperaquine (40/320 mg, DP, group A) or 6-dose course of artemether/lumefantrine (20/120 mg tablets, AL, group B) over three days. They were followed up with clinical and laboratory examinations until day 28 using standard WHO in vivo antimalarial drug test protocol. RESULTS: Altogether 107 eligible patients were enrolled but 106 completed the study. Adequate clinical and parasitological response (ACPR) was observed in 51 (100%) and 55 (100%) cases in groups A and B respectively. The mean time of fever clearance and mean time of asexual parasite clearance were (20.99 +/- 11.38) h and (36.45 +/- 12.60) h in AL and (22.35 +/- 13.26)h and (34.99 +/- 12.28) h in DP, respectively. There was no statistical difference on the mean time of fever clearance and asexual parasite clearance between AL and DP (P > 0.05). None of the participants showed recrudescence and serious adverse effect. CONCLUSION: Both combinations artemether-lumefantrine and dihydroartemisinin-piperaquine show a high cure rate and proper tolerability among the patients with uncomplicated falciparum malaria in Hainan.
Authors: William Yavo; Babacar Faye; Thomas Kuete; Vincent Djohan; Serge A Oga; Richard R Kassi; Mariama Diatta; Moor V Ama; Roger Tine; Jean-Louis Ndiaye; Jean-Bedel Evi; Albert Same-Ekobo; Oumar Faye; Moussa Koné Journal: Malar J Date: 2011-07-20 Impact factor: 2.979