Open-Label Comparative Clinical Study of Chlorproguanil？Dapsone Fixed Dose Combination (Lapdap？) Alone or with Three Different Doses of Artesunate for Uncomplicated Plasmodium falciparum Malaria 英文参考文献.docVIP

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Open-Label Comparative Clinical Study of Chlorproguanil？Dapsone Fixed Dose Combination (Lapdap？) Alone or with Three Different Doses of Artesunate for Uncomplicated Plasmodium falciparum Malaria 英文参考文献.doc

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Open-Label Comparative Clinical Study of Chlorproguanil？Dapsone Fixed Dose Combination (Lapdap？) Alone or with Three Different Doses of Artesunate for Uncomplicated Plasmodium falciparum Malaria 英文参考文献

Open-LabelComparativeClinicalStudyof Chlorproguanil2DapsoneFixedDoseCombination (LapdapTM)AloneorwithThreeDifferentDosesof ArtesunateforUncomplicatedPlasmodiumfalciparum Malaria DanielG.Wootton1,2,HyginusOpara3,GiancarloA.Biagini4,MaxwellK.Kanjala2,StephanDuparc5, PaulaL.Kirby5,MaryWoessner5,ColinNeate5,MaggieNyirenda6,HannahBlencowe6,QueenDube- Mbeye6,ThomasKanyok7,StephenWard4,MalcolmMolyneux2,4,SamDunyo3,PeterA.Winstanley1* 1Department of Pharmacology Therapeutics, University of Liverpool, Liverpool, United Kingdom, 2Malawi-Liverpool-Wellcome Trust Major Overseas Programme, College of Medicine, Blantyre, Malawi, 3MRC Laboratories, Banjul, Fajara, The Gambia, 4Liverpool School of Tropical Medicine, Liverpool, United Kingdom, 5GlaxoSmithKline,Greenford,Middlesex,UnitedKingdom,6DepartmentofPaediatrics,CollegeofMedicine,Blantyre,Malawi,7GlobalHealth-InfectiousDiseases,Billand Melinda Gates Foundation, Seattle, Washington, United States of America (formerly at the WHO-UNDP-World Bank Special Programme for Research and Training in TropicalMedicine(WHO-TDR),Geneva,Switzerland) Abstract Theobjectiveofthisstudywastodeterminetheappropriatedoseofartesunateforuseinafixeddosecombinationtherapy with chlorproguanil2dapsone (CPG2DDS) for the treatment of uncomplicated falciparum malaria.Methods: Open-label clinical trial comparing CPG2DDS alone or with artesunate 4, 2, or 1mg/kg at medical centers in Blantyre, Malawi and Farafenni,TheGambia.ThetrialwasconductedbetweenJune2002andFebruary2005,including116adults(medianage 27years) and 107 children (median age 38months) with acute uncomplicated Plasmodium falciparum malaria. Subjects were randomized into 4 groups to receive CPG–DDS alone or plus 4, 2 or 1mg/kg of artesunate once daily for 3days. AssessmentstookplaceonDays023inhospitalandfollow-uponDays7and14asout-patients.Efficacywasevaluatedin the Day 3 per-protocol (PP) population using mean time to reduce baseline parasitemia by 90% (PC90). A number of secondaryoutcomeswerea