Pyronaridine-Artesunate versus Chloroquine in Patients with Acute Plasmodium vivax Malaria A Randomized, Double-Blind, Non-Inferiority Trial 英文参考文献.docVIP

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Pyronaridine-Artesunate versus Chloroquine in Patients with Acute Plasmodium vivax Malaria A Randomized, Double-Blind, Non-Inferiority Trial 英文参考文献.doc

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Pyronaridine-Artesunate versus Chloroquine in Patients with Acute Plasmodium vivax Malaria A Randomized, Double-Blind, Non-Inferiority Trial 英文参考文献

Pyronaridine-ArtesunateversusChloroquineinPatients withAcutePlasmodiumvivaxMalaria:ARandomized, Double-Blind,Non-InferiorityTrial YiPoravuth1,DuongSocheat1,RonnatraiRueangweerayut2,ChirapongUthaisin3,AungPyaePhyo4, NeenaValecha5,B.H.KrishnamoorthyRao6,EmilianaTjitra7,AsepPurnama8,IsabelleBorghini- Fuhrer9*,StephanDuparc9,Chang-SikShin10,LawrenceFleckenstein11 1NationalMalariaCenter,PhnomPenh,Cambodia,2DepartmentofInternalMedicine,MaeSotGeneralHospital,MaeSot,Thailand,3DepartmentofInternalMedicine, Mae RamatHospital,Mae Ramat, Thailand, 4ShokloMalariaResearchUnit,Mae Sot,Thailand,5NationalInstitute ofMalariaResearch,Delhi,India, 6WenlockDistrict Hospital,KasturbaMedicalCollege,Mangalore,India,7NationalInstituteofHealthResearchandDevelopment,MinistryofHealth,Jakarta,Indonesia,8InternalMedicine Department, TC Hillers General Hospital, Maumere, Indonesia, 9Medicines for Malaria Venture, Geneva, Switzerland, 10Shin Poong Pharmaceutical Company, Seoul, RepublicofKorea,11CollegeofPharmacy,UniversityofIowa,IowaCity,Iowa,UnitedStatesofAmerica Abstract Background: New antimalarials are needed for P. vivax and P. falciparum malaria. This study compared the efficacy and safetyofpyronaridine-artesunatewiththatofchloroquineforthetreatmentofuncomplicatedP.vivaxmalaria. MethodsandFindings:ThisphaseIIIrandomized,double-blind,non-inferioritytrialincludedfivecentersacrossCambodia, Thailand,India,andIndonesia.Inadouble-dummydesign,patients(aged.3–#60years)withmicroscopicallyconfirmedP. vivaxmono-infectionwererandomized(1:1)toreceivepyronaridine-artesunate(targetdose7.2:2.4mg/kgto13.8:4.6mg/ kg) or chloroquine (standard dose) once daily for three days. Each treatment group included 228 randomized patients. Outcomesfortheprimary endpoint,Day-14curerate intheper-protocol population,were99.5%,(217/218;95%CI 97.5, 100)withpyronaridine-artesunateand100%(209/209;95%CI98.3,100)withchloroquine.Pyronaridinewasnon-inferiorto chloroquine: treatment difference 20.5% (95%CI 22.6, 1.4), i