Efficacy and Safety of Nitazoxanide, Albendazole, and Nitazoxanide-Albendazole against Trichuris trichiura Infection A Randomized Controlled Trial 英文参考文献.docVIP

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Efficacy and Safety of Nitazoxanide, Albendazole, and Nitazoxanide-Albendazole against Trichuris trichiura Infection A Randomized Controlled Trial 英文参考文献.doc

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Efficacy and Safety of Nitazoxanide, Albendazole, and Nitazoxanide-Albendazole against Trichuris trichiura Infection A Randomized Controlled Trial 英文参考文献

EfficacyandSafetyofNitazoxanide,Albendazole,and Nitazoxanide-AlbendazoleagainstTrichuristrichiura Infection:ARandomizedControlledTrial BenjaminSpeich1,2,ShaaliM.Ame3,SaidM.Ali3,RainerAlles4,JanHattendorf2,5,Ju¨rgUtzinger2,5 , MarcoAlbonico6,JenniferKeiser1,2* 1DepartmentofMedicalParasitologyandInfectionBiology,SwissTropicalandPublicHealthInstitute,Basel,Switzerland,2UniversityofBasel,Basel,Switzerland,3Public HealthLaboratory(Pemba)-IvodeCarneri,ChakeChake,Tanzania,4DivisionofPharmaceuticalTechnology,DepartmentofPharmaceuticalSciences,UniversityofBasel, Basel,Switzerland,5DepartmentofEpidemiologyandPublicHealth,SwissTropicalandPublicHealthInstitute,Basel,Switzerland,6IvodeCarneriFoundation,Milano,Italy Abstract Background:Thecurrentlyusedanthelminticdrugs,insingleoralapplication,havelowefficacyagainstTrichuristrichiura infection,andhencenovelanthelminticdrugsareneeded.Nitazoxanidehasbeensuggestedaspotentialdrugcandidate. Methodology: The efficacy and safety of a single oral dose of nitazoxanide (1,000mg), or albendazole (400mg), and a nitazoxanide-albendazole combination (1,000mg–400mg), with each drug administered separately on two consecutive days,wereassessedinadouble-blind,randomized,placebo-controlledtrialintwoschoolsonPemba,Tanzania.Cureand eggreductionrateswerecalculatedbyper-protocolanalysisandbyavailablecaseanalysis.Adverseeventswereassessed andgradedbeforetreatmentandfourtimesaftertreatment. PrincipalFindings:Completedatafortheper-protocolanalysiswereavailablefrom533T.trichiura-positivechildren.Cure ratesagainstT.trichiurawerelowregardlessofthetreatment(nitazoxanide-albendazole,16.0%;albendazole,14.5%;and nitazoxanide, 6.6%). Egg reduction rates were 54.9% for the nitazoxanide-albendazole combination, 45.6% for single albendazole,and13.4%forsinglenitazoxanide.Similarcureandeggreductionrateswerecalculatedusingtheavailable caseanalysis.Childrenreceivingnitazoxanidehadsignificantlymoreadverseeventscomparedtoplaceborecipients.Most oftheadverseeventsweremilda