Safety and Efficacy of the 10-Day Melarsoprol Schedule for the Treatment of Second Stage Rhodesiense Sleeping Sickness 英文参考文献.docVIP

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Safety and Efficacy of the 10-Day Melarsoprol Schedule for the Treatment of Second Stage Rhodesiense Sleeping Sickness 英文参考文献.doc

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Safety and Efficacy of the 10-Day Melarsoprol Schedule for the Treatment of Second Stage Rhodesiense Sleeping Sickness 英文参考文献

SafetyandEfficacyofthe10-DayMelarsoprolSchedule fortheTreatmentofSecondStageRhodesienseSleeping Sickness IreneKuepfer1,2*,CaeciliaSchmid1,2,MpairweAllan3,AndrewEdielu3,EmmaP.Haary4, AbbasKakembo5,StaffordKibona6,JohannesBlum1,2,ChristianBurri1,2 1SwissTropicalandPublicHeathInstitute,Basel,Switzerland,2UniversityofBasel,Basel,Switzerland,3LwalaHospital,Lwala,Uganda,4KaliuaHealthCentre,Kaliua, Tanzaina,5MinistryofHealth,VectorControlDivision,Kampala,Uganda,6NationalInstituteforMedicalResearch,TaboraResearchCentre,Tabora,Tanzania Abstract Objective:Assessmentofthesafetyandefficacyofa10-daymelarsoprolscheduleinsecondstageT.b.rhodesiensepatients andtheeffectofsuramin-pretreatmentontheincidenceofencephalopathicsyndrome(ES)duringmelarsoproltherapy. Design: Sequential conduct of a proof-of-concept trial (n=60) and a utilization study (n=78) using historic controls as comparator. Setting:TwotrialcentresintheT.b.rhodesienseendemicregionsofTanzaniaandUganda.Participants:Consentingpatients with confirmed second stage disease and a minimum age of 6 years were eligible for participation. Unconscious and pregnantpatientswereexcluded. Main Outcome Measures: The primary outcome measures were safety and efficacy at end of treatment. The secondary outcomemeasurewasefficacyduringfollow-upafter3,6and12months. Results: The incidence of ES in the trial population was 11.2% (CI 5–17%) and 13% (CI 9–17%) in the historic data. The respective case fatality rates were 8.4% (CI 3–13.8%) and 9.3% (CI 6–12.6%). All patients discharged alive were free of parasites at end of treatment. Twelve months after discharge, 96% of patients were clinically cured. The mean hospitalizationtimewasreducedfrom29to13days(p,0.0001)perpatient. Conclusions:The10-daymelarsoprolscheduledoesnotexposepatientstoahigherriskofESordeaththandoestreatment accordingtonationalschedulesincurrentuse.Theefficacyofthe10-daymelarsoprolschedulewashighlysatisfactory.No benefitcouldbeattributedtothesuraminpre-treatment. TrialRegistra