Paromomycin for the Treatment of Visceral Leishmaniasis in Sudan A Randomized, Open-Label, Dose-Finding Study 英文参考文献.docVIP

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Paromomycin for the Treatment of Visceral Leishmaniasis in Sudan A Randomized, Open-Label, Dose-Finding Study 英文参考文献.doc

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Paromomycin for the Treatment of Visceral Leishmaniasis in Sudan A Randomized, Open-Label, Dose-Finding Study 英文参考文献

ParomomycinfortheTreatmentofVisceral LeishmaniasisinSudan:ARandomized,Open-Label, Dose-FindingStudy AhmedM.Musa1*,BrimaYounis1,AhmedFadlalla2,CatherineRoyce3,ManicaBalasegaram3 ,Monique Wasunna4,AsratHailu5,TansyEdwards6,RaymondOmollo4,MahmoudMudawi1,GilbertKokwaro7,8, AhmedEl-Hassan1,EltahirKhalil1 1Institute of Endemic Diseases, University of Khartoum, Khartoum, Sudan, 2Faculty of Medicine, Gedaref University, Gedaref, Sudan, 3Drugs for Neglected Diseases initiative(DNDi),Geneva,Switzerland,4CentreforClinicalResearch,KenyaMedicalResearchInstitute(KEMRI),Nairobi,Kenya,5AddisAbabaUniversity,AddisAbaba, Ethiopia,6LondonSchoolofHygieneandTropicalMedicine,London,UnitedKingdom, 7FacultyofPharmacy, UniversityofNairobi,Nairobi,Kenya, 8Consortiumfor NationalHealthResearch(CNHR),Nairobi,Kenya Abstract Background:Arecentstudyhasshownthattreatmentofvisceralleishmaniasis(VL)withthestandarddoseof15mg/kg/day ofparomomycinsulphate(PM)for21dayswasnotefficaciousinpatientsinSudan.Wethereforedecidedtotesttheefficacyof paramomycinforalongertreatmentduration(15mg/kg/dayfor28days)andatthehigherdoseof20mg/kg/dayfor21days. Methods: This randomized, open-label, dose-finding, phase II study assessed the two above high-dose PM treatment regimens.Patientswithclinicalfeaturesandpositivebone-marrowaspiratesforVLwereenrolled.Allpatientsreceivedtheir assignedcoursesofPMintramuscularlyandadverseeventsweremonitored.Parasiteclearanceinbone-marrowaspirates was tested by microscopy at end of treatment (EOT, primary efficacy endpoint), 3 months (in patients who were not clinicallywell)and6monthsafterEOT(secondaryefficacyendpoint).Pharmacokineticdatawereobtainedfromasubsetof patientsweighingover30kg. Findings:42patients(21pergroup)agedbetween4and60yearswereenrolled.AtEOT,85%ofpatients(95%confidence interval[CI]:63.7%to97.0%)inthe20mg/kg/daygroupand90%ofpatients(95%CI:69.6%to98.8%)inthe15mg/kg/day grouphadparasiteclearance.Sixmonthsaftertreatment,efficacywas80.0%(95%CI:56.3%to94.3%)and81.0%(95