Randomized Clinical Trial on Ivermectin versus Thiabendazole for the Treatment of Strongyloidiasis 英文参考文献.docVIP

Randomized Clinical Trial on Ivermectin versus Thiabendazole for the Treatment of Strongyloidiasis 英文参考文献.doc

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Randomized Clinical Trial on Ivermectin versus Thiabendazole for the Treatment of Strongyloidiasis 英文参考文献

RandomizedClinicalTrialonIvermectinversus ThiabendazolefortheTreatmentofStrongyloidiasis ZenoBisoffi1*,DoraBuonfrate1,AndreaAngheben1,MarinaBoscolo1,MariellaAnselmi1 ,Stefania Marocco1,GeraldoMonteiro1,MariaGobbo1,GiuliaBisoffi2,FedericoGobbi1 1CentreforTropicalDiseases,S.CuoreHospital,Negrar(Verona),Italy,2BiostatisticUnit,UniversityHospital,Verona,Italy Abstract Background: Strongyloidiasis may cause a life-threatening disease in immunosuppressed patients. This can only be prevented by effective cure of chronic infections. Direct parasitologic exams are not sensitive enough to prove cure if negative.Weusedanindirectimmunefluorescentantibodytest(IFAT)alongwithdirectmethodsforpatientinclusionand efficacyassessment. Methodology/PrincipalFindings:Prospective,randomized,openlabel,phaseIIItrialconductedattheCentreforTropical Diseases(Verona,Italy)tocompareefficacyandsafetyofivermectin(singledose,200mg/kg)andthiabendazole(twodaily th dosesof25mg/Kgfortwodays)tocurestrongyloidiasis.Thefirstpatientwasrecruitedon6 December,2004.Follow-up visit of the last patient was on 11th January, 2007. Consenting patients responding to inclusion criteria were randomly assignedtooneofthetreatmentarms.Primaryoutcomewas:negativedirectandindirect(IFAT)testsatfollow-up(4to6 monthsaftertreatment)orsubjectswithnegativedirecttestanddropoftwoormoreIFATtiters.Considering198patients who concluded follow-up, efficacy was 56.6% for ivermectin and 52.2% for thiabendazole (p=0.53). If the analysis is restrictedto92patientswithIFATtiter80ormorebeforetreatment(virtually100%specific),efficacywouldbe68.1%for ivermectin and 68.9% for thiabendazole (p=0.93). Considering direct parasitological diagnosis only, efficacy would be 85.7%forivermectinand94.6%forthiabendazole(p=0.21).Inivermectinarm,mildtomoderatesideeffectswereobserved in24/115patients(20.9%),versus79/108(73.1%)inthiabendazolearm(p=0.00). Conclusion:Nosignificantdifferenceinefficacywasobserved,whilesideeffectswerefarmorefrequentinthiaben

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