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