Randomised Controlled Double-Blind Non-Inferiority Trial of Two Antivenoms for Saw-Scaled or Carpet Viper (Echis ocellatus) Envenoming in Nigeria 英文参考文献.docVIP
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Randomised Controlled Double-Blind Non-Inferiority Trial of Two Antivenoms for Saw-Scaled or Carpet Viper (Echis ocellatus) Envenoming in Nigeria 英文参考文献
RandomisedControlledDouble-BlindNon-Inferiority
TrialofTwoAntivenomsforSaw-ScaledorCarpetViper
(Echisocellatus)EnvenominginNigeria
IsaS.Abubakar1,SaiduB.Abubakar2,AbdulrazaqG.Habib3*,AbdulsalamNasidi4,NandulDurfa4,
PeterO.Yusuf5,SolomonLarnyang{,JohnGarnvwa6,ElijahSokomba7,LateefSalako8,R.DavidG.
Theakston6,EdJuszczak9,NicolaAlder9,DavidA.Warrell10,fortheNigeria-UKEchiTabStudyGroup
1DepartmentofCommunityMedicine,BayeroUniversityofKano,Kano,Nigeria,2GeneralHospitalKaltungo,Kaltungo,GombeState,Nigeria,3DepartmentofMedicine,
BayeroUniversityKano,Kano,Nigeria,4SpecialProjectsUnit,FederalMinistryofHealth,Abuja,Nigeria,5FacultyofVeterinaryMedicine,AhmaduBelloUniversity,Zaria,
Nigeria,6AlistairReidVenomResearchUnit,LiverpoolSchoolofTropicalMedicine,Liverpool,UnitedKingdom,7DepartmentofPharmacology,UniversityofJos,Jos,
Nigeria,8DepartmentofPharmacologyandTherapeutics,UniversityofIbadan,Ibadan,Nigeria,9CentreforStatisticsinMedicine,UniversityofOxford,Oxford,United
Kingdom,10NuffieldDepartmentofClinicalMedicine,JohnRadcliffeHospital,UniversityofOxford,Oxford,UnitedKingdom
Abstract
Background: In West Africa, envenoming by saw-scaled or carpet vipers (Echis ocellatus) causes great morbidity and
mortality,butthereisacrisisinsupplyofeffectiveandaffordableantivenom(ISRCT.
Methods: In a randomised, double-blind, controlled, non-inferiority trial, ‘‘EchiTAb Plus-ICP’’ (ET-Plus) equine antivenom
madebyInstitutoClodomiroPicadowascomparedto‘‘EchiTAbG’’(ET-G)ovineantivenommadebyMicroPharm,whichis
thestandardofcareinNigeriaandwasdevelopedfromtheoriginalEchiTAb-Fabintroducedin1998.Botharecaprylicacid
purified whole IgG antivenoms. ET-G is monospecific for Echis ocellatus antivenom (initial dose 1 vial) and ET-Plus is
polyspecificforE.ocellatus,NajanigricollisandBitisarietans(initialdose3vials).Bothhadbeenscreenedbypre-clinicaland
preliminaryclinicaldose-findingandsafetystudies.Patientswhopresentedwithincoagulableblood,indicativeofsystemic
envenomingbyE.ocellatus,wererecruited
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