A Randomized Placebo-Controlled Trial of Acetaminophen for Prevention of Post-Vaccination Fever in Infants 英文参考文献.docVIP

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A Randomized Placebo-Controlled Trial of Acetaminophen for Prevention of Post-Vaccination Fever in Infants 英文参考文献.doc

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A Randomized Placebo-Controlled Trial of Acetaminophen for Prevention of Post-Vaccination Fever in Infants 英文参考文献

ARandomizedPlacebo-ControlledTrialof AcetaminophenforPreventionofPost-VaccinationFever inInfants LisaA.Jackson1*,DoPeterson1,JohnDunn1,SimonJ.Hambidge2,MayaDunstan1,PattyStarkovich1, OncheeYu1,JoyceBenoit1,ClaraP.Dominguez-Islas1,BarbaraCarste1,PattiBenson1,JenniferC. Nelson1,3 1Group Health Research Institute, Seattle, Washington, United States of America, 2Institute for Health Research, Kaiser Permanente Colorado and Denver Health CommunityHealthServices,Denver,Colorado,UnitedStatesofAmerica,3DepartmentofBiostatistics,UniversityofWashington,Seattle,Washington,UnitedStatesof America Abstract Background:Feveriscommonfollowinginfantvaccinations.Tworandomizedcontrolledtrialsdemonstratedtheefficacyof acetaminophenprophylaxisinpreventingfeverafterwholecellpertussisvaccination,butacetaminophenprophylaxishas notbeenevaluatedforpreventionoffeverfollowingcontemporaryvaccinesrecommendedforinfantsintheUnitedStates. Methods: Children six weeks through nine months of age were randomized 1:1 to receive up to five doses of acetaminophen (10–15mg per kg) or placebo following routine vaccinations. The primary outcome was a rectal temperature $38uC within 32hours following the vaccinations. Secondary outcomes included medical utilization, infant fussiness, and parents’ time lost from work. Parents could request unblinding of the treatment assignment if the child developed fever or symptoms that would warrant supplementary acetaminophen treatment for children who had been receivingplacebo. Results:Atemperature$38uCwasrecordedfor14%(25/176)ofchildrenrandomizedtoacetaminophencomparedwith 22%(37/176)ofthoserandomizedtoplacebobutthatdifferencewasnotstatisticallysignificant(relativerisk[RR],0.63;95% CI,0.40–1.01).Childrenrandomizedtoacetaminophenwerelesslikelytobereportedasbeingmuchmorefussythanusual (10%vs24%)(RR,0.42;95%CI,0.25–0.70)ortohavethetreatmentassignmentunblinded(3%vs9%)(RR,0.31;95%CI, 0.11–0.83)thanthoserandomized toplacebo. Inage-stratifiedanalyses,amongchildren $24weeks