Greater Response to Placebo in Children Than in Adults A Systematic Review and Meta-Analysis in Drug-Resistant Partial Epilepsy 英文参考文献.docVIP
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Greater Response to Placebo in Children Than in Adults A Systematic Review and Meta-Analysis in Drug-Resistant Partial Epilepsy 英文参考文献
o
PL SMEDICINE
GreaterResponsetoPlaceboinChildrenThanin
Adults:ASystematicReviewandMeta-Analysis
inDrug-ResistantPartialEpilepsy
Sylvain Rheims1,2,Michel Cucherat3,Alexis Arzimanoglou2,4,Philippe Ryvlin1,2,5*
1DepartmentofFunctionalNeurologyandEpileptology,HospicesCivilsdeLyon,Lyon,France,2CTRSINSERM-IDEE,InstituteforChildrenandAdolescentswithEpilepsy,
Hospices Civils de Lyon, Lyon, France, 3 Department of Clinical Pharmacology, EA 643, Lyon-1 University, Laennec Faculty of Medicine, Lyon, France, 4 Department of
Epileptology,SleepandPediatricNeurophysiology,HospicesCivilsdeLyon,Lyon,France5INSERMU821,Lyon,France
Funding:Theauthorsreceivedno
specificfundingforthisstudy.
ABSTRACT
CompetingInterests:SRhas
Background
receivedspeakerfeesfromPfizer.
MChasnoconflictofinterest.AA
hasreceivedspeakerorconsultant
feesfromPfizer,Sanofi-Aventis,
GlaxoSmithKline(GSK),Jansen-Cilag,
UCBPharma,EISAI,andValeant.PR
hasreceivedspeakerfeesfrom
Cyberonics,Eisai,GSK,Janssen-Cilag,
Novartis,Pfizer,Sanofi-Synthelabo,
andUCB;andconsultantfeesfrom
Cyberonics,GSK,Janssen-Cilag,
Novartis,Pfizer,UCB,andValeant.
Despite guidelines establishing the need to perform comprehensive paediatric drug
development programs, pivotal trials in children with epilepsy have been completed mostly
inPhaseIVasapostapprovalreplicationofadultdata.However,ithasbeenshownthatthe
treatment response in children can differ from that in adults. It has not been investigated
whetherdifferencesindrugeffectbetweenadultsandchildrenmightoccurinthetreatmentof
drug-resistantpartialepilepsy,althoughsuchdifferencesmayhaveasubstantialimpactonthe
designandresultsofpaediatricrandomisedcontrolledtrials(RCTs).
AcademicEditor:TerryKlassen,
UniversityofAlberta,Canada
MethodsandFindings
ThreeelectronicdatabasesweresearchedforRCTsinvestigatinganyantiepilepticdrug(AED)
in the add-on treatment of drug-resistant partial epilepsy in both children and adults. The
treatmenteffectwascomparedbetweenthetwoagegroupsusingtheratiooftherelativerisk
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