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MessagePosté le: Mer 26 Oct - 08:51 (2016)    Sujet du message: Activated Protein C In Sepsis Pdf Download Répondre en citant




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Activated Protein C In Sepsis Pdf Download

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2010...Sep;...35(9):...504-508,...529....Accessed....June....7,....2010.5.....Lancet...Available...at:...www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/UCM164902.pdf....2005;33:24262428....Abraham....E,....Laterre....P-F,....Garg....R,....et....al.....Over....10....million....scientific....documents....at....your....fingertips....Home....Impressum....Legal....Information....Contact....Us........2016....Springer....International....Publishing....AG.....Crit....Care....Med.....Serious....bleeding....was....defined....as....any....one....of....the....following....events:....intracranial....hemorrhageany....life-threatening....bleeding....episodeany....bleeding....classified....as....serious....by....the....investigatorany....bleeding....that....causes....a....patient....to....require....3....units....of....packed....red....blood....cells....(RBCs)....on....two....consecutive....daysTable....2Bleeding....Risk....Criteria....in....the....PROWESS....Study....and....in....the....Product....Label....for....Activated....Protein....CThe....incidence....of....serious....bleeding....in....PROWESS....was....3.5%....in....the....APC....patients....and....2%....in....the....placebo....group.....(From....FDA....briefing....document,....BLA....#125029/0.29)Concerns....over....the....study’s....findings....resulted....in....a....vote....of....10....to....10....by....the....FDA’s....advisory....group....regarding....APC....approval.3....Statistical....evaluation....of....mortality....in....the....pre-amendment....and....post-amendment....groups....resulted....in....a....P....value....of....0.08.4....Although....the....FDA....acknowledged....a....potential....for....the....amendment’s....effect,....data....showing....that....patients....with....chronic....health....problems....derived....the....most....benefit....from....the....drug....(even....though....the....protocol....amendment....decreased....enrollment....of....these....patients)....led....the....FDA....to....conclude....that....the....differences....arose....by....chance.....

Crit....Care....Med.....Vincent...JL,...Bernard...GR,...Beale...R,...et...al....This....placebo-controlled....trial....is....evaluating....APC....with....and....without....low-dose....corticosteroids....for....the....management....of....septic....shock.16A....meta-analysis....on....the....use....of....APC....for....severe....sepsis,....from....2008,....concluded....that....there....was....no....evidence....to....support....the....use....of....APC....for....managing....severe....sepsis....or....septic....shock.17....The....meta-analysis....included....four....studies....involving....4,911....patients....(4,434....adults....and....477....children).2,5,12,18....The....investigators....recommended....a....moratorium....on....the....use....of....APC....until....additional....randomized....controlled....trials....showed....a....benefit....of....therapy.The....need....for....PROWESS–SHOCK....and....APROCCHS....is....a....strong....indicator....that....a....state....of....clinical....equipoise....has....been....reached....in....terms....of....using....APC....for....sepsis.....Finfer..S,..Ranieri..VM,..Thompson..BT,..et..al...What....Gets....Stored....in....a....Cookie?.....2009;37:1925.....[PubMed]19...

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