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2010 2011 2012 2013 2014 2015. Year[r]

(1)

KhacDungpNguyena3b3pLeilapChebanea3pHoangAnhpNguyenb3pJeanLouispMontastruca3pHalehpBagheria apLaboratoire1de1Pharmacologie1Médicale1et1/linique(1–quipe1de1Pharmacoépidémiologie1de1lHUMR1INS–RM1wk.W(1Xaculté1de1Médecine1

de1lHUniversité1Paul‐Sabatier(1/entre1Hospitalier1Universitaire(1/entre1Midi‐Pyrénées1de1PharmacoVigilance(1de1Pharmacoépidémiologie1 et1dHInformation1sur1le1Médicament1de1lHUMR1INS–RM1wk.WToulouse(1yXranceV1bpThe1National1/entre1of16rug1Information1and1]dverse1 6rug1Reaction1Monitoring(1Hanoi1University1of1Pharmacy(1Hanoi1yVietnamV

Method

Introduction

Socialpharmacology

Results

6rug‐induced1anaphylactic1

reactions1is1an1acute1severe1and1

life‐threatening1]dverse16rug1

Reaction1y]6RV1and1the1risk1 differs1between1populationsD1

The1understanding1in1the1

developing1countries1and1the1

influences1of1resource‐limited1

seting1on1the1incidence1of1drug‐1

induced1anaphylaxis1still1remains1 limitedD

cefoperazon

rif

ampicinOisoniazidOp

yr

azinamid

dihydroartemisininOpiperaquin gentamicin

metronidazol

paracetamol

ethambutol

diclof

enac rifampicinclindamycin

rif

ampicinOisoniazidOp

yr

azinamidOethamb

utol

vancomycin

streptomycin

primaquin

iobitridol

isoniazid

pyr

azinamid

haloper

idol

levofloxacinampicillin

ampicilinOsulbactam

amoxicilinOacid3clavulanic

cefotaxim

amoxicillin

cefalexin

ceftriaxon

sulfamethoxazolOtrimethoprim

cefuro

xim

ciproflo

xacin

ceftazidim

The1National1Pharmacovigilance1/enter1created1in1.kkJ1and1 w1Regional1Pharmacovigilance1/enter1created1in1.kww1

manage1the1Pharmacovigilance1activities1in1Vietnam

In1Xrance(1Xrench1Pharmacovigilance1system1contains1xw1 Regional1Pharmacovigilance1/enters1which1collect1and1 mange1the1]6R1reporting1with1the11first1establishment1in1 wJWxD11

Demographicpcharacteristics

0 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 95

150 100 50 50 100 150 200

Age

sex

Female Male

France Vietnam

SuspectedpdrugspinpFrenchpdata

Seting

Main1features1of1the1cases1of1drug‐induced1anaphylaxis1in1

Vietnam1and1Xrench1database1were1separately1described1 and1the1comparisons1of1gender(1age1between1.1groups1

were1analyzed1by1the1Mann‐Whitney1U1nonparametric1

test1for1ordinal1variables1and1the1Xisher’s1exact1test1or1the1

chi‐squared1test1for1categorical1variablesD1

Statisticalpanalysisp

b8v8oh56d8kmn JvbD Mv3A b583ohk9d89mn

34bohbvd7kmn JvbC NvbA b549ohk9dk5mn

b74oh5d47mn JvbM JvbC 995ohb8d79mn

b5boh4d75mn Vv8A LvbX 583ohbbdvbmn

bk4oh3d9mn MvbA JvbD 476oh8d99mn

bb5oh3d6bmn NvkB Vv8A 4v9oh7d7kmn

76ohkd39mn JvbG NvkB b7koh3dk5mn

7bohkdk3mn AvkB MvbA b53ohkd89mn

7vohkdkmn Jv4A HvkA b36ohkd57mn

66ohkdv7mn NvbB Nv5C b33ohkd5bmn

63ohbd98mn JvbX NvbB bk5ohkd36mn

58ohbd8kmn Bv5C LvbC bkkohkd3mn

57ohbd79mn NvbA Vv8C bv9ohkdv6mn

53ohbd67mn Bv5X Lv4A 97ohbd83mn

46ohbd45mn JvbE AvkB 95ohbd79mn

France Vietnam

cefotaxime 6k7ohb9d7mn suxamethonium bvvkohb8d9kmn

ceftriaxone 33kohbvd43mn propofol 67kohbkd69mn

ceftazidime k94oh9dk4mn sufentanil 497oh9d38mn

ciprofloxacine bv4oh3dk7mn amoxicilline 483oh9dbkmn

cefoperazone 98oh3dv8mn amoxiciline/

acidoclavulanic 453oh8d55mn

cefuroxime 87ohkd73mn atracurium k4boh4d55mn

cefalexine 83ohkd6bmn cefazoline kb4oh4dv4mn

paracetamol 8kohkd58mn cetuximab b89oh3d57mn

diclofenac 7kohkdk6mn cisatracurium b54ohkd9bmn

amoxiciline/

acidoclavulanic 63ohbd98mn iomeprol b5bohkd85mn

iobitridol 54ohbd7mn rocuronium b49ohkd8bmn

amoxicilline 48ohbd5bmn oxaliplatine b39ohkd6kmn

levofloxacine 48ohbd5bmn midazolam bk9ohkd44mn

iopromid 43ohbd35mn ketamine bb4ohkdb5mn

amoxicilin 4kohbd3kmn ceftriaxone bbkohkdbbmn

cefoperazon/

sulbactam 4bohbdk9mn carboplatine bv7ohkdvkmn

diclofenac 4bohbdk9mn paracetamol bv7ohkdvkmn

ampicilline 39ohbdk3mn remifentanil bv4ohbd96mn

bupivacain 39ohbdk3mn paclitaxel 89ohbd68mn

cefepime 39ohbdk3mn cefuroxime 68ohbdk8mn

Vietnam France

Spontaneous1]6R1reports1from1January1.kwk1to1

6ecember1.kw31were1collected1for1retrospective1analysis51 in1XPV6(1all1]6Rs1containing1High1Level1Term1

“Anaphylactic and anaphylactoid reactions”1were1 selected:1in1VPV6(1all1]6Rs1meeting1the1anaphylaxis1

definition1by1the1Second1Symposiumw1on1the16efinition1

and1Management1of1]naphylaxis1were1selectedD1

6emographic1data(1suspected1drugs1according1to1 ]natomical1Therapeutic1/hemical1classification1were1 comparedD

Selectionpcriteria

739 769 1027 958 859 935

0 10000 20000 30000 40000

03ppm 253ppm 503ppm 753ppm

2010 2012 2014

Year

Numbe

r3of3anaphyl

axis3repo

rtOyear

Mortal

ity3rate3in3Fra

nce3popul

ation

Statistics1calculation1was1done1by1Software1R

1yversion1xD9Dk(1issued1.w1]pril1.kwWV

AgepandpSexpdistributionpofpdrug

inducedpanaphylaxis

SuspectedpdrugspinpVietnamesepdata

ComparisionpofpPharmacologicalpgroups

References

[w]1Sampson1H]1et1alD1Second1symposium1on1the1definition1and1management1of1 anaphylaxis51Summary1report—Second1National1Institute1of1]llergy1and1Infectious1 6iseaseAXood1]llergy1and1]naphylaxis1Network1symposiumD1JD1]llergy1/linD1ImmunolD1 y.kkzV1wwWy.V1xJw–xJWD

Conlusion

‐1These1data1show1some1differences1for1the1characteristics1of1drug‐induced1anaphylaxis1

cases1between1Xrance1and1VietnamD

‐1The1discrepancy1of1drug‐induced1anaphylaxis1between1.1countries1could1be1explained1by1

the1antibiotic1overuse1in1VietnamD

‐1The1further1analysis1is1required1to1fully1discuss1on1social1pharmacology1aspectsD

iobitr

idol

remif

entanil

paclitaxel

oxaliplatine

atracurium

association

suf

entanil

cefuroxime

amoxicilline

infliximab

ketamine

ceftr

iaxone

amoxicillineclavulanic

lidocaine

methylprednisolone

vancomycine

cefazoline

suxamethonium

ketoprofene

cetuximab

carboplatine

rocuronium

acide

par

acetamol

iomeprol

etomidate

propof

ol

cisatr

acur

ium

brom

ure

midazolam

250 500 750 1000

2010 2011 2012 2013 2014 2015

Year

Number3of3ADR3repor

ts AntibioticsMinduced3anaphylaxis

Total3drugsMinduced3anaphylaxis

Topp2:ppofpdrugsinducedpanaphylaxispinp2pcountries

J:1D1/ephalosporins1and1carbapenems:1J:1C1Penicillins:1J:1M1quinolones:1V:8Ap

iodinated1X‐ray1contrast1media

M:3A1Muscle1relaxants:1N:1A1general1anesthetics1LkwX1other1antineoplastic1 agents

Numberpofpdruginducedpanaphylaxispinvolvingp antibioticspcomparedptoptotalpdrugspinpVietnampp Objectivep:p/ompare1the1characteristics1of1the1

drug‐induced1anaphylaxis1between1Xrench1

pharmacovigilance1database1yXPV6V1and1 Vietnamese1pharmacovigilance1database1 yVPV6VD

FRANCE

161 231 330 580

856 1024

0 2000 4000 6000 8000

03ppm 53ppm 103ppm 153ppm

2010 2012 2014

Year

Numbe

r3of3anaphyl

axis3repo

rtOyear

Mortal

ity3rate3in3Vie

tnamese3po

pulation

Other3ADR Anaphylaxis

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