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1. $GHSUHVV]Ly ....................................................................................................................................... 5

1.1. %HYH]HWpV........................................................................................................................................ 5

1.2. $GHSUHVV]LyWtSXVDL ....................................................................................................................... 5

1.3. $GHSUHVV]LySDWRJHQH]LVH ............................................................................................................. 5

1.4. $GHSUHVV]LyHWLROyJLiMD ................................................................................................................. 6

1.5. $GHSUHVV]LypVD]|QJ\LONRVViJ .................................................................................................... 6

1.6. gVV]HJ]pV ....................................................................................................................................... 6

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2.2. $QWLGHSUHVV]iQVWHUiSLDIHMOĘGpVH .................................................................................................. 9

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2.2.3. SzelekttYV]HURWRQLQYLVV]DYpWHOJiWOyN 665,-k) ............................................................ 10

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2.3. gVV]HIRJODOiV................................................................................................................................ 12

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3.1.3. 1HPNtYiQWJ\yJ\V]HUKDWiV ............................................................................................. 15

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3.1.7. gVV]HJ]pV ......................................................................................................................... 18

 
 

3.2. A farmakovigilancia rendszer ...................................................................................................... 19

3.2.1. A farmakovigilancia fogalma ........................................................................................... 19

3.2.2. A farmakovigilancia rendszer tagjai................................................................................. 20

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3.3. $QWLGHSUHVV]iQVRNPHOOpNKDWiVDL ................................................................................................. 22

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4.5.2. Szignifikancia szint .......................................................................................................... 37

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6.3. gVV]HJ]pV ..................................................................................................................................... 48

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1.3. $GHSUHVV]LySDWRJHQH]LVH

$GHSUHVV]LySDWRJHQH]LVHPpJQHPWHOMHVHQWLV]Wi]RWWPDOHJLQNiEED6FKLOGNUDXW-IpOH
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PRQRDPLQRNDEV]RO~W vagy relDWtYKLiQ\iYDOMiUHJ\WW6FKLOGNUDXWD]HOPpOHWHWDUUDD

5  
 
 

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D UHV]HUSLQ PHO\ PHOOpNKDWiVNpQW GHSUHVV]LyW RNR]RWW FV|NNHQWHWWH D NDWHNRODPLQRN
V]LQWMpW [4.]

1.4. $GHSUHVV]LyHWLROyJLiMD

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LViOO(QQHNPHJpUWpVHD]pUWIRQWRVDV]DNGROJR]DWRPV]HPSRQWMiEyOKRJ\PHJOiVVXN,
PLpUWQHPHJ\V]HUĦDGHSUHVV]LyVEHWHJHNYL]VJiODWD

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KLSSRFDPSXVEDQ DP\JGDOiEDQ>@ $ FV|NNHQW V]HURWRQLQ V]LQW pU]pNHWOHQVpJHW
LQJHUOpNHQ\VpJHW |QJ\LONRVViJL NpS]HOJpVHNHW RNR] D FV|NNHQW QRUDGUHQDOLQ V]LQW
OHWDUJLiWWRPSDViJRWHUHGPpQ\H] [5.]

(]HQ NtYO V]HUHSHW MiWV]KDWQDN EHQQH JpQ-N|UQ\H]HW N|OFV|QKDWiVRN N|UQ\H]HWL


faktorok (szer-IJJĘVpJ UiN FVDOiGWDJ HOYHV]WpVH  HQGRNULQ WpQ\H]ĘN PHWDEROLNXV
PHGLiWRURNLPPXQROyJLDLIRO\DPDWRNLOOHWYHFVDOiGLKDOPR]yGiVWPXWDW>5.]

1.5. $GHSUHVV]LypV D]|QJ\LONRVViJ

$] |QJ\LONRVViJ VDMQRV D YH]HWĘ KDOiORNRN N|]p WDUWR]LN PLQG $PHULNiEDQ PLQG
KD]iQNEDQ (J\HV EHFVOpVHN V]HULQW D GHSUHVV]LyV EHWHJHN -70%-iQDN YDQQDN
|QJ\LONRVViJL JRQGRODWDL PLQWHJ\ -15%-XN PHJ LV NtVpUOL D]W [2.] 0iV IRUUiVRN
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6  
 
 

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YL]VJiODWDNRULVKLV]HQRNR]KDWMDD]DODSEHWHJVpJLV

7  
 
 

2. $GHSUHVV]LyJ\yJ\V]HUHVNH]HOpVH

(EEHQ D IHMH]HWEHQ U|YLGHQ EHPXWDWRP D] DQWLGHSUHVV]iQV J\yJ\V]HUNLQFVQNHW $


J\yJ\V]HUHNHW WHUiSLiED YDOy EHYH]HWpVN VRUUHQGMpEHQ YH]HWHP EH OHtURP
KDWiVPHFKDQL]PXVXNDWIĘHOĘQ\HLNHWKiWUiQ\DLNDW

2.1. $QWLGHSUHVV]iQVRNKDWiViQDNELRNpPLDLpOHWWDQLDODSMDL

$] DQWLGHSUHVV]iQVRN OHJW|EE FVRSRUWMD PHJHPHOL D V]LQDSWLNXV UpVEHQ D V]HURWRQLQ


QRUDGUHQDOLQGRSDPLQV]LQWHW(]WDKDWiVWDSUHV]LQDSWLNXVDQHOKHO\H]NHGĘV]HURWRQLQ
transzporter (SERT serotonin transzporter), noradrenalin transzporter (NET,
QRUHSLQHIULQ WUDQV]SRUHU  LOOHWYH GRSDPLQ WUDQV]SRUWHU '$7  JiWOiViYDO pULN HO $
WUDQV]SRUWHUHN JiWOiVD PLDWW D] LQJHUOHWiWYLYĘ DQ\DJRN QHP YHYĘGQHN YLVV]D D
preszinaptikus neuronokba, s ez iOWDO PDJDV NRQFHQWUiFLyEDQ OHV]Qek jelen a
posztszinaptikus receptorokon. [7.]

0iV DQWLGHSUHVV]iQVRN D PLWRNRQGULXP NOVĘ IDOiKR] U|J]OĘ PRQRDPLQR[LGi]W


JiWROMiN[7.] $ PRQRDPLQR[LGi] HQ]LP D V]LQDSWLNXV UpVEĘO YLVV]DYHWW PRQRDPLQ
LQJHUOHWiWYLYĘ DQ\DJRN HOERPOiViW NDWDOL]iOMD [12.] A OHERQWiV JiWOiViYDO D
QHXURWUDQV]PLWWHUHN~MUDKDV]QRVXOKDWQDNYH]LNXOiNEDQWiUROyGQDN, H]iOWDODN|YHWNH]Ę
LQJHUOHWpUNH]pVpQpOPDJDVDEENRQFHQWUiFLyEDQOHV]QHNMHOHQDV]LQDSWLNXVUpVEHQ [7.]
$ PRQRDPLQR[LGi] HQ]LP R[LJpQ IHOKDV]QiOiViYDO D ELRJpQ DPLQRN DPLQRFVRSRUWMiW
DOGHKLGGp DODNtWMD [9] $ PRQRDPLQR[LGizQDN NpW DOWtSXVD YDQ PHO\HN V]XEV]WUiW
VSHFLILFLWiVXNEDQ pV V]HUYH]HWEHQ YDOy HOKHO\H]NHGpVNEHQ NO|QE|]QHN[7.] Az
LGHJUHQGV]HUEHQ PLQGNpW L]RIRUPD KDVRQOy PHQQ\LVpJEHQ YDQ MHOHQ PtJ D J\RPRU-
bpOWUDNWXVQ\iONDKiUW\iMiEDQIĘNpQWD0$2-$HQ]LPDYpUOHPH]NpNEHQIĘNpQWD0$2-
%HQ]LPWDOiOKDWyPHJ[7.]

A preszinaptikus autoreceptor-DQWDJRQLVWiN D QRUDGUHQDOLQ IHOV]DEDGXOiVW JiWOy Į2-


UHFHSWRUKR] N|WĘGQHN $ JiWOiV DQWDJRQL]iOiVD PLDWW IRNR]]iN D QRUDdrenalin
IHOV]DEDGXOiVW>7.]

eUGHNHV NOLQLNDL PHJILJ\HOpV D] KRJ\ PtJ D] DQWLGHSUHVV]iQVRN PROHNXOiULV KDWiVD
V]LQWH D]RQQDO OpWUHM|Q >@ D]RQEDQ D] DQWLGHSUHVV]iQV KDWiV EHiOOWD FVDN W|EE KHWHV
ODWHQFLDXWiQM|QOpWUH(J\HVIRUUiVRNV]HULQWH]DNpVpVLLGĘ-KpW>@PiVIRUUiVRN
V]HULQWOHJDOiEE-4 hpt szNVpJHVDWQHWPHQWHVVpJHOpUpVpLJ>10.]

8  
 
 

2.2. $QWLGHSUHVV]iQVWHUiSLDIHMOĘGpVH
2.2.1. 1HPV]HOHNWtYLUUHYHU]LELOLV0$2-JiWOyN

/HJHOĘV]|UD]-HVpYHNEHQIHMOHV]WHWWHNNLDQWLGHSUHVV]iQVKDWyDQ\DJRNDW
PHO\HNHWV]HOHNWtYLUUHYHU]LELOLVPRQRDPLQR[LGi]JiWOyNNpQWLVPHUQN.[11.] Ide
WDUWR]yYHJ\OHWHNIHQHO]LQQLDODPLG(]HNDJ\yJ\V]HUHNEiULJHQKDWpNRQ\DN
YROWDNDONDOPD]iVXNPHOOHWWV]LJRU~GLpWiWNHOOHWWWDUWDQL
2.2.1.1. +DWiVPHFKDQL]PXV
,UUHYHU]LELOLVHQJiWROMiNPLQGD0$2-A, mind a MAO-B enzimet.
2.2.1.2. (OĘQ\|N
,JHQKDWiVRVDQWLGHSUHVV]tYXPRNIĘNpQWYLVV]DYpWHOJiWOyNUDQHPUHDJiOy
EHWHJHNQpOMyOKDWQDN>10.]
2.2.1.3. +iWUiQ\RN
$ONDOPD]iVXNPHOOHWWV]LJRU~GLpWiWNHOOWDUWDQL>10@.HUOQLNHOODVDMWRN
HUMHV]WpVVHOHOĘiOOtWRWWWHUPpNHNY|U|VERUIVW|OWKDOIRJ\DV]WiViW(]HND
WiSOiOpNRNQDJ\PHQQ\LVpJEHQWDUWDOPD]]iNDWLUDPLQQHYĦELRJpQDPLQW
DPHO\HWQRUPiOLVHVHWEHQDEpOQ\iONDKiUW\D0$2-A enzime bont le. [12.]
+D LUUHYHU]LELOLVHQ JiWROMXN D] HQ]LPHW D WiSOiOpN tiramin-tartalma nem
ERPOLN HO D EpOEHQ KDQHP YiOWR]DWODQXO IHOV]tYyGLN pV VWLPXOiOMD D
QRUDGUHQDOLQ IHOV]DEDGXOiVW D V]LPSDWLNXV LGHJYpJ]ĘGpVEĘO H]iOWDO
pOHWYHV]pO\HVKLSHUWyQLiVNUt]LVWRNR] ~QVDMW-UHDNFLy [7.]
2.2.2. 7ULFLNOXVRVDQWLGHSUHVV]iQVRN

Az 1960-DV pYHNWĘO NH]GĘGĘHQ OpSWHN D WHUiSLiED D WULFLNOXVRV


DQWLGHSUHVV]iQVRN(]HNIĘ~MGRQViJDD]YROWKRJ\QHPRNR]WDNpOHWYHV]pO\HV
KLSHUWyQiiVNUt]LVWWLUDPLQ-WDUWDOP~WiSOiOpNRNIRJ\DV]WiVDHVHWpQtJ\QHPNHOOHWW
V]LJRU~ WiSOiOkR]iVL PHJV]RUtWiVRNDW WDUWDni. [11.] $ FVRSRUWED WDUWR]y
YHJ\OHWHN LPLSUDPLQ 0HOLSUDPLQŠ FORPLSUDPLQ $QDIUDQLOŠ WULPLSUDPLQ
6DSLOHQWŠ DPLWULSW\OLQ 7HSHULQHSŠ PDSURWLOLQ /XGLRPLOŠ  
2.2.2.1. +DWiVPHFKDQL]PXV
1HP V]HOHNWtY PRQRDPLQ UHXSWDNH-LQKLELWRURN $ V]HURWRQLQ pV YDJ\
noradrHQDOLQpVYDJ\GRSDPLQSUHV]LQDSWLNXV~MUDIHOYpWHOpQHNJiWOiViYDO
jeOHQWĘVHQ pV WDUWyVDQ PHJQ|YHOLN D V]LQDSWLNXV UpVben a monoamin
NRQFHQWUiFLyMiW>7.]

9  
 
 

2.2.2.2. (OĘQ\|N
+DWpNRQ\ViJXNDW HJ\HWOHQ PiV ~MDEE J\yJ\V]HUFVRSRUW VH WXGWD
IHOOP~OQL>10.] 1HPV]NVpJHVGLpWiWWDUWDQLPHOOHWWN
2.2.2.3. +iWUiQ\RN
6~O\RVPHOOpNKDWiVDLNPLDWWYLVV]DV]RUXOWDNDWHUiSLiEDQ$J\yJ\V]HUHN
JiWROMiN D KLV]WDPLQ DGUHQHUJ PXV]NDULQ-UHFHSWRURNDW H]HNEĘO
HUHGH]WHWKHWĘNDPHOOpNKDWiVDLN V]HGiFLyV~O\J\DUDSRGiVorthosztatikus
hypotonia, V]iMV]iUD]ViJ YL]HOHWUHWHQFLy REVWLSiFLy OiWiV]DYDU
tachycardia) [7@ (UUH NpVĘEE UpV]OHWHVHQ NLWpUHN D] $QWLGHSUHVV]iQVRN
PHOOpNKDWiVDLIHMH]HWEHQ
7RYiEEL KiWUiQ\XN KRJ\ DNXW WR[LFLtiVXN pOHWYHV]pO\HV W~ODGDJROYD
NDPUDLWDFK\FDUGLiWDUU\WPLiNDWVĘWDNiUNyPiWLVRNR]KDWQDN>7.] Ez
D]pUW LVNO|Q|VHQYHV]pO\HVPLYHONLVWHUiSLiVV]pOHVVpJNPLDWWN|QQ\Ħ
YHON|QJ\LONRVViJRWHON|YHWQLDPLDGHSUHVV]LyVRNQiOJ\DNRUL
2.2.3. 6]HOHNWtYV]HURWRQLQYLVV]DYpWHOJiWOyN 665,-k)

$N|YHWNH]ĘOpSpVD]DQWLGHSUHVV]iQVWHUiSLiEDQDz 1970-HVpYHNWĘl az 1990-es


pYHNLJ NLIHMOHV]WHWW V]HOHNWtY V]HURWRQLQ YLVV]DYpWHO JiWOyN YROWDN (OVĘNpQW
1974-EHQ D IOXR[HWLQ NHUOW EHYH]HWpVUH PDMG NO|QE|]Ę J\iUWyNWyO D
FLWDORSUDPV]HUWUDOLQIOXYR[DPLQpVDSDUR[HWLQ>13.] )Ę~MGRQViJXNKRJ\D
WULFLNOXVRV YHJ\OHWHNKH] NpSHVW HQ\KpEE pV ULWNiEE PHOOpNKDWiVDLN YDQQDN
WRYiEEi V]pOHV WHUiSLiV V]pOHVVpJN PLDWW QHKH]HEE YHON |QJ\LONRVsiJRW
HON|YHWQL
2.2.3.1. +DWiVPHFKDQL]PXV
1DJ\V]HOHNWLYLWiVVDOJiWROMiNDSUHV]LQDSWLNXVLGHJVHMWHNEĘOIHOV]DEDGXOy
V]HURWRQLQ YLVV]DYpWHOpW [10.] Nem rendelkeznek antikolinerg,
DQLKLV]WDPLQHUJ pV DQWLDGUHQHUJ KDWiVVDO >10.] $ FVRSRUWED WDUWR]y
YHJ\OHWHN IOXR[HWLQ IOXYR[DPLQ SDUR[HWLQ VHUWUDOLQ FLWDORSUDP,
escitalopram
2.2.3.2. (OĘQ\|N
6RNNDONHGYH]ĘEEPHOOpNKDWiV-profiljuk miatt MREEDQWROHUiOKDWyN
6]pOHVWHUiSLiVV]pOHVVpJNPLDWWDW~ODGDJROiVRV|QJ\LONRVViJQHKH]HEE
[10.]

10  
 
 

2.2.3.3. +iWUiQ\RN
$QWLGHSUHVV]iQV KDWiVXN QHP P~OMD IHOO D WULFLNOXVRV
DQWLGHSUHVV]iQVRNpW[14.]
2.2.4. 6]HOHNWtYUHYHU]LELOLV0$2-$EpQtWyN 5,0$ UHYHUVLEOHLQKLELWRURI
monoaminoxidase A)

Az 1980-DV pYHN HOHMpQ IHMOHV]WHWWpN NL D NRUiEEL PRQRDPLQR[LGi] JiWOyNQiO


VRNNDO HOĘQ\|VHEE WXODMGRQViJRNNDO UHQGHONH]Ę reverzibilis V]HOHNWtY
PRQRDPLQR[LGi]JiWOyNDW [15.] $FVRSRUWIĘNpSYLVHOĘMHDPRFOREHPLG
2.2.4.1. +DWiVPHFKDQL]PXV
5HYHU]LELOLVHQ JiWROMiN D 0$2-A enzimet az agy monoaminerg
SiO\DUHQGV]HUHLEHQpVDEpOQ\iONDKiUW\iEDn. A noradrenalin, a szerotonin
pVDGRSDPLQPHWDEROL]PXVDFV|NNHQH]iOWDOQĘD]DJ\EDQDV]LQDSWLNXV
UpVEHUOĘPHQQ\LVpJN[16.]
2.2.4.2. (OĘQ\HL
$ONDOPD]iVXNVRNNDOEL]WRQViJRVDEEPLQWD]LUUHYHU]LELOLVJiWOyNpQHP
V]NVpJHV V]LJRU~ GLpWiW WDUWDQL V]HGpVN PHOOHWW 0LYHO D V]HUHN D
EpOQ\iONDKiUW\iEDQOpYĘ0$2-$HQ]LPKH]LVUHYHU]LELOLVHQN|WĘGQHND
WiSOiOpNNDOEHMXWyWLUDPLQOHV]RUtWMDDN|WpVEĘODJ\yJ\V]HUPROHNXOiWpVD
V]DEDGGiYiOW0$2-A azonnal bontanLNH]GLDWLUDPLQWtJ\D]QHPMXWEH
DNHULQJpVEHQHPRNR]KLSHUWyQLiVUHDNFLyW.  [10.]  
2.2.5. ÒMDEEDQWLGHSUHVV]iQVRN

Az 1990-HVpYHNWĘOD-HVpYHNLJNLIHMOHV]WHWWJ\yJ\V]HUHNQHPVRUROKDWyDN
DIHQWLQDJ\NDWHJyULiNEDV]iPRVNO|QE|]ĘKDWiVPHFKDQL]PXV~V]Hr tartozik
LGHDN|YHWNH]ĘNEHQH]HNHWLVPHUWHWHPU|YLGHQ [17.]
2.2.5.1. Szerotonin, noradrenalin reuptake inhibitorok (SN R I)
$FVRSRUWYHJ\OHWHLYHQODID[LQGXOR[HWLQ
0LQGNpW J\yJ\V]HU JiWROMD mind a norepinefrin, mind a szerotonin
YLVV]DYpWHOpW .O|QEVpJ D WULFLNOXVRV DQWLGHSUHVV]iQVRNWyO PHO\HN
V]LQWpQ PLQGNpW LQJHUOHWiWYLYĘ YLVV]DYpWHOpW JiWROMiN), hogy nem
PXWDWKDWy NL HJ\LN J\yJ\V]HU HVHWpEHQ VHP DQWLNROLQHUJ DQWLDGUHQHUJ
DQWLKLV]WDPLQHUJDNWLYLWiVHPLDWWDWULFLNOXVRVQHPV]HOHNWtYYLVV]DYpWHO
JiWOyNUDMHOOHP]ĘV~O\RVPHOOpNKDWiVDLNQHPMHOHQWNH]QHN>7.]

11  
 
 

2.2.5.2. Noradrenalin dopamin reuptake inhibitorok (ND R I)


A bupropion J\HQJpQ JiWROMD D QRUDGUHQDOLQ pV D GRSDPLQ QHXURQiOLV
YLVV]DYpWHOpW [7.] Csak mLQLPiOLV V]HURWRQLQ UHXSWDNH LQKLELWRU KDWiVD
van.[18.] Nem hat az adrenerg, hisztaminerg, kolinerg rendszeren sem,
HPLDWW QHP RNR]QDN V]H[XiOLV YiOWR]iVRNDW WHVWV~O\Q|YHNHGpVW MyO
WROHUiOKDWyDN. [7.]
2.2.5.3. Noradrenalin reuptake inhibitorok (N R I)
$FVRSRUWEDWDUWR]yYHJ\OHWDUHER[HWLQ
6]HOHNWtY JiWOiVW IHMW NL a NET-HQ QHP JiWROMD D] -+7 pV D GRSDPLQ
YLVV]DYpWHOpW 1DJ\ Gy]LVEDQ LV EL]WRQViJRV QHP RNR] DUU\WPLiNDW
(OĘQ\H D WULFLNOXVRV YHJ\OHWHNKH] NpSHVW KRJ\ PHOOpNKDWiVDL
HOPDUDGQDND]RNpWyO>7.]
2.2.5.4. 3UHV]LQDSWLNXVĮ2-UHFHSWRUDQWDJRQLVWiN
$PLUWD]DSLQpVDPLDQV]HULQEORNNROMiNDSUHV]LQDSWLNXVĮ2-receptorokat,
H]WiOWDO JiWROMiN D QRUDGUHQDOLQ IHOV]DEDGXOiV JiWOiViW HQQHN
N|YHWNH]WpEHQ IRNR]yGLN D QRUDGUHQDOLQ NRQFHQWUiFLyMD D V]LQDSWLNXV
UpVEHQ[7.]
2.2.5.5. 5-H T-UHFHSWRUEORNNROyN
$ WUD]RGRQ JiWROMD D V]HURWRQLQ YLVV]DYpWHOpW pV D] -HT2-receptorokat.
$QWLPXV]NDULQ KDWiVD QLQFV D]RQEDQ Į1-receptor-DQWDJRQLVWD +iWUiQ\D
DQWLDGUHQHUJ WXODMGRQViJiEyO V]iUPD]LN RUWKRV]WDWLNXV K\SRWRQLiW
V]H[XiOLVGLV]IXQNFLyWRNR]KDW[7.]
2.2.5.6. T ianeptin
$WLDQHSWLQSRQWRVPROHNXOiULVKDWiVPHFKDQL]PXVDQHPLVPHUW6HUNHQWL
DV]HURWRQLQIHOYpWHOpWDW|EELDQWLGHSUHVV]iQVVDOV]HPEHQ0HOOpNKDWiV-
SURILOMDDWULFLNOXVRVV]HUHNpKH]KDVRQOtWGHD]RNpQiOHQ\KpEE>7.]

2.3. gVV]HIRJODOiV

$] HOĘ]ĘHNEHQ D WHOMHVVpJ LJpQ\H QpONO LVPHUWHWWHP D] DQWLGHSUHVV]iQV


KDWyDQ\DJRNDW$MREE iWOiWKDWyViJpUGHNpEHQH]HNHWD] ,WiEOi]DWEDQ foglalom
|VV]H

12  
 
 

IWiEOi]DW

$QWLGHSUHVV]iQVRNKDWiVPHFKDQL]PXVDL
+DWiVPHFKDQL]PXV +DWyDQ\DJRN
imipramin
amitriptylin
clomipramin
maprotilin
desipramin
nortriptylin
protriptylin
doxepin,
lofepramin
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amineptin
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fluvoxamin
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escitalopram
inhibitorok (SSRI)
paroxetin
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alaproclat
etoperidon,
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reuptake inhibitorok) duloxetin
NDRI (noradrenalin dopamin
bupropion (amfebutamon)
reuptake inhibitorok)
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reboxetin
(J\pEDQWLGHSUHVV]iQVRN inhibitor)
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fenelzin
tranylcipromin
iproclozid

13  
 
 

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pOHWPLQĘVpJpUHN|]pU]HWpUH

14  
 
 

3. 0HOOpNKDWiVRN

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3.1. $PHOOpNKDWiV fogalma


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$QHPNtYiQWHVHPpQ\DEHWHJV]HUYH]HWpQHNRO\DQNiURVRGiVDDPHO\HWQHPD
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IDUPDNROyJLDL KDWiVDLEyO HUHGKHWQHN [21.] SO D WULFLNOXVRV DQWLGHSUHVV]iQVRN

15  
 
 

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3.1.4. *\yJ\V]HUHOpVLKLED

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|VV]HiOOtWiViKR] J\yJ\V]HUFVHUH  DGDJROiViKR]V]pWRV]WiViKR]EHDGiViKR]
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KDV]QiODWiKR]>22.]
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tartoznak. [23.]
3.1.5. $QHPNtYiQWJ\yJ\V]HUWHUiSLiVHVHPpQ\HNQHPNtYiQW
J\yJ\V]HUKDWiVRNpVDJ\yJ\V]HUHOpVLKLEiNNDSFVROata

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J\yJ\V]HUHOpVLKLEiNN|]|WWLNDSFVRODWRWD]iEUiQV]HPOpOWHWHP.

16  
 
 

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Nem
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J\yJ\V]HU-
KDWiV

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17  
 
 

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esetben, ha azW YL]VJiOMXN, van-H HJ\ KDWyDQ\DJQDN YDODPLO\HQ NiURV KDWiVD,
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18  
 
 

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OiWKDWMXNKRJ\ nem mindegyKRJ\PLO\HQIRJDOPDWKDV]QiOXQN

3.2. A farmakovigilancia rendszer

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3.2.1. A farmakovigilancia fogalma

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|VV]HVVpJH [27.]
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NOLQLNDL YL]VJiODWRN IRO\DPDWD VRUiQ NLVV]iP~ EHWHJHQ YpJ]LN D

19  
 
 

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3.2.2. A farmakovigilancia rendszer tagjai

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1950 1960 [LFLWiV 1970 IHMIiMiV 1980 1990-­‐ ULWNiEE
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hypotonia kus KDWiVRN
hypotonia

 
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PHO\HN pUYpQ\HV IRUJDORPED KR]DWDOL HQJHGpOO\HO UHQGHONH]Ę
J\yJ\V]HUNpV]tWPpQ\HNHWDGWDN QHPW|U]VN|Q\vEĘOW|U|OWiOODSRW~ ,
NLYiODV]WRWWDP |QNpQ\HVHQ HJ\QHN D] DONDOPD]iVL HOĘtUiViW pV
OHW|OW|WWHP
3.3.2.1.2. $IHOKDV]QiOWDONDOPD]iVLHOĘtUiVRNIHOVRUROiVD
Imipramin: Melipramin 25 mg filmtabletta, amitriptilin: TeperinEP
10 mg/25 mg/50 mg filmtabletta, clomipramin: Anafranil 10 mg/25
mg/ 75 mg (SR) filmtabletta, Maprotilin: Ludiomil 10 mg/25 mg/75
mg filmtabletta, )OXR[HWLQ 3UR]DF  PJ  PO EHOVĘOHJes oldat,
Fluvoxamin: Fevarin 50 mg/100 mg filmtabletta, Sertralin: Zoloft 50
PJ ILOPWDEOHWWD  PJPO NRQFHQWUiWXP  EHOVĘOHJHV ROGDWKR]
Paroxetin: Seroxat 20 mg filmtabletta, Escitalopram: Cipralex 10 mg

27  
 
 

filmtabletta, Aurorix 150 mg/300 mg filmtabletta, bupropion:


Wellbutrin SR 150 mg retard tabletta, duloxetin: Cymbalta 30 mg
J\RPRUQHGY HOOHQiOOy WDEOHWWD PLDQV]HULQ 7ROYRQ  PJ
filmtabletta, mirtazapin: Mirtadepi 15 mg/30 mg/45 mg filmtabletta,
reboxetin: Edronax 4 mg tabletta, tianeptin: Coaxil 12,5 mg bevont
tabletta, trazodon: Trittico AC 75 mg / 150 mg retard tabletta,
YHQODID[LQ9HOR[DQPJPJPJUHWDUGNHPpQ\NDSV]XOD
3.3.2.2. 7iEOi]DWRN
$WiEOi]DWRNaz 1-PHOOpNOHWEHQ WHNLQWKHWĘNPHJ [40.]
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- K|QQ\HQ |VV]HKDVRQOtWKDWyYi YiOLN D] DQWLGHSUHVV]iQVRN PHOOpNKDWiV-
profilja, s ez iOWDO PHJN|QQ\tWKHWL D WHUiSLD NLYiODV]WiViW PLYHO D]
DQWLGHSUHVV]iQVWHUiSLDNLYiODV]WiViEDQDEHWHJHNPHOOpNKDWiV-WROHUDQFLiMD
LVJ\DNUDQV]HUHSHWMiWV]LN>7.]
- FHOWQWHWL D PHOOpNKDWiVRN J\DNRULViJit YL]XiOLVDQ MyO HONO|QtWKHWĘ
IRUPiEDQ Ez iOWDON|QQ\HEEHQWXGMXNPHJtWpOQLD]RNNOLQLNDLUHOHYDQFLiMiW,
KRJ\KiQ\EHWHJHWpULQW
- ÈWWHNLQWpVWNDSKDWXQNDPHOOpNKDWiV-SURILOIHMOĘGpVpUĘO
3.3.2.4. $WiEOi]DWKiWUiQ\DL
- D]DONDOPD]iVL HOĘtUiVRNIHOGROJR]iVDVRUiQ J\DNUDQQHKp]Vpget jelentett,
hogy egy-HJ\ PHOOpNKDWiV HOWpUĘ KHO\HQ V]HUHSHOW D NO|QE|]Ę
KDWyDQ\DJRNQiO OHJJ\DNUDEEDQ D SV]LFKLiWULDL pV QHXUROyJLDL
PHOOpNKDWiVRN N|]|WW YROW LO\HQ ]DYDU  tJ\ HOĘIRUGXOKDWRWW KRJ\
valamelyiket nem vettem figyelembe.
3.3.3. gVV]HJ]pV

Az antLGHSUHVV]iQVRNPHOOpNKDWiVDLW|VV]HVtWĘWiEOi]DWMyOHKHWĘVpJHWDGRWWDUUD
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SUREOpPiNDWDPHOOpNKDWiVRNWHNLQWHWpEHQ
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YpJH]QL KRJ\ PHJiOODStWVXN PHO\LN J\yJ\V]HUHVHV NH]HOpV RSWLPiOLV D
betegnek, illetve, hogy ez-H D OHJFpOV]HUĦEE NH]HOpV $] HOĘQ\ KiWUiQ\
pUWpNHOpVQpODN|YHWNH]ĘNet lehetne figyelembe venni:

28  
 
 

- 0LO\HQEHWHJVpJHWNH]HOQHN"
$NpUGpVD]pUWIRQWRVPHUWD] DQWLGHSUHVV]iQVRNDWQHPFVDNDGHSUHVV]Ly
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esetben lehet, hogy e kedvezĘWOHQ KDWiVRN LQNiEE FVDN URQWDQL IRJQDN a
EHWHJ KDQJXODWL iOODSRWiQ MHOHQWĘV MDYXOiV QpONO Ebben az esetben
HOĘQ\|VHEE OHKHW SV]LFKRWHUiSLD DONDOPD]iVD LOOHWYH RO\DQ J\yJ\V]HUHN
PHO\HN NHYpVEp RNR]QDN LO\HQ PHOOpNKDWiVW SpOGiXO a moclobemid.
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DQWLGHSUHVV]iQVRN DONDOPD]iVD PLYHO D PiQLiV K\SRPiQLiV iWFVDSiV
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(] RO\DQ V]HPSRQWEyO OHKHW SUREOpPiV KRJ\ HNNRU KLUWHOHQ IHOiOOiVQiO
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iJ\KR]N|W|WWVpJV~O\RVEtthatja a hangulati negatiYLWiVW DNLOiWiVWDODQViJRW
VH]iOWDODGHSUHVV]LyURPOiViWLGp]KHWLHOĘ
- 0LO\HQV~O\RVViJ~GHSUHVV]LyWNH]HOQN"
(OHQJHGKHWHWOHQ D]W LV ILJ\HOHPEH YHQQL KRJ\ PLO\HQ V~O\RVViJ~ D
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YHV]pO\ MHOHQWHQHN D PHOOpNKDWiVRNQiO (]HQ NtYO LO\HQ HVHWHNEHQ D
SiFLHQVHN KRVV]~ LGĘUH NLHVQHN D PXQNiEyO DPL DQ\DJL SUREOpPiNDW pV
WRYiEELV]RFLiOLVHOV]LJHWHOĘGpVWRNR]

29  
 
 

- Ismertek-e genetikai elWpUpVHNSROLPRUIL]PXVRNDEHWHJHVHWpEHQ"6]iPRV


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SpOGiXOD&<3'-tal, vagy a CYP2C19-cel). [41.] Abban az esetben, ha
valaki ismert, hogy valaki ODVV~ PHWDEROL]iOy WRYiEE iOOKDWQDN IHQQ D
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OHKHW PHOOpNKDWiVD D] RUWKRV]WDWLNXV K\SRWRQLD, HOJRQGRONRGWDWy KRJ\
alkalmazzunk-e RO\DQ DQWLGHSUHVV]iQVRNDW, melyek orthosztatikus
K\SRWRQLiW RNR]QDN SpOGiXO WULFLNOXVRV DQWLGHSUHVV]iQVRN LUUHYHU]LELOLV
MAO-JiWOyN PLYHOHNNRU|VV]HDGyGKDWDKDWiVXN

30  
 
 

4. $EL]RQ\tWpNRNRQDODSXOyRUYRVOiV

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$ EL]RQ\tWpNRNRQ DODSXOy RUYRVOiV  %$2 (YLGHQFH %DVHG 0HGLFLQH  (%M)


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D] HJ\HV EHWHJHN NH]HOpVpEHQ KR]RWW G|QWpVHLNHW OHONLLVPHUHWHVHQ D MHOHQOHJ
UHQGHONH]pVUH iOOy OHJMREE DGDWRN V]DNLURGDOPL VWDWLV]WLNDL WDSDV]WDODWL DGDWRN 
figyelembe vpWHOpYHOKR]]iNPHJ [42.] 2O\DQPyGV]HUWDQWpUWQNDODWWDPHO\DPD
HOpUKHWĘOHJMREENXWDWiVLHUHGPpQ\HNHWN|QQ\HQpUWKHWĘIRUPiEDQDGMDiWVH] iOWDO
V]DNPDLODJ PHJDODSR]]D D G|QWpVKR]DWDOW HJ\-HJ\ WHUiSLiV NpUGpVEHQ 1HP
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RUYRV J\yJ\V]HUpV] H]HNHW D WiPSRQWRNDW pV VDMiW V]DNPDL WDSDV]WDODWiW
IHOKDV]QiOYDG|QW[43.]

4.2. $EL]RQ\tWpNXOV]ROJiOyYL]VJiODWRNWtSXVDLQDNpUWpNHOpVH

A k|YHWNH]ĘNEHQV]HUHWQpPLVPHUWHWQLD]WKRJ\DEL]RQ\tWpNRNRQDODSXOyRUYRVOiV
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fokozza, hogy rendszerint nem reprezentaWtYpVNLVV]iP~ HVHWHWYL]VJiO
nincs kontroll csoport. $ODSYHWĘHQ IĘ FpOMD nem az, hogy egy klinikai
NpUGpVUH YiODV]W NHUHVVHQ 9L]VJiOQDN YDODPLW pV HN|]EHQ PLQWHJ\
YpOHWOHQOWHV]LNDPHJILJ\HOpVWPHO\HWD]WiQHOHPH]QHN [44.]

31  
 
 

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Az eset-NRQWUROO WDQXOPiQ\RN UHWURVSHNWtY YL]VJiODWRN $]W YL]VJiOMiN
KRJ\ PLO\HQ J\DNUDQ IRUGXOW HOĘ D P~OWEDQ HJ\ HVHPpQ\ H[SR]tFLy  D
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N|YHWNH]WHWQL KRJ\ D] HVHPpQ\ KDWiVVDO YROW-H D] HJpV]VpJUH. [44.] Ha
VRNNDO J\DNUDEEDQ IRUGXO HOĘ D EHWHJHN N|]|WW H] D P~OWEHOL HVHPpQ\,
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[44.]
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$YL]VJiOati csopoUWEDQH[SR]tFLyQDN SRWHQFLiOLVDQNiURVKDWiVQDN kitett
V]HPpO\HNYDQQDNPtJDNRQWUROOFVRSRUWEDQH[SR]tFLy-PHQWHVHJ\pQHN
$WDQXOPiQ\LGHMHDODWWLGĘQNpQWIHOPpULNDFVRSRUWRNEDQOpYĘNHJpV]VpJL
iOODSRWiW $ N|YHWpVL LGĘ VRUiQ ILJ\HOLN HJ\ PHJKDWiUR]RWW NLPHQHW
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32  
 
 

V]ROJiOtDWMiN D OHJPDJDVDEE V]LQWĦ EL]RQ\tWpNRNDW (QQpO D YL]VJiODWL


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NHUOQHNDYL]VJiODWEDQUpV]WYHYĘ|QNpQWHVHN>@ Ez azt jelenti, hogy
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(PLDWW LQWHUDNFLyN ~MDEE QHP YiUW J\yJ\V]HUKDWiVRN OpSKHWQHN IHO $

33  
 
 

KXPiQ NOLQLNDL YL]VJiODWRN HJ\LN IĘ SUREOpPiMD KRJ\ PHQQ\LUH


iOWDOiQRVtWKDWyDN D NLV OpWV]iP~ PHJV]ĦUW PLQWiQ pV]OHOW HUHGPpQ\HN D
teljes EHWHJSRSXOiFLyUD
4.2.2.2. Meta-DQDOt]LVHNV]LV]WHPDWLNXViWWHNLQWpVHN
A meta-DQDOt]LVHNWXODMGRQNpSSHQD]HOHP]pVHNHOHP]pVHL>@ A meta-
DQDOt]LVHNQDJ\MiEyOKDVRQOyFpO~YL]VJiODWRNDWHOHPH]QHNpVYRQQDNOH
EHOĘON HJ\ |VV]HIRJODOy N|YHWNH]WHWpVW >@ Arra My KD HJ\ NpUGpVUĘO
W|EE NO|QE|]Ę HUHGPpQ\Ħ NOLQLNDL YL]VJiODW LV PHJMHOHQW |VV]H WXGMD
VĦUtWHQLHJ\N|QQ\HQPHJIRJKDWyHUHGPpQQ\p$EL]RQ\tWpNRNRQDODSXOy
RUYRVOiV OHJPDJDVDEE V]LQWĦ DMiQOiVDL HUHGPpQ\HLN HJ\ WHUiSLiV
NpUGpVEHQ QDJ\RQ HUĘV iOOiVIRJODOiVW MHOHQWHQHN +iWUiQ\XN D]RQEDQ
KRJ\ D V]DNLURGDORPEDQ MHOHQWNH]Ę SXEOLNiFLyV WRU]tWiV KDWiViW QHP
WXGMiN NLNV]|E|OQL >@ 3pOGiXO J\DNUDQ D J\iUDN QHP SXEOLNiOMiN D
QHJDWtYNLPHQHWHOĦYL]VJiODWDLNDW$PHWD-DQDOt]LVHNFVDNDWXGRPiQ\RV
YLOiJEDNLERFViMWRWWYL]VJiODWRNDWWXGMiNIHOKDV]QiOQLH]pUWW|UYpQ\V]HUĦ
KRJ\FVDNDSR]LWtYNLPHQHWHOĦ YL]VJiODWRNDWYL]VJiOMiNPHO\HNQHNtJ\
D]|VV]HIRJODOyHUHGPpQ\HLVSR]LWtYOHV]«

4.3. $EL]RQ\tWpNXOV]ROJiOyYL]VJiODWRNEL]RQ\tWyHUHMH

$YL]VJiODWRNDWPHJEt]KDWyViJXNDODSMiQKLHUDUFKLNXVUHQGV]HUEHiOOtWKDWMXN(]WD
iEUD V]HPOpOWHWL0LQpOPDJDVDEEV]LQWHQKHO\H]NHGLNHODYL]VJiODWLWtSXVDQQiO
PDJDVDEEDEL]RQ\tWyHUHMH(]D]WMHOHQWLKRJ\KDD]RUYRVJ\yJ\V]HUpV]XWiQD
DNDU Qp]QL HJ\ NpUGpVQHN UiNHUHV KRJ\ PLO\HQ WXGRPiQ\RV HUHGPpQ\HN iOOQDN
UHQGHONH]pVUH+DVRNPDJDVV]LQWHQiOOyNXWDWiViOOtWYDODPLW, QDJ\DYDOyV]tQĦVpJH
KRJ\ ~J\ LV YDQ s HNNRU QDJ\REE HVpOO\HO G|QW D IHOWHWW NpUGpV HOYHWpVe, vagy
J\DQ~MiQDN PHJHUĘV|GpVe mellett +D NHYpV URVV]DEE PLQĘVpJĦ YL]VJiODW YDQ,
akkor QHPNDSDQQ\LUDHUĘVWiPRJDWiVWDIHOWHWWNpUGpVUH

34  
 
 

4iEUD>@

PHWDDQDOt]LVHN
szisztematikus
|VV]HIRJODOyN

UDQGRPL]iOW
NRQWUROOiOWKXPiQ
NOLQLNDLYL]VJiODWRN

NRKRUV]YL]VJiODW

HVHWNRQWUROOYL]VJiODWRN

QHPNRQWUROOiOWNOLQLNDLYL]VJiODWRN

HVHWOHtUiVRNHVHWVRUR]DWRN

QDJ\V]DNWHNLQWpO\ĦHPEHUHNYpOHPpQ\HL
 

4.4. 0LEHQDGMXNPHJD]HUHGPpQ\HNHWDYL]VJiODWRNQiO"

(EEHQ D UpV]EHQ V]HUHWQpP LVPHUWHWQL KRJ\ D J\yJ\V]HUpUWpNHOpVHN VRUiQ PLN D


lHJJ\DNUDEEDQPHJDGRWWSDUDPpWHUHNpVH]HNPLWMHOHQWHQHN
4.4.1. 5HODWtYNRFNi]DW 55
ாாோ
- 6]iPtWiVDܴܴ ൌ ஼ாோ [45.]
௘௦௘௠±௡௬௘௞௦௭ž௠௔௔௩௜௭௦௚ž௟௔௧௜௖௦௢௣௢௥௧௕௔௡
- EER= , [45.]
௕௘௧௘௚௘௞௦௭ž௠௔௔௩௜௭௦௚ž௟௔௧௜௖௦௢௣௢௥௧௕௔௡
௘௦௘௠±௡௬௘௞௦௭ž௠௔௞௢௡௧௥௢௟௟௖௦௢௣௢௥௧௕௔௡
- CER= [45.]
௕௘௧௘௚௘௞௦௭ž௠௔௔௞௢௡௧௥௢௟௟௖௦௢௣௢௥௧௕௔௡

- eUWHOPH YL]VJiOW FVRSRUWEDQ pV]OHOW J\DNRULViJ KiQ\DG UpV]H D NRQWUROO


FVRSRUWpQDN[45.]

4.4.2. 5HODWtYNRFNi]DWFV|NNHQpV 555 UHODWtYNRFNi]DWQ|YHNHGpV 55,


஼ாோିாாோ ாாோି஼ாோ
- 6]iPtWiVD555 RRI= [45.]
஼ாோ ஼ாோ

35  
 
 

- eUWHOPH]pVHDYL]VJiOWFVRSRUWEDQKiQ\V]i]DOpNNDOFV|NNHQWYDJ\QĘWWD]
HVHPpQ\J\DNRULViJDDNRQWUROOFVRSRUWKR]Nppest. 5HODWtYPHUWDNRQWUROO
FVRSRUWKR] NpSHVW YLV]RQ\tW +iWUiQ\D KRJ\ QHP IHMH]L NL D] HVHPpQ\
YDOyGLJ\DNRULViJiWDSRSXOiFLyEDQ [45.]
4.4.3. $EV]RO~WNRFNi]DWFV|NNHQpV $55 $EV]RO~WNRFNi]DWQ|YHNHGpV
(A R I)

- 6]iPtWiVD$55 &(5-EER, ARI=EER-CER [45.]


- eUWHOPH]pVH$ODSEyOLVHOĘIRUGXOYDODPHNNRUDJ\DNRULViJJDOD]HVHPpQ\
&(5 HEEĘO NLYRQMXNKRJ\DYL]VJiOWFVRSRUWEDQPLO\HQ J\DNRULViJJDO
IRUGXOHOĘtJ\PHJNDSMXNKRJ\WpQ\OHJHVHQKiQ\V]i]DOpNNDONHYHVHEEV]HU
IRUGXOHOĘD]HVHPpQ\[45.]
4.4.4. O dds Ratio (O R)

- 6]iPtWiVD$ODSMDD]HVpO\pUWpN(VpO\pUWpN HVHPpQ\HNV]iPDDYL]VJiOW
YDJ\ NRQWUROO FVRSRUWEDQ QHP N|YHWNH]HWW EH HVHPpQ\ D YL]VJiOW YDJ\
kontroll csoportban. [45.]
೐ೞ೐೘±೙೤೐ೖೞ೥ž೘ೌೌೡ೔೥ೞ೒ž೗೟೎ೞ೚೛೚ೝ೟್ೌ೙
೙೔೙೎ೞ೐ೞ೐೘±೙೤ೌೡ೔೥ೞ೒ž೗೟೎ೞ೚೛೚ೝ೟್ೌ೙
OR= ೐ೞ೐೘±೙೤೐ೖೞ೥ž೘ೌೌೖ೚೙೟ೝ೚೗೗೎ೞ೚೛೚ೝ೟್ೌ೙ [45.]
೙೔೙೎ೞ೐ೞ೐೘±೙೤ೌೖ೚೙೟ೝ೚೗೗೎ೞ೚೛೚ೝ೟್ೌ೙

- eUWHOPH]pVH$NH]HOWFVRSRUWEDQKiQ\V]RURVDD]HVHPpQ\HOĘIRUGXOiViQDN
DNRQWUROOFVRSRUWKR]NpSHVW [45.]
4.4.5. 6]NVpJHVNH]HOHQGĘEHWHJV]iP 11711+

- 6]iPtWiVD117 $5511+ $5, [45.]


- eUWHOPH]pVN117KiQ\EHWHJHWNHOONH]HOQLDKKR]KRJ\HJ\QpODMDYXOiV
DJ\yJ\V]HUN|YHWNH]PpQ\HOHJ\HQ11+KiQ\EHWHJHWNell kezelni ahhoz,
KRJ\ HJ\ EHWHJQpO D PHOOpNKDWiV D J\yJ\V]HU N|YHWNH]PpQ\HNpQW OpSMHQ
fel. [45.]

4.5. 0LO\HQV]HPSRQWRNDWYHV]QNILJ\HOHPEHDEL]RQ\tWpNRNRQDODSXOy
RUYRVOiVQiO"
4.5.1. K onfidencia intervallum

$NRQILGHQFLDLQWHUYDOOXPD]RNDWD]pUWpNKDWiURNDWMHO|OLDPHO\HNN|]pDYDOyV
pUWpNHN D PHJDGRWW iOWDOiEDQ   YDOyV]tQĦVpJJHO HVQHN >@ $zon
pUWpNKDWiURNDW MHO|OL PHO\ N|]p D SRSXOiFLy -a esik.[45.] 6]pOHVVpJpEĘO
N|YHWNH]WHWKHWQNDPpUpVSRQWRVViJiUD0LQpOV]pOHVHEEYROW, DQQiOQDJ\REE

36  
 
 

pUWpNKDWiURN N|]p HVWHN D PpUpVL DGDWRN DQQiO SRQWDWODQDEE YROW D PpUpV


YDOyV]tQĦOHJ +D FV|NNHQ D YL]VJiOW EHWHJV]iP, iOWDOiEDQ V]pOHVedik a
NRQILGHQFLDLQWHUYDOOXPPLYHOQĘDYpOHWOHQKLEDHVpO\H
4.5.2. Szignifikancia szint

Megadja a nullKLSRWp]LV KLEiVHOYHWpVpQHNYDOyV]tQĦVpJpW. [45.] Azt fejezi ki,


KRJ\PHNNRUDDYDOyV]tQĦVpJHDQQDNKRJ\DWDOiOWNO|QEVpJDYpOHWOHQPĦYH
ÈOWDOiEDQ   N|UOL pUWpN 7HKiW SpOGiXO   QDJ\RQ NLFVL  DQQDN D
YDOyV]tQĦVpJHKRJ\QLQFVLVYDOyGLNO|QEVpJQLQFVLVDYL]VJiOWpVDNRQWroll
FVRSRUWN|]|WW.

37  
 
 

5. $]DQWLGHSUHVV]iQVRNpVD]|QJ\LONRVViJ

5.1. %HYH]HWpV

5.1.1. )RNR]]iN-H D] DQWLGHSUHVV]iQVRN D] |QJ\LONRVViJL NRFNi]DWRW pV PLO\HQ


EL]RQ\tWpNRNYDQQDNHUUH"
$KRJ\ D]W D V]DNGROJR]DW EHYH]HWpVpEHQ OHtUWDP D] DQWLGHSUHVV]iQVRN QHP
NtYiQWKDWiVDLN|]OOHJLQNiEEDIHOWpWHOH]HWW|QJ\LONRVViJIRNR]yKDWiVNHOWHWWH
IHO D] pUGHNOĘGpVHP (EEHQ D IHMH]HWEHQ V]HUHWQpP WLV]Wi]QL D] H]]HO
NDSFVRODWEDQUHQGHONH]pVUHiOOyLQIRUPiFLyNDW

5.2. gQJ\LONRVViJPHJMHOHQpVHD]DQWLGHSUHVV]iQVRNDONDOPD]iVLHOĘtUiVDLEDQ

$ONDOPD]iVLHOĘtUiVEDQ|QJ\LONRVViJLKDMODPIRNR]yGiViUDXWDOyPHJMHJ\]pVHNNpW
KHO\HQ MHOHQQHN PHJ HJ\UpV]W D PHOOpNKDWiVRNDW |VV]HJ\ĦMWĘ WiEOi]DWRNEDQ
PiVUpV]DNO|QOHJHVILJ\HOPH]WHWpVHNSRQWDODWW$N|YHWNH]ĘNEHQLVPHUWHWHPD]
LWWWDOiOWDNDW
1) MellpNKDWiVRN QHP NtYiQW J\yJ\V]HUKDWiVRN HOĘIRUGXOiVL J\DNRULViJiW
|VV]HJ\ĦMWĘWiEOi]DWRNEDQ [40.]
$ J\DNRULViJL WiEOi]DWRNEDQ DKRJ\ D WiEOi]DWEyO LV OiWV]LN D WULFLNOXVRV
DQWLGHSUHVV]iQVRNQiONLYpWHOQpONOQHPLVPHUWJ\DNRULViJ~NpQWIRUGXOWDNHOĘ
a fluo[HWLQDV]HUWUDOLQDPRFOREHPLGLOOHWYHDGXOR[HWLQSHGLJQHPJ\DNRULpV
ULWNDPHOOpNKDWiVRNNpQWIRUGXOQDNHOĘ -pV-0,01%). Az SSRI-NN|]O
DIOXYR[DPLQDSDUR[HWLQpVD]HVFLWDORSUDPQHPLVPHUWJ\DNRULViJ~YDODPLQW
D]HJ\pEDQWLGHSUHVV]iQVRNV]LQWpQQHPLVPHUWJ\DNRULViJJDOIRUGXOQDNHOĘ
2) Ä.O|QOHJHVILJ\HOPH]WHWpVHNpVD]DONDOPD]iVVDONDSFVRODWRVyYLQWp]NHGpVHN´
pont alatt DN|YHWNH]ĘWHUOHWHNYDQQDN [40.]:
- A NH]HOpV NRUDL V]DNDV]iEDQ HOVĘ QpKiQ\ KpWHQ  IRNR]yGKDW D]
|QJ\LONRVViJL KDMODP, H]pUW HEEHQ D] LGĘV]DNEDQ IRNR]RWW RGDILJ\HOpVW
LJpQ\HOQHNDEHWHJHN
- $SHGLiWULDLJ\DNRUODWEDQpYQpOILDWDODEEJ\HUHNHNHWpVILDWDONRU~DNDW
NH]HOYHPDJDVDEEYROWD]|QJ\LONRVViJRN|QJ\LONRVViJLNtVpUOHWHNV]iPD
D]DQWLGHSUHVV]iQVVDONH]HOWFVRSRUWEDn, mint a placebo csoportban.
- pYDODWWLIHOQĘWWHNEHQSODFHERNRQWUROORVYL]VJiODWRNPHWDDQDOt]LVHD]W
PXWDWWDKRJ\DNH]HOWFVRSRUWEDQPDJDVDEEYROWD]|QJ\LONRVViJLUiWDPLQW
a placebo csoportban

38  
 
 

- +DDSiFLHQVQHN|QJ\LONRVViJLNtVpUOHWHYROWYDJ\WXGMiNUyODKRJ\LO\HQ
JRQGRODWRNJ\DNUDQIRJODONR]WDWMiNPHJILJ\HOpVWLJpQ\HOQHN

5.3. 0LO\HQEL]RQ\tWpNRNYDQQDND]|QJ\LONRVViJIRNR]yKDWiVUD"

5.3.1. +RJ\WDOiOWDPUiDYL]VJiODWRNUD"
SzakdolgozatoPEDQ HOHP]HWW YL]VJiODWRN IRUUiVD HJ\UpV]W HJ\ -ben
Nature-ben megMHOHQW |VV]HIRJODOy FLNN YROW PHO\ MyO |VV]HJ\ĦMWL D] DGGLJ
PHJMHOHQWWDQXOPiQ\RNDWD]DQWLGHSUHVV]iQVRN|QJ\LONRVViJIRNR]yKDWiViUyO
D] HVHWWDQXOPiQ\RNWyO D V]LV]WpPiV |VV]HIRJODOyNLJ >@ 0iVUpV]W -.
$URQVRQ0H\OHU¶V6LGH(IIHFWVRI3V\FKLDWULF'UXJVFtPĦN|Q\YpQHNV]HOHNWtY
V]HURWRQLQ YLVV]DYpWHO JiWOyNNDO IRJODONR]y IHMH]HWpEHQ WDOiOW HOHP]pVHN
V]ROJiOWDN NLLQGXOySRQWXO D NXWDWiVRPKR] >@ (]HQ IRUUiVRN
LURGDORPMHJ\]pNpEĘO NLNHUHVWHP D] HPOtWHWW WDQXOPiQ\RNDW pV D 3XG0HG
VHJtWVpJpYHO DPHO\QHN HOpUKHWĘ YROW D WHOMHV V]|YHJH OHW|OW|WWHP (J\
YL]VJiODWRWQHPWDOiOWDPPHJD],QWHUQHWHVDGDWEi]LVban, de ennek absztraktja,
LOOHWYHDIHQWL|VV]HIRJODOyNEDQOHtUWDNHOpJYROWDKKR]D]LQIRUPiFLyKR], amire
V]NVpJHPYROW
5.3.2. $YL]VJiODWRN|VV]HIRJODOiVD
A taliOW YL]VJiODWRNDW QHKp] OHQQH |VV]HKDVRQOtWDQL KD FVDN OHtUQiP PLUĘO
V]yOWDNpVPLNYROWDND]HUHGPpQ\HLNPLYHOUHQGV]HULQWHOpJNO|QE|]ĘYROWD
FtPN YDODPLQW FpONLWĦ]pVN (]pUW WiEOi]DWRW NpV]tWHttem EHOĘON PHO\EHQ
D]RNDWD]DGDWRNDWGROJRNDWtURm le, melyek mindegyikben szerepelne.
$]HUHGPpQ\HND,,WiEOi]DWEDQ WHNLQWKHWĘNPHJ

39  
 
 

,,WiEOi]DW
9L]VJiODW 0LYROWDFpOMD" K iket 0LO\HQWtSXV~ 0LYROWD]HUHGPpQ\H" +iQ\DQYROWDND K ontroll csoport
YL]VJiOWDN" YL]VJiODW" YL]VJiODWEDQ"
1. T eicher IOXR[HWLQW V]HGĘ HVHWWDQXOPiQ\ EHWHJQHN|QJ\LONRVViJLJRQGRODWDLOHWWHN
1990 betegek DPHJYRQiVXWiQ
[46.]

2. J A M A Jick |QJ\LONRVViJL YLVHONHGpV pV 10- pYHV eset kontroll x 1LQFV NO|QEVpJ D KDWyDQ\DJRN 159 810 beteg GRWKLHSLQW V]HGĘN PiVLN
2004 JRQGRODWRN UHODWtY NRFNi]DWD betegek, akik 4 N|]|WW D] |QJ\LONRVViJL KDMODP pYHVLGĘV]DNDODWW DQWLGHSUHVV]iQVKR]
[47.] DQWLGHSUHVV]iQV WHUiSLiW NH]GĘN antiGHSUHVV]iQV IRNR]yGiViEDQ D GRVXOHSLQKH] YLV]RQ\tWYD
N|UpEHQ N|]O HJ\LNHW YLV]RQ\tWYD
HONH]GWpN x Dosulepin OR=1
szedni x amitriptilin OR=0,83 CI=0,61-1,13
(nem tudjuk x fluoxetin OR=1,16 CI= 0,9-1,13
milyen x paroxetin OR=1,29 CI= 0,97-1,7
EHWHJVpJEHQ x $ IHOtUiVW N|YHWĘ HOVĘ LGĘV]DNEDQ
PDJDVDEED]|QJ\LONRVViJLNRFNi]DW
DNpVĘEELLGĘV]DNRNKR]NpSHVW
x HOVĘ  QDS |QJ\LONRVViJL YLVHONHGpV
QHP KDOiORV  25  &, -
 |QJ\LONRVViJ KDOiORV  25 
CI=6,2-231
3. A ndersen kaptak-e valamilyen |QJ\LONRVViJRW HVHWWDQXOPiQ\ QHPV]HGHWWDQWLGHSUHVV]iQVWD] |QJ\LONRVHVHW
2001 SV]LFKRIDUPDNROyJLDLNH]HOpVWD] HON|YHWĘN |QJ\LONRVViJHOĘWWL
[48.] |QJ\LONRVViJHOĘWWD]RN, akik pYHVLGĘWDUWDP 30 napban
|QJ\LONRVViJRWN|YHWWHNHO alatt
4. M artinez |QJ\LONRVViJRNpV|QJ\LONRVViJL 10-pYHV eset kontroll x SSRI-k nem hordoznak nagyobb 146 095 WULFLNOXVRVDQWLGHSUHVV]iQV
2005 NtVpUOHWHN665,-WV]HGĘNN|]|WWD DQWLGHSUHVV]iQVW NRFNi]DWRWD7&$'-RNQiO DQWLGHSUHVV]iQVW
[49.] WULFLNOXVRVDQWLGHSUHVV]iQVW V]HGQLNH]GĘN x QHPKDOiORV|QJ\LONRVViJLNtVpUOHW V]HGĘEHWHJ
V]HGĘNK|]NpSHVW OR=0,99 CI (95%)= 0,86-1,14
x KDOiORVNLPHQHWHOĦ|QJ\LONRVViJ
OR=0,57 CI (95%)=0,26-1,25
x Gyerekkorban (10-pYHVHNQpO 
YDODPHO\HVIRNR]RWW|QJ\LONRVViJ
OR=1,59 CI (95%)= 1,01-2,50)
5. Isacsson 1994 gQJ\LONRVViJRWHON|YHWĘN |QJ\LONRVViJRW HVHWWDQXOPiQ\ 16 %-QiOWDOiOWDNDQWLGHSUHVV]iQVWD |QJ\LONRVHVHW
[50.] YpUpQHNWR[LNROyJLDLDQDOt]LVH HON|YHWĘN WR[LNROyJLDLDQDOt]LVWN|YHWĘHQ
VRUiQKiQ\QiOWDOiOWDN
DQWLGHSUHVV]iQVW

36  
 
 

9L]VJiODW 0LYROWDFpOMD" K iket 0LO\HQWtSXV~ 0LYROWD]HUHGPpQ\H" +iQ\DQYROWDND K ontroll csoport


YL]VJiOWDN" YL]VJiODW" YL]VJiODWEDQ"
6. Juredini 2004 DQWLGHSUHVV]iQVRN pYDODWWL 7 placebo x KDWiVRVViJQDJ\RQHQ\KHMDYXOiVD 477 SSRI-vel SODFHERNRQWUROOiOW
[51.] KDWiVRVViJiQDNpV gyerekek NRQWUROOiOW SODFHERFVRSRUWKR]NpSHVW kezelt, 464
EL]WRQViJRVViJiQDNiWWHNLQWpVH klinikai SMD=0,26 CI=(95%) 0,13-0,4 placeboval kezelt
YL]VJiODW x EL]WRQViJRVViJDOiEHFVOWpND gyerek
klinikai V~O\RV, QHPNtYiQWKDWiVRNDW
iWWHNLQWpVH SpOGiXO|QJ\LONRVViJRWDQQDN
HOOHQpUH, KRJ\NLVV]iP~EHWHJHQLV
PHJILJ\HOKHWĘNYROWDN
7. A nne J\HUHNHNQpO|QJ\LONRVViJL SSRI-WHJ\pE SHGLiWULDL MDMRUGHSUHVV]LyVYL]VJiODWRN D]|VV]HV SODFHERNRQWUROOiOW
T rontell, NRFNi]DWPHJiOODStWiVDSODFHER- DQWLGHSUHVV]iQVW klinikai |VV]HVtWpVpEHQD]|QJ\LONRVViJLHVHWHN YL]VJiODWEDQ
Mosholder KR]NpSHVW (mirtazapin, YL]VJiODWRN DUiQ\D25  &, -3,21), J\yJyV]HUWV]HGĘ
2004 nefazodon, iWWHNLQWpVH S65,YL]VJiODWRN|VV]HVtWpVpEHQ pVSODFHEyW
[2.] bupropion) |QJ\LONRVViJLHVHWHNDUiQ\D25  V]HGĘJ\HUek
V]HGĘPDMRU (CI=1,10-3,18)
GHSUHVV]LyVLOO. Nem PDMRUGHSUHVV]LyVYL]VJiODWRNEDQD]
nem major V]XLFLGDUiQ\OR=1,31 (CI=0,266,72)
GHSUHVV]LyV OHJW|EEDQWLGHSUHVV]iQV 665,pVHJ\pE
gyerekek LV IRNR]RWW|QJ\LONRVViJLNRFNi]DWWDOMiU
PDMRUGHSUHVV]LyVJ\HUHNHNQpO
DONDOPD]YDGHNHYpVEpNRFNi]DWRVQHP
GHSUHVV]LyVJ\HUHNHNQpO
fOXR[HWLQEL]WRQViJRV
8. K ahn 2003 |QJ\LONRVViJRNDUiQ\iQDN SSRI-WHJ\pE UDQGRPL]iOW nincs MHOHQWĘV NO|QEVpJVHPD] SiFLHQV SODFHERNRQWUROOiOW
[52.] |VV]HKDVRQOtWiVD665,-WPiV DQWLGHSUHVV]iQVW NRQWUROOiOt DQWLGHSUHVV]iQVRNpVDSODFHERN|]|WW
DQWLGHSUHVV]iQVWpVSODFHERWNDSy (pl nefazodon, klinikai sem az SSRI-NpVPiVDQWLGHSUHVV]iQVRN
HJ\pQHNQpO trazodon, YL]VJiODWRN N|]|WWSSRI (0.59%, 95% confidence
bupropion, iWWHNLQWpVH interval [CI]=0.31%-0.87%), a standard
maprotilin) DNWtYNRQWUROO &, -
V]HGĘIHOQĘWWHN 1.03%), placebo (0.45%, 95% CI=0.01%-
0.89%)
9. W hittington SSRI-NKDWiVRVViJDpV 5-pYHV UDQGRPL]iOW gQJ\LONRVViJLYLVHONHGpVpV OHJW|EE SODFHERNRQWUROOiOW
2004 EL]WRQViJRVViJiQDN GHSUHVV]LyV NRQWUROOiOW |QJ\LONRVViJLHVHWHNUHODWtYNRFNi]DWD YL]VJiODWEDQ
[53. ] megiOODStWiVDSXEOLNiOWpVQHP gyerekek YL]VJiODWPHWD- x fluoxetin: (RR=0,94 CI=0,37-2,40, kevesebb, mint 200
SXEOLNiOWYL]VJiODWRN DQDOt]LVH RR=1,26 CI=0,36-4,40) IĘYHV]UpV]WPLQGD
|VV]HJ]pVpYHO x paroxetin RR= 10,30 CI=0,58- placebo, mind a
183,53 kontroll csoportban
x sertralin RR=2,43 CI=0,48-12,39 PD[LPXPIĘ
x citalopram RR=1,99 CI= 0,83-4,77
x venlafaxin RR=13,77 CI=1,83-
103,61

37  
 
 

9L]VJiODW 0LYROWDFpOMD" K iket 0LO\HQWtSXV~ M i volt az HUHGPpQ\H" +iQ\DQYROWDND K ontroll csoport


YL]VJiOWDN" YL]VJiODW" YL]VJiODWEDQ"
10. G unnel, IHOQĘWWHNQpO665,-k okoznak-e DQWLGHSUHVV]iQVW UDQGRPL]iOW x |QJ\LONRVViJRN|VV]HVtWHWWNRFNi]DWD 40 UpV]WYHYĘ SODFHERNRQWUROOiOW
Ashby 2005 maJDVDEE|QJ\LONRVViJL V]HGĘIHOQĘWWHN NRQWUROOiOW OR=0,74 CI (95%)=0,25-2,21
[54.] NRFNi]DWRW DSODFHEyKR]NpSHVW YL]VJiODWPHWD x 1HPKDOiORV|QJ\LONRVViJL
DQDOt]LVH NtVprletek OR=1,26 CI (95%) =0,88-
1,80
x gQJ\LONRVViJLJRQGRODWRN25 
CI (95 %)= 0,53-1,26
x gQJ\LONRVViJpV|QNiURVtWy
PDJDWDUWiVQHP]iUKDWyNLEiUD
YL]VJiODWRNDODSMiQHUUHNHYpVD]
HVpO\J\HQJHEL]RQ\tWpNYDQUi
KRVV]DEEN|YHWpVLLGHMĦYL]VJiODWRN
OHQQpQHNV]NVpJHVHN

38  
 
 

5.4. 0LpUWV]NVpJHVHNDEL]RQ\tWpNRNRQDODSXOyRUYRVOiVPyGV]HUHLDNpUGpVUĘOa
YpOHPpQ\ NLDODNtWiViKR]"

5.4.1. A] iOWDODP IHOWHWW NpUGpV KRJ\ IRNR]]iN-H D] DQWLGHSUHVV]iQVRN D]
|QJ\LONRVViJLNRFNi]DWRWOiWV]yODJHJ\V]HUĦD]RQEDQDIHQWLHNEĘOOiWV]LNKRJ\
YDOyMiEDQW|EESUREOpPDN|UUHERQWKDWMXNIHO
5.4.1.1. 0HO\LNpOHWNRUEDQIRNR]yGLND]|QJ\LONRVViJLNRFNi]DW"
0iUD]DONDOPD]iVLHOĘtUiVRNEyOLVOiWV]RWWKRJ\YDODPLNpSSNO|QNHOO
NH]HOQLDJ\HUHNpVDIHOQĘWWSRSXOiFLyW
5.4.1.2. 0LO\HQEHWHJVpJEHQV]HQYHGĘNnpOIRNR]yGLNDNRFNi]DW"
5.4.1.3. $NH]HOpVPHO\LGĘV]DNiEDQIRNR]RWWD]|QJ\LONRVsiJLNRFNi]DW"
$ NH]HOpV NRUDL LGĘV]DNiEDQ IRNR]RWW |QJ\LONRVViJL NRFNi]DW YDOyEDQ
QHP NtYiQW J\yJ\V]HUKDWiV" (] HOOHQWPRQGDQD DQQDN D NOLQLNDL
WDSDV]WDODWQDNKRJ\D]DQWLGHSUHVV]iQVKDWiVLGHMpQHNEHiOOWDDNiU-KpW
is lehet (21-QDS +LV]HQHNNRUPpJYDOyV]tQĦOHJQHPiOOWEHDKDWiV
azaz lehet PDJiQDN D GHSUHVV]LyQDN D N|YHWNH]PpQ\H LV 8J\DQDNNRU
DKRJ\ D] DONDOPD]iVL HOĘtUiVRNEyO NpV]tWHWW WiEOi]DWEDQ OiWV]LN D]
DQWLGHSUHVV]iQVRNQDNVDMQRVV]iPRVHJ\pEQHPNtYiQWKDWiVDYDQPHO\HN
URVV]KDWiVVDOOHKHWQHNDEHWHJHNpOHWPLQĘVpJpUH3pOGiXOJ\akori DEHOVĘ
nyugWDODQViJHUHNWLOLVGLV]IXQNFLyKiQ\LnJHUpPHO\JpVIHMIiMiV(]HND
KDWiVRN PiU D NH]HOpV NRUDL V]DNDV]iEDQ LV MHOHQWNH]KHWQHN V D WHVWL
URVV]XOOpWHUĘVtWKHWLDGHSUHVV]LyVRNDP~J\LVURVV]KDQJXODWiWH]iOWDOD]
HVWHOHJHV |QJ\LONRVViJL JRQGRODWRNDW (EEHQ D] pUWHOHPEHQ SHGLJ
N|]YHWHWW QHP NtYiQW J\yJ\V]HUKDWiVQDN WHNLQWKHWĘ D] |QJ\LONRVViJL
NRFNi]DWIRNR]yGiVD
5.4.2. $YL]VJiODWRNVRNIpOHPLQĘVpJĦHN
5.4.2.1. &pONLWĦ]pVHN
$] iOWDODP YL]VJiOW WDQXOPiQ\RN N|]|WW QHP YROW RO\DQ DPHO\EHQ D
UDQGRPL]iOW NRQWUROOiOW YL]VJiODWRN HOVĘGOHJHV FpONLWĦ]pVH DQQDN
PHJiOODStWiVD YROW KRJ\ IRNR]]iN-H D] DQWLGHSUHVV]iQVRN D]
|QJ\LONRVViJL NRFNi]DWRW (] YDODKRO pUWKHWĘ KD EHOHJRQGROXQN KD H]W
tUQiNLHJ\YL]VJiODWFpONLWĦ]pVHNpQWYDOyV]tQĦOHJD](WLNDL%L]RWWViJse
IRJDGQi HO KLV]HQ SRWHQFLiOLVDQ KDOiORV NLPHQHWHOĦ HVHPpQ\HNUĘO
EHV]pOQN  WRYiEEi NL MHOHQWNH]QH HJ\ LO\HQ YL]VJiODWUD" 3OiQH KD

39  
 
 

GHSUHVV]LyV« (]HQ RNRN PLDWW D YL]VJiODWRN QDJ\ UpV]H V]LV]WpPiV


iWWHNLQWĘ PHWD-DQDOt]LV PHO\HN PHJSUyEiOMiN |VV]HIRgni azokat a
YL]VJiODWRNDWDKROPHJILJ\HOWpNH]HNHWDQHPNtYiQWHVHPpQ\HNHW
5.4.2.2. Eset-NRQWUROOYL]VJiODWRNSUREOpPiMD
$] HVHW NRQWUROO YL]VJiODWRN EiU QDJ\V]iP~ DGDWRW HOHPH]QHN H]iOWDO
FV|NNHQDYpOHWOHQKLEDHVpO\H FVDNNRUOiWR]RWWDQDGQDNLQIRUPiFLyWD]
DQWLGHSUHVV]iQVRN |QJ\LONRVViJ IRNR]y KDWiViUyO $] LO\HQ
YL]VJiODWRNEDQ QLQFV N|YHWpV tJ\ D] DGKHUHQFLD QHP WDQXOPiQ\R]KDWy
1HP WXGMXN KRJ\ D SiFLHQV PHQQ\LUH IRJDGWD HO EHWHJVpJpW V H] iOWDO
PHQQ\LUHpUWHWWHPHJDJ\yJ\V]HUHVNH]HOpVIRQWRVViJiW0LOyen volt az
orvos-beteg kapcsolat? Kapott-HPHOOHWWHSV]LFKRWHUiSLiW"
5.4.2.3. .RQWUROOFVRSRUWSUREOpPiMD
Gyakori volt, hogy nem alkalmaztak kontroOO FVRSRUWRW YDJ\ FVDN PiV
KDWyDQ\DJRNKR]NpSHVWQp]WpNPHJD]|QJ\LONRVViJLNRFNi]DWRW(]]HOD]
D SUREOpPD KRJ\ ha nem alkalmazunk placebo kontrollt, nem tudjuk
NLV]ĦUQLD]GHSUHVV]Ly|QJ\LONRVViJIRNR]yKDWiViW

5.5. %L]RQ\tWpNRNUDQJVRUROiVD

A YL]VJiODWRNVRNV]tQĦHN voltaktJ\QHKp]volt HJ\NDSWDIiUDYHQQLĘNHWpVHJ\


HJ\pUWHOPĦ N|YHWNH]WHWpVW OHYRQQL EHOĘON (]pUW DV]HULQW KRJ\ D YL]VJiODW FpOMD
PHQQ\LUHIHOHOWPHJD]iOWDODPIHOWHWWNpUGpVQHNPLO\HQPLQĘVpJĦYROWDYL]VJiODW
KiQ\DQ YROWDN D YL]VJiODWEDQ LOOHWYH KRJ\ DONDOPD]WDN-e kontroll csoportot,
SRQWR]iVLUHQGV]HUWDODNtWRWWDP NLpVH]DODSMiQUDQJVRUROtaPDIHQWLYL]VJiODWRW
$]pUWH]HNHWDV]HPSRQWRNDWYiODV]WRWWDP PHUWH]HNPHJIHOHOQHNDEL]RQ\tWpNRNRQ
DODSXOy RUYRVOiV DODSHOYHLQHN pV ~J\ JRQGRORP KRJ\ H]HN DODSMiQ WXGRP ĘNHW
YLV]RQ\ODJREMHNWtYHQ|VV]HKDVRQOtWDQL
$N|YHWNH]ĘNEHQLVPHUWHWHPDSRQWR]iVLUHQGV]HUHOHPHLWPDMGPDJukat a kapott
HUHGPpQ\HNHW
5.5.1. 3RQWR]iVLUHQGV]HU
5.5.1.1. 0LO\HQPLQĘVpJĦYROWDYL]VJiODW"
(VHWWDQXOPiQ\SRQW
Eset kontroll 2 pont
5DQGRPL]iOWNRQWUROOiOWYL]VJiODWSRQW
5DQGRPL]iOWNRQWUROOiOWYL]VJiOatok meta-DQDOt]LVHSRQW

40  
 
 

0LpUW tJ\ SRQWR]WDP" $ EL]RQ\tWpNRNRQ DODSXOy pUWpNHOpV HOYHLQHN


PHJIHOHOĘHQDPDJDVDEEEL]RQ\tWyHUHMĦQHNDGWDPW|EESRQWRW
5.5.1.2. Mennyire felelt meg az IHOWHWWNpUGpVQHNDYL]VJiODWFpOMD"
/HJLQNiEE PHJIHOHO  SRQW PDJDVDEE-H D] |QJ\LONRVViJL UiWD D]
antideSUHVV]iQVWV]HGĘNN|]|WWPLQWD]RNN|]|WW, akik nem szedtek?)
0pJHOpJMyOPHJIHOHOSRQW
.HYpVEpIHOHOPHJSRQW
/HJNHYpVEp IHOHO PHJ  SRQW QHP D] YROW D YL]VJiODW FpOMD KRJ\
|VV]HIJJpVWiOOtWVDQDNIHOFVDNYpOHWOHQOPHJILJ\HOWpN
0LpUWtJ\SRQWR]WDP"$QQiONHYHVHEESRQWRWNDSWDNDYL]VJiODWRNPLQpO
LQNiEE N|]YHWHWWHQOHKHWett FVDN|VV]HIJJpVWOHYRQQL
5.5.1.3. +iQ\DQYROWDNDYL]VJiODWEDQ"  
IĘDODWWSRQW
1000- 10.000 2 pont
10.000-100.000 3 pont
100.000 < 4 pont
0LpUW tJ\ SRQWR]WDP" $ OpWV]iP Q|YHOpVpYHO FV|NNHQ D YpOHWOHQ KLED
HVpO\HUHSUH]HQWDWtYDEEDEHYRQWSRSXOiFLy
5.5.1.4. KontrROOiOWYROW-HDYL]VJiODW"
1HPNRQWUROOiOWSRQW
0iVLNDQWLGHSUHVV]iQVKR]NpSHVWSRQW
Placebo kontroll: 3 pont
0LpUWtJ\SRQWR]WDP"$GHSUHVV]Ly|QJ\LONRVViJIRNR]yKDWiViWOHJMREEDQ
SODFHERFVRSRUWKR]YLV]RQ\tWYDV]ĦUKHWMNNL

41  
 
 

5.5.2. 7iEOi]DW

,,,WiEOi]DW

1990

2004

2001

2005

1994

2004

2005

2004

2005
J A M A Jick

Juredini
Isacsson
T eicher

A ndersen

M artinez

Mosholder
T rontell,

W hittington

G unnel, Ashby
K ahn 2003
9L]VJiODW

9L]VJiODW
1 2 1 2 1 4 4 4 4 4
PLQĘVpJH
0HJIHOHOĘVpJH 1 3 2 3 2 3 4 4 3 4
/pWV]iP 1 4 1 4 2 1 2 3 2 3
.RQWUROOiOW-
1 2 1 2 1 3 3 3 3 3
e?
gVV]HVHQ 4 11 5 11 6 11 13 14 12 14

5.5.3. A WiEOi]DWHOĘQ\HLKiWUiQ\DL
5.5.3.1. (OĘQ\|N
- N|QQ\HQiWOiWKDWyYiWHV]LDIHOGRlgozott szakirodalmat
- EL]RQ\tWpNRNRQDODSXOyRUYRVOiVHOYHLQHNHOHPHLWWDUWDOPD]]D
- V]iPV]HUĦVtWL D PHJEt]KDWyViJRW IHOWHWW NpUGpVQHN YDOy
PHJIHOHOĘVpJHW
-­‐ OiWKDWy KRJ\DNpUGpV HOVĘ IHOYHWĘGpVHXWiQKRJ\OHWW HJ\UHW|EE pV
MREEPLQĘVpJĦEL]RQ\tWpND]LGĘHOĘUHKDODGWiYDO
5.5.3.2. +iWUiQ\RN
- a szempontok nem biztos, KRJ\RSWLPiOLVDQYDQQDNV~O\R]YD
- HJ\V]HUĦVtWpVHNHWWDUWDOPD]
5.5.4. gVV]HJ]pV

gVV]HVVpJpEHQWHKiWDFpORPQHPD]YROWDWiEOi]DWHONpV]tWpVpYHOKRJ\DIHOWHWW
NpUGpVUH NRQNUpW YiODV]W DGMDN LJHQ IRNR]]iN D] DQWLGHSUHVV]iQVRN D]
|QJ\LONRVViJL NRFNi]DWRW LOOHWYH QHP QLQFV LO\HQ KDWiVXN  KDQHP D] KRJ\
UHQGV]HUEHIRJODOMDPDIHOGROJR]RWWEL]RQ\tWpNRNDWVH] iOWDON|QQ\HEEHQ|VV]H
WXGMDPKDVRQOtWDQLD]DONDOPD]iVLHOĘtUiVRNEDQWDOiOWDNNDO$IHQWLWiEOizatban
NDSRWW HUHGPpQ\HN WHKiW QHP D] HUHGPpQ\HNUH KDQHP D PyGV]HUUH
vonatkoznak.

42  
 
 

5.6. +RJ\DQYLV]RQ\XOQDNHJ\PiVKR]D]DONDOPD]iVLHOĘtUiVRNpVDEL]RQ\tWpNRN"

A]DONDOPD]iVLHOĘtUiVRNV]HULQW a]DQWLGHSUHVV]iQVRNNDOYDOyNH]HOpVHOHMpQMREEDQ
oda kell figyeOQL D EHWHJHNUH PLYHO HNNRU PDJDVDEE OHKHW D] |QJ\LONRVViJL
NtVpUOHWHNV]iPD(]W N|]HSHVV]LQWĦEL]RQ\tWpNWiPDV]WMDDOiD]iOWDODPpUWpNHOW
YL]VJiODWRNN|]OSRQWRWNDSRWW-$0$-EDQPHJMHOHQWHVHWNRQWUROOYL]VJiODW(
YL]VJiODW NRQNO~]LyMD D] KRJ\ D NH]HOpV NpVĘEEL LGĘV]DNDLKR] NpSHVW PDJDVDEE
OHKHWD]|QJ\LONRVViJLUiWD9pOHPpQ\HPV]HULQWH]FVDNN|]YHWHWWHQNDSFVROKDWyD]
DQWLGHSUHVV]iQVRNKR] $ NH]HOpV HOHMpQ D] DQWLGHSUHVV]iQV KDWiVD PpJ QHP iOOW
IHOWpWOHQO EH YLV]RQW D W|EEL PHOOpNKDWiVD PiU jelentkezhet, emiatt rosszabbul
OHKHWQHNDEHWHJHNVIRNR]yGKDWQDNLO\HQLUiQ\~JRQGRODWDLN(]pUW~J\YpOHPD
NH]GHWL LGĘV]DNEDQ elengedhetetlen a gyakori orvRVL J\yJ\V]HUpV]L NRQWUROO
(OVĘVRUEDQ QHP D]pUW KRJ\ D] |QJ\LONRVViJL NtVpUOHWHNHW NLV]ĦUMpN, hiszen ez
QDJ\RQ QHKp] OHQQH PHJ D EHWHJ H]HNHW QHP IHOWpWOHQO YDOOMD EH $UUD QDJ\RQ
IRQWRV IHOKtYQL D SiFLHQV ILJ\HOPpW KRJ\ KD D] HOVĘ QpKiQ\ KpWHQ RO\DQ
PHOOpNKDWiVRNDW WDSDV]WDO PHO\HN QRUPiO pOHWYLWHOpW PHJQHKH]tWLN ]DYDUMiN,
IHOWpWOHQO M|MM|Q YLVV]D NRQ]XOWiOQL PLYHO QHP PLQGHQNL XJ\DQ~J\ UHDJiO D
J\yJ\V]HUHNUH VDMQRV HOĘIRUGXOKDWQDN LO\HQHN YLV]RQW OHKHWĘVpJ YDQ D WHUiSLD
iWiOOtWiViUD $ODSYHWĘ OHQQH LVPHUWHWQL YHOH KRJ\ PLO\HQ HJ\pE WHUiSLiV
OHKHWĘVpJHNHW YHKHW LJpQ\EH SpOGiXO SV]LFKRWHUDSHXWiW SV]LFKROyJXVW (]]HO
EL]DOPDWNHOWKHWQNEHQQHKRJ\IRQWRVQHNQND]KRJ\iOODSRWDMDYXOMRQVH]iOWDO
YDOyV]tQĦOHJ EiWUDEEDQ HOPRQGMD PDMG QHNQN D J\yJ\V]HUHOpV DODWW HVHtlegesen
MHOHQWNH]Ę SUREOpPiLW $EEDQ D] HVHWEHQ KD QHP PĦN|GLN D] DGRWW KDWyDQ\DJ
IHOWpWOHQO iW NHOO iOOtWDQL KD PLQGHQNpSS FVDN D J\yJ\V]HUHV WHUiSLiW YiODV]WMD
)RQWRV KRJ\ PLQGHQ HVHWEHQ D OHKHWĘVpJHN PHJLVPHUpVH XWiQ Ę G|QWKHVVHQ D
NH]HOpVUĘO
%iUYROWDNRO\DQYL]VJiODWRNPHO\HNV]HULQWIRNR]]iND]|QJ\LONRVViJRN DUiQ\iW
D] DQWLGHSUHVV]iQVRN H]HN IĘNpQW DODFVRQ\ HYLGHQFLD V]LQWĦHN YROWDN D]
pUWpNHOpVHPEHQLVDODWWLSRQWV]iPRWNDSWDN )ĘNpQWUpJHEEHQYpJ]HWWYL]VJiODWRN
voltak. (]HNNHODYL]VJiODWRNNDOD]YROWDSUREOpPDKRJ\NLVOpWV]iP~DNYROWDN
valamint vDJ\ QHP YROW NRQWUROO FVRSRUW YDJ\ FVDN HJ\ PiVLN DQWLGHSUHVV]iQV
KDWyDQ\DJKR]NpSHVWYLV]RQ\tWRWWDN(]D]pUWJRQGPLYHOLO\PyGRQQHKp]NLV]ĦUQL
D]WKRJ\D]HVHWHNKiQ\DGUpV]pEHQYROWPDJDDGHSUHVV]LyD]|QJ\LONRVViJRND
0DJDV EL]RQ\tWy HUHMĦ V]LV]WpPiV |VV]HIRJODOyN pV PHWD-anaOt]LVHN V]HULQW QLQFV

43  
 
 

NO|QEVpJVHPD]DQWLGHSUHVV]iQVRNN|]|WWVHPDSODFHERFVRSRUWKR]YLV]RQ\tWYD
D] |QJ\LONRVViJL UiWD WHNLQWHWpEHQ ( YL]VJiODWRNDW W|EE UDQGRPL]iOW NRQWUROOiOW
YL]VJiODWEHYRQiViYDOYpJH]WpNVRNEHWHJEHYRQiViYDO$*XQQHOOpVPXQNDWiUVDL
iOWDO -EHQ SXEOLNiOW PHWD-DQDOt]LV HUHGPpQ\HL V]HULQW   D] DQWLGHSUHVV]iQVRN
V]HGpVH DODWW D]   |QJ\LONRVViJRN |VV]HVtWHWW NRFNi]DWD 0,74-szerese a kontroll
FVRSRUWpQDNWHKiWDODFVRQ\DEED]|QJ\LONRVViJNRFNi]DWDD kezelt csoportban. A
QHPKDOiORV|QJ\LONRVViJLNtVpUOHWHN-V]RURVDND]DQWLGHSUHVV]iQVRNNDONH]HOW
csoportEDQ D QHP NH]HOWKH] NpSHVW (] D]W PXWDWMD XJ\DQ KRJ\ QDJ\RQ NLFVLW
PDJDVDEED]DQWLGHSUHVV]iQVWV]HGĘNN|]|WWDNRFNi]DWGHDYL]VJiODWPHJMHJ\zi,
KRJ\U|YLGYROWDN|YHWpVLLGĘ7HKiWV]iPROKDWXQND]]DODPLWD]HOĘ]ĘEHNH]GpVEHQ
UpV]OHWH]WHP KRJ\ D NH]HOpV HOHMpQ D NHOOHPHWOHQ QHP NtYiQW KDWiVRN PLDWW
IRNR]yGKDWD]|QJ\LONRVViJLNpV]WHWpV
$]DONDOPD]iVLHOĘtUiVNO|QILJ\HOPH]HWDJ\HUHNNRUUD$OHJW|EEDQWLGHSUHVV]iQV
(az SSRI-N pV D] ~MDEEDN LV  HOĘtUiVD WLOWMD D PDMRU GHSUHVV]LyV J\HUHNHNQpO D
IHOKDV]QiOiVW (]W QpPLOHJ DODFVRQ\DEE V]LQWĦ GH PpJ PLQGLJ HOpJ My PLQĘVpJĦ
WDQXOPiQ\RNWiPDV]WMiNDOi D]pQSRQWR]iVLUHQGV]HUHPEHQ-13 pontot kaptak).
+iWUiQ\XN DQQ\L KRJ\ YLV]RQ\ODJ NLV EHWHJSRSXOiFLyW YL]VJiOWDN HPLDWW QĘKHW D
YpOHWOHQKLEDHVpO\H*\HUHNHNNHOVDMQRVNHYpVNOLQLNDLYL]VJiODWiOOUHQGHONH]pVUH
GHH]QHPFVDND]DQWLGHSUHVV]iQVRNUDLJD]HJ\pENpQW Ennek egyik oka, hogy nem
WHOMHVHQpUYpQ\HVOHVHWNEHQD]|QNpQWHVEHOHHJ\H]pVD]D]DV]OHLNMyYiKDJ\iVD
V]NVpJHVDYL]VJiODWEDQYDOyUpV]YpWHOKH]PtJHJ\IHOQĘWWNL]iUyODJ|QPDJDG|QW
DNH]HOpVUĘO
$IOXR[HWLQDONDOPD]iVLHOĘtUiVDQHPWLOWMDHJ\HGODPDMRUGHSUHVV]LyNH]HOpVpWD
SHGLiWULiEDQ(]HJ\EHKDQJ]LND]iOWDODPWDOiOtakkal is, tudniillik a fluoxetinnek volt
D OHJNLVHEE UHODWtY NRFNi]DWD D SODFHEyKR] NpSHVW 55  &, -2,40) [53.]
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>@6HPPHOZHLV(J\HWHP3V]LFKLiWULDLpV3V]LFKRWHUiSLiV.OLQLND3V]LFKRWHUiSLiV
RV]WiO\http://semmelweis.hu/pszichoterapiasosztaly/2015/04/a-depresszio-tunetei-es-
kezelese/ PHJMHOHQtWYHMDQXiU

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http://nol.hu/archivum/archiv-31945-20878 PHJMHOHQtWYHIHEUXiU

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460-468

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6]iV]*\7DNiFVQp1RYiN. V]HUN *\yJ\V]HUpV]L.pPLD6HPPHOZHLV.LDGy
(2010) 26-46

[10.] 5LKPHU=3HVWDOLW\3$QWLGHSUHVV]tYXPRNpVKDQJXODWVWDELOL]iWRURN)UHGL-
1pPHWK$7DULVND3 V]HUN $SV]LFKLiWULDPDJ\DUNp]LN|Q\YH0HGLFLQD
.|Q\YNLDGy  -494

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.|Q\YNLDGy  -651.

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[16.]  2UV]iJRV*\yJ\V]HUpV]HWLpVeOHOPH]pV-HJpV]VpJJ\L,QWp]HW
*\yJ\V]HULQIRUPiFLy*\yJ\V]HUDGDWEi]LV
http://www.ogyei.gov.hu/gyogyszeradatbazis/ Aurorix 150 mg, 300 mg tabletta,
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[19.] BRW]/$J\yJ\V]HUHOpVVHO|VV]HIJJĘQHPNtYiQDWRVHVHPpQ\HNBaranyai
=VROW+DUViQ\L/iV]Oy V]HUN %HWHJEL]WRQViJ0HGLFLQD  PHJMHOHQpVDODWW

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PHJMHOHQtWYHDXJXV]WXV

[21.] Beard K: Introduction. Lee, A. (szerk.): Adverse Drug Reactions, London:


Pharmaceutical Press (2006) 7-8

[22.] National Coordinating Council for Medication Error Reporting and Prevention:
About medication errors: http://www.nccmerp.org/about-medication-errors
PHJMHOHQtWYHM~OLXV

[23.] Eurpean Medicines Agency: Medication errors.

http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_c
ontent_000570.jsp PHJMHOHQtWYH 2015. M~OLXV

[24.] *\yJ\V]HUpV]HWL pV (JpV]VpJJ\L 0LQĘVpJ pV 6]HUYH]HWIHMOHV]WpVL ,QWp]HW


Informatikai pV 5HQGV]HUHOHP]pVL )ĘLJD]JDWyViJ -RJV]DEiO\N|YHWpV
http://www.eski.hu/new3/jogszabaly/jogszabaly_teteles.php?id=390 PHJMHOHQtWYH
2015. augusztus)

[25.] Official Journal of the European Union: Directive 2010/84/EU of the European
Parliament and of the Council. http://ec.europa.eu/health/files/eudralex/vol-
1/dir_2010_84/dir_2010_84_en.pdf PHJMHOHQtWYHDXJXV]WXV

[26@;&9W|UYpQ\D]HPEHULDONDOPD]iVUD NHUOĘJ\yJ\V]HUHNUĘOpVHJ\pE
J\yJ\V]HUSLDFRWV]DEiO\R]yW|UYpQ\HNPyGRVtWiViUyO†

[27.] World Health Organisation: Essential medicines and health products,


Pharmacovigilance.
http://www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/
PHJMHOHQtWYHDXJXV]WXV

[28.] ;&9W|UYpQ\  D]HPEHULDONDOPD]iVUDNHUOĘJ\yJ\V]HUHNUĘOpVHJ\pE


J\yJ\V]HUSLDFRWV]DEiO\R]yW|UYpQ\HNPyGRVtWiViUyO† 

[29.] 0DJ\DU*\yJ\V]HUpV]L.DPDUD(OQ|NVpJLWiMpNR]WDWy7iMpNR]WDWyD
IDUPDNRYLJLODQFLDIRJDOPiUyOMRJLV]DEiO\R]iViUyOpVDJ\DNRUOyJ\yJ\V]HUpV]HN

52  
 
 

V]DNPDLIHODGDWDLUyOKWWSZZZPJ\NSPKXILOHVIDUPDNRYLJLODQFLD-taj-vegl.pdf
PHJMHOHQtWYHDXJXV]WXV 

[30@2UV]iJRV*\yJ\V]HUpV]HWLpVeOHOPH]pV-HJpV]VpJJ\L,QWp]HW%HMHOHQWpV
IHOWpWHOH]HWWJ\yJ\V]HU-PHOOpNKDWiVRNUyO
http://www.ogyei.gov.hu/dynamic/mellhat_bejelentolap2015_MG2.pdf PHJMHOHQtWYH
IHEUXiU

[31.] ;&9W|UYpQ\  D]HPEHULDONDOPD]iVUDNHUOĘJ\yJ\V]HUHNUĘOpVHJ\pE


J\yJ\V]HUSLDFRWV]DEiO\R]yW|UYpQ\HNPyGRVtWiViUyO†  H

[32.]European Medicines Agency, Human Regulatory, Pharmacovigilance,Periodic Safety


Update Reports:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/docu
ment_listing_000361.jsp& PHJMHOHQtWYHDXJXV]WXV 

[33.] 2UV]iJRV*\yJ\V]HUpV]HWLpVeOHOPH]pV-HJpV]VpJJ\L,QWp]HW0HOOpNKDWiVRN
EHMHOHQWpVH)RQWRVWiMpNR]WDWiVDPHOOpNKDWiV-EHMHOHQWpVUĘOpVDMHOHQWpVHN
pUWpNHOpVpQHNIRO\DPDWiUyO
http://www.ogyei.gov.hu/tajekoztatas_a_mellekhatas_jelentessel_kapcsolatban/

PHJMHOHQtWYHIHEUXiU

[34.] European Medicines Agency, Commitees, Pharmacovigilance Risk Assessment


Commitee.  
http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content
_000537.jsp PHJMHOHQtWYHIHEUXiU)

[35@$URQVRQ-.0H\OHU¶V6LGH(IIHFWVRI3V\FKLDWULF'UXJV(OVHYLHU2[IRUG
Ú 2009) 77-80

[36.]  $URQVRQ-.0H\OHU¶V6LGH(IIHFWVRI3V\FKLDWULF'UXJV(OVHYLHU2[IRUG
Ú  -16

[37.] $URQVRQ-.0H\OHU¶V6LGH(IIHFWVRI3V\FKLDWULF'UXJV(lsevier,Oxford,
Ú  -43.

53  
 
 

[38.] $URQVRQ-.0H\OHU¶V6LGH(IIHFWVRI3V\FKLDWULF'UXJV(OVHYLHU2[IRUG
Ú  -88

[39.] World Health Organisation Collaborating for Drug Statistics Methodology:


ATC/DDD Index, N06A Antidepressants:
http://www.whocc.no/atc_ddd_index/?code=N06A PHJMHOHQtWYHV]HSWHPEHU

[40@2UV]iJRV*\yJ\V]HUpV]HWLpVeOHOPH]pV-HJpV]VpJJ\L,QWp]HW
*\yJ\V]HULQIRUPiFLy*\yJ\V]HUDGDWEi]LV
http://www.ogyei.gov.hu/gyogyszeradatbazis/ PHJMHOHQtWYHV]HSWHPEHU

Melipramin 25 mg filmtabletta, TeperinEP 10 mg/25 mg/50 mg filmtabletta, Anafranil


10 mg/25 mg/ 75 mg (SR) filmtabletta, Ludiomil 10 mg/25 mg/75 mg filmtabletta,
3UR]DFPJPOEHOVĘOHJHVROGDW)HYDULQPJPJILOPWDEOHWWD=RORIWPJ
ILOPWDEOHWWDPJPONRQFHQWUiWXPEHOVĘOHJHVROGDWKR]6HUR[DWPJILOPWDEOHWWD
Cipralex 10 mg filmtabletta, Aurorix 150 mg/300 mg filmtabletta, Wellbutrin SR 150
PJUHWDUGWDEOHWWD&\PEDOWDPJJ\RPRUQHGYHOOHQiOOyWDEOHWWD7ROYRQPJ
filmtabletta, Mirtadepi 15 mg/30 mg/45 mg filmtabletta, Edronax 4 mg tabletta, Coaxil
12,5 mg bevont tabletta, Trittico AC 75 mg / 150 mg retard tabletta, Veloxan 37,5
PJPJPJUHWDUGNHPpQ\NDSV]XOD

[41.] +iEHUÈ6]ĦFV)2VYiWK3pVPWVDL$F\WRFKURP3'pV&
JHQRWtSXVLGĘV]HUĦNpUGpVHLD]DQWLGHSUHVV]tYIDUPDNRWHUiSLiEDQ*\yJ\V]HUpV]HW
Ú  -734

[42.] Sackett D.L., Rosenberg W0*UD\-$pVPWVDL(YLGHQFHEDVHGPHGLFLQH


what it is and what it isn't, British Medical Journal (1996) 312: 71-72

[43@%RW]/$WXGRPiQ\RVEL]RQ\tWpNRNV]HUHSHDJ\yJ\tWiVEDQpVD
J\yJ\V]HUWHUiSLiQiO%RW]/ V]HUN $J\yJ\V]HUWHUiSLDEL]RQ\tWpNRNRQpV
J\yJ\V]HUDGDWEi]LVRNRQDODSXOypUWpNHOpVpQHNJ\DNRUODWD3pFVL7XGRPiQ\HJ\HWHP
(2014) 26-28.

[44@+iEHUÈ9L]VJiODWLWtSXVRNpVHOUHQGH]pVHN0HJD-WULDOV]LV]WHPDWLNXVHOHP]pV
%RW]/ V]HUN $J\yJ\V]HUWHUiSLDEL]RQ\tWpNRNRQpVJ\yJ\V]HUDGDWEi]LVRNRQ
DODSXOypUWpNHOpVpQHNJ\DNRUODWD3pFVL7XGRPiQ\HJ\HWHP  -25

54  
 
 

[45.] %RW]/%L]RQ\tWpNRNRQDODSXOyJ\yJ\V]HUpUWpNHOpVV]DNPDLpVJD]GDViJL
HOHP]pVpQHN~MLVPHUHWDQ\DJDL%RW]/ V]HUN $J\yJ\V]HUWHUiSLDEL]RQ\tWpNRNRQpV
J\yJ\V]HUDGDWEi]LVRNRQDODSXOypUWpNHOpVpQHNJ\DNRUODWD3pFVL7XGRPiQ\HJ\HWHP
(2014) 29-35

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The Journal of the American Medical Association (2004) 292: 338-343

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treatment and psychiatric morbidity in 390 cases of suicide with special focus on
affective disorders. Acta Psychiatrica Scandinavica (2001) 104: 458-465

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of non fatal self harm in first episode depression: nested case control study. British
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people committing suicide in Sweden. British Medical Journal (1994) 308: 506-509  

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antidepressants for children and adolescents. British Medical Journal (2004) 328: 879-
883

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antidepressants, and placebo: analysis of FDA reports.American Journal of Psychiatry.
(2003) 160: 790-792.

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inhibitors in childhood depression: systematic review of published versus unpublished
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56  
 
 

0HOOpNOHWHN

 
 
 

.|V]|QHWQ\LOYiQtWiV

(]~WRQV]HUHWQpNN|V]|QHWHWPRQGDQL WpPDYH]HWĘPQHNdr. Botz Lajosnak,

a szakdolgozatom HONpV]tWpVHVRUiQQ\~MWRWWV]DNPDL IHONpV]tWpVpUW pVWiPRJDWiVpUW

 
 
1. számú melléklet
Mellékhatások
Antidepresszánsok mellékhatásai
Cardiovaszkuláris rendszer
orthosztatikus h!hullám EKG tachycardia. vezetési palpitatio arrythmia hypertonia hypotonia perifériás hypertenzív kardiális myocardiális extrasystole mellkasi értágulat vasculitis perifériás hematuria bradycardia ventrikuláris ventrikuláris vérzés purpura
Hatóanyag csoport Hatóanyag hypotonia kipirulás eltérések zavar vazospazmus krízis dekompenzáció infarktus fájdalom ischaemia fibrilláció tachycardia

imipramin """"" """"" """"" """"" """" """" """" "" "" ""
Tri és tetraciklusos amitriptylin """" """" """" """" """" "" """ ""
antidepresszánsok clomipramin """" """" """" """" " """" """ """
maprotilin """" """" """" " """" "" " " "
fluoxetin """" """" "" """ "" ""
fluvoxaim """ """" """" #
SSRI sertralin """" # """ # """" """ "" "" #
escitalopram # # """ # # ""
paroxetin """ """ """ """ ""
MAO-A gátlók moclobemid "" """"
venlafaxin """ """" """ """" """" # # # #
duloxetin """ """" """ """" """ """" """ ""
bupropion " """" """ " """" "
reboxetin """" """" """" """" """"
Egyéb antidepresszánsok
mianszerin # # #
mirtazapin """" """
trazodon # # # # # #
tianeptin """" """" """" """" !
Jelmagyarázat
Nagyon gyakori 10 % ! !!!!!
gyakori 10%"# "1% !!!!
nem gyakori 1%" "0,1 % !!!
ritka 0,1%" "0,01 % !!
nagyon ritka 0,01 % > !
nem ismert " !
2. számú melléklet
Mellékhatások
Antidepresszánsok mellékhatásai
Pszichiátriai kórképek

hypomania álmosság rendellenes pszichózis emelkedett gondolkodási konverziós gyógyszer panaoid suicid
Hatóanyag csoport Hatóanyag delírium hallucináció dezorientáció agitatio nyugtalanság szorongás agresszió fáradékonyság álmatlanság alvászavar izgatottság fogcsikorgatás zavarodottság idegesség apathia pánikroham dadogás akathisia alvajárás
mania aluszékonyság álmok aktiválódás hangulat zavar zavar függ!ség téveszmék gondolatok

imipramin """" """" """" """" """" """" """" """" """" """" """ "" #
amitriptylin "" "" """ """ """ """" """ #
Tri és tetraciklusos antidepresszánsok
clomipramin """" """" """" """" """" """"" """" """" """"" """" """" """ #
maprotilin "" "" """" """" """" """" """" """" """" """" " "" "" #
fluoxetin "" "" """" """" """"" """" """" """" "" """ """ "" """" "" "" "" """
fluvoxamin """ "" """" """" """" """" """ """" #
SSRI sertralin """ """" """ """"" """" """" "" """ """" """" """ """ "" "" "" "" ""
escitalopram "" # """ """" """" "" """" """" """" """ """ """ """ #
paroxetin """ "" "" # """" """" """" """" """ "" "" #
MAO-A gátlók moclobemid """" """" """"" """" """/""
venlafaxin # """ "" """ # """" """" """ """" """" """ """ #
duloxetin "" """ "" """" "" """" """ """" """ """ """ """ """/""
bupropion " """" " """"" " """" """ " #
reboxetin # """" """" # """"" """" #
Egyéb antidepresszánsok
mianszerin # """" """" """" #
mirtazapin """ """ "" """" """ """" """ #
trazodon # # # # # # # # # # # # #
tianeptin # """" """" """" # """ # !
Jelmagyarázat
Nagyon gyakori 10 % ! !!!!!
gyakori 10%"# "1% !!!!
nem gyakori 1%" "0,1 % !!!
ritka 0,1%" "0,01 % !!
nagyon ritka 0,01 % > !
nem ismert " !
3. számú melléklet

Mellékhatások
Antidepresszánsok mellékhatásai
Vérképz#szervi és nyirokrendszeri

abnormális aplasztikus
Hatóanyag csoport Hatóanyag agranulocytosis leukopenia thrombocytopenia eosinophylia lymphadenopathia anaemia granulocytopenia
vérzések anaemia

imipramin !! !! !! !!
amitriptylin !! !! !! !!
Tri és tetraciklusos antidepresszánsok
clomipramin ! ! ! ! !
maprotilin ! ! ! !
fluoxetin !!
fluvoxaim
SSRI sertralin " " !!
escitalopram "
paroxetin ! !!!
MAO-A gátlók moclobemid
venlafaxin " " "
duloxetin
bupropion " " "
reboxetin
Egyéb antidepresszánsok
mianszerin " "
mirtazapin " " " " "
trazodon " " " " "
tianeptin
!

Jelmagyarázat
Nagyon gyakori 10 % ! !!!!!
gyakori 10%"# "1% !!!!
nem gyakori 1%" "0,1 % !!!
ritka 0,1%" "0,01 % !!
nagyon ritka 0,01 % > !
nem ismert " !
! !
4. számú melléklet
Mellékhatások
Antidepresszánsok mellékhatásai
Endokrin rendszer és szexuális funkció

Erektilis késleltetett menstrucáiós eml! vércukorszint hüvelyi atrophiás ejaukációs


Hatóanyag csoport Hatóanyag Libidózavar anorgasmia gynecomascia galactorrhoea SIADH hyperprolaktinaemia priapismus hyportireózis balanoposthitis herefájdalom
diszfunkció ejakuláció zavarok megnagyobbodás változás folyás vulvovaginitis fájdalom

imipramin "" "" "" ""


amitriptylin """" """" """"
Tri és tetraciklusos antidepresszánsok
clomipramin """"" """"" """" """" "
maprotilin """" " " "
fluoxetin """" """" """" "" "" "" ""
fluvoxaim """ # # "" # #
SSRI sertralin """" """"" """ # "" "" "" "" ""
escitalopram """" """" "
paroxetin """"" """"" "" "" " "" "
MAO-A gátlók moclobemid
venlafaxin """" """" """" """" """" #
duloxetin """" """" """ "" "" "" "" """
bupropion
reboxetin """" """" # """"
Egyéb antidepresszánsok
mianszerin
mirtazapin #
trazodon #
tianeptin
!

Jelmagyarázat
Nagyon gyakori 10 % ! !!!!!
gyakori 10%"# "1% !!!!
nem gyakori 1%" "0,1 % !!!
ritka 0,1%" "0,01 % !!
nagyon ritka 0,01 % > !
! ! nem ismert " !
! !
5. számú melléklet

Mellékhatások
Antidepresszánsok mellékhatásai
Anyagcsere változások

Hatóanyag csoport Hatóanyag testtömeg ! testtömeg " étvágy! étvágy" anorexia hyponatraemia hypercholesterinaemia hypoglycaemia hyperglycaemia

imipramin ##### ## ####


amitriptylin #### ## #### ##
Tri és tetraciklusos antidepresszánsok
clomipramin ##### ####
maprotilin #### #### #
fluoxetin #### ##
fluvoxaim $ $ #### $
SSRI sertralin #### #### ## ## $
escitalopram #### ### #### #### $ $
paroxetin #### ## ####
MAO-A gátlók moclobemid ## ##
venlafaxin #### $
duloxetin ### #### #### ## ## ###
bupropion ### #### # #
reboxetin #### $
Egyéb antidepresszánsok
mianszerin $
mirtazapin ##### #####
trazodon $ $ $ $
tianeptin #### $ !

Jelmagyarázat
Nagyon gyakori 10 % ! !!!!!
gyakori 10%"# "1% !!!!
nem gyakori 1%" "0,1 % !!!
ritka 0,1%" "0,01 % !!
nagyon ritka 0,01 % > !
nem ismert " ! !
6. számú melléklet
Mellékhatások
Antidepresszánsok mellékhatásai
Idegrendszeri tünetek
csökkent malignus
ízérzés epilepsziás pszichomotoros extrapiramidális serotonin egyensúly
Hatóanyag csoport Hatóanyag tremor paraesthesia fejfájás szédülés koncentráló memóriazavar fásultság convulsio ataxia myoclonus beszédzavar ájulás neuroleptikus.
zavara roham nyugtalanság tünetek syndroma zavar
képesség Szindróma
imipramin !!!!! !!!! !!!! !!!! !!! !! !! !! !!
amitriptylin !!!! !!!! !!!! !!!! !!!! !!!! !! !!!!
Tri és tetraciklusos antidepresszánsok
clomipramin !!!!! !!!! !!!!! !!!!! !!!! !!!! !!!! !!! !!! !!!!! !!!! !
maprotilin !!!!! !!!! !!!!! !!!!! !!!! ! !!!! !! ! !! !!!!! ! !
fluoxetin !!!! !!!!! !!!! !!!! !!!! !!!! !!! !!
fluvoxaim !!!! " !!!! !!!! " !! " !!! !!! " "
SSRI sertralin !!!! !!!! !!!!! !!!!! !!!! !!!! !!! !!! !!! !!!
escitalopram !!!! !!!! !!!!! !!!! !!! " " !! !! !!!
paroxetin !!!! !!!! !!!! !! !!! !
MAO-A gátlók moclobemid !!!! !!!!! !!!!!
venlafaxin !!!! !!!! !!!!! !!!!! !!! !! !!! " !!! " !!! !!! "
duloxetin !!!! !!!! !!!!! !!!! !!! !!! !!!! !! !! !! !!! !!
bupropion !!!! ! !!!!! !!!! !!!! !!!! ! !! ! !
reboxetin !!!! !!!! !!!!! !!!!
Egyéb antidepresszánsok
mianszerin " " "
mirtazapin !!!! !!! !!!!! !!!! !!!! " !!! !! " !!!
trazodon " " " " " " " " "
tianeptin !!!! !!!! !!!! " !

Jelmagyarázat
Nagyon gyakori 10 % ! !!!!!
gyakori 10%"# "1% !!!!
nem gyakori 1%" "0,1 % !!!
ritka 0,1%" "0,01 % !!
nagyon ritka 0,01 % > !
nem ismert " !
! !
7. számú melléklet

Mellékhatások
Antidepresszánsok mellékhatásai
Anyagcsere változások

Hatóanyag csoport Hatóanyag testtömeg ! testtömeg " étvágy! étvágy" anorexia hyponatraemia hypercholesterinaemia hypoglycaemia hyperglycaemia

imipramin ##### ## ####


amitriptylin #### ## #### ##
Tri és tetraciklusos antidepresszánsok
clomipramin ##### ####
maprotilin #### #### #
fluoxetin #### ##
fluvoxaim $ $ #### $
SSRI sertralin #### #### ## ## $
escitalopram #### ### #### #### $ $
paroxetin #### ## ####
MAO-A gátlók moclobemid ## ##
venlafaxin #### $
duloxetin ### #### #### ## ## ###
bupropion ### #### # #
reboxetin #### $
Egyéb antidepresszánsok
mianszerin $
mirtazapin ##### #####
trazodon $ $ $ $
tianeptin #### $ !

Jelmagyarázat
Nagyon gyakori 10 % ! !!!!!
gyakori 10%"# "1% !!!!
nem gyakori 1%" "0,1 % !!!
ritka 0,1%" "0,01 % !!
nagyon ritka 0,01 % > !
nem ismert " ! !
8. számú melléklet

Mellékhatások
Antidepresszánsok mellékhatásai
Érzékszervek

akkomodációs emelkedett
Hatóanyag csoport Hatóanyag látászavar mydriasis fülzúgás glaucoma vertigo
zavar szembelnyomás
imipramin !!!!! !!!!! !! " !!
amitriptylin !!!! !!!! !!!! !!! !!!
Tri és tetraciklusos antidepresszánsok
clomipramin !!!!! !!!!! !!!! !!!! !
maprotilin !!!! !
fluoxetin !!!! !!! !!!
fluvoxaim " "
SSRI sertralin !!!! !!! !!
escitalopram !!! !!! !!!
paroxetin !!!! !!! " !
MAO-A gátlók moclobemid !!!
venlafaxin !!!! !!!! !!!! "
duloxetin !!!! !!! !!!! !! !!!
bupropion !!!! !!!!
reboxetin !!!! !!! !! " !!!
Egyéb antidepresszánsok
mianszerin
mirtazapin
trazodon
tianeptin !

Jelmagyarázat
Nagyon gyakori 10 % ! !!!!!
gyakori 10%"# "1% !!!!
nem gyakori 1%" "0,1 % !!!
ritka 0,1%" "0,01 % !!
nagyon ritka 0,01 % > !
nem ismert " ! !
9. számú melléklet

Mellékhatások
Antidepresszánsok mellékhatásai
Vese és húgyutak
vizelettartási
Hatóanyag csoport Hatóanyag vizeletretenció vizelési zavar nehézség/gyakori
vizeletürítés
imipramin !!!!
amitriptylin !!!
Tri és tetraciklusos antidepresszánsok
clomipramin ! !!!!!
maprotilin ! !!!!
fluoxetin !! !!! !!!!
fluvoxaim !
SSRI sertralin !!! !!
escitalopram "
paroxetin !!! !!!
MAO-A gátlók moclobemid
venlafaxin !!! !!!! !!
duloxetin !!! !!!!
bupropion !
reboxetin !!!! !!!!
Egyéb antidepresszánsok
mianszerin
mirtazapin "
trazodon
tianeptin !

Jelmagyarázat
Nagyon gyakori 10 % ! !!!!!
gyakori 10%"# "1% !!!!
nem gyakori 1%" "0,1 % !!!
ritka 0,1%" "0,01 % !!
nagyon ritka 0,01 % > !
nem ismert " ! !
10. számú melléklet

Mellékhatások
Antidepresszánsok mellékhatásai
B!r és b!r alatti szövetek

hideg erythema steven-johnson toxikus epidermális


Hatóanyag csoport Hatóanyag izzadás b!rkiütés urticaria fényérzékenység ödéma pruritus hajhullás
verejték multiform syndróma necrosis
imipramin """"" """" """" "" "" "" ""
amitriptylin """" """ """ "" """ ""
Tri és tetraciklusos antidepresszánsok
clomipramin """"" """" """" """"
maprotilin """" """" """" """" " " " "
fluoxetin """" """" """" "" """ """
fluvoxaim """" """ "" """ """
SSRI sertralin """" """" """ # """ """ """ """ # #
escitalopram """" """ """ # """ """
paroxetin """" """ " " " " "
MAO-A gátlók moclobemid """" """ """
venlafaxin """"" """ # """ """ # """ # # #
duloxetin """" """" """ """ "" """ ""
bupropion """" """" " "
reboxetin """"" """"
Egyéb antidepresszánsok
mianszerin #
mirtazapin """" # # #
trazodon # # #
tianeptin """ """ """ !

Jelmagyarázat
Nagyon gyakori 10 % ! !!!!!
gyakori 10%"# "1% !!!!
nem gyakori 1%" "0,1 % !!!
ritka 0,1%" "0,01 % !!
nagyon ritka 0,01 % > !
nem ismert " !

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