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臺北高等行政法院 高等庭(含改制前臺北高等行政法院)108年度訴字第1929號

關鍵資訊

  • 裁判案由
    藥害救濟法
  • 案件類型
    行政
  • 審判法院
    臺北高等行政法院 高等庭(含改制前臺北高等行政法院)
  • 裁判日期
    110 年 12 月 16 日

10819291101125 1081091080190108 10761 10762 使quetiapineSinzacfluoxetineLexapro escitalopramzolon ZopicloneEra/ErispanFludiazepam510765107724 108221288 使 1084161081402665A 108417調10840002271084171081091080190108 1073261075 10761 20mg100mg 調7.5mg 10762 0.25mg10mg107649 43107651235 19119 96仿/suicidality 使 1 20174,00010AD 4002008 15 200 1077243208使 調 調31108221288 使Sinzac24使108417 10761 2 10762 10775 Quetiapine 0.010μg/mL 0.195-0.632μg/mLZopiclone0.010μg/mL 0.9μg/mL 24使 使 15102 723 108-10917 123 2 2 131()108221 使 調 1 5 2510841715使 使使 314 使使使412 1使 2 1211212 13使使使143使 3113使使使使使13109 616 122 21315941 ()30421109123 使200 使 調553 109838 107326 3,100 107328 107517/ 尿chest X-ray 10761 2 sometimes fluoxetine 20mg PO qdKowell® 1tab PO tidzopiclone 7.5mg PO hsquetiapine 100mg PO hs7 1076210 E.K.G80/escitalopram 10mg PO qdγ-oryzano l 1 PO bidfludiazepam 0.25mg 0.5tab PO bid7 4 107753531143211 3 107651 1511071071101711 651510764900043 109 10mg/dL 0.010 Quetiapine0.010μg/mL0.195 -0.632μg/mLZopiclone0 .010μg/mL0.9μg/m L尿 15 127 1 800 調 調 調108-109 171212213 1.107326517 51852561Prozac 20mg(Zopiclone()Seroquel 100mg() 2.使61ProzacZopicloneSeroquel 100mg 62Lexapro(Erispan()r-Oryzanol(6561(6265 65Prozac30使 FDA25 ZopicloneSeroquelErispanLexapro 3. 4.使(quetiapinefluoxeti neescitalopram)使 使Quetiapine(Seroquel)Fluoxetine(Prozac)Escitalopram(Lexapro)使(2)使Anti-depressant 使Antidepressant2016Tarang Sharma 70US SSRIs/SNRIs18,500( 使使SSRIs Akathisia (4) ? i.Quetiapine 100mg(Sedation)ii. (Major depressive disorder(MDD) with psychotic featuresSedation (5) ?使使 使 1.10761 (psychotic symptoms)fluoxetinequetiapine10762 escitalopram2.使FDA200310 20052007(young adult) FDA FDA FDA FDAFDA254031(10761fluoxetine 20mgquetiapine 100mg2 escitalopram10765 使3.25使fluoxetinequetiapineescitalopram使 / 10761 fluoxetineKowell()zopiclonequetiapine 62escitalopramγ-oryzanol(調fludiazepam 2.使10765 quetiapine0.01μg/mL(0.195-0.632μg/mL)zo piclone0.01μg/mL( 0.9μg/mL)尿quetiapine0.020μg/m Lzopiclone0.148μg/mL 尿( fluoxetineescitalopramfludiazepam 656162調1818-2425使 3.4.使(quetiapine fluoxetineescitalopram)使 quetiapinefluoxetineescitalopram使(使 )使 使Anti-depressant 18quetiapine(14 18-24525-64 165 6 24使61調62654 調 ? 62?使 使使 1() 1.調 fluoxetinequetiapineescitalopram仿 US FDA仿(Ref 1.)25(antidepressant,AD) 70 trials18,526 (level of evidence) 使(Ref 2,3)仿使AD /(Ref 4 5)2.使fluoxetineZopiclonequetiapineescitalopramfludiazepammaximal dose) quetiapineZopiclone0.010μg/mL(0.9μg/mL)drug ove rdose(7.5mg0.06μg/ mL(Ref 6.)3. drag overdose depression ( 4. ie°Zopiclone 16165 (0.010μg/mL) 4 108221288 使Sinzac 穿尿107326 107561fluoxetinequetiapinezopiclone 6210escitalopram6 5 Quetiapine ( 0.010μg/mL(0 .195-0.632μg/mL) ; Zopiclone(0.010μg/mL(0.9μ g/mL) 107612fluoxetinequetiapineescitalopram使242 fluoxetine(041606quetiapine (049496escitalopram ( 023960仿BMJ.2016 Jan27352i65.)243 fluoxetine(041606 quetiapine(049496escitalopram(023960仿 / Arch.Clin.Psychiatry(Sāo Paulo) [online].2016,vol.43,n.3,pp.60-66.Men tal Health ClinicianSeptember 2015,Vol.5,No.5,pp.202-211.)4Sc i Rep.2016 May l2625770.PLoS One.2018 Jan 513(l)e0000000.)使5使fl uoxetinezopiclonequetiapineescitalopramfludiazepam quetiapine0.0 10μg/mLzopiclone0.010μg/mL7.5mg 0.06 μg/mLhttps://www.medicines.org.uk/e mc/product/4060/smpc)6 5 108417 107 510 107649 0043 34107 7326-7107510 107644 3326107613 調 176-177 1011-15 使 10761 2 3Sinzac (fluoxet ine/201 仿1) 2020Utapine (queti apine/1001仿2) 1100100Zolon (zopiclone/7.51仿3) 1110762 Lexapro (escitalopram/10 1仿4) 1010Era/Erispan (fludiazepam/0.25 0.5仿5) 0.750.25使2.(6Sadock BJ et al, Chapter 8Mood Disorders, Synopsis of Psychiatry. 201511th editionp361 & p374.7Sadock BJ et al, Chapter 23 Emergency Psychiatric Medicine, Synopsis of Psychiatry. 2015llth edition p764.1077327 1075106)258Stone M et al, Risk of suicidality in clinical trials of antidepressants in adults analysisof proprietary data submitted to US Food and Drug Administration. British Medical Journal. 2009 339p2880.9Barbui et al, Selective serotoninreuptake inhibitors and risk of suicide a systematic review of observational studies. Canadian Medical Association Journal. 2009180(3)291-7.)41使2 使2 調調2 Sinzac(fluoxetine/20 Utapi ne (quetiapine/100) 便Zolon (zopiclon e/7.5 empathy) Lexapro (escitalopram/10 便Era/Erispan (fludiazepam/O.25 便108651080058107 2690-110 678 678(25)使8 6 600 Table 3 "harms of Interest"anxiety, agitation, nightmares 7(Letter to Editor) Khan et al(Psychopharmacology(berl)20182351455-1462)(Table 1)7使(patient-year)Khan etalTable 1使9,4661,423(15) (使)Khan et al調西2000使西2000使西2000Table 124 (25)調Table 1 Escitalopram"suicide attempt"40Table 1Escitalopram07調使3-4weeksTable 14 weeks (25 "Letter to Editor" 87 (24)使 8 Sharma et al.BMJ/2016352i65使antidepres sant(mortality)(suicidality)7018,526 Stone et al.BMJ2009339b288025-64使99,231 TFDAFDA仿 109721FDA 1090020106505-506509-510 Up To Date(2019.May 28) 2004US FDA使"completed suicides" (Q uetiapine)仿(MDD)() /(suicidality)(Quetiapine)Sinzac(Fluoxetine)Lexapro(Escitalopram)仿(SSRIs ) (MDD) (18-24)(suicidality)24使Zolon(Zopiclone)仿Benzodiazepines Zopiclone Zolon(Zopiclone)仿Erispan(Fludiazepam)仿 1091222109420422621-33 (:quetiapine)Sinzac(:fluoxetine)Lexapro(:escitalopram)zolon(:Zopiclone)ERA(:Erispan)(:Fludiazepam)5 quetiapinefluoxetineescitalopramerispanfludiazepam complex sleep behaviors, CSBs)zolpiclonezolpicloneGABAa 調2013ChenL.F.zolpidemzopiclone zolpidem使(CSBs)3.27zopiclone使CSBs3. 41fluoxetine escitalopramquetiapineerispanfludiazepamzolpiclone仿fluoxetineescitalopram(Major depressi ve disorder,MDD)使2024655 使zolpiclone使fluoxetineescitalopram(24)quetiapineerispanfludiazepamZ-drug(zolpidem, zaleplon zolpiclone) zolpidemCYP450fluoxetineescitalopramzolpicloneCYPs(CYP1A2,2C8,2C9,2C18,2C19, 2D6,2E1,and 3A4)zolpidem使 5 11041911000054386971-73 使使24 107326 107510761 120mg100mg 10762 1010764 9431076519152調 1098171077321090083102521 109911109388517 523525 10761 10762 使 使2540 使 使 1 5 151 21117 313124212 3 5215 2412 20174,00010 AD4002008 1 15108-10917 1212調 2 1 3 1 410822128813135 1524AD調1-4 20173,871(Suicides in Taiwan rise for thirdyear in a row 2018/9/9)4,00010AD4002008 PS. #2119Oseltamivir 1 200         110    12    16         202024111 12   1. 2. 3. 1. 2. 3. 4.         110    12    16