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薬剤疫学. 日本薬剤疫学会. 2010 年 8 月. 1. 1. 薬学の中の薬剤疫学 薬物療法の変遷とこれからの 薬剤師職能の展開. 2. 薬物療法の過去. 医師の独自の裁量により医薬品が選択され、患者は医師の指示通りに使用する。 薬剤師による医薬品情報活動により、より客観的な薬物療法が行われるようになった。 患者の自己決定権、セカンドオピニオンの採用、医療訴訟などを背景にインフォームドコンセント(説明、理解と同意)のもとに薬物療法が行われるようになってきた。. 3. 薬物療法の現在.

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薬剤疫学

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  • up-to-date

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http://www.jspe.jp/index.html

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Strom

Strom

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  • Five TOOs

    • Too Few)

    • Too Simple)

    • Too brief)

    • Too median-aged)

    • Too Narrow)

      Rogers A.S., Drug Intel Clin Pharm., 21: 915-20 (1987)

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Pharmacovigilance

Pharmacovigilance

  • Pharmacovigilance

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Pharmacovigilance1

Pharmacovigilance

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Pharmacovigilance2

Pharmacovigilance

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  • (

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.

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    • []

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  • (nested case-control study)

    • 1

    • random daterandom date

  • (case-cohort study)

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  • ecological study

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(

  • Randomized Controlled Trial:RCT)

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Itt pp

ITTPP

  • ITTintent-to-treatintention-to-treat)

  • PP(per protocol, protocol compatible)

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.

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  • Asahi.com2005/02/12)

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  • (point prevalence)

  • (period prevalence)

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  • (cumulative incidence rate)

  • incidence rate)

    time at risk

=

Time at risk

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Relative risk rr

(relative risk: RR)

  • (cumulative incidence rate ratio)

  • (risk ratio)

  • incidence rate ratiorate ratio)

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Odds ratio or

(odds ratio: OR)

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Attributable risk ar

(attributable risk: AR)

  • (cumulative incidence rate difference)risk difference

  • (incidence rate difference)

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95%

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n1n0

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Risk RatioRR)95%CI(confidence interval)

b = n1 - a, d = n0 - c

Risk DifferenceRD)95%CI(confidence interval)

Risk DifferenceRisk Difference

2

Relative RiskRate RatioRiskRatioOdds Ratio

Modern EpidemiologyPage 67

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R1R0

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RRRR:rate ratio)95%CI(confidence interval)

Rate DifferenceRD)95%CI(confidence interval)

2

Absolute RiskCumulative incidenceIncidence rateAbsolute rate

Modern Epidemiology 3redition P 40

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t1t0

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OR:OddsRatio)95%CI(confidence interval)

2

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  • NNT

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2/2000-5/2000=0.0015

2/2000(5/2000)=0.4

40%

1/0.0015=667

NNT667

6671

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(attributable fraction, AF)

(population attributable risk, PAR)

(population attributable fraction, PAFAFp)

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p

    • p0.05

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  • 95%

  • 95%95%CI

  • 95%05%

  • 95%15%

  • 01

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  • 2000

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  • ACE

  • 36:205-217, 2007

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  • ACE

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  • BMI

  • Ca

  • Ca

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  • 26,361

  • 9472,841

  • ACE (Ca)

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  • arbekacin45:995-1001, 1997

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  • Imatinib2:357-362, 2007

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  • 23:1247-1263, 1979

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  • Kono S et al.,Class of Antihypertensive drugs, blood pressure status, and risk of cardiovascular disease in hypertensive patients: A case-control study in Japan. Hypertens. Res., 28:811-817 2005

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  • M. Takadaet al., The relationship between risk of hypoglycemia and use of cibemzoline and disopyramide. Eur. J. Clin. Pharmacol., 56: 335-342, 2000

  • M. Tanaka et al., Efficacy of therapeutic drug monitoring in prevention of hypoglycemia caused by cibenzoline. Eur. J. Clin. Pharmacol., 58: 695-700, 2001

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  • Al3+Mg2+26:867-873, 1995

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  • Ishiguro C et al., Assessing the effect of non-steroidal anti-inflammatory drugs on antihypertensive drug therapy using post-marketing surveillance database. J. Epidemiol. 18: 119-124 2008

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  • 36:205-217, 2007

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  • Nakamura H et al., Primary prevention of cardiovascular disease with pravastatine in Japan (MEGA study): a prospective randomized controlled trial. Lancet 368-1155-1163, 2006

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  • 49: 277-283, 1989

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  • ACECa

  • ACECaGLANT3630:26-34, 1993

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  • NSAIDs

  • 26:865-874, 1991

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  • ,5: 1-10, 2000

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Yamamoto M et al: Dopamine agonist and cardiac valvulopathy in Parkinson disease. Neurology 67: 1225-1229, 2006.

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NSAIDs

Sakamoto C et al: Case-control study on the association of upper gastrointestinal bleeding and nonsteroidal anti-inflammatory drugs in Japan. Eur J Clin Pharmacol 62: 765-772, 2006.

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Okada K et al.: Effectiveness of an acellular pertussis vaccine in Japanese children during a non-epidemic period: a matched case-control study. Epidemiol Infect 137: 124-130, 2009.

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Kudoh S et al: Interstitial lung disease in Japanese patients with lung cancer: a cohort and nested case-control study. Am J Respir Crit Care Med 177: 1348-1357, 2008.

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  • :

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    • 80%)

    • ITTPP

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    • 80%

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