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メタアナリシスの原理と 医療 ... - biostar.co.jp

2008 5 17 2 (STED) PMDA 1 Albert A Meta-Analysis of 16 randomized Trials of Sirolimus-Eluting tents Versus Paclitaxel-Eluting Stents in Patients With Coronary Artery DiseaseAlbert Sch mig, MD, Alban Dibra, MD, Stephan Windecker, MD,Julinda Mehilli, MD,Jos Suarez de Lezo, MD, Christoph Kaiser, MD,Seung-Jung Park, MD, Jean-Jacque Goy, MD,Jae-Hwan Lee, MD,Emilio Di Lorenzo, MD,Jinjin Wu, MD, Peter J ni, MD,Matthias E. Pfisterer, MD, Bernhard Meier, MD, Adnan Kastrati, MDJournal of the American College of Cardiology Vol. 50, No. 14, 2007 2002 -1 -2 -3 = 60% 95% 110100100010000020406080100 600/1000 60/100 12/20 6/10 3/5

メタアナリシスはどのような場合に活用されるか 医療機器分野における過去2年間の経験 • 審査資料(sted)における機器の ...

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Transcription of メタアナリシスの原理と 医療 ... - biostar.co.jp

1 2008 5 17 2 (STED) PMDA 1 Albert A Meta-Analysis of 16 randomized Trials of Sirolimus-Eluting tents Versus Paclitaxel-Eluting Stents in Patients With Coronary Artery DiseaseAlbert Sch mig, MD, Alban Dibra, MD, Stephan Windecker, MD,Julinda Mehilli, MD,Jos Suarez de Lezo, MD, Christoph Kaiser, MD,Seung-Jung Park, MD, Jean-Jacque Goy, MD,Jae-Hwan Lee, MD,Emilio Di Lorenzo, MD,Jinjin Wu, MD, Peter J ni, MD,Matthias E. Pfisterer, MD, Bernhard Meier, MD, Adnan Kastrati, MDJournal of the American College of Cardiology Vol. 50, No. 14, 2007 2002 -1 -2 -3 = 60% 95% 110100100010000020406080100 600/1000 60/100 12/20 6/10 3/5 se se nn11se+ -1 No B-A 20 20/10045 40/10025 80 8/1016 2/10 -64 20 40/20045 80/20025 40 35 -5A B 0100 100 10 200 A B A B B-A 20 100 45 100 25 40 80 10 16 10 -64 320 20 200 45 200 25 20

2 40 35 22 39 B -80-40040 100 10 200 B-A B-A -1 -2 Simpson's Paradox A-B 70% (14/20) 50% (40/80) 20 30% (24/80) 10% (2/20)20 38% (38/100) 42% (42/100) -4 20A B %) Simpson's Paradox 020406080100A B (%) -2 A B outcome RCT -3 SE 2 1/

3 IrbrainbnawDseDwdwDDnbrbnbrbnaranarawinb rbpbnarapapapbDDpbpaiiiiikiiKiiKiiiiiiii iiiiiiiiiiiiiiii,,K1i1)()()(,)(B)(A11133 ==== = + === =Q B-A 1/ 100 20 100 45 100 25 40 10 80 10 16 10 -64 320 200 20 200 45 200 25 20 B Ia Ib IIa IIb III IV Centre of Evidence-Based Medicine 1998 outcome Albert Methods clinical trial selection SES PES key (2007)

4 4 PubMed, NIH database, Cochrane Central Register of Controlled Trial, American Heart Association, American College of cardiology, European Society of CardiologyInternet WHO UMIN JAPIC Albert Methods Data collection and assessment of quality outcome MI TLR 9 16 11 QC ITT outcome QC QC Q&A Albert forest plot

5 ( )p< SES PES I2 I2 I2 I2 0 25% I2=50% 75% I2 H0 I2 0 I2= p= I2 I2= p= SES PES I2 I2 Q Q di dm wi (1) Q Q (2) :K(2)1))/Q-(K - (Q100% = I)1(~)(Q sCochran'21122QM = = KiKmiiddw I2= < = evidence Hylan Versus Hyaluronic Acid for Osteoarthritis of the Knee: A Systematic Review and Meta-Analysis STEPHAN REICHENBACH, SACHA BLANK, ANNE W.

6 S. RUTJES, AIJING SHANG,ELIZABETH A. KING, PAUL A. DIEPPE, PETER JU NI, AND SVEN TRELLE Albert ( ) p< I2= p= Albert Limitation TLR MI TLR Albert vs The Emperor s New Clothes VS p FDA RCT (meta-analysis) EBM con RCT RCT RCT Randomized Controlled Trial)

7 Pros con 1 p RCT pros RCT RCT con OPC Q&A Odds - Thomas Lumley Network meta-analysis for indirect treatment comparisons Statist. Med. 2002; 21:2313 2324 (DOI: ) 1A 40%B 60%B-A=20% 2B 55%C 65%C-B=10%C-A= C-B + B-A 30% Odds vs DES VS DES vs DES DES vs DES