書籍詳細

第1章 spin 東スポ化する論文たち

P.71 掲載の参考文献

• 1) Boutron I, et al. Reporting and interpretation of randomized controlled trials with statistically nonsignificant results for primary outcomes. JAMA. 2010 ; 303(20) : 2058-64.
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• 2) Yokoyama M, et al. the JELIS Investigators : Effects of eicosapentaenoic acid on major coronary events in hypercholesterolaemic patients (JELIS) : a randomised open-label, blinded endpoint analysis. Lancet 2007 ; 369(9567) : 1090-8.
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• 3) Saito Y, et al. the JELIS Investigators : Effects of EPA on coronary artery disease in hypercholesterolemic Study (JELIS). Atherosclerosis 2008 ; 200(1) : 135-40.
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• 4) Julisu S, et al. The Valsartan Antihypertensive Long-Term Use Evaluation (VALUE) trial : outcomes in patients receiving monotherapy. Hypertension. 2006 Sep ; 48(3) : 385-91.

• 5) Mochizuki S, et al. Valsartan in a Japanese population with hypertension and other cardiovascular disease (Jikei Heart Study) : a randomised, open-label, blinded endpoint morbidity-mortality study. Lancet. 2007 Apr 28 ; 369(9571) : 1431-9. [Retraction in : Lancet. 2013 Sep 7 ; 382(9895) : 843.]

• 6) ディオバン問題 JIKEI HEART Study LANCET誌掲載のメイン図表に重大な誤り. ミクスOnline http://www.mixonline.jp/Article/tabid/55/artid/45049/Default.aspx

• 7) 山崎力, ドキドキワクワク論文☆吟味. 医学統計ライブスタイル. SCICUS, 2009.

• 8) Nakao K, et al. Role of diabetes and obesity in outcomes of the candesartan antihypertensive survival evaluation in Japan (CASE-J) trial. Hypertens Res. 2010 Jun ; 33(6) : 600-6.

• 9) 日本高血圧学会高血圧治療ガイドライン作成委員会編. 高血圧治療ガイドライン2014. ライフサイエンス出版, 2014.

• 10) 2010年度合同研究班報告. 心筋梗塞二次予防に関するガイドライン (2011年改訂版) http://www.j-circ.or.jp/guideline/pdf/JCS2011_ogawah_h.pdf

• 11) Blood Pressure Lowering Treatment Trialists' Collaboration, Turnbull F, et al. Blood pressure-dependent and independent effects of agents that inhibit the renin-angiotensin system. J Hypertens. 2007 May ; 25(5) : 951-8.
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• 12) 日本高血圧学会高血圧治療ガイドライン作成委員会編. 高血圧治療ガイドライン2009. ライフサイエンス出版, 2009

• 13) ONTARGET Investigators, Yusuf S, et al. Telmisartan, ramipril, or both in patients at high risk for vascular events. N Engl J Med. 2008 Apr 10 ; 358(15) : 1547-59.

• 14) Dickstein K, et al. Effects of losartan and captopril on mortality and morbidity in high-risk patients after acute myocardial infarction : the OPTIMAAL randomised trial. Optimal Trial in Myocardial Infarction with Angiotensin II Antagonist Losartan. Lancet. 2002 Sep 7 ; 360(9335) : 752-60.
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• 15) Pitt B, et al. Randomised trial of losartan versus captopril in patients over 65 with heart failure (Evaluation of Losartan in the Elderly Study, ELITE). Lancet, 1997 Mar 15 ; 349(9054) : 747-52.

• 16) Pitt B, et al. Effect of losartan compared with captopril on mortality in patients with symptomatic heart failure : randomised trial--the Losartan Heart Failure Survival Study ELITE II. Lancet, 2000 May 6 ; 355(9215) : 1582-7.

• 17) Telmisartan Randomised AssessmeNt Study in ACE iNtolerant subjects with cardiovascular Disease (TRANSCEND) Investigators, Yusuf S, et al. Effects of the angiotensin-receptor blocker telmisartan on cardiovascular events in high-risk patients intolerant to angiotensin-converting enzyme inhibitors : a randomised controlled trial. Lancet. 2008 Sep 27 ; 372(9644) : 1174-83.

第2章 ディオバン事件の背景にあるもの

P.106 掲載の参考文献

• 1) Ridker PM, Torres J. Reported outcomes in major cardiovascular clinical trials funded by for-profit and not-for-profit organizations : 2000-2005. JAMA. 2006 ; 295(19) : 2270-4.

• 2) Kasenda B, et al. Prevalence, characteristics, and publication of discontinued randomized trials, JAMA. 2014 Mar 12 ; 311(10) : 1045-51.
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• 3) Kohro T, Yamazaki T. Cardiovascular clinical trials in Japan and controversies regarding prospective randomized open-label blinded end-point design. Hypertens Res. 2009 Feb ; 32(2) : 109-14.
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• 4) Hansson L, et al. Prospective Randomized Open Blinded End-poing (PROBE) Study : a novel design for intervention trials. Blood Press. 1992 Aug ; 1(2) : 113-9.

• 5) Echt DS, et al. Mortality and morbidity in patients receiving encainide, flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial. N Engl J Med. 1991 Mar 21 ; 324(12) : 781-8.

• 6) 青木薫訳. 代替医療のトリック. 新潮社, 2010 (Singh S and Ernst E. Trick or Treatment? : Alternative Medicine on Trial, 2008).

• 7) Kohro T, Yamazaki T, et al. Intensively lowering both low-density lipoprotein cholesterol and blood pressure does not reduce cardiovascular risk in Japanese coronary artery disease patients. Circ J. 2011 ; 75(9) : 2062-70.

• 8) Mochizuki S, et al. Valsartan in a Japanese population with hypertension and other cardiovascular disease (Jikei Heart Study) : a randomised, open-label, blinded endpoint morbidity-mortality study. Lancet. 2007 Apr 28 ; 369(9571) : 1431-9. [Retraction in : Lancet. 2013 Sep 7 ; 382(9895) : 843.]

• 9) Sawada T, et al. Effects of valsartan on morbidity and mortality in uncontrolled hypertensive patients with high cardiovascular risks : KYOTO HEART Study. Eur Heart J. 2009 Oct ; 30(20) : 2461-9. [Retraction in : Eur Heart J. 2013 Apr ; 34(14) : 1023.]

第3章 spinを見破るための論文吟味

P.143 掲載の参考文献

• 1) 山崎力. ドキドキワクワク論文☆吟味. 医学統計ライブスタイル. SCICUS, 2009.

• 2) Maggioni AP, et al. Valsartan reduces the incidence of atrial fibrillation in patients with heart failure : results from the Valsartan Heart Failure Trial (Val-HeFT). Am Heart J. 2005 Mar ; 149(3) : 548-57.
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• 3) Schmieder RE, et al. Reduced incidence of new-onset atrial fibrillation with angiotensin II receptor blockade : the VALUE trial. J Hypertens. 2008 Mar ; 26(3) : 403-11.

• 4) GISSI-AF Investigators, Disertori M, et al. Valsartan for prevention of recurrent atrial fibrillation. N Engl J Med. 2009 Apr 16 ; 360(16) : 1606-17.
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• 5) Goette A, et al. Angiotensin II-antagonist in paroxysmal atrial fibrillation (ANTIPAF) trial. Circ Arrhythm Electrophysiol. 2012 Feb ; 5(1) : 43-51.
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• 6) Yamashita T, et al. Randomized trial of angiotensin II-receptor blocker vs. dihydropiridine calcium channel blocker in the treatment of paroxysmal atrial fibrillation with hypertension (J-RHYTHM II study). Europace. 2011 Apr ; 13(4) : 437-9.

• 7) Haller H, et al. Olmesartan for the delay or prevention of microalbuminuria in type 2 diabetes. N Engl J Med. 2011 Mar 10 ; 364(10) : 907-17.

第4章 ランダム化比較試験は最強か ?

P.169 掲載の参考文献

• 1) Hayashi D, Yamazaki T ; JACD study Investigators. Design and rationale of the Japanese Coronary Artery Disease (JCAD) Study : a large-scale, multicentered prospective cohort study. Jpn Heart J. 2004 Nov ; 45(6) : 895-911.

• 2) Kohro T, et al. Effects of medication on cardiovascular events in the Japanese coronary artery disease (JCAD) study. Circ J. 2007 Dec ; 71(12) : 1835-40.
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• 3) Fletcher RH, et al. Clinical Epidemiology. The Essentials (3rd ed.). Williams & Wilkins, 1996.

第5章 ディオバン事件を起こさない国づくり

P.212 掲載の参考文献

• 1) 日本製薬工業会医薬産業政策研究所. 政策研ニュース No.35 2012年3月.

• 2) 文部科学省. 国別・分野別のノーベル賞の受賞者数 (1901〜2012年) (15. 科学技術・学術). 文部科学統計要覧 (平成25年版), 2013.

• 3) Echt DS, et al. Mortality and morbidity in patients receiving encainide, flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial. N Engl J Med. 1991 Mar 21 ; 324(12) : 781-8.

• 4) 津谷喜一郎ほか訳. CONSORT 2010声明ランダム化並行群間比較試験報告のための最新版ガイドライン (Schulz KF, et al. CONSORT 2010 Statement : updated guidelines for reporting parallel group randomised trials). Jpn Pharmacol Ther 2010 ; 38(11) : 939-49.

• 5) von Elm E, et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement : guidelines for reporting observational studies. J Clin Epidemiol. 2008 Apr ; 61(4) : 344-9.
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• 6) 司馬遼太郎. 花神, 改版. 新潮社, 1976.

• 7) Jamerson K, et al. Benazepril plus amlodipine or hydrochlorothiazide for hypertension in high-risk patients. N Engl J Med. 2008 Dec 4 ; 359(23) : 2417-28.

• 8) Cortes J, et al. Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE) : a phase 3 open-label randomised study. Lancet. 2011 Mar 12 ; 377(9769) ; 914-23.
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第6章 ディオバン事件を起こさない人づくり

P.248 掲載の参考文献

• 1) 山崎力. ドキドキワクワク論文☆吟味. 医学統計ライブスタイル. SCICUS, 2009.

• 2) Mochizuki S, et al. Valsartan in a Japanese population with hypertension and other cardiovascular disease (Jikei Heart Study) : a randomised, open-label, blinded endpoint morbidity-mortality study. Lancet. 2007 Apr 28 ; 369(9571) : 1431-9. [Retraction in : Lancet. 2013 Sep 7 ; 382(9895) : 843.]

• 3) 山崎力. より高い日本発エビデンスを生み出すために何をなすべきか? 日本高血圧学会総会プログラム・抄録集. 2010 ; 33 : 203.

• 4) 福田治彦. 「臨床試験データマネジメント (大橋靖雄監修, 辻井敦著)」書評. 週刊医学界新聞2611. 医学書院, 2004.

• 5) Sawada T, et al. Effects of valsartan on morbidity and mortality in uncontrolled hypertensive patients with high cardiovascular risks : KYOTO HEART Study. Eur Heart J. 2009 Oct ; 30(20) : 2461-9. [Retraction in : Eur Heart J. 2013 Apr ; 34(14) : 1023.]

• 6) Amano K, et al. Enhanced cardio-renal protective effects of valsartan in high-risk hypertensive patients with chronic kidney disease : A sub-analysis of KYOTO HEART Study. Int J Cardiol. 2012 Feb 13. [Withdrawn]

• 7) Kimura S, et al. Effects of valsartan on cardiovascular morbidity and mortality in high-risk hypertensive patients with new-onset diabetes mellitus. Circ J. 2012. [Retraction in : Shimokawa H. Circ J. 2013 ; 77(2) : 552a]

• 8) Yui Y, Concerns about the Jikei Heart Study. Lancet. 2012 Apr 14 ; 379(9824) : e48.

• 9) 古楽府『君子行』.

あとがきにかえて 捏造しない・させないための補講の時間

P.307 掲載の参考文献

• 1) Mochizuki S, et al. Valsartan in a Japanese population with hypertension and other cardiovascular disease (Jikei Heart Study) : a randomised, open-label, blinded endpoint morbidity-mortality study. Lancet. 2007 Apr 28 ; 369(9571) : 1431-9. [Retraction in : Lancet. 2013 Sep 7 ; 382(9895) : 843.]

• 2) Sawada T, et al. Effects of valsartan on morbidity and mortality in uncontrolled hypertensive patients with high cardiovascular risks : KYOTO HEART Study. Eur Heart J. 2009 Oct ; 30(20) : 2461-9. [Retraction in : Eur Heart J. 2013 Apr ; 34(14) : 1023.]

• 3) ノバルティスファーマ株式会社. 第2回高血圧症治療薬の臨床研究事案に関する検討委員会 説明資料. 2013年9月2日 http://www.mhlw.go.jp/file/05-Shingikai-10801000-Iseikyoku-Soumuka/0000020260.pdf

• 4) UMIN症例データレポジトリ (UMIN-ICDR) http://www.umin.ac.jp/icdr/index-j.html

• 5) Nahm M. "Data Accuracy in Medical Record Abstraction" (2010). UT SMBI Dissertations (Open Access). Paper 15.

• 6) Black HC. Black's Law Dictionary (6th ed.). West Group, 1990.

• 7) WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. 64th WMA General Assembly, Fortaleza, Brazil, Oct 2013.

• 8) Frobert O, et al. Thrombus aspiration during ST-segment elevation myocardial infarction. N Engl J Med. 2013 Oct 24 ; 369(17) : 1587-97.