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1 Upper limit of reference value of QT interval for rest electrocardiograms Hiroshi Goto, Noriaki Ikeda, Masuo Shirataka, Hideo Miyahara of healthy young Japanese men

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12 13) Efron B, Tibshirani, RJ : An introduction to the bootstrap. Chapman & Hall CRC, ) Fenichel RR, Malik M, Antzelevitch C, Sanguinetti M, Roden DM, Priori SG, Ruskin JN, Lipicky RJ, Cantilena LR ; Independent Academic Task Force : Drug-Induced Torsade de Pointes and implications for drug 1) Shah RR : The significance of QT interval in drug development. Br J Clin Pharmacol, 2002 ; 54 :188 `202 2) Shah RR : Drugs, QTc interval prolongation and final ICH E14 guideline. An important milestone with challenges ahead. Drug Safety, 2005 ; 28 :1009 `1028 3) Bazett HC : An analysis of the time-relations of electrocardiograms. Heart, 1920 ; 7 : 353 `370 4) Fridericia LS : Die Systolendauer im Elektrokardiogramm bei normalen Menschen and bei Herzkranken. Acta Medica Scandinavica,1920 ; 57 : 469 `486 5 ) Puddu PE, Jouve R, Mariotti S, Giampaoli S, Lanti M, Reale A, Menotti A : Evaluation of 10 QT prediction formulas in 881 middle-aged men from the seven countries study. Emphasis on the cubic root Fridericia's equation. J Electrocardiol, 1988; 21: 219 `229 6) Rautaharju PM, Warren JW, Calhoun HP : Estimation of QT prolongation. A persistent, avoidable error in computer electrocardiography. J Electrocardiol, 1990 ; 23 (Suppl) :111 `117 8) Simonson E, Cady LD Jr, Woodbury M : The normal Q- T interval. Am Heart J, 1962 ; 63 : 747 `753 9) Sadanaga T, Sadanaga F, Yao H, Fujishima H : Heart rate dependent modification of the QTc cut-off values can improve accurate evaluation of QT prolongation. Am J Cardiol, 2004; 93 : 772 `775 10) Karjalainen J, Viitasalo M, Manttari M, Manninen V Relation between QT intervals and heart rates from 40 to 120 beats/min in rest electrocardiograms of men and a simple method to adjust QT interval values. J Am development. J Cardiovasc Electrophysiol, 2004 ; 15: 475 `495 16) Malik M, Farbom P, Batchvarov V, Hnatkova K, Camm AJ : Relation between QT and RR intervals is highly individual among healthy subjects : implications for heart rate correction of the QT interval. Heart, 2002 ; 87: 220 `228 18) 0kin PM : QT interval prolongation and prognosis further validation of the quantitative approach to electrocardiography. J Am Coil CardioL 2004 ; 43: 572 ` ) Batchvarov VN, Ghuran A, Smetana P, Hnatkova K, Harries M, Dilaveris P, Camm AJ, Malik M : QT-RR relationship in healthy subjects exhibits substantial intersubject variability and high intrasubject stability. Am J Physiol Heart Circ Physiol, 2002 ; 282 : H2356 ` H ) Piotrovsky V : Pharmacokinetic-pharmacodynamic modeling in the data analysis and interpretation of drug-induced QT/QTc prolongation. AAPS journal, 2005; 7 : E609 `E624 22) Vincent GM, Tomothy KW, Leppert M, Keating M The spectrum of symptoms and QT intervals in carriers of the gene for the long-qt syndrome. N Engl Coll Cardiol, 1994; 23: 1547 `1553 J Med,1992 ; 327: 846 `852

88 豊橋創造大学紀要第 15 号 2. 対象と方法 2. 1 解析対象 2006 年 3 月 20 日から2007 年 7 月 26 日までにAクリニックの第 1 相および第 2 相臨床試験に志願した20 歳から35 歳までの日本人健康若年男子 1320 名に対し, スクリーニング時に 12 誘導

88 豊橋創造大学紀要第 15 号 2. 対象と方法 2. 1 解析対象 2006 年 3 月 20 日から2007 年 7 月 26 日までにAクリニックの第 1 相および第 2 相臨床試験に志願した20 歳から35 歳までの日本人健康若年男子 1320 名に対し, スクリーニング時に 12 誘導 Bulletin of Toyohashi Sozo University ブートストラップ法による QT 間隔基準値の上限の設定 2011, No. 15, 87 97 87 ブートストラップ法による QT 間隔基準値の上限の設定 宮原英夫後藤寛司池田憲昭 日本人健康若年男子の安静時心電図におけるQT 基準値の上限を与える式を,A 施設から提供された1276 例の心電図データよりブートストラップ法を用いて作成した.

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