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Exploration of nonpharmacological control in thorough QT/QTc studies

Exploration of nonpharmacological control in thorough QT/QTc...

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第三届中日双边药理学和临床药理学学术会议

作者： SAHASHI Kunihiko KUMAGAI Yuji FUJITA Tomoe IKEDA Yasuhiko HASUNUMA Tomoko iijima hajime KOSUGE Kazuhito OHTANI Yoshio Kitasato University East Hospital Japan Kitasato University East Hospital Japan Kitasato University East Hospital Japan Kitasato University East Hospital Japan Kitasato Institute Japan Kitasato Institute Japan Kitasato Institute Japan Kitasato University East Hospital Japan

＜正＞AIM Drug induced QT prolongation is a risk factor of torsade de pointes,a lethal ventricular tachycar- *** ICH-E14 guideline concerning QT/QTc pro- longation reached step5 in USA and *** the guideline, use of a positive control is recommended to detect changes in QT ***,a pharmacological control such as moxifloxaein is used in a thorough QT/QTc study,how- ever Japanese authority suggests use of nonpharmacological *** studied the possibility of such controls. METHODS The study included 2 parts in healthy male *** part A,effects of standing for 5 min and valsalva maneuver were studied in 74 subjects,and in part B effects of hand grip with 30% of max load for 3 min was studied in 50 *** were recorded for 15 s and QT intervals were measured in lead Ⅱ on *** in- terval was corrected by 2 methods of Bazette （QTcB） and of Fridericia （QTcF）.RESULTS QT interval itself was shortened markedly by standing although corrected QTcs showed changes of opposite *** observed chan- ges were a prolongation in QTcB and a shortening in *** maneuver caused no significant changes. QTcB and QTcF decreased immediately after hand grip but they increased after 3 min’ hand *** Changes in QT by physiological loads may be affected by heart rate,a cautious interpretation is necessary in discus- sing the possibility of such loads as positive controls.

关键词： QT interval ICH-E14 positive control standing,hand grip

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