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本指导原则指出抗心律失常药物治疗目的是减少致残症状和/或与节律紊乱相关的后遗效应、和/或延长寿命;有效性评估方法包括临床特征、心电图、Holter监测、运动试验、经电话监测、电生理研究、ICD病人的研究、存活率的研究;安全性评估包括致心律失常作用、特殊副作用、心血管作用和一般副作用;并对试验步骤和病例选择作了概述。在初始研究阶段主要进行药代动力学及药效动力学研究,在疗效研究阶段主要显示药物在同时减少心律失常、主要症状和/或死亡率方面的药效和安全性。
The guidelines state that the purpose of antiarrhythmic drug therapy is to reduce crippling symptoms and / or sequelae associated with rhythm disorders and / or to prolong lifespan; efficacy assessment methods include clinical features, electrocardiograms, Holter monitoring, exercise testing, Telephone monitoring, electrophysiological studies, studies of ICD patients, and survival rates; safety assessment including arrhythmogenic effects, specific side effects, cardiovascular effects and general side effects; and an overview of trial procedures and case selection. Pharmacokinetic and pharmacodynamic studies were conducted initially in the initial study phase. Pharmacodynamic and pharmacokinetic studies were primarily conducted during the efficacy study phase to show the efficacy and safety of the drug in reducing arrhythmia, major symptoms and / or mortality.