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Recainam是新近合成的丙脲类化合物,具有Ⅰ类抗心律失常的特性。本试验评价Recainam口服治疗室性心律失常的效果和安全性。受试者为57±11(45~73)岁的11(男10、女1)例慢性频繁室性心律失常患者,曾经5.3±1.8(3~8)种其它抗心律失常药物治疗无效或者无法耐受,平均室(性)早(搏)至少30次/小时,连续心搏>9次的室性心动过)速者(1例)已除外。本组无一例妊娠,重度心力衰竭,3个月内心肌梗塞,持续性室速史,重度肝、肾、呼吸、内分泌疾患或者其它终末期疾患。第一期试验由11例受试者住院按单盲法进行。试验前停用抗心律失常药物至少4个半衰期、试验第3、6和9日起分别口服Recainam 100、300和500μg、q8h,连续3天。第1、2、5、8、11、12和13日连续记录24
Recainam is a newly synthesized propanamide compound with Class I anti-arrhythmic properties. This trial evaluated the efficacy and safety of Recainam’s oral treatment of ventricular arrhythmias. Subjects with chronic ventricular arrhythmias in 11 (10 male and 1 female) with 57 ± 11 (45-73) years of age were previously treated with 5.3 ± 1.8 (3-8) other antiarrhythmic drugs ineffective or unable Tolerated, average room (sexual) early (stroke) at least 30 beats / hour, continuous heartbeat> 9 times of ventricular tachycardia) (1 case) have been excluded. There were no cases of pregnancy, severe heart failure, myocardial infarction within 3 months, persistent VT, severe liver, kidney, respiratory, endocrine disorders or other end-stage disorders. The first trial was conducted in 11 patients admitted to hospital by single-blind method. At least 4 half-lives of at least 4 anti-arrhythmic drugs were discontinued before the trial. Recaneam 100, 300 and 500 μg, q8h were administered orally on days 3, 6 and 9 of the trial for 3 consecutive days. Records 1, 2, 5, 8, 11, 12 and 13 consecutively