Abi-Mansour P, Carberry P A, McCowan R J, Henthorn R W, Dunn G H, Perry K T
Christ Hospital Medical Center, Pharmacia & Upjohn, Charleston Area Medical Center, and The Christ Hospital, Kalamazoo, Mich 49001-0199, USA.
Am Heart J. 1998 Oct;136(4 Pt 1):632-42. doi: 10.1016/s0002-8703(98)70010-9.
A study was conducted to determine the efficacy and safety of ibutilide fumarate versus placebo in the acute termination of atrial flutter and fibrillation.
Two hundred sixty-two patients aged 28 to 88 years with atrial flutter or fibrillation duration of 3 hours to 90 days were randomly assigned in a 5:1 ratio (ibutilide:placebo) to receive two 10-minute infusions, 10 minutes apart, of ibutilide (1 mg) or placebo. Patients were hospitalized and monitored by telemetry for 24 hours, with follow-up 72 hours later. Seventy-three (34.9%) of 209 evaluable ibutilide recipients had termination of atrial flutter or fibrillation within 1.5 hours compared with 0 (0%) of 41 placebo recipients. Those with atrial flutter had a higher success rate. At hour 24, 86.3% remained in normal or alternative sinus rhythm. Of the patients who received ibutilide, 2.3% experienced drug-related sustained polymorphic or monomorphic ventricular tachycardia and recovered after intervention. Additionally, 7.3% experienced nonsustained polymorphic or monomorphic ventricular tachycardia. Other frequent medical events in ibutilide recipients were generally also noted in the placebo group.
Ibutilide is effective and safe for acute termination of atrial fibrillation or atrial flutter.
进行了一项研究以确定富马酸伊布利特与安慰剂相比在急性终止心房扑动和心房颤动方面的疗效和安全性。
262例年龄在28至88岁、心房扑动或心房颤动持续时间为3小时至90天的患者按5:1的比例（伊布利特：安慰剂）随机分组，接受两次10分钟的静脉输注，两次输注间隔10分钟，分别输注伊布利特（1毫克）或安慰剂。患者住院并通过遥测进行24小时监测，72小时后进行随访。209例可评估的伊布利特接受者中有73例（34.9%）在1.5小时内终止了心房扑动或心房颤动，而41例安慰剂接受者中无一例（0%）终止。心房扑动患者的成功率更高。在24小时时，86.3%的患者维持正常或交替性窦性心律。接受伊布利特的患者中，2.3%发生了与药物相关的持续性多形性或单形性室性心动过速，经干预后恢复。此外，7.3%的患者发生了非持续性多形性或单形性室性心动过速。伊布利特接受者中的其他常见医疗事件在安慰剂组中通常也有记录。
富马酸伊布利特在急性终止心房颤动或心房扑动方面有效且安全。
