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冠状动脉搭桥术后静脉注射地尔硫䓬与地高辛治疗心房颤动的随机双盲对照研究。

A randomized, double-blind comparison of intravenous diltiazem and digoxin for atrial fibrillation after coronary artery bypass surgery.

作者信息

Tisdale J E, Padhi I D, Goldberg A D, Silverman N A, Webb C R, Higgins R S, Paone G, Frank D M, Borzak S

机构信息

College of Pharmacy and Allied Health Professions, Wayne State University and Department of Pharmacy Services, Henry Ford Hospital, Detroit, Mich 48202, USA.

出版信息

Am Heart J. 1998 May;135(5 Pt 1):739-47. doi: 10.1016/s0002-8703(98)70031-6.

Abstract

BACKGROUND

Atrial fibrillation (AF) after coronary bypass graft surgery may result in hypotension, heart failure symptoms, embolic complications, and prolongation in length of hospital stay (LOHS). The purpose of this study was to determine whether intravenous diltiazem is more effective than digoxin for ventricular rate control in AF after coronary artery bypass graft surgery. A secondary end point was to determine whether ventricular rate control with diltiazem reduces postoperative LOHS compared with digoxin.

METHODS AND RESULTS

Patients with AF and ventricular rate > 100 beats/min within 7 days after coronary artery bypass graft surgery were randomly assigned to receive intravenous therapy with diltiazem (n = 20) or digoxin (n = 20). Efficacy was measured with ambulatory electrocardiography (Holter monitoring). Safety was assessed by clinical monitoring and electrocardiographic recording. LOHS was measured from the day of surgery. Data were analyzed with the intention-to-treat principle in all randomly assigned patients. In addition, a separate intention-to-treat analysis was performed excluding patients who spontaneously converted to sinus rhythm. In the analysis of all randomly assigned patients, those who received diltiazem achieved ventricular rate control (> or = 20% decrease in pretreatment ventricular rate) in a mean of 10 +/- 20 (median 2) minutes compared with 352 +/- 312 (median 228) minutes for patients who received digoxin (p < 0.0001). At 2 hours, the proportion of patients who achieved rate control was significantly higher in patients treated with diltiazem (75% vs 35%, p = 0.03). Similarly, at 6 hours, the response rate associated with diltiazem was higher than that in the digoxin group (85% vs 45%, p = 0.02). However, response rates associated with diltiazem and digoxin at 12 and 24 hours were not significantly different. At 24 hours, conversion to sinus rhythm had occurred in 11 of 20 (55%) patients receiving diltiazem and 13 of 20 (65%) patients receiving digoxin (p = 0.75). Results of the analysis of only those patients who remained in AF were similar to those presented above. There was no difference between the diltiazem-treated and digoxin-treated groups in postoperative LOHS (8.6 +/- 2.2 vs 7.7 +/- 2.0 days, respectively, p = 0.43).

CONCLUSIONS

Ventricular rate control occurs more rapidly with intravenous diltiazem than digoxin in AF after coronary artery bypass graft surgery. However, 12- and 24-hour response rates and duration of postoperative hospital stay associated with the two drugs are similar.

摘要

背景

冠状动脉搭桥手术后发生心房颤动(AF)可能导致低血压、心力衰竭症状、栓塞并发症以及住院时间(LOHS)延长。本研究的目的是确定静脉注射地尔硫䓬在冠状动脉搭桥手术后房颤的心室率控制方面是否比地高辛更有效。次要终点是确定与地高辛相比,地尔硫䓬控制心室率是否能缩短术后住院时间。

方法与结果

冠状动脉搭桥手术后7天内发生AF且心室率>100次/分钟的患者被随机分配接受静脉注射地尔硫䓬治疗(n = 20)或地高辛治疗(n = 20)。通过动态心电图(Holter监测)测量疗效。通过临床监测和心电图记录评估安全性。从手术当天开始测量住院时间。对所有随机分配的患者按照意向性分析原则进行数据分析。此外,进行了一项单独的意向性分析,排除自发转为窦性心律的患者。在对所有随机分配患者的分析中,接受地尔硫䓬治疗的患者平均在10±20(中位数2)分钟内实现了心室率控制(治疗前心室率降低≥20%),而接受地高辛治疗的患者为352±312(中位数228)分钟(p<0.0001)。在2小时时,接受地尔硫䓬治疗的患者实现心率控制的比例显著高于地高辛治疗组(75%对35%,p = 0.03)。同样,在6小时时,地尔硫䓬组的反应率高于地高辛组(85%对45%,p = 0.02)。然而,地尔硫䓬和地高辛在12小时和24小时时的反应率没有显著差异。在24小时时,20例接受地尔硫䓬治疗的患者中有11例(55%)转为窦性心律,20例接受地高辛治疗的患者中有13例(65%)转为窦性心律(p = 0.75)。仅对仍处于房颤状态的患者进行分析的结果与上述结果相似。地尔硫䓬治疗组和地高辛治疗组的术后住院时间没有差异(分别为8.6±2.2天和7.7±2.0天,p = 0.43)。

结论

在冠状动脉搭桥手术后房颤患者中,静脉注射地尔硫䓬比地高辛能更快地控制心室率。然而,两种药物在12小时和24小时时的反应率以及术后住院时间相似。

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