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盐酸拉贝洛尔预防左心功能障碍患者心脏手术后心房颤动的安全性和有效性:盐酸拉贝洛尔预防左心室功能障碍心脏手术后心房颤动(PLATON)试验。

Safety and efficacy of landiolol hydrochloride for prevention of atrial fibrillation after cardiac surgery in patients with left ventricular dysfunction: Prevention of Atrial Fibrillation After Cardiac Surgery With Landiolol Hydrochloride for Left Ventricular Dysfunction (PLATON) trial.

机构信息

Department of Cardiovascular Surgery, Nihon University School of Medicine, Tokyo, Japan.

Department of Cardiovascular Surgery, Nihon University School of Medicine, Tokyo, Japan.

出版信息

J Thorac Cardiovasc Surg. 2015 Oct;150(4):957-64. doi: 10.1016/j.jtcvs.2015.07.003. Epub 2015 Jul 10.

DOI:10.1016/j.jtcvs.2015.07.003
PMID:26254752
Abstract

OBJECTIVES

We previously conducted a prospective study of landiolol hydrochloride (INN landiolol), an ultrashort-acting β-blocker, and reported that it could prevent atrial fibrillation after cardiac surgery. This trial was performed to investigate the safety and efficacy of landiolol hydrochloride in patients with left ventricular dysfunction undergoing cardiac surgery.

METHODS

Sixty patients with a preoperative left ventricular ejection fraction of less than 35% were randomly assigned to 2 groups before cardiac surgery and then received intravenous infusion with landiolol hydrochloride (landiolol group) or without landiolol (control group). The primary end point was occurrence of atrial fibrillation as much as 1 week postoperatively. The secondary end points were blood pressure, heart rate, intensive care unit and hospital stays, ventilation time, ejection fraction, biomarkers of ischemia, and brain natriuretic peptide.

RESULTS

Atrial fibrillation occurred in 3 patients (10%) in the landiolol group versus 12 (40%) in the control group, and its frequency was significantly lower in the landiolol group (P = .002). During the early postoperative period, levels of brain natriuretic peptide and ischemic biomarkers were significantly lower in the landiolol group than the control group. The landiolol group also had a significantly shorter hospital stay (P = .019). Intravenous infusion was not discontinued for hypotension or bradycardia in either group.

CONCLUSIONS

Low-dose infusion of landiolol hydrochloride prevented atrial fibrillation after cardiac surgery in patients with cardiac dysfunction and was safe, with no effect on blood pressure. This intravenous β-blocker seems useful for perioperative management of cardiac surgical patients with left ventricular dysfunction.

摘要

目的

我们之前进行了一项盐酸兰地洛尔(INN 兰地洛尔)的前瞻性研究,盐酸兰地洛尔是一种超短效 β 受体阻滞剂,报告称其可预防心脏手术后的心房颤动。本试验旨在研究盐酸兰地洛尔在左心室功能障碍患者心脏手术后的安全性和有效性。

方法

术前左心室射血分数低于 35%的 60 例患者在心脏手术前被随机分为 2 组,然后接受盐酸兰地洛尔(兰地洛尔组)或不接受盐酸兰地洛尔(对照组)的静脉输注。主要终点是术后 1 周内发生心房颤动。次要终点是血压、心率、重症监护病房和住院时间、通气时间、射血分数、缺血生物标志物和脑利钠肽。

结果

兰地洛尔组 3 例(10%)发生心房颤动,对照组 12 例(40%)发生心房颤动,兰地洛尔组发生率明显较低(P=0.002)。在术后早期,兰地洛尔组的脑利钠肽和缺血生物标志物水平明显低于对照组。兰地洛尔组的住院时间也明显缩短(P=0.019)。两组均未因低血压或心动过缓而停止静脉输注。

结论

小剂量盐酸兰地洛尔输注可预防心脏功能障碍患者心脏手术后的心房颤动,且安全,对血压无影响。这种静脉用β受体阻滞剂似乎对左心室功能障碍的心脏手术患者的围手术期管理有用。

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