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不同剂量他汀类药物预防体外循环冠状动脉搭桥术后房颤及炎症反应的随机对照试验

Prevention of atrial fibrillation and inflammatory response after on-pump coronary artery bypass using different statin dosages: a randomized, controlled trial.

作者信息

Pierri Michele Danilo, Crescenzi Giuseppe, Zingaro Carlo, D'Alfonso Alessandro, Capestro Filippo, Scocco Vitangelo, Brugia Marina, Torracca Lucia

机构信息

Division of Cardiac Surgery of Azienda Ospedaliero-Universitaria Ospedali Riuniti, Ancona, Italy.

Division of Postoperative Intensive Care of Azienda Ospedaliero-Universitaria Ospedali Riuniti, Ancona, Italy.

出版信息

Gen Thorac Cardiovasc Surg. 2016 Jul;64(7):395-402. doi: 10.1007/s11748-016-0647-y. Epub 2016 Apr 13.

Abstract

BACKGROUND

This randomized controlled trial aimed to evaluate the effects of seven-day preoperative treatment with two different dosages of atorvastatin on the incidence of postoperative atrial fibrillation (POAF) and release of inflammatory markers such as high-sensitive C-reactive protein (hsCRP) and interleukin-6 in patients undergoing elective first-time on-pump coronary artery bypass grafting (CABG).

METHODS

The cohort study comprised 212 consecutive patients, already taking statins, who underwent elective first-time CABG with cardiopulmonary bypass without history of atrial fibrillation (AF). Patients were randomly divided into two groups: those who received atorvastatin 40 mg (TOR40 group, 111 patients) and those who received 80 mg (TOR80 group, 101 patients) once a day for 7 days before the planned operation. The primary endpoint was the incidence of AF. The secondary endpoints were the postoperative variations of inflammatory markers, hospital length of stay, and the incidence of major adverse cardiac and clinical events.

RESULTS

A total of 26 patients (23.6 %) pretreated with atorvastatin 40 mg and 16 (15.8 %) patients pretreated with atorvastatin 80 mg had postoperative AF but the difference did not reach the statistical significance (p = 0.157). Median values of interleukin-6 and hsCRP at 12 and 24 h did not have differences between the two groups. No statistically significant differences in the other secondary endpoints were detected.

CONCLUSIONS

According to our result, 7-day preoperative treatment with a high dose of atorvastatin is associated with a trend to a decrease in the incidence of POAF compared with treatment at a lower dose, although it does not impact on the level of inflammatory markers.

CLINICAL TRIAL REGISTRATION

European Clinical Trials Database (EudraCT: 2006-005757-30).

摘要

背景

这项随机对照试验旨在评估两种不同剂量的阿托伐他汀进行为期7天的术前治疗对择期首次体外循环冠状动脉旁路移植术(CABG)患者术后房颤(POAF)发生率以及炎症标志物如高敏C反应蛋白(hsCRP)和白细胞介素-6释放的影响。

方法

这项队列研究纳入了212例连续的患者,这些患者已在服用他汀类药物,接受择期首次体外循环CABG,且无房颤病史。患者被随机分为两组:在计划手术前7天,每天接受40毫克阿托伐他汀的患者(TOR40组,111例)和每天接受80毫克阿托伐他汀的患者(TOR80组,101例)。主要终点是房颤的发生率。次要终点是炎症标志物的术后变化、住院时间以及主要不良心脏和临床事件的发生率。

结果

共有26例(23.6%)接受40毫克阿托伐他汀预处理的患者和16例(15.8%)接受80毫克阿托伐他汀预处理的患者发生了术后房颤,但差异未达到统计学意义(p = 0.157)。两组在12小时和24小时时白细胞介素-6和hsCRP的中位数没有差异。在其他次要终点方面未检测到统计学上的显著差异。

结论

根据我们的结果,与低剂量治疗相比,术前7天高剂量阿托伐他汀治疗有使POAF发生率降低的趋势,尽管它对炎症标志物水平没有影响。

临床试验注册

欧洲临床试验数据库(EudraCT:2006 - 005757 - 30)。

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