琥珀酸美托洛尔缓释片在非心脏手术患者中的作用（POISE试验）：一项随机对照试验。

Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomised controlled trial.

作者信息

Devereaux P J, Yang Homer, Yusuf Salim, Guyatt Gordon, Leslie Kate, Villar Juan Carlos, Xavier Denis, Chrolavicius Susan, Greenspan Launi, Pogue Janice, Pais Prem, Liu Lisheng, Xu Shouchun, Málaga German, Avezum Alvaro, Chan Matthew, Montori Victor M, Jacka Mike, Choi Peter

机构信息

McMaster University, Faculty of Health Sciences, Clinical Epidemiology and Biostatistics, Room 2C8, 1200 Main Street West, Hamilton, ON, L8N 3Z5, Canada.

出版信息

Lancet. 2008 May 31;371(9627):1839-47. doi: 10.1016/S0140-6736(08)60601-7. Epub 2008 May 12.

DOI:10.1016/S0140-6736(08)60601-7

PMID:18479744

Abstract

BACKGROUND

Trials of beta blockers in patients undergoing non-cardiac surgery have reported conflicting results. This randomised controlled trial, done in 190 hospitals in 23 countries, was designed to investigate the effects of perioperative beta blockers.

METHODS

We randomly assigned 8351 patients with, or at risk of, atherosclerotic disease who were undergoing non-cardiac surgery to receive extended-release metoprolol succinate (n=4174) or placebo (n=4177), by a computerised randomisation phone service. Study treatment was started 2-4 h before surgery and continued for 30 days. Patients, health-care providers, data collectors, and outcome adjudicators were masked to treatment allocation. The primary endpoint was a composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal cardiac arrest. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00182039.

FINDINGS

All 8351 patients were included in analyses; 8331 (99.8%) patients completed the 30-day follow-up. Fewer patients in the metoprolol group than in the placebo group reached the primary endpoint (244 [5.8%] patients in the metoprolol group vs 290 [6.9%] in the placebo group; hazard ratio 0.84, 95% CI 0.70-0.99; p=0.0399). Fewer patients in the metoprolol group than in the placebo group had a myocardial infarction (176 [4.2%] vs 239 [5.7%] patients; 0.73, 0.60-0.89; p=0.0017). However, there were more deaths in the metoprolol group than in the placebo group (129 [3.1%] vs 97 [2.3%] patients; 1.33, 1.03-1.74; p=0.0317). More patients in the metoprolol group than in the placebo group had a stroke (41 [1.0%] vs 19 [0.5%] patients; 2.17, 1.26-3.74; p=0.0053).

INTERPRETATION

Our results highlight the risk in assuming a perioperative beta-blocker regimen has benefit without substantial harm, and the importance and need for large randomised trials in the perioperative setting. Patients are unlikely to accept the risks associated with perioperative extended-release metoprolol.

摘要

背景

关于β受体阻滞剂在非心脏手术患者中的试验报告结果相互矛盾。这项在23个国家的190家医院进行的随机对照试验，旨在研究围手术期使用β受体阻滞剂的效果。

方法

我们通过计算机随机电话服务，将8351例患有动脉粥样硬化疾病或有动脉粥样硬化疾病风险且正在接受非心脏手术的患者随机分配，分别接受琥珀酸美托洛尔缓释片治疗（n = 4174）或安慰剂治疗（n = 4177）。研究治疗在手术前2 - 4小时开始，并持续30天。患者、医护人员、数据收集者和结果判定者均对治疗分配情况不知情。主要终点是心血管死亡、非致命性心肌梗死和非致命性心脏骤停的复合终点。分析采用意向性治疗。本试验已在ClinicalTrials.gov注册，注册号为NCT00182039。

结果

所有8351例患者均纳入分析；8331例（99.8%）患者完成了30天的随访。美托洛尔组达到主要终点的患者少于安慰剂组（美托洛尔组244例[5.8%]，安慰剂组290例[6.9%]；风险比0.84，95%可信区间0.70 - 0.99；p = 0.0399）。美托洛尔组发生心肌梗死的患者少于安慰剂组（176例[4.2%]对239例[5.7%]患者；0.73，0.60 - 0.89；p = 0.0017）。然而，美托洛尔组的死亡患者多于安慰剂组（129例[3.1%]对97例[2.3%]患者；1.33，1.03 - 1.74；p = 0.0317）。美托洛尔组发生中风的患者多于安慰剂组（41例[1.0%]对19例[0.5%]患者；2.17，1.26 - 3.74；p = 0.0053）。