Effect of simvastatin on postoperative complications in patients undergoing one-lung ventilation during surgery: the Prevention HARP-2 randomised controlled trial.

Statins may limit inflammation involved in the development of these complications.

他汀类药物可能限制这些并发症发展过程中涉及的炎症。

Background

We tested the hypothesis that perioperative simvastatin use reduces postoperative cardiopulmonary complications, compared with placebo, in surgery requiring one-lung ventilation.

我们测试了围手术期使用辛伐他汀是否能减少需要单肺通气的手术后心肺并发症，与安慰剂相比。

Methods

Randomised, double-blind, multicentre trial of simvastatin versus placebo in patients undergoing elective oesophagectomy, lobectomy or pneumonectomy at 15 sites throughout the UK.

在英国15个地点进行的随机、双盲、多中心试验，比较了接受择期食管切除术、肺叶切除术或肺切除术的患者中辛伐他汀与安慰剂的效果。

Planned sample size is 452 patients.

计划的样本量为452名患者。

Participants were randomised to either simvastatin 80 mg or placebo for 4 days preoperatively and up to 7 days postoperatively.

参与者被随机分配到接受辛伐他汀80毫克或安慰剂，术前4天和术后最多7天。

measurements

The primary outcome measure was a composite endpoint of the incidenceof acute respiratory distress syndrome, postoperative pulmonary complications, myocardial infarction and/or myocardial ischaemia during the first 7 days postoperatively or until hospital discharge.

主要结果指标是急性呼吸窘迫综合征、术后肺部并发症、心肌梗死和/或心肌缺血在术后第1天至第7天或直至出院期间发生率的复合终点。

A modified intention-to-treatanalysis excluded patients who did not receive the intervention preoperatively or proceed with the planned surgery.

改良意向治疗分析排除了那些术前未接受干预或未按计划进行手术的患者。

main_results

251 patients were randomised, 126 assigned to simvastatin and 125 to placebo, with 208 included in the modified intention-to-treatpopulation.

共有251名患者被随机分配，其中126名被分配至辛伐他汀组，125名被分配至安慰剂组，最终有208名患者被纳入改良意向治疗人群。

The trial was stopped early because of futility following recommendations from the data monitoring and ethics committee.

由于数据监测和伦理委员会的建议，该试验因无效而提前终止。

The primary outcome occurred in 45/106 patients (42.5%) in the simvastatin group and 39/102 patients (38.2%) in the placebo group (OR 1.19 (95% CI 0.68 to 2.08); p=0.54).

主要结果发生在45/106名患者（42.5%）的辛伐他汀组和39/102名患者（38.2%）的安慰剂组（OR 1.19 (95% 置信区间0.68至2.08); p=0.54）。

Secondary and safety outcomes were similar between the groups.

次要结果和安全性结果在两组之间相似。

Conclusions

In patients undergoing one-lung ventilation, simvastatin did not reduce the incidenceof postoperative cardiopulmonary complications.

在接受单肺通气的患者中，辛伐他汀并未降低术后心肺并发症的发生率。

trial_registration_number

isrctn.org identifier, ISRCTN48095567.

isrctn.org注册标识符，ISRCTN48095567。