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心脏手术围手术期他汀类药物治疗:随机对照试验的荟萃分析

Perioperative statin therapy in cardiac surgery: a meta-analysis of randomized controlled trials.

作者信息

Putzu Alessandro, Capelli Bruno, Belletti Alessandro, Cassina Tiziano, Ferrari Enrico, Gallo Michele, Casso Gabriele, Landoni Giovanni

机构信息

Department of Cardiovascular Anesthesia and Intensive Care, Cardiocentro Ticino, Via Tesserete 48, Lugano, Switzerland.

Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Via Olgettina 60, Milano, Italy.

出版信息

Crit Care. 2016 Dec 5;20(1):395. doi: 10.1186/s13054-016-1560-6.

Abstract

BACKGROUND

Several studies suggest beneficial effects of perioperative statin therapy on postoperative outcome after cardiac surgery. However, recent randomized controlled trials (RCTs) show potential detrimental effects. The objective of this systematic review is to examine the association between perioperative statin therapy and clinical outcomes in cardiac surgery patients.

METHODS

Electronic databases were searched up to 1 November 2016 for RCTs of preoperative statin therapy versus placebo or no treatment in adult cardiac surgery. Postoperative outcomes were acute kidney injury, atrial fibrillation, myocardial infarction, stroke, infections, and mortality. We calculated odds ratios (ORs) and 95% confidence intervals (CIs) using fixed-effects meta-analyses. Primary analysis was restricted to trials with low risk of bias according to Cochrane methodology, and sensitivity analyses examined whether the risk of bias of included studies was associated with different results. We performed trial sequential analysis (TSA) to test the strength of the results.

RESULTS

We included data from 23 RCTs involving 5102 patients. Meta-analysis of trials with low risk of bias showed that statin therapy was associated with an increase in acute kidney injury (314 of 1318 (23.82%) with statins versus 262 of 1319 (19.86%) with placebo; OR 1.26 (95%CI 1.05 to 1.52); p = 0.01); these results were supported by TSA. No difference in postoperative atrial fibrillation, myocardial infarction, stroke, infections, or mortality was present. On sensitivity analysis, statin therapy was associated with a slight increase in hospital mortality. Meta-analysis including also trials with high or unclear risk of bias showed no beneficial effects of statin therapy on any postoperative outcomes.

CONCLUSIONS

There is no evidence that statin therapy in the days prior to cardiac surgery is beneficial for patients' outcomes. Particularly, statins are not protective against postoperative atrial fibrillation, myocardial infarction, stroke, or infections. Statins are associated with a possible increased risk of acute kidney injury and a detrimental effect on hospital survival could not be excluded. Future RCTs should further evaluate the safety profile of this therapy in relation to patients' outcomes and assess the more appropriate time point for discontinuation of statins before cardiac surgery.

摘要

背景

多项研究表明围手术期他汀类药物治疗对心脏手术后的术后结局有有益影响。然而,近期的随机对照试验(RCT)显示出潜在的有害影响。本系统评价的目的是研究围手术期他汀类药物治疗与心脏手术患者临床结局之间的关联。

方法

检索电子数据库至2016年11月1日,查找关于成人心脏手术中术前他汀类药物治疗与安慰剂或不治疗对比的随机对照试验。术后结局包括急性肾损伤、心房颤动、心肌梗死、中风、感染和死亡率。我们使用固定效应荟萃分析计算比值比(OR)和95%置信区间(CI)。主要分析限于根据Cochrane方法偏倚风险低的试验,敏感性分析检查纳入研究的偏倚风险是否与不同结果相关。我们进行了试验序贯分析(TSA)以检验结果的强度。

结果

我们纳入了来自23项随机对照试验、涉及5102例患者的数据。对偏倚风险低的试验进行荟萃分析表明,他汀类药物治疗与急性肾损伤增加相关(使用他汀类药物的1318例中有314例(23.82%),使用安慰剂的1319例中有262例(19.86%);OR 1.26(95%CI 1.05至1.52);p = 0.01);试验序贯分析支持了这些结果。术后心房颤动、心肌梗死、中风、感染或死亡率无差异。在敏感性分析中,他汀类药物治疗与医院死亡率略有增加相关。纳入偏倚风险高或不明确的试验的荟萃分析表明,他汀类药物治疗对任何术后结局均无有益影响。

结论

没有证据表明心脏手术前数天进行他汀类药物治疗对患者结局有益。特别是,他汀类药物不能预防术后心房颤动、心肌梗死、中风或感染。他汀类药物与急性肾损伤风险可能增加相关,且不能排除对医院生存有不利影响。未来的随机对照试验应进一步评估这种治疗与患者结局相关的安全性,并评估心脏手术前停用他汀类药物更合适的时间点。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fe39/5139027/17e6cacac6e7/13054_2016_1560_Fig1_HTML.jpg

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