围手术期他汀类药物使用对非心脏手术患者心血管并发症的影响：系统评价、荟萃分析和试验序贯分析方案。
Effects of perioperative statin use on cardiovascular complications in patients submitted to non-cardiac surgery: protocol for a systematic review, meta-analysis, and trial sequential analysis.
机构信息
Research Institute, Hospital do Coração (HCor), Rua Abílio Soares 250, 12° andar, CEP: 04005-000, São Paulo, SP, Brazil.
Graduate Program in Epidemiology, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.
出版信息
Syst Rev. 2017 Jun 19;6(1):116. doi: 10.1186/s13643-017-0500-0.
BACKGROUND
Preliminary evidence suggests statins may reduce major perioperative vascular events. However, evidence is limited to observational studies, underpowered trials, and non-comprehensive systematic reviews. This review aims to assess the effects of perioperative statin use on cardiovascular complications in patients submitted to non-cardiac surgery.
METHODS
We will search MEDLINE/PubMed, EMBASE, LILACS, CENTRAL, Web of Science, and CINAHL for randomized controlled trials assessing the effects of perioperative statin use in adults undergoing non-cardiac surgery and reporting cardiovascular complications. For patients already using statins for hyperlipidemia, a preoperative loading dose of statin is required in the experimental group. We will place no language or publication restriction on our search. Teams of two reviewers will independently assess eligibility and risk of bias, and will extract data from the included trials. Our primary outcome is a combination of cardiovascular mortality or non-fatal myocardial infarction. We will also assess the following outcomes: individual components of the primary outcome, all-cause mortality, total myocardial infarction, elevated troponin in the first seven postoperative days, total stroke, total venous thromboembolism, postoperative atrial fibrillation, elevation of creatine phosphokinase or liver enzymes, and rates of myalgia or rhabdomyolysis. We will conduct meta-analyses using random-effects model and will use trial sequential analysis to establish monitoring boundaries to limit global type I error due to repetitive testing for our primary outcome. We will rate the quality of evidence using the GRADE system.
DISCUSSION
The results of this systematic review may help to inform clinical practice and also the design of future large-scale randomized trials.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO CRD42016035987.
背景
初步证据表明他汀类药物可能减少主要围手术期血管事件。然而，证据仅限于观察性研究、效力不足的试验和非全面的系统评价。本综述旨在评估围手术期他汀类药物使用对非心脏手术患者心血管并发症的影响。
方法
我们将检索 MEDLINE/PubMed、EMBASE、LILACS、CENTRAL、Web of Science 和 CINAHL，以评估评估围手术期他汀类药物使用对接受非心脏手术并报告心血管并发症的成年人的影响的随机对照试验。对于已经因高脂血症使用他汀类药物的患者，实验组需要术前给予他汀类药物负荷剂量。我们对搜索不设语言或出版限制。两名评审员团队将独立评估资格和偏倚风险，并从纳入的试验中提取数据。我们的主要结局是心血管死亡率或非致死性心肌梗死的组合。我们还将评估以下结局：主要结局的各个组成部分、全因死亡率、总心肌梗死、术后 7 天内肌钙蛋白升高、总卒中、总静脉血栓栓塞、术后心房颤动、肌酸磷酸激酶或肝酶升高以及肌痛或横纹肌溶解的发生率。我们将使用随机效应模型进行荟萃分析，并使用试验序贯分析来建立监测边界，以限制由于对我们的主要结局进行重复测试而导致的总体 I 类错误。我们将使用 GRADE 系统评估证据质量。
讨论
本系统评价的结果可能有助于为临床实践提供信息，也有助于未来大规模随机试验的设计。
系统评价注册
PROSPERO CRD42016035987。
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