负荷剂量他汀类药物预防经皮冠状动脉介入治疗患者主要心血管事件的系统评价

Prevention of Major Cardiovascular Events with Load-dose Statins in Patients Treated with Percutaneous Coronary Intervention:A Systematic Review

目的系统评价负荷剂量他汀类药物预防经皮冠状动脉介入治疗(PCI)患者围手术期主要不良心血管事件的有效性和安全性。方法计算机检索Pubmed、Embase、Cochrane Library、中国期刊全文数据库、万方知识服务平台,收集PCI术前应用负荷剂量他汀类药物治疗对患者围手术期心血管事件影响的随机对照试验(RCT)。采用Cochrane系统评价员手册5.1.0偏倚风险评估工具进行方法学质量评价,应用Stata15.1软件进行Meta分析。结果共纳入14项RCT,合计3576例患者。Meta分析结果显示,他汀治疗组患者PCI围手术期心肌梗死事件发生率(RR=0.401,95%CI:0.315~0.510,Z=7.43,P<0.001)、主要不良心血管事件发生率(RR=0.475,95%CI:0.384~0.589,Z=6.82,P<0.001)和TIMI血流分级小于3级事件发生率(RR=0.426,95%CI:0.299~0.607,Z=4.73,P<0.001)显著低于对照组,两组差异有统计学意义。同时他汀治疗组能够显著降低PCI围手术期肌酸激酶同工酶水平超过1倍与3倍正常值上限的发生率,负荷剂量的他汀类药物并未显著增加肝酶和肌酸激酶异常升高的发生率。结论术前应用负荷剂量他汀类药物能够改善PCI围手术期患者心肌的血流灌注,减少无复流现象的发生,降低心肌梗死和主要不良心血管事件的发生率,并具有良好的安全性和耐受性。

Objective To systematically evaluate the efficacy and safety of load-dose statins in preventing major adverse cardiovascular events in patients undergoing percutaneous coronary intervention(PCI), and to provide an evidence-based reference for clinical decision-making. Methods Computer retrieval was performed on Pubmed, Embase, Cochrane Library, Chinese journal full-text database, Wanfang database. Randomized controlled trials were collected about the effect of loading statin therapy before PCI on perioperative cardiovascular events in patients. Methodological quality assessment was conducted using the Cochrane reviewers’ manual 5.1.0 risk assessment tool. Meta-analysis was performed by using Stata15.1 software. Results Fourteen RCTs with a total of 3 576 patients were included. Meta analysis results showed that the incidence of perioperative myocardial infarction events(RR=0.401, 95% CI:0.315-0.510, Z=7.43, P<0.001), major adverse cardiovascular events(RR=0.475, 95% CI:0.384-0.589, Z=6.82, P<0.001), and TIMI blood flow grade<grade 3 events(RR=0.426,95% CI:0.299-0.607, Z=4.73, P<0.001) in the statin treatment group were significantly lower than those in the control group, and the differences between the two groups were statistically significant. Meanwhile the incidence that the isoenzyme level of creatine kinase exceeded 1 times and 3 times the upper limit of normal value in the perioperative period of PCI was significantly reduced in the statin treatment group, while the incidence of abnormal increase of liver enzyme and creatine kinase was not significantly increased in the loading dose of statin. Conclusion Preoperative administration of loading statin can improve myocardial perfusion during perioperative period of PCI, reduce the occurrence of non-reflow, reduce the incidence of myocardial infarction and major adverse cardiovascular events, and has good safety and tolerability.