择期经皮冠状动脉介入术前单次、负荷量氟伐他汀钠缓释片对围手术期心肌损伤的影响

Effect of single loading dose of fluvastatin sodium extended release tablets on periprocedural myocardial injury in patients undergoing elective percutaneous coronary intervention

目的研究择期经皮冠状动脉介入治疗（percutaneous coronary intervention，PCI）术前单次、负荷量氟伐他汀钠缓释片有无预防围手术期心肌损伤（perioperative myocardial injury，PMI）的作用。方法采用前瞻性研究，择期PCI前将患者分为3组。①术前无应用他汀药物病史，术前不给予氟伐他汀钠缓释片（对照组）27例；②术前有应用他汀药物病史，术前1天晚上给予氟伐他汀钠缓释片80mg（他汀1组）39例；③术前无应用他汀药物病史，术前1天晚上给予氟伐他汀钠缓释片80mg（他汀2组）30例。测定术前及术后16～24小时静脉血肌酸激酶同工酶（CK—MB）、肌钙蛋白I（cTnI）水平，作为评估围手术期心肌损伤指标，并观察住院期间主要不良心血管事件（MACE）发生率。结果3组患者基线资料基本均衡。对照组、他汀1组、他汀2组3组患者PCI术后cTnI升高1倍发生率分别为22．2％（6／27）、18．0％（7／39）、33．3％（10／30）（P〉0．05）；3组患者PCI术后cTnI升高3倍以上发生率分别为18．5％（5／27）、12．8％（5／39）、13．3％（4／30）（P〉0．05）；cTnI升高5倍以上发生率分别为14．8％（4／27）、7．7％（3／39）、6．7％（2／30）（P〉0．05）。3组患者PCI术后CK—MB升高发生率分别为11．1％（3／27）、20．5％（8／39）、20．0％（6／30）（P〉0．05）；CK—MB升高3倍以上的人数占总人数1．0％（1／96），发生在他汀2纽，差异无统计学意义（P〉0．05）。Logistic相关分析显示，应用尼可地尔对PMI有保护作用，支架长度为发生PMI的独立危险因素。3组患者住院期间均无MACE（心绞痛复发，心肌梗死，紧急血运重建，心源性死亡等）发生。结论无论有无他汀类药物应用史，择期PCI术前给予单次、80mg负荷量氟伐他汀钠缓释片不足以降低PMI的发生率。

Objective This reseach focuses on whether single loading dose of fluvastatin sodium extended release tablets before elective percutaneous coronary intervention （PCI） has protective effects on perioperative myocardial injury（PMI）. Methods Patients were prospectively enrolled. The patients were divided into three groups before elective PCI. ①The patients who did not receive statins before PCI served as control group②those who had received statins before PCI and fluvastatin sodium extended release tablet 80 mg the night before PCI as statin group 1 ; ③those who did not receive statins but received fluvastatin sodium extended release tablet 80 mg the night before PCI as statin group 2. Serum creatine kinase myocardial isoform（CK-MB） and serum cardiac troponin I（cTnI） levels were measured as PMI indicators preoperatively and repeated at 16-24 h postoperatively： The major adverse cardiovascular events（MACE） during the hospitalization were recorded. Results The baseline data were comparable among the patients of three groups. The incidence of cTnI elevation was 22.2% （6/27） in control group, 18.0% （7/39） in statin group 1,and 33.3 % （10/30） in the statin group 2 （ P 〉0.05）. The incidence of cTnI elevation ≥3 X ULN was 18.5 % （5/27）, 12.8 % （5/39） and 13.3 % （4/30） in the control group, statin group 1, and statin group 2, respectively（ P 〉0.05）. The incidence of cTnI elevation ≥5XULN was 14.8%（4/27）,7.7%（3/39）,and 6.7%（2/30） in control group,statin group 1 ,and statin group 2,respectively（ P 〉0.05）. The incidence of CKMB elevation was 11.1% （3/27） ,20.5% （8/ 39）,and 20.0 % （6/30） in control group, statin group 1, and statin group 2 （ P 〉 0.05 ）. The incidence of CK-MB elevation ≥3 ×ULN was 1.0% （1/96） in total, which occurred in statin group 2,also without significant difference among the three groups （ P 〉0.05）. In the multivariate mode,the administration of nicorandil was a protective factor for PMI,while stent length was an independent risk factor for PMI. No MACE such as recurrent angina, myocardial infarction, urgent revascularization, cardiac death events occurred in all three groups during hospitalization. Conclusion Administration of a single 80 mg loading dose of fluvastatin sodium extended release tablet the night before elective PCI seems not enough to reduce the incidence of PMI,whether in statin use or statin naive patients.