冠状动脉搭桥术后患者应用中等剂量瑞舒伐他汀和辛伐他汀的疗效及安全性比较

doi:10.13481/j.1671-587X.20210229

摘要/Abstract

摘要： 目的

评价和比较中国患者在接受冠状动脉搭桥术（CABG）后应用中等剂量瑞舒伐他汀和辛伐他汀的有效性和安全性，以提供合理的CABG术后二级预防策略。

方法

纳入本院符合研究标准的行CABG的患者。根据术后应用他汀类药物的种类分为瑞舒伐他汀组和辛伐他汀组，各150例。收集患者基线资料。记录2组患者入院时和术后1年时血脂状况。收集术后心血管死亡、再发心绞痛等主要不良心血管事件（MACE）和肝功能异常、肌病等安全性相关不良事件的发生情况，以及术后1年时复查冠状动脉CT血管造影（CTA）结果，并计算狭窄指数。

结果

共完成随访286例，随访率95.3%，其中瑞舒伐他汀组完成随访140例，辛伐他汀组完成随访146例。血脂方面，与术前比较，瑞舒伐他汀组和辛伐他汀组患者术后1年时总胆固醇（TC）和低密度脂蛋白胆固醇（LDL-C）水平均明显降低（P<0.05），高密度脂蛋白胆固醇（HDL-C）水平明显升高（P<0.05）。MACE和安全性方面，2组组间比较差异无统计学意义（P>0.05）。桥血管狭窄情况，瑞舒伐他汀组和辛伐他汀组患者狭窄指数分别为4.55（0~11.86）和 5.78（0~13.00），差异无统计学意义（P>0.05）。

结论

中等剂量瑞舒伐他汀和辛伐他汀均能使血清LDL-C水平达到降脂标准；2种药物的有效性和安全性无差异，均可用于中国冠心病患者CABG术后的二级预防策略。

关键词: 冠状动脉搭桥术, 瑞舒伐他汀, 辛伐他汀：二级预防

Abstract: Objective

To evaluate and compare the efficacies and safeties of moderate dose of rosuvastatin and simvastatin in the Chinese patients underwent coronary artery bypass grafting （CABG）， and to provide a reasonable strategy for secondary prevention after CABG.

Methods

The patients underwent CABG who met the study criteria in our hospital were included. According to the types of postoperatively administered statin drugs， the patients were divided into rosuvastatin group and simvastatin group， and there were 150 cases in each group. The baseline characteristics of patients and theirs blood lipid status at admission and 1 year after CABG were recorded. The occurrence of major adverse cardiovascular events （MACE） such as cardiovascular death and recurrent angina， as well as safety-related adverse events such as abnormal liver function and myopathy were noted. Meanwhile coronary computed tomography angiography（CTA） was performed 1 year after operation， and its stenosis index was calculated.

Results

A total of 286 cases were followed up， with a follow-up rate of 95.3%， including 140 cases in rosuvastatin group and 146 cases in simvastatin group. In terms of blood lipid changes， compared with before operation， the total cholestrol（TC） and low density lipoprotein-cholesterol（LDL-C） levels in rosuvastatin grouop and simvastatin group 1 year after operation were significantly decreased （P<0.05），and the levels of high density lipoprotein-cholesterol（HDL-C） were significantly increased（P<0.05）. In terms of MACE and safety events， there were no statistically significant differences between two groups （P>0.05）. The stenosis indexes of the patients in rosuvastatin group and simvastatin group were 4.55（0 —11.86） vs 5.78（0 —13.00）， and the difference was not statistically significant （P>0.05）.

Conclusion

Moderate dose of rosuvastatin and simvastatin can make the serum LDL-C level meet the standard of lipid lowering. There is no difference in the efficacies or safeties between two kinds of drugs， and both drugs could be used as secondary prevention strategies after CABG in the Chinese patients with coronary heart disease.

Key words: coronary artery bypass grafting, rosuvastatin, simvastatin, secondary prevention

中图分类号:

R654.2

赵晨宇,罗晓康,段亚冰,鞠帆,孙寒松. 冠状动脉搭桥术后患者应用中等剂量瑞舒伐他汀和辛伐他汀的疗效及安全性比较[J]. 吉林大学学报(医学版), 2021, 47(2): 477-482.

Chenyu ZHAO,Xiaokang LUO,Yabing DUAN,Fan JYU,Hansong SUN. Comparison of efficacies and safeties between moderate dose of rosuvastatin and simvastatin in patients after coronary artery bypass grafting[J]. Journal of Jilin University(Medicine Edition), 2021, 47(2): 477-482.

图/表 4

表 1

表 2

表 3

表 4

参考文献 21

1	SHAEFI S， MITTEL A， LOBERMAN D， et al. Off-pump versus on-pump coronary artery bypass grafting-A systematic review and analysis of clinical outcomes［J］. J Cardiothorac Vasc Anesth， 2019，33（1）：232-244.
2	KULIK A， ABREU A M， BORONAT V， et al. Impact of ticagrelor versus aspirin on graft patency after CABG： Rationale and design of the TARGET （ticagrelor antiplatelet therapy to reduce graft events and thrombosis） randomized controlled trial （NCT02053909）［J］. Contemp Clin Trials， 2018， 68：45-51.
3	PALOMÄKI A，HÄLLBERG V， ALA-KORPELA M，et al. Prompt impact of first prospective statin mega-trials on postoperative lipid management of CABG patients： a 20-year follow-up in a single hospital［J］. Lipids Health Dis， 2016，15（1）：124-127.
4	KATSIKI N， ŽREINER， TEDESCHI REINER E， et al. Improvement of endothelial function by pitavastatin：a meta-analysis［J］.Expert Opin Pharmacother，2018，19（3）：279-286.
5	NISHIKIDO T， OYAMA J， KEIDA T， et al. High-dose statin therapy with rosuvastatin reduces small dense LDL and MDA-LDL： The standard versus high-dose therapy with rosuvastatin for lipid lowering （SARD） trial［J］. J Cardiol， 2016，67（4）：340-346.
6	PARK J B， JUNG J H， YOON Y E， et al. Long-term effects of high-dose pitavastatin on diabetogenicity in comparison with atorvastatin in patients with Metabolic syndrome （LESS-DM）： study protocol for a randomized controlled trial［J］. Trials， 2017，18（1）：501.
7	GRUNDY S M， STONE N J. 2018 American heart association/american college of cardiology/multisociety guideline on the management of blood cholesterol-secondary prevention［J］.JAMA Cardiol，2019，4（6）：589.
8	CHAN J C， KONG A P， BAO W， et al. Safety of atorvastatin in Asian patients within clinical trials［J］. Cardiovasc Ther， 2016，34（6）：431-440.
9	DEHARO P， PANKERT M， QUILICI J， et al. Safety and effectiveness of the association ezetimibe-statin （E-S） versus high dose rosuvastatin after acute coronary syndrome： the SAFE-ES study［J］. Ann Cardiol Angeiol （Paris）， 2014，63（4）：222-227.
10	KULIK A， RUEL M， JNEID H， et al. Secondary prevention after coronary artery bypass graft surgery： a scientific statement from the american heart association［J］. Circulation， 2015， 131（10）：927-964.
11	陆再英，余保平. 内科学［M］. 2版. 北京：人民卫生出版社，2007：197.
12	MASANA L， CABRÉA， PLANA N. HPS2-THRIVE results： Bad for niacin/laropiprant， good for ezetimibe？［J］. Atherosclerosis， 2013， 229（2）：449-450.
13	TAGUCHI I， IIMURO S， IWATA H， et al. High-dose versus low-dose pitavastatin in Japanese patients with stable coronary artery disease（REAL-CAD）： A randomized superiority trial［J］. Circulation， 2018， 137（19）：1997-2009.
14	YANG Z J， LIU J， GE J P， et al. Prevalence of cardiovascular disease risk factor in the Chinese population： the 2007-2008 China national diabetes and metabolic disorders study［J］. Eur Heart J， 2012， 33（2）：213-220.
15	H R COLLABORATIVE GROUP， BOWMAN L， HOPEWELL J C，et al. Effects of anacetrapib in patients with atherosclerotic vascular disease［J］. N Engl J Med， 2017， 377（13）：1217-1227.
16	PEDERSEN T R， FAERGEMAN O， KASTELEIN J J P， et al. High-dose atorvastatin vs usual-dose simvastatin for secondary prevention after myocardial infarction： the IDEAL study： a randomized controlled trial［J］. JAMA， 2005， 294（19）：2437-2445.
17	The Stroke Prevention by Aggressive Reduction in Cholesterol Levels （SPARCL） Investigators.High-dose atorvastatin after stroke or transient ischemic attack［J］. N Engl J Med， 2006， 355（6）：549-559.
18	SATTAR N， PREISS D， MURRAY H M， et al. Statins and risk of incident diabetes： a collaborative meta-analysis of randomised statin trials［J］. Lancet， 2010，375（9716）：735-742.
19	YEON C J， UNG C C， SOON Y H， et al. Effect of pitavastatin compared with atorvastatin and rosuvastatin on new-onset diabetes mellitus in patients with acute myocardial infarction［J］. Am Cardiol， 2018，166（6）：922-928.
20	HUIJGEN R， BOEKHOLDT S M， ARSENAULT B J， et al. A nested case-control study［J］. J Am Coll Cardiol， 2012， 59（20）：1778-1784.
21	中华医学会心血管病学分会流行病学组，中国医师协会心血管内科医师分会，中国老年学学会心脑血管病专业委员会. 糖代谢异常与动脉粥样硬化性心血管疾病临床诊断和治疗指南［J］. 中华心血管病杂志， 2015， 43（6）：488-506.

Group	n	Age(year)	Height(l/cm)	Weight(m/kg)	BMI(kg·m^－2)	PCI(η/%)
Rosuvastatin	140	66.21±6.54	172.53±10.07	75.75±15.11	24.66±3.70	27.86
Simvastatin	146	63.54±5.78	169.88±10.76	72.08±13.12	25.77±4.86	30.00
P		0.765	0.068	0.395	0.887	0.666
Group	n	Smoking(η/%)	Hypertension(η/%)	Hyperlipemia(η/%)	MI(η/%)	TIA(η/%)
Rosuvastatin	140	58.57	70.00	72.86	30.00	17.86
Simvastatin	146	61.64	77.86	80.00	33.57	13.57
P		0.766	0.978	0.832	0.905	0.767

Group		n	TC	LDL-C	HDL-C
Rosuvastatin	Before operation	140	5.69±1.78	3.71±2.53	1.03±0.52
Rosuvastatin	1 year after operation		4.22±0.88^*	1.64±0.65^*	1.50±0.47^*
Simvastatin	Before operation	146	5.55±1.46	3.49±1.93	0.95±0.38
Simvastatin	1 year after operation		4.02±0.82^*	1.56±0.77^*	1.35±0.57^*

Group	n	MACE						Safety-related events
Group	n	Cardiovascular death	Recurrent MI	Recurrent argina	Recurrent PCI	Heart failure	Total	Hepatic injury	Myopathy	New-onset DM	Total
Rosuvastatin	140	2.14	2.86	2.14	1.43	3.57	12.14	5.71	2.86	3.57	12.14
Simvastatin	146	1.37	2.05	3.42	0	1.37	8.22	6.85	2.05	4.11	13.01
P		0.521	0.476	0.132	0.072	0.102	0.099	0.141	0.448	0.209	0.328

Group	n	Number of graft stenosis per capita			Stenosis index
Group	n	Vein	Artery	Total	Stenosis index
Rosuvastatin	115	2.26±1.20	0.95±0.16	3.21±0.80	4.55(0－11.86)
Simvastatin	130	2.22±1.08	0.92±0.13	3.14±0.55	5.78(0－13.00)
P		－	－	0.533	0.202
“-”：No data.

[1]	杜彪, 谢星星, 张杰, 范小冬, 叶云. 瑞舒伐他汀治疗中国原发性高胆固醇血症患者疗效与安全性的系统评价[J]. 吉林大学学报(医学版), 2016, 42(05): 968-974.
[2]	吕文轩, 李文耀, 范思佳, 赵殊, 郭五虎, 陈丽娟, 邓悦. 瑞舒伐他汀对载脂蛋白E基因敲除小鼠动脉粥样硬化的治疗作用及其机制[J]. 吉林大学学报(医学版), 2016, 42(02): 240-244.
[3]	孙丽娟, 刘婷, 徐秀梅, 李杰. 瑞舒伐他汀治疗老年人下肢动脉粥样硬化的效果评价[J]. 吉林大学学报(医学版), 2015, 41(06): 1260-1263.