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一项关于二十碳五烯酸对接受他汀类药物治疗的冠心病患者疗效的随机对照试验。

A randomized controlled trial of eicosapentaenoic acid in patients with coronary heart disease on statins.

作者信息

Watanabe Tetsu, Ando Kaoru, Daidoji Hyuma, Otaki Yoichiro, Sugawara Shigeo, Matsui Motoyuki, Ikeno Eiichiro, Hirono Osamu, Miyawaki Hiroshi, Yashiro Yoshinori, Nishiyama Satoshi, Arimoto Takanori, Takahashi Hiroki, Shishido Tetsuro, Miyashita Takehiko, Miyamoto Takuya, Kubota Isao

机构信息

Department of Cardiology, Pulmonology, and Nephrology, Yamagata University School of Medicine, Yamagata, Japan.

Department of Cardiology, Pulmonology, and Nephrology, Yamagata University School of Medicine, Yamagata, Japan.

出版信息

J Cardiol. 2017 Dec;70(6):537-544. doi: 10.1016/j.jjcc.2017.07.007. Epub 2017 Aug 31.

DOI:10.1016/j.jjcc.2017.07.007
PMID:28863874
Abstract

BACKGROUND

There is a residual risk of coronary heart disease (CHD) despite intensive statin therapy for secondary prevention. The aim of this study was to investigate whether coronary plaque regression and stabilization are reinforced by the addition of eicosapentaenoic acid (EPA) to high-dose pitavastatin (PTV).

METHODS

We enrolled 193 CHD patients who underwent percutaneous coronary intervention (PCI) in six hospitals. Patients were randomly allocated to the PTV group (PTV 4mg/day, n=96) or PTV/EPA group (PTV 4mg/day and EPA 1800mg/day, n=97), and prospectively followed for 6-8 months. Coronary plaque volume and composition in nonstenting lesions were analyzed by integrated backscatter intravascular ultrasound (IB-IVUS).

RESULTS

The PTV/EPA group showed a greater reduction in total atheroma volume compared to PTV group. IB-IVUS analyses revealed that lipid volume was significantly decreased during follow-up period in only PTV/EPA group. The efficacy of additional EPA therapy on lipid volume reduction was significantly higher in stable angina pectoris (SAP) patients compared to acute coronary syndrome patients. EPA/AA ratio was significantly improved in PTV/EPA group compared to PTV group. There was no significant difference in the incidence of major adverse cardiovascular events and side effects.

CONCLUSIONS

Combination EPA/PTV therapy significantly reduced coronary plaque volume compared to PTV therapy alone. Plaque stabilization was also reinforced by EPA/PTV therapy in particular SAP patients. The addition of EPA is a promising option to reduce residual CHD risk under intensive statin therapy.

摘要

背景

尽管采用强化他汀类药物治疗进行二级预防,但冠心病(CHD)仍存在残余风险。本研究的目的是调查在大剂量匹伐他汀(PTV)基础上加用二十碳五烯酸(EPA)是否能增强冠状动脉斑块的消退和稳定。

方法

我们纳入了在六家医院接受经皮冠状动脉介入治疗(PCI)的193例CHD患者。患者被随机分配至PTV组(PTV 4mg/天,n = 96)或PTV/EPA组(PTV 4mg/天和EPA 1800mg/天,n = 97),并进行前瞻性随访6 - 8个月。通过背向散射积分血管内超声(IB-IVUS)分析非支架病变中的冠状动脉斑块体积和成分。

结果

与PTV组相比,PTV/EPA组的总粥样硬化体积减少幅度更大。IB-IVUS分析显示,仅PTV/EPA组在随访期间脂质体积显著降低。与急性冠状动脉综合征患者相比,额外的EPA治疗对稳定型心绞痛(SAP)患者脂质体积减少的疗效显著更高。与PTV组相比,PTV/EPA组的EPA/AA比值显著改善。主要不良心血管事件和副作用的发生率无显著差异。

结论

与单独使用PTV治疗相比,EPA/PTV联合治疗显著降低了冠状动脉斑块体积。EPA/PTV治疗尤其在SAP患者中也增强了斑块稳定性。在强化他汀类药物治疗下,加用EPA是降低CHD残余风险的一个有前景的选择。

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