阿托伐他汀联合依洛尤单抗治疗极高风险动脉粥样硬化心血管疾病患者效果的研究  

Study on the Effect of Atorvastatin Combined with Evolocumab in Patients with Very High-risk Atherosclerotic Cardiovascular Disease

作　　者：郝敬严 刘菁晶[1,2,3] 杨瑞飞 卢宇杰[1,2,3] 王雅洁 王群[1,2,3] 张健 刘霖泽[1,2,3] 林文华 HAO Jingyan;LIU Jingjing;YANG Ruifei;LU Yujie;WANG Yajie;WANG Qun;ZHANG Jian;LIU Linze;LIN Wenhua(Department of Cardiology,TEDA International Cardiovascular Hospital,Tianjin 300457,China;不详)

机构地区：[1]泰达国际心血管病医院内一科,天津300457 [2]天津医科大学心血管病临床学院,天津300070 [3]天津大学心血管病研究所,天津300072

出　　处：《中国医学创新》2024年第9期10-15,共6页Medical Innovation of China

基　　金：滨海新区卫生健康委员会重点支持项目(2019BWKZ002);天津市医学重点学科(专科)建设项目(TJYXZDXK-020A)。

摘　　要：目的:评估阿托伐他汀联合依洛尤单抗治疗极高风险动脉粥样硬化心血管疾病(ASCVD)患者的效果,应用光学相干断层扫描(OCT)测量粥样斑块变化,探讨依洛尤单抗对血管炎症因子的影响。方法:将泰达国际心血管病医院2021年1月—2023年1月冠脉造影检查(CAG)结果为冠状动脉中度狭窄(50%~70%)和低密度脂蛋白胆固醇(LDL-C)升高符合条件的极高风险ASCVD患者60例,按1∶1随机分配到依洛尤单抗组(依洛尤单抗+阿托伐他汀)或标准治疗组(阿托伐他汀),在基线和36周随访时,采用OCT评估靶血管斑块稳定性。结果:治疗36周后,依洛尤单抗组和标准治疗组LDL-C水平均显著降低,依洛尤单抗组低于标准治疗组(P<0.0001)。与标准治疗组相比,依洛尤单抗组最小纤维帽厚度(FCT)差值[(9.41±2.23)μm vs.(21.66±4.46)μm,P<0.001]、靶血管病变最小腔内面积差值[0.13(0.09,0.19)mm^(2) vs.0.23(0.16,0.27)mm^(2),P<0.001]均显著更大,最大脂质弧度差值显著更小[(-8.12±2.40)°vs.(-18.13±3.60)°,P<0.001]。依洛尤单抗组脂蛋白磷脂酶A2(LpA2)更低(P=0.001),而两组C反应蛋白水平(CRP)差异无统计学意义(P=0.574)。此外,标准治疗组中有4例患者发生靶血管血运重建,而依洛尤单抗组发生1例非致死性急性心肌梗死(P=0.098)。未发现药物不良反应事件。结论:阿托伐他汀联用依洛尤单抗可大幅降低血脂LDL-C水平,并明显改善粥样斑块的特征和表型。依洛尤单抗可显著降低血管特异性炎症标志物LpA2水平,或可为ASCVD二级预防及治疗提供新方向。Objective:To evaluate the effect of Atorvastatin combined with Evolocumab in patients with very high-risk atherosclerotic cardiovascular disease(ASCVD),to measure atherosclerotic plaque changes by optical coherence tomography(OCT)and to explore the influence of Evolocumab on vascular inflammatory factors.Method:From January 2021 to January 2023,sixty patients in TEDA International Cardiovascular Hospital with very high-risk ASCVD and with intermediate coronary lesions(50%-70%)by coronary angiography(CAG)and elevated low-density lipoprotein cholesterol(LDL-C)were randomly assigned 1∶1 to Evolocumab group(Evolocumab+Atorvastatin)or standard treatment group(Atorvastatin).At baseline and 36 weeks of follow-up,OCT was used to assess the stability of target vascular lesions.Result:At the treatment of 36 weeks,the LDL-C levels were significantly reduced in the Evolocumab group and standard treatment group,while that in the Evolocumab group was lower than that in the standard treatment group(P<0.0001).Compared with the standard treatment group,the difference of minimum fibrous cap thickness(FCT)[(9.41±2.23)μm vs.(21.66±4.46)μm],the minimum 2 lumen area difference of target vessel lesions[0.13(0.09,0.19)mm vs.0.23(0.16,0.27)mm^(2)]in the Evolocumab group were significantly greater(P<0.001).The maximum lipid radian difference was significantly smaller[(-8.12±2.40)°vs.(-18.13±3.60)°,P<0.001].Lipoprotein phospholipase A2(LpA2)was lower in the Evolocumab group(P=0.001),while C reactive protein(CRP)level was similar between the two groups(P=0.574).In addition,4 cases of target vessel revascularization occurred in the standard treatment group,while 1 case of non-fatal acute myocardial infarction was observed in the Evolocumab group(P=0.098).No adverse drug reactions were detected in the study.Conclusion:The combination of Atorvastatin and Evolocumab can significantly reduce LDL-C lipid levels and significantly improve the characterization and phenotype of atherosclerotic plaques.Evolocumab can substantially reduce the

关 键 词：动脉粥样硬化性心血管疾病 低密度脂蛋白胆固醇 依洛尤单抗 阿托伐他汀 光学相干成像 C反应蛋白 脂蛋白磷脂酶A2 

分 类 号：R543.5[医药卫生—心血管疾病]