动脉粥样硬化性心血管疾病-冠脉多支病变患者应用依洛尤单抗的疗效与安全性研究  

Therapeutic efficacy and safety of evolocumab in atherosclerotic cardiovascular disease patients with multivessel coronary artery disease

作　　者：李伟[1] 刘洋[1] 李一[1] 姜云发[1] 范卫泽[1] 苗青[1] 谷新顺[1] LI Wei;LIU Yang;LI Yi(Department of Cardiology,The Second Hospital of Hebei Medical University,Hebei,Shijiazhuang 050000,China)

机构地区：[1]河北医科大学第二医院心内科,石家庄市050000

出　　处：《河北医药》2022年第23期3573-3577,共5页Hebei Medical Journal

基　　金：河北省卫生健康委员会课题(编号:20210859)。

摘　　要：目的 评价依洛尤单抗对动脉粥样硬化性心血管疾病(ASCVD)冠脉多支病变患者的血脂水平、主要不良心血管事件(MACE)的影响及药物安全性。方法 本研究为单中心、前瞻性、注册研究,共纳入患者200例,分为试验组和对照组,每组100例,试验组在他汀降脂治疗基础上,加用依洛尤单抗(140 mg),每2周皮下注射1次。对照组仅他汀降脂治疗。观察依洛尤单抗对患者的血脂水平[总胆固醇(TC)、三酯甘油(TG)、低密度脂蛋白胆固醇(LDL-C)、脂蛋白(a)(LP(a))]、MACE(心源性死亡、心肌梗死、因不稳定型心绞痛再次住院、冠状动脉血运重建)的影响及药物安全性。结果 2组患者在年龄、男性比例、体重指数、合并心血管高危因素(高血压、糖尿病、吸烟)、院前他汀及依折麦布应用比例、其他心血管常用药物应用比例、基线TC、TG、CK值及左心室射血分数(LVEF)等方面差异均无统计学意义(P>0.05)。与对照组比较,试验组Lp(a)、LDL-C、ALT、AST水平更高(P<0.05)。试验组的ALT、AST水平更高,但也在指标的正常参考值范围内。2组患者冠脉病变的特征方面,均为三支病变的比例更高,2组在钙化病变、累及左主干(LM)病变、慢性完全闭塞(CTO)病变、分叉病变方面均无差异(P>0.05)。试验组支架置入的数量多于对照组(P<0.01)。试验组治疗1、3、6个月LDL-C水平低于对照组,差异有统计学意义(P<0.05)。试验组在半年的随访期内没有心源性死亡和心梗事件发生,仅2例患者因心绞痛反复发作而再次住院,其中1例患者再次行冠脉血运重建,而对照组复合MACE发生率高于试验组,差异有统计学意义(P<0.05)。几乎没有出现不可耐受的或严重的不良安全事件。依洛尤单抗组有1例患者自诉肌肉酸痛,但查CK在正常范围内,未发现其他如横纹肌溶解、新发糖尿病、神经认知功能损害、肝功能损害等不良反应。结论 对于ASCVD-冠脉多支�Objective To evaluate the therapeutic efficacy and safety of evolocumab in atherosclerotic cardiovascular disease(ASCVD) patients with multivessel coronary artery disease(MVD), and its effect on blood lipid level and major adverse cardiovascular events(MACEs). Methods It was a single-center, prospective, registry study involving 200 ASCVD patients with MVD. They were randomly assigned into the control group and the experimental group, with 100 cases in each group. All patients were intervened by statin-based lipid lowering therapy, and those in experimental group were additionally given to subcutaneous injection of evolocumab 140mg every two weeks. Blood lipid levels(total cholesterol [TC], triglyceride [TC], low-density lipoprotein cholesterol [LDL-C] and lipoprotein a [LP(a)]), MACEs(cardiac death, myocardial infarction, re-admission due to unstable angina and coronary artery revascularization) and the safety were compared between groups.Results There were no significant differences in the age, male proportion, body mass index(BMI), consolidated cardiovascular risk factors(hypertension, diabetes, smoking), use of statins, ezetimibe and common drugs for cardiovascular diseases before admission, baseline TC, TG, creatine kinase(CK) and left ventricular ejection fraction(LVEF) between groups(all P>0.05). Lp(a), LDL-C, alanine aminotransferase(ALT) and aspartate aminotransferase(AST) of patients in the experimental group were significantly higher than those in the control group(P<0.05), which were in the normal ranges. The proportion of patients with three-vessel lesion significantly increased in both groups. The difference was not statistically significant in the calcification lesions, lesions involving the left main(LM), chronic total occlusion(CTO) lesions, bifurcated lesion between groups(P>0.05). Moreover, the number of scaffolds was significantly higher in the experimental group(P<0.01). LDL-C level at 1, 3, and 6 months in the experimental group was significantly lower than that in the control group(P<0.05).

关 键 词：依洛尤单抗 动脉粥样硬化性心血管疾病 冠脉多支病变 低密度脂蛋白胆固醇 主要不良心血管事件 安全性 

分 类 号：R541.4[医药卫生—心血管疾病]