2021 年第 4 期 第 16 卷

依洛尤单抗降低中国急性冠状动脉综合征患者低密度脂蛋白胆固醇水平的有效性与安全性研究

Efficacy and safety of evolocumab reducing low-density lipoprotein cholesterol level on Chinese patients with acute coronary syndrome

作者：许晓晗柴萌程宇婧彭萍安刘晓丽闫振娴郭永和赵迎新周玉杰

英文作者：Xu Xiaohan Chai Meng Cheng Yujing Peng Ping′an Liu Xiaoli Yan Zhenxian Guo Yonghe Zhao Yingxin Zhou Yujie

单位：首都医科大学附属北京安贞医院心内科北京市心肺血管疾病研究所冠心病精准治疗北京市重点实验室首都医科大学冠心病临床诊疗与研究中心 100029

英文单位：Department of Cardiology Beijing Anzhen Hospital Capital Medical University Beijing Institute of Heart Lung and Blood Vessel Diseases Beijing Key Laboratory of Precision Medicine of Coronary Atherosclerotic Heart Disease Clinical Center for Coronary Heart Disease Capital Medical University Beijing 100029 China

关键词：急性冠状动脉综合征；低密度脂蛋白胆固醇；依洛尤单抗

英文关键词：Acutecoronarysyndrome;Low-densitylipoproteincholesterol;Evolocumab 

• 摘要：

• 目的 评估在中国急性冠状动脉综合征（ACS）患者住院期间启动依洛尤单抗以降低低密度脂蛋白胆固醇（LDL-C）水平的有效性和安全性。方法 选取2019年5月至2020年8月在首都医科大学附属北京安贞医院心内科住院的LDL-C水平不达标的ACS患者，根据是否接受前蛋白转化酶枯草杆菌蛋白酶/kexin9型抑制剂治疗分为依洛尤单抗组和对照组。对照组仅接受口服调脂治疗，依洛尤单抗组在口服调脂治疗的基础上联合依洛尤单抗（每2周皮下注射140 mg）。比较2组LDL-C等血脂指标从基线到治疗第12周的变化和安全性指标。结果 本研究共入选426例患者，其中依洛尤单抗组128例，对照组298例。294例（69.0%）患者以前未规律口服他汀类药物治疗。基线时依洛尤单抗组LDL-C水平高于对照组［3.57(3.20,3.92)mmol/L比3.22(2.62,3.69)mmol/L］（P＜0.001）。治疗第12周随访时，依洛尤单抗组LDL-C较基线变化的百分比与对照组比较，差异有统计学意义（P＜0.001）。治疗第12周时，依洛尤单抗组中LDL-C＜1.8 mmol/L和＜1.4 mmol/L比例均明显高于对照组［97.5%（117/120）比36.4%（103/283）、92.5%（111/120）比9.9%（28/283）］（均P＜0.001）。依洛尤单抗组治疗第12周随访时总胆固醇、高密度脂蛋白胆固醇、三酰甘油较基线变化的百分比与对照组比较，差异均有统计学意义（均P＜0.05）。2组均无死亡及因心力衰竭住院治疗病例。2组安全性指标比较差异均无统计学意义（均P＞0.05）。结论 与单独使用他汀类药物相比，他汀类药物联合依洛尤单抗用于中国ACS患者治疗12周后可显著降低LDL-C水平，使超过92%的患者达到了指南推荐的LDL-C目标，且安全性良好。

• Objective  To evaluate the efficacy and safety of initiating evolocumab to reduce low-density lipoprotein cholesterol (LDL-C) level during the hospitalization of Chinese patients with acute coronary syndrome (ACS). Methods Patients with ACS whose LDL-C level was not up to the standard in the Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University from May 2019 to August 2020 were enrolled. They were divided into the evolocumab group and the control group. The evolocumab group were given evolocumab on the basis of oral lipid-lowering therapy (subcutaneous injection of 140 mg every 2 weeks), while the control group were only given oral lipid-lowering therapy. The changes of LDL-C and other blood lipid indexes from baseline to the 12th week and safety indexes were compared between the two groups. Results A total of 426 patients were enrolled in this study, including 128 patients in the evolocumab group and 298 patients in the control group. There were 294 cases (69.0%) not treated with statins regularly before. The LDL-C level in the evolocumab group was higher than that in the control group at baseline［3.57(3.20,3.92)mmol/L vs 3.22(2.62,3.69)mmol/L］（P＜0.001）. At the 12th week of treatment to follow-up, the difference in percentage of LDL-C change from baseline between the evolocumab group and the control group was statistically significant（P＜0.001）. At the 12th week of treatment, the proportions of LDL-C＜1.8 mmol/L and ＜1.4 mmol/L in the evolocumab group were significantly higher than those in the control group［97.5%（117/120） vs 36.4%（103/283）, 92.5%（111/120） vs 9.9%（28/283）］（both P＜0.001）. At the 12th week of treatment to follow-up, the percentage of changes in total cholesterol, high-density lipoprotein cholesterol and triglyceride compared with baseline in the evolocumab group were significantly different from those in the control group (all P＜0.05). No deaths occurred and no hospitalization was available for heart failure in both groups. There were no significant differences in safety indexes between the two groups (all P＞0.05). Conclusion Compared with the statins alone, statins combined with evolocumab in Chinese ACS patients can significantly reduce LDL-C level after treatment for 12 weeks, and more than 92% of patients have reached the LDL-C target recommended in the guidelines, and the safety is good.