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PCSK9抑制剂联合他汀类药物治疗高胆固醇血症的疗效和安全性

Efficacy and safety of PCSK9 inhibitors combined with statins in the treatment of hypercholesterolemia
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摘要 目的评估前蛋白转化酶枯草溶菌素9(proprotein convertase subtilisin/kexin type 9,PCSK9)抑制剂联合高强度他汀类药物治疗高胆固醇血症的疗效与安全性。方法回顾性选择2023年6月至2024年12月在郑州大学第一附属医院确诊为高胆固醇血症的患者,根据实际治疗方案分为观察组(接受阿利西尤单抗联合阿托伐他汀)和对照组(仅接受阿托伐他汀)。治疗周期为6个月。观察指标包括低密度脂蛋白胆固醇(low-density lipoprotein cholesterol,LDL-C)、载脂蛋白B(apolipoprotein B,apoB)、脂蛋白a[lipoprotein(a),Lp(a)]等血脂参数;颈动脉内膜中层厚度(intima-media thickness,IMT)、斑块数量和面积等颈动脉超声指标;高敏C反应蛋白(high-sensitivity C-reactive protein,hs-CRP)、白细胞介素6(interleukin-6,IL-6)和肿瘤坏死因子α(tumour necrosis factor-α,TNF-α)等炎症因子。记录不良事件发生情况。结果共纳入103例高胆固醇血症患者,观察组53例、对照组50例。治疗6个月后,观察组的LDL-C、总胆固醇(total cholesterol,TC)、三酰甘油(triglyceride,TG)及apoB的降幅均显著大于对照组(P<0.05)。观察组颈动脉斑块数量和面积的改善程度均优于对照组(P=0.004)。观察组TNF-α水平的下降幅度大于对照组(P=0.006)。两组间不良事件发生率差异无统计学意义。结论PCSK9抑制剂联合高强度他汀类药物可有效降低高胆固醇血症患者的LDL-C水平,改善颈动脉粥样硬化斑块和系统性炎症状态,且安全性良好。 Objective To evaluate the efficacy and safety of proprotein convertase subtilisin/kexin type 9(PCSK9)inhibitors combined with high-intensity statins in the treatment of hypercholesterolemia.Methods A retrospective study was conducted on patients diagnosed with hypercholesterolemia at the First Affiliated Hospital of Zhengzhou University from June 2023 to December 2024.Patients were divided into an observation group(receiving alirocumab combined with atorvastatin)and a control group(receiving atorvastatin alone)based on their actual treatment regimens.The treatment period was 6 months.Primary outcome measures included lipid parameters such as low-density lipoprotein cholesterol(LDL-C),apolipoprotein B(apoB),and lipoprotein(a),(Lp[a]);carotid ultrasound parameters such as intima-media thickness(IMT),plaque number,plaque area;and inflammatory markers including high-sensitivity C-reactive protein(hs-CRP),interleukin-6(IL-6),and tumour necrosis factor-α(TNF-α).Adverse reactions were also recorded.Results A total of 103 patients with hypercholesterolemia were included,with 53 in the observation group and 50 in the control group.After six months of treatment,the observation group demonstrated significantly greater reductions in LDL-C,total cholesterol(TC),triglyceride(TG),and apoB compared to the control group(P<0.05).The reduction in plaque count and plaque area were also significantly greater in the observation group than in the control group(P=0.004).The reduction in TNF-αwas also greater in the observation group(P=0.006).There was no statistically significant difference in the incidence of adverse reactions between the two groups.Conclusions PCSK9 inhibitors combined with high-intensity statins can effectively reduce LDL-C levels,improve carotid atherosclerotic plaques and systemic inflammatory status in patients with hypercholesterolemia,and demonstrate good safety in real-world clinical settings.
作者 张超伟 郭守玉 陈英伟 ZHANG Chaowei;GUO Shouyu;CHEN Yingwei(Department of Cardiology,the First Affiliated Hospital of Zhengzhou University,Zhengzhou 450000,Henan,China;Department of Cardiology,the Second Affiliated Hospital of Nanjing Medical University,Nanjing 210029,Jiangsu,China)
出处 《中国临床医学》 2025年第6期1010-1016,共7页 Chinese Journal of Clinical Medicine
基金 国家卫生健康委员会医药卫生科技发展研究中心(WKZX2022JG0122)。
关键词 高胆固醇血症 PCSK9抑制剂 动脉粥样硬化斑块 低密度脂蛋白胆固醇 他汀类药物 炎症因子 hypercholesterolemia PCSK9 inhibitor atherosclerotic plaque low-density lipoprotein cholesterol statins inflammatory factor
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