英克司兰与PCSK9单抗治疗急性冠脉综合征患者的降脂效果及血脂变异性:一项真实世界回顾性分析OA
Efficacy and lipid variability of inclisiran compared to PCSK9 monoclonal antibodie in ACS:A real-world retrospective analysis
目的 通过真实世界数据评估英克司兰与前蛋白转化酶枯草溶菌素9/Kexin9型(proprotein convertase subtilisin/kexin type 9,PCSK9)单克隆抗体在急性冠脉综合征(acute coronary syndrome,ACS)患者中的降脂疗效差异.方法 本研究为单中心回顾性队列研究,纳入2022年1月至2024年3月于天津市胸科医院心内科接受他汀类药物联合英克司兰或PCSK9单抗治疗的ACS成人患者,所有患者接受稳定中等剂量他汀治疗≥30 d后低密度脂蛋白胆固醇(low-density lipoprotein cholesterol,LDL-C)仍未达标.采用倾向性评分匹配按1∶2将患者分为英克司兰组(n=31)和PCSK9单抗组(n=55).收集并分析患者治疗起始时及3次随访时(出院后1~3个月、3~9个月、9~12个月)的血脂谱,比较两组间LDL-C相对于基线的降幅百分比、LDL-C达标率、LDL-C变化趋势及随访期间LDL-C累积暴露量等方面的差异.通过标准差(standard deviation,SD)和平均连续变异性(average successive variability,ASV)评估两组间LDL-C变异性的差异.结果 英克司兰组在3次随访中LDL-C降幅均显著优于PCSK9单抗组(P<0.05).达标率方面,英克司兰较PCSK9单抗在各访视点均展现出更高的LDL-C达标率(P<0.05),且高达80.65%的患者实现了持续达标(以1.8 mmol/L为目标值时).在校正基线LDL-C水平后,英克司兰组较PCSK9单抗组呈现更显著的LDL-C降幅(β=-0.300,95%CI:-0.535~-0.064,P=0.013).两组LDL-C水平随时间的变化趋势相似.此外,英克司兰组较PCSK9单抗组表现出更好的稳定性(PSD组间=0.034,PASV组间=0.029)以及更低的LDL-C累积暴露量(P<0.01).结论 在接受他汀类药物治疗的ACS患者中,英克司兰在降低LDL-C水平、提高达标率、减少LDL-C累积暴露量及维持LDL-C稳定性方面均优于PCSK9单抗.
Objective This study aims to assess the lipid-lowering efficacy of Inclisiran and proprotein convertase subtilisin/kexin type 9(PCSK9)monoclonal antibodies(PCSK9mAbs)in patients with Acute Coronary Syndrome(ACS)by utilizing real-world clinical data.Methods This study adopted a single-center retrospective cohort design,enrolling patients with ACS who were treated with Inclisiran or PCSK9 monoclonal antibodies(mAbs,including evolocumab and alirocumab)at the Cardiology Department of Tianjin Chest Hospital from Janu-ary 2022 to March 2024.All enrolled patients were those who failed to reach the low-density lipoprotein cholesterol(LDL-C)targets after at least 30 days of stable moderate-intensity statin therapy.By using propensity score match-ing at a 1∶2 ratio,the patients were divided into an Inclisiran group(n=31)and a PCSK9 monoclonal antibody group(n=55).Lipid profiles were collected and analyzed at the start of treatment and during three follow-up visits(1~3 months,3~9 months,and 9~12 months after discharge).The differences between the two groups were compared in terms of the percentage reduction of LDL-C from the baseline,the LDL-C target achievement rates,the trend of LDL-C changes,and the cumulative LDL-C exposure during the follow-up period.The differences in LDL-C variability between the two groups were evaluated by the standard deviation(SD)and the average successive variability(ASV).Results The LDL-C reduction in the Inclisiran group was significantly superior to that in the PCSK9 mAbs group at all three follow-up visits(P<0.05).In terms of the attainment rate,the Inclisiran group demonstrated a higher LDL-C target attainment rate than the PCSK9 monoclonal antibody group at each visit(P<0.05),and up to 80.65%of patients achieved sustained attainment(with a target value of 1.8 mmol/L).After adjusting for baseline LDL-C levels,the Inclisiran group showed a more substantial reduction in LDL-C than the PCSK9 monoclonal antibody group(β=-0.300,95%CI:-0.535 to-0.064,P=0.013).The trends of LDL-C changes over time were similar between the two groups.Moreover,the Inclisiran group had lower lipid variability(between-group P for SD=0.034;between-group P for ASV=0.029)and lower cumulative LDL-C exposure(P<0.01)compared to the PCSK9 monoclonal antibody group.Conclusion In statin-treated ACS patients,inclisiran demonstrated superiority over PCSK9 monoclonal antibodies(mAbs)in reducing LDL-C levels,enhancing target achievement rates,decreasing cumulative LDL-C exposure,and maintaining LDL-C stability.
邵独婧;刘晓罡;刘玉洁;郭思佳;张颖
天津市胸科医院心内科(天津 300222)天津市胸科医院心内科(天津 300222)天津市胸科医院心内科(天津 300222)天津市胸科医院心内科(天津 300222)天津市胸科医院心内科(天津 300222)
医药卫生
急性冠脉综合征英克司兰PCSK9单克隆抗体低密度脂蛋白胆固醇LDL-C变异性累积暴露量真实世界研究
acute coronary syndromeinclisiranPCSK9 monoclonal antibodieslow-density lipo-protein cholesterolLDL-C variabilitycumulative exposurereal-world study
《实用医学杂志》 2026 (11)
1933-1941,9
河北省中医药管理局科研计划项目(编号:T2026025)天津市医学重点学科项目(编号:TJYXZDXK-3-017B)
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