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（P_SD组间=0.034，P_ASV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 January 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 matching 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.