PCSK9抑制剂治疗超高危ASCVD的降脂有效性与安全性

韩鹏; 朱伯达; 杨媛; 李金; 陈宇豪; 王紫薇; 杨丽; 廉坤; 李成祥

doi:10.12125/j.chj.202011080

PCSK9抑制剂治疗超高危ASCVD的降脂有效性与安全性

Efficacy and safety of PCSK9 inhibitor of lipid-lowering therapy in patients with ultra-high-risk atherosclerotic cardiovascular disease

摘要

摘要:
目的观察PCSK9抑制剂对超高危动脉粥样硬化性心血管疾病（atherosclerotic cardiovascular disease，ASCVD）患者的降脂治疗有效性与安全性。
方法收集2017年9月～2020年3月于空军军医大学第一附属医院接受PCI治疗的超高危ASCVD患者138例，划分为术后单纯他汀类药物降脂治疗的他汀对照组（n=100）和他汀联合PCSK9降脂治疗的PCSK9抑制剂组（n=38）。用药3月后复查血脂水平，观察血脂降幅及药物不良反应发生情况。
结果两组患者年龄、BMI、收缩压、舒张压等多项指标差异无统计学意义。与他汀对照组比较，PCSK9抑制剂组的男性比例低，既往心肌梗死病史率低，多次PCI史率低（P<0.01），多血管床病变率低，术后应用β-受体阻滞剂率低（P<0.05）。接受降脂治疗后与他汀对照组比较，PCSK9抑制剂组LDL-C明显降低，其中低密度脂蛋白胆固醇（LDL-C）（<1.4 mmol/L）组和LDL-C平均降幅降低程度的统计学差异为（P<0.01），LDL-C(<1.8 mmol/L)组降低的统计学差异为（P<0.05）。所有患者均未观察到肝肾功损害及血糖升高，PCSK9抑制剂组患者未观察到药物不良反应的发生。
结论 PCSK9抑制剂能够有效降低超高危ASCVD患者的LDL-C水平，显著提高其LDL-C达标率，具有良好的有效性和安全性。

Abstract:
AIM To study the efficacy and safety of PCSK9 inhibitor in lipid-lowering therapy in patients with ultra-high-risk atherosclerotic cardiovascular disease.
METHODS Continuously collected for this study were 138 ultra-high-risk ASCVD patients who received PCI treatment from September 2017 to March 2020 at the First Affiliated Hospital (Xijing Hospital) of the Air Force Military Medical University. After operation, all except one patient were treated with statins based lipid-lowering regimen combined with PCSK9 inhibitors and the one patient was treated with PCSK9 inhibitor alone due to statins allergy. Their blood lipid levels were detected after 1 to 3 months of medication and the lipid-lowering effect and adverse drug reactions were observed.
RESULTS A total of 138 patients were enrolled in this study. Among the 138 patients. Blood lipid levels before and after PCSK9 inhibitor treatment were TC、TG、LDL-C(P<0.005). The compliance rate of LDL-C<1.4 mmol/L and the average decrease of LDL-C were lower than before and the difference was statistically significant (P<0.01). No liver and kidney function damage, blood sugar level changes, or other adverse reactions were observed in all the patients.
CONCLUSION PCSK9 inhibitors effectively reduce the LDL-C level of patients with ultra-high-risk ASCVD and significantly increase their LDL-C compliance rate, with good effectiveness and safety.

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