PCSK9抑制剂对急性冠脉综合症(Acute Coronary Syndrome, ACS)患者的临床观察

Clinical Observation of PCSK9 Inhibitor in Patients with Acute Coronary Syndrome

摘要: 目的：探索PCSK9抑制剂(proprotein convertase subtilisin-kexin type 9 inhibitors)对血脂及颈动脉血管斑块的影响，进而明确该药对心血管疾病的影响，是否有显著的心血管获益。方法：研究纳入了从2019年10月至2021年9月份期间于我院住院治疗，并且诊断为急性冠脉综合症(ACS)的54名住院患者(无论是否行冠脉介入干预治疗)，患者的年龄范围为在35~75岁之间的成年男/女性，入院时发生ACS事件并用PCSK9抑制剂治疗1~3个月。出院后(6~12个月内)进行随访复查。观察1. 对比治疗前后1) 血脂(总胆固醇、甘油三酯、LDL-C、apo-A1、apo-B、HDL、LpA)，2) 炎症指标CRP，3) 颈动脉内膜厚度或颈动脉斑块的面积前后变化情况；2. 患者出院后MACE事件的再发率；3. 有无明显的不良反应。结果：纳入实验的ACS (acute coronary syndrome)患者，住院后经1~3个月治疗后，复查对比治疗后6~12个月的结果，包括1) 血脂(总胆固醇、甘油三酯、LDL-C、apo-a1、apo-B、LpA)有显著的统计学意义(P < 0.05)、HDL治疗前后数值无明显的差异(P > 0.05)；2) CRP等相关指标数值有显著的统计学意义(P < 0.05)；3) 颈动脉内膜厚度及颈动脉斑块的面积明显减小；随访患者出院后均未再次出现严重的心血管事件，仅有1例出现轻度心绞痛症状，休息后很快缓解，无严重的心血管事件情况再次发生；随访54名患者中仅有一人诉每次用药后2~7天内可出现轻微的腰背部酸痛感，1周后逐渐减轻至消失，复查各相关指标无明显异常。结论：PCSK9抑制剂可以明显降低血脂；通过降低血脂从而逆转甚至减小颈动脉斑块的大小和面积，降低颈动脉内膜厚度；可以降低炎症指标从而减轻血管壁的炎症反应；能明显降低患者心血管事件的再发率，有明显的心血管获益。

Abstract: Objective: To explore the effects of PCSK9 inhibitors (proprotein convertase subtilisin-kexin type 9 inhibitors) on blood lipid and carotid vascular plaque, so as to clarify the effect of PCSK9 inhibitors on cardiovascular disease and whether it has significant cardiovascular benefits. Methods: The study included 54 hospitalized patients (whether undergoing coronary intervention or not) with acute coronary syndrome (ACS) who were hospitalized in our hospital from October 2019 to September 2021. The age range of patients was adult male/female between 35 and 75 years old. ACS events occurred at admission and were treated with PCSK9 inhibitors for 1 to 3 months. Follow up and reexamination were performed after discharge (within 6~12 months). Observation 1. The changes of 1) blood lipid (total cholesterol, triglyceride, LDL-C, apo-A1, apo-B, HDL, LPA), 2) inflammatory index CRP, 3) carotid intima thickness or carotid plaque area before and after treatment were compared; 2. Recurrence rate of mace events after discharge; 3. Whether there are obvious adverse reactions. Results: ACS (acute coronary syndrome) patients included in the experiment, after 1~3 months of treatment after hospitalization, recheck and compare the results of 6~12 months after treatment, including 1) there was significant statistical significance in blood lipid (total cholesterol, triglyceride, LDL-C, apo-A1, apo-B, LPA) (P < 0.05), and there was no significant difference in the value of HDL before and after treatment (P > 0.05); 2) CRP and other related indexes had significant statistical significance (P < 0.05); 3) The thickness of carotid intima and the area of carotid plaque decreased significantly; No serious cardiovascular events occurred again after discharge. Only 1 case had mild angina pectoris, which was relieved quickly after rest, and no serious cardiovascular events occurred again; During the follow-up, only one of the 54 patients complained that slight low back pain could occur within 2~7 days after each medication, which gradually reduced to disappear after 1 week. There was no obvious abnormality in all relevant indexes. Conclusion: PCSK9 inhibitor can significantly reduce blood lipid; by reducing blood lipid, the size and area of carotid plaque and carotid intimal thickness can be reversed or even reduced; it can reduce the inflammatory index and reduce the inflammatory reaction of vascular wall; it can significantly reduce the recurrence rate of cardiovascular events and have obvious cardiovascular benefits.