依洛尤单抗联合阿托伐他汀用于ACS患者PCI术后的临床研究OA
Clinical trial of evolocumab combined with atorvastatin in patients with ACS after PCI
目的 探讨依洛尤单抗注射液联合阿托伐他汀钙片用于急性冠状动脉综合征(ACS)患者经皮冠状动脉介入治疗(PCI)术后的临床疗效和安全性.方法 将ACS患者根据降脂治疗方案分为对照组和试验组.对照组于PCI术后24 h内开始,每晚睡前口服阿托伐他汀钙片(每次20 mg,每日1次);试验组在对照组基础上,于PCI术后24 h内起始皮下注射依洛尤单抗注射液(每次140 mg,每2周1次).2组均持续治疗6个月,比较2组血脂水平包括总胆固醇(TC)、甘油三酯(TG)、低/高密度脂蛋白胆固醇(LDL-C、HDL-C)、脂蛋白(a)[Lp(a)],载脂蛋白B(ApoB)、血管超声指标[颈动脉斑块面积、颈动脉内-中膜厚度(IMT)]、心功能[左心室舒张/收缩末期内径(LVEDD、LVESD)、二尖瓣血流早期流速与二尖瓣环早期舒张期流速比值(E/e')、左心室射血分数(LVEF)]和血管内皮功能与炎症标志物[内皮素-1(ET-1)、一氧化氮(NO)、血管性血友病因子(vWF)、白细胞介素-6(IL-6)、超敏C反应蛋白(hs-CRP)],并进行安全性评价.随访至术后12个月,比较2组主要不良心血管事件(MACE)发生率.结果 本研究共纳入107例,其中对照组53例,试验组54例.治疗后,试验组和对照组患者有效率分别为94.44％(51例/54例)和79.25％(42例/53例)(P＜0.05).治疗6个月后,试验组和对照组患者血清TC 分别为(3.11±0.46)和(3.66±0.52)mmol·L-1,TG 分别为(1.40±0.28)和(1.69±0.30)mmol·L-1,LDL-C分别为(1.39±0.31)和(2.05±0.44)mmol.L-1,HDL-C 分别为(1.09±0.21)和(1.04±0.25)mmol·L-1,Lp(a)分别为(196.74±63.69)和(256.61±57.71)mg·L-1;颈动脉 IMT 分别为(0.94±0.11)和(1.01±0.18)mm,斑块面积分别为(1.36±0.24)和(1.54±0.33)cm2;LVEF 分别为(58.86±4.10)％和(55.44±3.75)％,E/e'分别为 11.20±1.06 和 12.43±1.15;vWF 分别为(121.29±18.85)％和(138.18±19.96)％,N O 分别为(65.71±10.31)和(57.39±9.06)μmol·L-1,hs-CRP 分别为(3.09±0.86)和(5.44±1.09)mg·L-1,IL-6 分别为(8.45±1.21)和(11.19±1.83)ng·L-1;上述指标在2组间比较,在统计学上差异均有统计学意义(均P＜0.05).术后12个月随访期间,试验组和对照组主要药物不良心血管事件(MACE)发生率分别为7.41％(4例/54例)和24.53％(13例/53例),在统计学上差异有统计学意义(P＜0.05).治疗期间,试验组与对照组患者总体药物不良反应发生率分别为12.96％(7例/54例)和9.43％(5例/53例),在统计学上差异无统计学意义(P＞0.05).结论 在ACS患者PCI术后,依洛尤单抗注射液联合阿托伐他汀片治疗可强效降脂,抑制动脉粥样硬化进展,增强心功能,改善内皮功能,减轻机体炎症,降低患者MACE发生风险,且安全性良好.
Objective To explore clinical curative effect and safety of evolocumab injection combined with atorvastatin calcium tablets in patients with acute coronary syndrome(ACS)after percutaneous coronary intervention(PCI).Methods According to different lipid-lowering regimens,patients with ACS were divided into control group and treatment group.Within 24 h after PCI,control group was treated with atorvastatin calcium tablets every night before sleep(20 mg once,once a day),while treatment group was given subcutaneous injection of evolocumab(140 mg/once,once every two weeks)on basis of control group.All patients were treated continuously for 6 months.The blood lipid profile including total cholesterol(TC),triglyceride(TG),low-density lipoprotein cholesterol(LDL-C),high-density lipoprotein cholesterol(HDL-C),lipoprotein(a)[Lp(a)],apolipoprotein B(ApoB),vascular ultrasound indexes[carotid plaque area,carotid intima-media thickness(IMT)],cardiac function[left ventricular end-diastolic/systolic diameter(LVEDD,LVESD),ratio of early mitral inflow velocity to early diastolic mitral annular velocity(E/e'),left ventricular ejection fraction(LVEF)]and vascular endothelial function and inflammatory markers[endothelin-1(ET-1),nitric oxide(NO),von Willebrand factor(vWF),interleukin-6(IL-6),high-sensitivity C-reactive protein(hs-CRP)]were compared between the two group,and the safety was evaluated.All patients were followed up till 12 months after surgery to compare the incidence of major adverse cardiovascular events(MACE)between the two groups.Results Among the 107 patients in this study,there were 53 cases in control group and 54 cases in treatment group.After treatment,response rate of treatment group and control group were 94.44％(51 cases/54 cases)and 79.25％(42 cases/53 cases),respectively(P＜0.05).After 6 months of treatment,levels of serum TC in treatment group and control group were(3.11±0.46)and(3.66±0.52)mmol·L-1,respectively;TG levels were(1.40±0.28)and(1.69±0.30)mmol·L-1,respectively;LDL-C levels were(1.39±0.31)and(2.05±0.44)mmol·L-1,respectively;HDL-C levels were(1.09±0.21)and(1.04±0.25)mmol·L-1,respectively;Lp(a)levels were(196.74±63.69)and(256.61±57.71)mg·L-1,respectively;carotid IMT was(0.94±0.11)and(1.01±0.18)mm,respectively;plaque areas were(1.36±0.24)and(1.54±0.33)cm,respectively;LVEF were(58.86±4.10)％and(55.44±3.75)％,respectively;E/e'were 11.20±1.06 and 12.43±1.15,respectively;vWF levels were(121.29±18.85)％and(138.18±19.96)％,respectively;NO levels were(65.71±10.31)and(57.39±9.06)μmol·L-1,respectively;hs-CRP levels were(3.09±0.86)and(5.44±1.09)mg·L-1,respectively;IL-6 levels were(8.45±1.21)and(11.19±1.83)ng·L-1,respectively;there were statistically significant differences in the above indexes between the two groups(all P＜0.05).During the 12 months of follow-up,incidence of major adverse cardiovascular events(MACE)in treatment group and control group were 7.41％(4 cases/54 cases)and 24.53％(13 cases/53 cases),respectively,with statistically significant difference(P＜0.05).During treatment,total incidence of adverse drug reactions between treatment group and control group were 12.96％(7 cases/54 cases)and 9.43％(5 cses/53 cases),respectively,without statistically significant difference(P＞0.05).Conclusion Evolocumab injection combined with atorvastatin tablet can effectively lower blood lipid,inhibit the progression of atherosclerosis,enhance cardiac function,improve endothelial function,alleviate inflammation and reduce the risk of MACE in patients with ACS after PCI,which has good safety.
李春晓;董瑜;王文竹;陈瑶刚
康复大学青岛中心医院心血管内一科,山东青岛 266011康复大学青岛中心医院麻醉与围术期医学科,山东青岛 266011青岛心血管病医院卒中中心,山东青岛 266011康复大学青岛中心医院卒中中心,山东青岛 266011
医药卫生
依洛尤单抗注射液阿托伐他汀钙片急性冠状动脉综合征经皮冠状动脉介入治疗血脂谱
evolocumab injectionatorvastatin calcium tabletacute coronary syndromepercutaneous coronary interventionblood lipid profile
《中国临床药理学杂志》 2026 (12)
1651-1658,8
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