依洛尤单抗联合匹伐他汀钙治疗急性冠状动脉综合征PCI术后患者的临床研究  

Clinical trial of evolocumab combined with pitavastatin calcium in the treatment of patients with acute coronary syndrome after PCI

作　　者：李萌 闫小菊 苏亚坤 张慧晶 LI Meng;YAN Xiao-ju;SU Ya-kun;ZHANG Hui-jing(Department of Cardiology,Hengshui People's Hospital,Hengshui 053000,Hebei Province,China)

机构地区：[1]衡水市人民医院心血管内科,河北衡水053000

出　　处：《中国临床药理学杂志》2025年第5期601-605,共5页The Chinese Journal of Clinical Pharmacology

基　　金：衡水市科技计划基金资助项目(2021014086Z)。

摘　　要：目的观察依洛尤单抗注射液联合匹伐他汀钙片治疗急性冠状动脉综合征经皮冠状动脉介入治疗(PCI)术后患者的临床疗效及安全性。方法将行PCI治疗的急性冠状动脉综合征患者按队列法分为对照组和试验组。2组患者均给予抗血小板、抗凝、降低心肌耗氧量、改善心肌缺血等常规治疗;在此基础上,对照组给予匹伐他汀钙每次2 mg,每日1次,睡前口服;试验组在对照组治疗的基础上,联合注射依洛尤单抗每次140 mg,每2周1次,皮下注射。2组患者均连续治疗6个月。比较2组患者的临床疗效、血脂情况、心肌损伤指标、血清淀粉样蛋白A1(SAA1)和富含Gla蛋白(GRP)水平、主要心血管不良事件(MACEs),以及安全性。结果试验组入组52例,对照组入组58例。治疗后,试验组和对照组的总有效率分别为94.23%(49例/52例)和75.86%(44例/58例),在统计学上差异有统计学意义(P<0.05)。治疗后,试验组和对照组的总胆固醇水平分别为(1.17±0.22)和(1.35±0.25)mmol·L^(-1),三酰甘油水平分别为(2.63±0.76)和(3.89±0.92)mmol·L^(-1),高密度脂蛋白胆固醇水平分别为(1.41±0.30)和(1.26±0.28)mmol·L^(-1),低密度脂蛋白胆固醇水平分别为(1.23±0.46)和(1.58±0.55)mmol·L^(-1),肌钙蛋白Ⅰ水平分别为(0.03±0.01)和(0.05±0.02)ng·mL^(-1),肌酸激酶同工酶水平分别为(12.35±2.38)和(14.23±2.89)U·L^(-1),SAA1水平分别为(213.92±41.58)和(274.18±43.36)μg·mL^(-1),GRP水平分别为(21.32±3.50)和(19.35±3.27)ng·mL^(-1),MACEs发生率分别为9.62%和24.14%,在统计学上差异均有统计学意义(均P<0.05)。2组患者的药物不良反应均以乏力、瘙痒、腹痛、转氨酶升高为主。试验组和对照组的总药物不良反应发生率分别为11.54%和13.79%,在统计学上差异无统计学意义(P>0.05)。结论依洛尤单抗注射液联合匹伐他汀钙片治疗急性冠状动脉综合征PCI术后患者的临床疗效显著,其能够有效地降低血脂水平和Objective To observe the clinical efficacy and safety of evolocumab injection combined with pitavastatin calcium tablets in the treatment of patients with acute coronary syndrome after percutaneous coronary intervention(PCI).Methods According to cohort method,the patients with acute coronary syndrome after PCI were divided into control group and treatment group.Two groups were treated with routine treatment(anti-platelet,anti-coagulation,reducing myocardial oxygen consumption,improving myocardial ischemia).On the routine treatment,control group was treated with pitavastatin calcium 2 mg per time,once a day,orally before bedtime.On the basis of control group,treatment group was given evolocumab 140 mg per time,once every 2 weeks,subcutaneous injection.Two groups were treated for 6 months.The clinical efficay,blood lipid,myocardial injury indexes,serum levels of amyloid A1(SAA1)and Gla-rich protein(GRP),major adverse cardiovascular events(MACEs)and safety were compared between two groups.Results Fifty-two patients were enrolled in the treatment group and 58 patients were enrolled in the control group.After treatment,the total effective rates of treatment and control groups were 94.23%(49 cases/52 cases)and 75.86%(44 cases/58 cases),and the difference was statistically significant(P<0.05).After treatment,the total cholesterol levels of treatment and control groups were(1.17±0.22)and(1.35±0.25)mmol·L^(-1),triglyceride levels were(2.63±0.76)and(3.89±0.92)mmol·L^(-1),high-density lipoprotein cholesterol levels were(1.41±0.30)and(1.26±0.28)mmol·L^(-1),lowdensity lipoprotein cholesterol levels were(1.23±0.46)and(1.58±0.55)mmol·L^(-1),cardiac troponin I levels were(0.03±0.01)and(0.05±0.02)ng·mL^(-1),creatine kinase isoenzyme levels were(12.35±2.38)and(14.23±2.89)U·L^(-1),SAA1 levels were(213.92±41.58)and(274.18±43.36)μg·mL^(-1),GRP levels were(21.32±3.50)and(19.35±3.27)ng·mL^(-1),incidences of MACEs were 9.62%and 24.14%,the differences were statistically significant between two groups(allP<0.05).T

关 键 词：依洛尤单抗注射液 匹伐他汀钙片 急性冠状动脉综合征 经皮冠状动脉介入治疗 安全性评价 

分 类 号：R972[医药卫生—药品]