阿利西尤单抗联合他汀治疗对急性心肌梗死PCI术后短期MACE的影响

陈冬梅; 宣玲; 李晶晶; 王茂林; 李小溪

doi:10.16766/j.cnki.issn.1674-4152.004530

阿利西尤单抗联合他汀治疗对急性心肌梗死PCI术后短期MACE的影响

doi: 10.16766/j.cnki.issn.1674-4152.004530

1.
蚌埠市第三人民医院心血管内科，安徽蚌埠 233000
2.
蚌埠医科大学第一附属医院心血管内科，安徽蚌埠 233004

基金项目:

安徽省卫生健康科研项目 AHWJ2024BAi20001

详细信息

通讯作者:
宣玲，E-mail：17893466@qq.com

中图分类号: R542.22 R730.7
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出版历程
- 收稿日期: 2025-09-25
- 网络出版日期: 2026-11-10

Effect of alirocumab combined with statin therapy on short-term major adverse cardiovascular events in patients with acute myocardial infarction after percutaneous coronary intervention

1.
Department of Cardiology, the Third People's Hospital of Bengbu City, Bengbu, Anhui 233000, China

摘要

摘要: 目的探讨阿利西尤单抗联合他汀类药物治疗对急性心肌梗死（AMI）经皮冠状动脉介入治疗（PCI）术后患者短期预后的影响，并分析主要不良心血管事件（MACE）的独立影响因素。方法回顾性纳入2022年1月—2023年12月在蚌埠市第三人民医院接受PCI治疗的AMI患者120例，根据是否联合应用阿利西尤单抗分为研究组和对照组，各60例。对照组给予常规二级预防治疗，研究组在此基础上加用阿利西尤单抗。比较2组治疗前及治疗14 d后血脂、肾功能及CRP水平变化，随访6个月记录MACE发生情况。采用Kaplan-Meier法比较累积事件率，并采用Cox比例风险模型分析MACE的独立影响因素。结果与对照组相比，研究组治疗14 d后TC、TG、低密度脂蛋白胆固醇（LDL-C）及CRP水平均显著降低，高密度脂蛋白胆固醇(HDL-C)显著升高（P＜0.05），血清肌酐（SCr）及BUN水平均显著下降（P＜0.05），ALT、AST组间差异均无统计学意义（P＞0.05）。6个月随访中，研究组MACE发生率显著低于对照组[10.0%（6/60）vs. 31.7%（19/60），P＜0.05]。Cox分析显示，联合应用阿利西尤单抗为MACE的独立保护因素（HR=0.451，95% CI：0.271~0.762，P=0.029），而基线LDL-C、CRP及SCr水平升高均为独立危险因素（P＜0.05）。结论在常规抗血小板及他汀治疗基础上联合应用阿利西尤单抗，可进一步改善AMI患者PCI术后血脂谱、减轻炎症反应、改善肾功能并降低短期MACE发生风险。
- 急性心肌梗死 /
- 经皮冠状动脉介入治疗 /
- 阿利西尤单抗 /
- P2Y12受体抑制剂 /
- 他汀类药物
Abstract: Objective To investigate the effect of alirocumab combined with statin therapy on the short-term prognosis of patients with acute myocardial infarction (AMI) after percutaneous coronary intervention (PCI), and to identify independent predictors of major adverse cardiovascular events (MACE). Methods A total of 120 AMI patients who underwent PCI between January 2022 and December 2023 were retrospectively enrolled and divided into an alirocumab group and a control group (n=60 each). The control group received standard secondary prevention therapy, whereas the alirocumab group received additional alirocumab treatment. Lipid profiles, renal function parameters, and CRP levels were assessed at baseline and 14 days after treatment. Patients were followed up for 6 months to record occurrence of MACE. Kaplan-Meier analysis was used to compare cumulative event rates, and Cox proportional hazards regression models were applied to identify independent predictors of MACE. Results Compared with the control group, the alirocumab group showed significantly lower levels of TC, TG, low density lipoprotein cholesterol (LDL-C), and CRP, as well as significantly higher levels of high-density lipoprotein cholesterol (HDL-C) levels at 14 days after treatment (P < 0.05). Serum creatinine and blood urea nitrogen levels were also significantly reduced (P < 0.05), while ALT and AST levels showed no significant differences between the two groups (P>0.05). During the 6-month follow-up period, the incidence of MACE was significantly lower in the alirocumab group [10.0% (6/60) vs. 31.7% (19/60), P < 0.05]. Cox regression analysis identified alirocumab use as an independent protective factor for MACE (HR=0.451, 95% CI: 0.271-0.762, P=0.029), whereas elevated baseline LDL-C, CRP, and serum creatinine levels were independent risk factors (P < 0.05). Conclusion The addition of alirocumab to standard antiplatelet and statin therapy can further improve lipid profiles, reduce inflammation, preserve renal function, and decrease the risk of short-term MACE in patients with AMI after PCI.
- Acute myocardial infarction /
- Percutaneous coronary intervention /
- Alirocumab /
- P2Y12 receptor inhibitor /
- Statins

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图 1 2组AMI患者6个月内MACE累积发生率的Kaplan-Meier曲线

Figure 1. Kaplan-Meier curves for cumulative incidence of MACE within 6 months in patients with AMI

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表 1 2组AMI患者一般资料比较

Table 1. Comparison of baseline characteristics between the two groups of patients with AMI

项目	对照组(n=60)	研究组(n=60)	统计量	P值
性别(男性/女性, 例)	41/19	40/20	0.038^a	0.845
年龄(x±s, 岁)	59.17±12.74	61.13±11.97	0.872^b	0.385
BMI(x±s)	23.04±1.13	23.08±1.16	0.191^b	0.849
高血压[例(%)]	22(36.67)	24(40.00)	0.141^a	0.707
糖尿病[例(%)]	12(20.00)	16(26.67)	0.745^a	0.388
吸烟[例(%)]	36(60.00)	39(65.00)	0.320^a	0.572
饮酒[例(%)]	44(73.33)	42(70.00)	0.164^a	0.685
梗死类型[例(%)]			0.173^a	0.678
STEMI	44(73.33)	46(76.67)
NSTEMI	16(26.67)	14(23.33)
梗死罪犯血管[例(%)]			0.292^a	0.864
左前降支	32(53.33)	30(50.00)
左回旋支	10(16.67)	12(20.00)
右冠状动脉	18(30.00)	18(30.00)
病变支数[例(%)]			0.214^a	0.899
单支	40(66.67)	38(63.33)
双支	14(23.33)	16(26.67)
多支	6(10.00)	6(10.00)
发病至血管开通时间[M(P₂₅, P₇₅), h]	6.3(5.2, 7.5)	6.3(5.1, 7.4)	0.100^c	0.921
注：^a为χ²值，^b为t值，^c为Z值。发病至血管开通时间指自症状起始至梗死相关血管首次恢复血流的时间。

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表 2 2组AMI患者治疗前后血脂及CRP水平比较(x±s)

Table 2. Comparison of blood lipid and CRP levels before and after treatment in patients with AMI between the two groups (x±s)

组别	例数	TC(mmol/L)		TG(mmol/L)		LDL-C(mmol/L)		HDL-C(mmol/L)		CRP(mg/L)
组别	例数	治疗前	治疗后	治疗前	治疗后	治疗前	治疗后	治疗前	治疗后	治疗前	治疗后
对照组	60	5.46±0.78	4.33±0.71^b	1.82±0.51	1.45±0.44^b	3.02±0.63	2.21±0.56^b	0.98±0.19	1.05±0.22^b	8.50±0.95	5.88±0.66^b
研究组	60	5.38±0.81	3.52±0.66^b	1.85±0.48	1.26±0.38^b	3.10±0.65	1.72±0.49^b	0.96±0.21	1.26±0.27^b	8.47±0.92	5.13±0.40^b
统计量		0.116^a	3.145^c	0.285^a	2.118^c	0.271^a	6.214^c	0.245^a	2.226^c	0.176^a	5.528^c
P值		0.760	＜0.001	0.878	0.014	0.652	＜0.001	0.740	0.041	0.861	＜0.001
注：^a为t值，^c为F值。与同组治疗前比较，^bP＜0.05。

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表 3 2组AMI患者治疗前后肝肾功能比较(x±s)

Table 3. Comparison of liver and renal function before and after treatment in patients with AMI between the two groups (x±s)

组别	例数	ALT(U/L)		AST(U/L)		SCr(μmol/L)		BUN(mmol/L)
组别	例数	治疗前	治疗后	治疗前	治疗后	治疗前	治疗后	治疗前	治疗后
对照组	60	23.87±5.39	24.94±6.14	22.59±4.45	23.39±4.68	94.14±10.05	91.02±9.41^c	6.79±1.54	5.87±1.45^c
研究组	60	23.78±4.39	25.25±6.21	22.60±4.34	23.80±4.75	93.43±10.14	86.13±8.70^c	6.71±1.50	5.01±1.21^c
统计量		0.100^a	0.185^b	0.012^a	0.506^b	0.385^a	4.256^b	0.288^a	7.951^b
P值		0.920	0.664	0.990	0.425	0.701	0.042	0.774	＜0.001
注：^a为t值，^b为F值。与同组治疗前比较，^cP＜0.05。

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表 4 2组AMI患者PCI术后随访期间实验室及心功能相关指标比较

Table 4. Comparison of laboratory and cardiac function parameters during follow-up after PCI in patients with AMI between the two groups

项目	组别	例数	1个月	3个月	6个月	组别效应		时间效应		交互效应
项目	组别	例数	1个月	3个月	6个月	统计量	P值	统计量	P值	统计量	P值
LDL-C(x±s, mmol/L)	对照组	60	2.23±0.55	2.20±0.58	1.91±0.60	11.390^a	0.001	7.114^a	＜0.001	6.381^a	0.002
	研究组	60	1.63±0.45	1.58±0.42	1.55±0.40
CRP(x±s, mg/L)	对照组	60	4.20±0.90	3.90±0.85	3.70±0.80	1.469^a	0.228	2.936^a	0.055	1.631^a	0.198
	研究组	60	3.60±0.80	3.35±0.75	3.20±0.70
SCr(x±s, μmol/L)	对照组	60	90.0±9.5	91.5±9.8	92.0±10.0	3.037^a	0.084	2.918^a	0.056	2.399^a	0.093
	研究组	60	86.5±8.8	86.8±9.0	87.0±9.2
BUN(x±s, mmol/L)	对照组	60	5.70±1.40	5.85±1.45	5.95±1.50	3.249^a	0.074	3.014^a	0.051	2.719^a	0.068
	研究组	60	5.01±1.20	5.00±1.18	5.02±1.20
NT-proBNP[M(P₂₅, P₇₅), pg/mL]	对照组	60	320(180, 560)	260(150, 450)	210(120, 380)	1.993^b	0.158	3.311^b	0.191	3.580^b	0.167
	研究组	60	260(150, 470)	200(120, 360)	160(95, 290)
心律失常[例(%)]	对照组	60	8(13.3)	7(11.7)	6(10.0)	0.436^b	0.509	1.221^b	0.543	1.339^b	0.512
	研究组	60	6(10.0)	5(8.3)	4(6.7)
注：^a为F值, ^b为Waldχ²值。

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表 5 心肌梗死患者PCI术后MACE发生的Cox回归分析

Table 5. Cox regression analyses of factors associated with MACE after PCI in patients with myocardial infarction

变量	单因素分析		多因素分析
变量	HR(95% CI)	P值	HR(95% CI)	P值
年龄(>60岁)	1.693(1.090~2.867)	0.040	1.200(0.765~1.883)	0.428
性别(男性)	1.300(0.751~2.251)	0.349
高血压	1.100(0.611~1.980)	0.753
糖尿病	1.200(0.707~2.037)	0.504
吸烟	1.500(0.937~2.401)	0.091
心肌梗死类型(STEMI)	1.600(0.943~2.716)	0.081
病变支数(多支)	1.405(0.841~2.336)	0.198
饮酒	1.200(0.712~2.023)	0.048
发病至血管开通>6 h	1.350(0.820~2.225)	0.232
ALT>40 U/L	1.002(0.555~1.800)	0.101
AST>45 U/L	1.509(0.861~2.580)	0.148
SCr>59 μmol/L	2.400(1.303~4.322)	0.004	1.947(1.058~3.420)	0.032
CRP>5 mg/L	1.930(1.098~3.267)	0.022	1.451(1.002~1.951)	0.047
TC(>5.70 mmol/L)	1.521(0.853~2.648)	0.162
TG(>2.25 mmol/L)	1.301(0.766~2.208)	0.331
LDL-C(>4.21 mmol/L)	1.811(1.104~2.916)	0.019	1.604(1.045~2.464)	0.031
HDL-C(>1.55 mmol/L)	0.702(0.428~1.141)	0.154
联合阿利西尤单抗	0.324(0.189~0.559)	＜0.001	0.451(0.271~0.762)	0.029
注：各变量赋值如下，PCI术后6个月内未发生MACE=0，发生=1；年龄≤60岁=0，>60岁=1；女性=0，男性=1；无高血压=0，有高血压=1；无糖尿病=0，有糖尿病=1；不吸烟=0，吸烟=1；不饮酒=0，饮酒=1；NSTEMI=0，STEMI=1；病变支数，非多支=0，多支=1；发病至血管开通时间≤6 h=0，>6 h=1；ALT≤40 U/L=0，>40 U/L=1；AST≤45 U/L=0，>45 U/L=1；SCr≤59 μmol/L=0，>59 μmol/L=1；CRP≤5 mg/L=0，>5 mg/L=1；TC≤5.70 mmol/L=0，>5.70 mmol/L=1；TG≤2.25 mmol/L=0，>2.25 mmol/L=1；LDL-C≤4.21 mmol/L=0，>4.21 mmol/L=1；HDL-C≤1.55 mmol/L=0，>1.55 mmol/L=1；未联合阿利西尤单抗=0，联合阿利西尤单抗=1。

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