Objective To systematically evaluate the efficacy and safety of alirocumab after percutaneous coronary intervention (PCI) in patients with acute myocardial infarction.
Methods CNKI, WanFang Data, VIP, PubMed, Embase, Web of Science, and The Cochrane Library were comprehensively searched from the inception of the databases to May 31, 2024. RevMan 5.4 software was used to perform a Meta-analysis.
Results A total of 13 randomized controlled trials (RCTs) with a cumulative total of 1 217 patients were included. On the basis of conventional treatment, the experimental group was treated with alirocumab in combination with statin, and the control group was treated with statin only. Meta-analysis results showed that compared with the control group, the efficiency of clinical treatment [OR=4.71, 95%CI (2.49, 8.94), P<0.001], rate of blood lipid compliance [OR=29.87, 95%CI (12.45, 71.68), P<0.001], coronary blood flow grading [OR=2.73, 95%CI (1.74, 4.30), P<0.001], left ventricular ejection fraction [MD=7.31, 95%CI (4.47, 10.15), P<0.001] in the experimental group were all improved, and the incidence of adverse cardiovascular events [OR=0.16, 95%CI (0.09, 0.29), P<0.001], low-density lipoprotein [MD=-1.00, 95%CI (-1.34, -0.67), P<0.001], triglyceride [MD=-0.22, 95%CI (-0.34, -0.10), P<0.001], total cholesterol [MD=-0.89, 95%CI (-1.19, -0.59), P<0.001], interleukin-6 [MD=-3.58, 95%CI (-5.03, -2.14), P<0.001] decreased. There was no statistically significant difference between the two groups in the reduction of high-sensitivity C-reactive protein [MD=- 0.89, 95%CI (-2.24, -0.46), P=0.20] and the incidence of adverse drug reactions [OR=0.77, 95%CI (0.32, 1.85), P=0.56].
Conclusion Combinated alirocumab injection therapy after PCI for acute myocardial infarction has superior clinical efficacy, and there was no significant difference in the reduction of high-sensitivity C-reactive protein and incidence of adverse drug reactions compared with statins alone.
1.中国血脂管理指南修订联合专家委员会. 中国血脂管理指南(2023年)[J]. 中华心血管病杂志, 2023, 51(3): 221-255. [Joint Committee on the Chinese Guidelines for Lipid Management. Chinese guidelines for lipid management (2023)[J]. Chinese Journal of Cardiology, 2023, 51(3): 221-255.] DOI: 10.3760/cma.j.cn112148-20230119-00038.
2.Khan SU, Talluri S, Riaz H, et al. A Bayesian network meta-analysis of PCSK9 inhibitors, statins and ezetimibe with or without statins for cardiovascular outcomes[J]. Eur J Prev Cardiol, 2018, 25(8): 844-853. DOI: 10.1177/ 2047487318766612.
3.Talasaz AH, Ho AJ, Bhatty F, et al. Meta-analysis of clinical outcomes of PCSK9 modulators in patients with established ASCVD[J]. Pharmacotherapy, 2021, 41(12): 1009-1023. DOI: 10.1002/phar.2635.
4.中华医学会心血管病学分会,中华心血管病杂志编辑委员会. 急性ST段抬高型心肌梗死诊断和治疗指南(2019)[J].中华心血管病杂志, 2019, 47(10): 766-783. [Chinese Society of Cardiology of Chinese Medical Association, Editorial Board of Chinese Journal of Cardiology. 2019 Chinese Society of Cardiology (CSC) guidelines for the diagnosis and management of patients with ST segment elevation myocardial infarction[J]. Chinese Journal of Cardiology, 2019, 47(10): 766-783.] DOI: 10.3760/cma.j.issn.0253?3758.2019.10.003.
5.马宇, 查磊, 张琦, 等. 急性心肌梗死治疗中应用前蛋白转化酶枯草杆菌蛋白酶/kexin9型抑制剂对对比剂所致急性肾损伤的影响[J]. 中华高血压杂志, 2022, 30(3): 260-266. [Ma Y, Cha L, Zhang Q, et al. Role of proprotein convertase subtilisin/kexin type 9 inhibitors on contrast-induced acute kidney injury in patients with acute myocardial infarction[J]. Chinese Journal of Hypertension, 2022, 30(3): 260-266.] DOI: 10.16439/j.issn.1673-7245.2022.03.010.
6.Deng CJ, Yan J, Zheng YY, et al. Effectiveness of lipid-lowering therapy on mortality and major adverse cardiovascular event outcomes in patients undergoing percutaneous coronary intervention: a network meta-analysis of randomised controlled trials[J]. BMJ Open, 2023, 13(11): e070827. DOI: 10.1136/bmjopen-2022-070827.
7.Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions:explanation and elaboration[J]. J Clin Epidemiol, 2009, 62(10): e1-e34. DOI: 10.1016/j.jclinepi. 2009.06.006.
8.曾宪涛, 黄伟, 田国祥. Meta分析系列之九:Meta分析的质量评价工具[J]. 中国循证心血管医学杂志, 2013, 5(1): 3-5. [Zeng XT, Huang W, Tian GX. Ninth part of series of Meta-analysis: quality evaluation tools of Meta-analysis[J]. Chinese Journal of Evidence-Based Cardiovascular Medicine, 2013, 5(1): 3-5.] DOI: 10.3969/ j.1674-4055.2013.01.002.
9.杨叶楠, 李逸元. 阿利西尤单抗辅助冠脉介入治疗ST段抬高型心肌梗死临床观察[J]. 西藏医药, 2024, 45(2): 51-52. [Yang YN, Li YY. Clinical observation on ST-segment elevation myocardial infarction treated with alirocumab-assisted coronary intervention[J]. Tibetan Medicine, 2024, 45(2): 51-52.] https://d.wanfangdata.com.cn/periodical/ChlQZXJpb2RpY2FsQ0hJTmV3UzIwMjQwNzA0Eg94enl5enoyMDI0MDIwMjIaCGxtdzVuaHlp
10.谢少平, 吴明祥, 张宏. PCSK9抑制剂对急性ST段抬高型心肌梗死PCI术后患者心功能及效果分析[J]. 心血管病防治知识, 2023, 13(35): 21-23, 27. [Xie SP, Wu MX, Zhang H. Analysis of PCSK9 inhibitors on cardiac function and effects in patients after PCI for acute ST-segment elevation myocardial infarction[J]. Xinxueguanbing Fangzhi Zhishi, 2023, 13(35): 21-23, 27.] DOI: 10.3969/j.issn.1672-3015(x).2023.35.008.
11.蓝胜峰, 赵辉婷. 阿利西尤单抗结合阿托伐他汀治疗ST段抬高型心肌梗死的疗效及对患者血脂、心功能的影响[J]. 药品评价, 2023, 20(10): 1239-1242. [Lan SF, Zhao HT. Efffcacy of alirocumab combined with atorvastatin in the treatment of ST segment elevation myocardial infarction and its effect on blood lipid and heart function[J]. Drug Evaluation, 2023, 20(10): 1239-1242.] DOI: 10.19939/j.cnki.1672-2809.2023.10.18.
12.黄福美, 何柳平, 韦文财, 等. 观察阿利西尤单抗短期使用对急性ST段抬高型心肌梗死(STEMI) PCI术后患者的疗效研究[J]. 中文科技期刊数据库(引文版)医药卫生, 2023, (11): 127-130. [Huang FM, He LP, Wei WC, et al. A study to observe the efficacy of short-term use of alirocumab in patients with acute ST-segment elevation myocardial infarction (STEMI) post PCI[J]. Chinese Science and Technology Journal Database (Citation Edition) Medicine and Hygiene, 2023, (11): 127-130.] https://www.cqvip.com/doc/journal/3294149253
13.卜令飞, 毛营营. 观察ST段抬高型心肌梗死患者应用阿利西尤单抗治疗的疗效[J]. 大医生, 2023, 8(16): 59-62. [Bu LF, Mao YY. Observation of the efficacy of treatment with alirocumab in patients with ST-segment elevation myocardial infarction[J]. Doctor, 2023, 8(16): 59-62.] DOI: 10.3969/j.issn.2096-2665.2023.16.019.
14.张倩倩, 王同, 王丰云, 等. 阿利西尤单抗早期应用对急性非ST段抬高型心肌梗死患者PCI术后心血管结局的影响[J]. 中国急救医学, 2022, 42(9): 742-746. [Zhang QQ, Wang T, Wang FY, et al. Effect of early application of alirocumab on cardiovascular outcomes after PCI in the patients with acute non-ST segment elevation myocardial infarction[J]. Chinese Journal of Critical Care Medicine, 2022, 42(9): 742-746.] DOI: 10.3969/j.issn. 1002-1949.2022.09.002.
15.刘倩, 梁珍珠. 阿利西尤单抗在老年急性ST段抬高型心肌梗死患者PCI术后的应用效果[J]. 中国民康医学, 2023, 35(11): 22-24. [Liu Q, Liang ZZ. Application effects of Alirocumab combined with conventional therapy in elderly patients with acute ST segment elevation myocardial infarction after PCI[J]. Medical Journal of Chinese People's Health, 2023, 35(11): 22-24.] DOI: 10.3969/j.issn.1672-0369.2023.11.007.
16.洪瑜, 周炳凤. 阿利西尤单抗联用阿托伐他汀对ST段抬高型心肌梗死患者血脂水平影响[J]. 世界最新医学信息文摘, 2023, 23(12): 110-116. [Hong Y, Zhou BF. The effect of alirocumab combined with atorvastatin on blood lipid levels in patients with ST-segment elevation myocardial infarction[J]. World Latest Medicine Information, 2023, 23(12): 110-116.] DOI: 10.3969/j.issn. 1671-3141.2023.012.020.
17.赵娟, 李伟, 郑永强, 等. 阿利西尤单抗联合瑞舒伐他汀对急性心肌梗死患者PCI术后冠脉微循环、炎症及心功能的影响[J]. 临床和实验医学杂志, 2022, 21(24): 2606-2610. [Zhao J, Li W, Zheng YQ, et al. Effect of aliximab combined with rosuvastatin on coronary microcirculation, inflammation and cardiac function in patients with acute myocardial infarction after PCI[J]. Journal of Clinical and Experimental Medicine, 2022, 21(24): 2606-2610.] DOI: 10.3969/j.issn.1671-4695. 2022.24.008.
18.代玉涵, 韩孝宇, 朱爱红, 等. ST段抬高型心肌梗死患者应用阿利西尤单抗治疗的疗效及对血脂、冠状动脉微循环的影响[J]. 中国临床医生杂志, 2023, 51(1): 41-43. [Dai YH, Han XY, Zhu AH, et al. The efficacy and effect on blood lipids and coronary microcirculation of treatment with alirocumab in patients with ST-segment elevation myocardial infarction[J]. Chinese Journal for Clinicians, 2023, 51(1): 41-43.] DOI: 10.3969/j.issn.2095-8552.2023.01.012.
19.Trankle CR, Wohlford G, Buckley LF, et al. Alirocumab in acute myocardial infarction: results from the Virginia Commonwealth University alirocumab response trial (VCU-AlirocRT)[J]. J Cardiovasc Pharmacol, 2019, 74(3): 266-269. DOI: 10.1097/FJC.0000000000000706.
20.Räber L, Ueki Y, Otsuka T, et al. Effect of alirocumab added to high-intensity statin therapy on coronary atherosclerosis in patients with acute myocardial infarction: the PACMAN-AMI randomized clinical trial[J]. JAMA, 2022, 327(18): 1771-1781. DOI: 10.1001/jama.2022.5218.
21.Mehta SR, Pare G, Lonn EM, et al. Effects of routine early treatment with PCSK9 inhibitors in patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: a randomised, double-blind, sham-controlled trial[J]. EuroIntervention, 2022, 18(11): e888-e896. DOI: 10.4244/EIJ-D-22-00735.
22.Shaya GE, Leucker TM, Jones SR, et al. Coronary heart disease risk: low-density lipoprotein and beyond[J]. Trends Cardiovasc Med, 2022, 32(4): 181-194. DOI: 10.1016/j.tcm.2021.04.002.
23.Wilson PWF, Polonsky TS, Miedema MD, et al. Systematic review for the 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol: a report of the American College of Cardiology/American Heart Association task force on clinical practice guidelines[J]. J Am Coll Cardiol, 2019, 73(24): 3210-3227. DOI: 10.1016/j.jacc.2018.11.004.
24.中华医学会, 中华医学会杂志社, 中华医学会全科医学分会, 等. 稳定性冠心病基层诊疗指南(实践版·2020)[J]. 中华全科医师杂志, 2021, 20(3): 274-280. [Chinese Medical Association, Chinese Medical Journals Publishing, Chinese Society of General Practice, et al. Guideline for primary care of stable coronary artery disease: practice version(2020)[J]. Chinese Journal of General Practitioners, 2021, 20(3): 274-280.] DOI: 10.3760/cma.j.cn114798-20210120-00080.
25.Gui HY, Liu SW, Zhu DF. Interaction between the left ventricular ejection fraction and left ventricular strain and its relationship with coronary stenosis[J]. World J Clin Cases, 2023, 11(10): 2246-2253. DOI: 10.12998/wjcc.v11.i10.2246.
26.秦巍, 单伟超, 薛文平, 等. 急性冠状动脉综合征患者冠状动脉病变严重程度与临床特征相关性及其影响因素[J]. 临床军医杂志, 2023, 51(1): 104-107. [Qin W, Shan WC, Xue WP, et al. Correlation between the severity of coronary artery lesions and clinical characteristics in patients with acute coronary syndrome and the factors influencing them[J]. Clinical Journal of Medical Officers, 2023, 51(1): 104-107.] DOI: 10.16680/j.1671-3826.2023.01.29.
27.Luo J, Liao W, Wang X, et al. PCSK9 inhibitors for anti-inflammation in atherosclerosis: protocol for a systematic review and meta-analysis of randomised controlled trials[J]. BMJ Open, 2022, 12(11): e062046. DOI: 10.1136/bmjopen-2022-062046.
28.Papastamos C, Antonopoulos AS, Simantiris S, et al. Interleukin-6 signaling in atherosclerosis: from molecular mechanisms to clinical outcomes[J]. Curr Top Med Chem, 2023, 23(22): 2172-2183. DOI: 10.2174/1568026623666230718141235.
29.Rose-John S. Local and systemic effects of interleukin-6 (IL-6) in inflammation and cancer[J]. FEBS Lett, 2022, 596(5): 557-566. DOI: 10.1002/1873-3468.14220.
30.王瑞杰, 王亮, 徐丹, 等. PCSK9抑制剂对冠心病患者血脂及炎症因子的影响[J]. 中国临床药理学与治疗学, 2022, 27(4): 409-417. [Wang RJ, Wang L, Xu D, et al. Effects of PCSK9 inhibitors on blood lipids and inflammatory factors in patients with coronary heart disease[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2022, 27(4): 409-417.] DOI: 10.12092/j.issn.1009-2501.2022.04.009.
31.王凡, 李庆勇, 牛锁成, 等. 联合PCSK9抑制剂对冠心病患者PCI术后有效性和安全性的meta分析[J]. 重庆医学, 2023, 52(16): 2512-2518. [Wang F, Li QY, Niu SC, et al. A meta-analysis of the efficacy and safety of combined PCSK9 inhibitors in patients with coronary heart disease after PCI[J]. Chongqing Medicine, 2023, 52(16): 2512-2518.] DOI: 10.3969/j.issn.1671-8348.2023.16.020.
32.张磊, 娄海东, 智昱, 等. PCSK9抑制剂对动脉粥样硬化性心血管疾病有效性及安全性的meta分析[J]. 临床荟萃, 2022, 37(12): 1074-1080. [Zhang L, Lou HD, Zhi Y, et al. Efficacy and safety of PCSK9 inhibitors on atherosclerotic cardiovascular disease: a meta-analysis[J]. Clinical Focus, 2022, 37(12): 1074-1080.] DOI: 10.3969/j.issn.1004-583X.2022.12.002.