中国临床药学杂志

参考文献

[1]国家卫生和计划生育委员会疾病预防控制局.中国居民营养与慢性病状况报告[R].北京:人民卫生出版社, 2015.

[2] SONG P K, MAN Q Q, LI H, et al. Trends in lipids level and dyslipidemia among Chinese adults, 2002-2015[J]. Biomed Environ Sci, 2019, 32(8):559.

[3]中国成人血脂异常防治指南修订联合委员会.中国成人血脂异常防治指南(2016年修订版)[J].中华心血管病杂志, 2016,44(10):833.

[4] GBD 2017 Causes of Death Collaborators. Global, regional, and national age-sex-specific mortality for 282 causes of death in 195countries and territories, 1980-2017:a systematic analysis for the Global Burden of Disease Study 2017[J]. Lancet, 2018,392(10159):1736.

[5] ANNEMANS L, STOCK J K, CHAPMAN M J. PCSK9 inhibition,atherosclerotic cardiovascular disease, and health economics:challenges at the crossroads[J]. J Clin Lipidol, 2019, 13(5):714.

[6] GRUNDY S M, STONE N J, BAILEY A L, et al. 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]. Circulation, 2019,139(25):e1082.

[7] MACH F, BAIGENT C, CATAPANO A L, et al. 2019 ESC/EAS guidelines for the management of dyslipidaemias:lipid modification to reduce cardiovascular risk[J]. Eur Heart J, 2020,41(1):111.

[8] AHAMAD S, MATHEW S, KHAN W A, et al. Development of small-molecule PCSK 9 in hibitors for the treatment of hypercholesterolemia[J]. Drug Discov Today, 2022, 27(5):1332.

[9]薛宇,刘海伟,李洋.前蛋白转换酶枯草溶菌素9抑制剂降低脂蛋白(a)作用的机制[J].生物化学与生物物理进展, 2024, 51(4):850.

[10] HUSSAIN A, BALLANTYNE C M. New approaches for the prevention and treatment of cardiovascular disease:focus on lipoproteins and inflammation[J]. Annu Rev Med, 2021, 72:431.

[11] BAYS H, GAUDET D, WEISS R, et al. Alirocumab as add-on to atorvastatin versus other lipid treatment strategies:ODYSSEY OPTIONS I randomized trial[J]. J Clin Endocrinol Metab, 2015,100(8):3140.

[12] SABATINE M S, GIUGLIANO R P, WIVIOTT S D, et al. Efficacy and safety of evolocumab in reducing lipids and cardiovascular events[J]. N Engl J Med, 2015, 372(16):1500.

[13] HIRAYAMA A, YAMASHITA S, INOMATA H, et al. One-year efficacy and safety of evolocumab in Japanese patients-A pooled analysis from the open-label extension OSLER studies[J]. Circ J,2017, 81(7):1029.

[14] KASICHAYANULA S, GROVER A, EMERY M G, et al. Clinical pharmacokinetics and pharmacodynamics of evolocumab, a PCSK9inhibitor[J]. Clin Pharmacokinet, 2018, 57(7):769.

[15] HIRAYAMA A, HONARPOUR N, YOSHIDA M, et al. Effects of evolocumab(AMG 145), a monoclonal antibody to PCSK9,in hypercholesterolemic, statin-treated Japanese patients at high cardiovascular risk:primary results from the phase 2 YUKAWA study[J]. Circ J, 2014, 78(5):1073.

[16] MURPHY S, O’DONOGHUE M L, WIVIOTT S, et al. Reduction in total cardiovascular events with the pcsk9 inhibitor evolocumab in patients with cardiovascular disease in the combined Fourier and Fourier open-label extension(ole)studies[J]. J Am Coll Cardiol,2023, 81(Suppl 8):1121.

[17] Cholesterol Treatment Trialists’(CTT)Collaboration, BAIGENT C, BLACKWELL L, et al. Efficacy and safety of more intensive lowering of LDL cholesterol:a meta-analysis of data from170, 000 participants in 26 randomised trials[J]. Lancet, 2010,376(9753):1670.

[18] GIUGLIANO R P, PEDERSEN T R, PARK J G, et al. Clinical efficacy and safety of achieving very low LDL-cholesterol concentration swith the PCSK 9 in hibitorevolocum a b:a prespecified secondary analysis of the FOURIER trial[J].Lancet, 2017, 390(10106):1962.

[19] ZHANG Y, SUO Y R, YANG L, et al. Effect of PCSK9 inhibitor on blood lipid levels in patients with high and very-high CVD risk:a systematic review and meta-analysis[J]. Cardiol Res Pract,2022, 2022:8729003.

[20] Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals:a randomised placebo-controlled trial[J].Lancet, 2002, 360(9326):7.

[21] ANDERSON J L, HEIDENREICH P A, BARNETT P G, et al.ACC/AHA statement on cost/value methodology in clinical practice guidelines and performance measures:a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures and Task Force on Practice Guidelines[J].Circulation, 2014, 129(22):2329.

[22] MA W R, PAN Q Y, PAN D F, et al. Efficacy and safety of lipidlowering drugs of different intensity on clinical outcomes:a systematic review and network meta-analysis[J]. Front Pharmacol, 2021, 12:713007.

[23] KHAN S U, TALLURI S, RIAZ H, et al. A Bayesian network metaanalysis of PCSK9 inhibitors, statins and ezetimibe with or without statins for cardiovascular outcomes[J]. Eur J Prev Cardiol,2018, 25(8):844.

[24] O’CONNELL E M, LOHOFF F W. Proprotein convertase subtilisin/kexin type 9(PCSK9)in the brain and relevance for neuropsychiatric disorders[J]. Front Neurosci, 2020, 14:609.

[25] BANDYOPADHYAYD, ASHISHK, HAJRAA, et al.Cardiovascular outcomes of PCSK9 inhibitors:with special emphasis on its effect beyond LDL-cholesterol lowering[J]. J Lipids, 2018, 2018:3179201.

[26] KHAN A R, BAVISHI C, RIAZ H, et al. Increased risk of adverse neurocognitive outcomes with proprotein convertase subtilisinkexin type 9 inhibitors[J]. Circ Cardiovasc Qual Outcomes,2017, 10(1):e003153.

[27] SABATINE M S, GIUGLIANO R P, KEECH A C, et al.Evolocumab and clinical outcomes in patients with cardiovascular disease[J]. N Engl J Med, 2017, 376(18):1713.

[28] SCHWARTZ G G, STEG P G, SZAREK M, et al. Alirocumab and cardiovascular outcomes after acute coronary syndrome[J]. N Engl J Med, 2018, 379(22):2097.

[29] GIUGLIANO R P, MACH F, ZAVITZ K, et al. Cognitive function in a randomized trial of evolocumab[J]. N Engl J Med, 2017,377(7):633.

[30] BAJAJ N S, PATEL N, KALRA R, et al. Neurological effects of proprotein convertase subtilisin/kexin type 9 inhibitors:direct comparisons[J]. Eur Heart J Qual Care Clin Outcomes, 2018, 4(2):132.

[31] HARVEY P D, SABBAGH M N, HARRISON J E, et al. No evidence of neurocognitive adverse events associated with alirocumab treatment in 3340 patients from 14 randomized Phase2 and 3 controlled trials:a meta-analysis of individual patient data[J]. Eur Heart J, 2018, 39(5):374.

[32] ROBINSON J G. Low LDL-C levels:likely No short-term cognitive harm[J]. J Am Coll Cardiol, 2020, 75(18):2294.

[33] DI MAURO G, ZINZI A, SCAVONE C, et al. PCSK9 inhibitors and neurocognitive adverse drug reactions:analysis of individual case safety reports from the eudravigilance database[J]. Drug Saf, 2021, 44(3):337.

[34] BLOM D J, DJEDJOS C S, MONSALVO M L, et al. Effects of evolocumab on vitamin E and steroid hormone levels:results from the 52-week, phase 3, double-blind, randomized, placebocontrolled DESCARTES study[J]. Circ Res, 2015, 117(8):731.

[35] KAWASHIRI M A, NOHARA A, HIGASHIKATA T, et al. Impact of evolocumab treatment on low-density lipoprotein cholesterol levels in heterozygous familial hypercholesterolemic patients withdrawing from regular apheresis[J]. Atherosclerosis, 2017,265:225.

[36] BLOM D J, CHEN J Y, YUAN Z Y, et al. Effects of evolocumab therapy and low LDL-C levels on vitamin E and steroid hormones in Chinese and globalpatients with type 2 diabetes[J].Endocrinol Diabetes Metab, 2020, 3(2):e00123.

[37] KOSMAS C E, SKAVDIS A, SOURLAS A, et al. Safety and tolerability of PCSK9 inhibitors:current insights[J]. Clin Pharmacol, 2020, 12:191.

[38] ZEWINGER S, KLEBER M E, TRAGANTE V, et al. Relations between lipoprotein(a)concentrations, LPA genetic variants, and the risk of mortality in patients with established coronary heart disease:a molecular and genetic association study[J]. Lancet Diabetes Endocrinol, 2017, 5(7):534.

[39] SABATINEMS, LEITERLA, WIVIOTTSD, et al.Cardiovascular safety and efficacy of the PCSK9 inhibitor evolocumab in patients with and without diabetes and the effect of evolocumab on glycaemia and risk of new-onset diabetes:a prespecified analysis of the FOURIER randomised controlled trial[J]. Lancet Diabetes Endocrinol, 2017, 5(12):941.

[40] MONAMI M, SESTI G, MANNUCCI E. PCSK9 inhibitor therapy:a systematic review and meta-analysis of metabolic and cardiovascular outcomes in patients with diabetes[J]. Diabetes Obes Metab, 2019, 21(4):903.

[41] KEECH A C, OYAMA K, SEVER P S, et al. Efficacy and safety of long-term evolocumab use among Asian subjects-A subgroup analysis of the further cardiovascular outcomes research with PCSK9 inhibition in subjects with elevated risk(FOURIER)trial[J]. Circ J, 2021, 85(11):2063.

[42] RAY K K, COLHOUN H M, SZAREK M, et al. Effects of alirocumab on cardiovascular and metabolic outcomes after acute coronary syndrome in patients with or without diabetes:a prespecified analysis of the ODYSSEY OUTCOMES randomised controlled trial[J]. Lancet Diabetes Endocrinol, 2019, 7(8):618.

[43] GRZE?K G, DOROTA B, WO?OWIEC?, et al. Safety of PCSK9inhibitors[J]. Biomed Pharmacother, 2022, 156:113957.

[44] MUNTNER P, GHAZI L, JONES J, et al. Persistence and adherence to PCSK9 inhibitor monoclonal antibodies versus ezetimibe in realworld settings[J]. Adv Ther, 2024, 41(6):2399.