浏览全部资源
扫码关注微信
1.北部战区空军医院药剂科,沈阳 110042
2.沈阳药科大学生命科学与生物制药学院,沈阳 110016
3.中国医科大学附属盛京医院药学部,沈阳 110004
4.中国医科大学附属第一医院药学部,沈阳 110122
5.辽宁省药学会,沈阳 110167
Published:15 June 2023,
Received:20 March 2023,
Revised:26 April 2023,
扫 描 看 全 文
司海娇,肇丽梅,蔡爽等.胰高血糖素样肽1受体激动剂类药物用药指导(2023版) Δ[J].中国药房,2023,34(11):1281-1292.
SI Haijiao,ZHAO Limei,CAI Shuang,et al.Medication guidelines for glucagon-like peptide-1 receptor agonist (2023 edition)[J].ZHONGGUO YAOFANG,2023,34(11):1281-1292.
司海娇,肇丽梅,蔡爽等.胰高血糖素样肽1受体激动剂类药物用药指导(2023版) Δ[J].中国药房,2023,34(11):1281-1292. DOI: 10.6039/j.issn.1001-0408.2023.11.01.
SI Haijiao,ZHAO Limei,CAI Shuang,et al.Medication guidelines for glucagon-like peptide-1 receptor agonist (2023 edition)[J].ZHONGGUO YAOFANG,2023,34(11):1281-1292. DOI: 10.6039/j.issn.1001-0408.2023.11.01.
我国糖尿病患病率呈逐年上升趋势,已成为全社会密切关注的健康问题。胰高血糖素样肽1(GLP-1)受体激动剂(GLP-1RA)作为一类新型降糖药物,因降糖疗效显著、低血糖发生风险低等优势,现被广泛应用于2型糖尿病(T2DM)的治疗。随着其改善心血管、保护肾脏以及减轻体质量等作用的证据等级的不断完善,该类药物在T2DM治疗指南中的地位逐渐提高。目前我国已批准9种GLP-1RA类药物用于临床治疗T2DM,这类药物虽然均基于激活体内GLP-1受体而发挥降糖作用,但由于药物自身结构和天然GLP-1氨基酸同源性的差异,导致不同药物间的药动学参数和临床疗效等差异较大。为使临床医生和药师全面了解该类药物的特点和临床证据,更好地发挥治疗作用,辽宁省药学会组织临床医学和药学专家,整理汇总了9种GLP-1RA类药物的药学特性、临床应用、不良反应、相互作用、特殊人群用药以及用药管理,制定了GLP-1RA类药物用药指导,为临床用药提供参考,促进该类药物的合理规范使用。
The prevalence of diabetes in China is increasing year by year, and has become a health issue of close concern to the whole society. Glucagon-like peptide-1 (GLP-1) receptor agonist (GLP-1RA), as a new class of glucose-lowering drugs, is now widely used in the treatment of type 2 diabetes mellitus (T2DM) because of its significant glucose-lowering efficacy and low risk of hypoglycemia. As the level of evidence for its effects on improving cardiovascular system and renal protection and reducing body mass continues to improve, its status in the treatment guidelines for T2DM is gradually increasing. Currently, nine GLP-1RA drugs have been approved for the clinical treatment of T2DM in China. Although all of these drugs exert hypoglycemic effects based on the activation of GLP-1 receptors in the body, the differences in their own structures and natural GLP-1 amino acid homology lead to large differences in pharmacokinetic parameters and clinical efficacy among different analogs. In order to enable clinicians and pharmacists to have a full understanding of the characteristics and clinical evidence of these analogs and to better perform their therapeutic effects, Liaoning Provincial Pharmaceutical Society organized clinical medicine and pharmacy experts to develop a medication guide for nine GLP-1RA drugs to provide a reference for clinical medication needs and promote rational and standardized use by compiling and summarizing the pharmacological characteristics, clinical applications, adverse reactions, interactions, the medications in special populations and medication management.
2型糖尿病胰高血糖素样肽1受体激动剂合理用药用药指导
glucagon-like peptide-1 receptor agonistsrational drug usemedication guideline
吴静,郭立新. 中国糖尿病地图[M]. 北京:人民卫生出版社,2022:1-307.
DALY A,HOVORKA R. Technology in the management of type 2 diabetes:present status and future prospects[J]. Diabetes Obes Metab,2021,23(8):1722-1732.
中国疾病预防控制中心,中国疾病预防控制中心慢性非传染性疾病预防控制中心. 中国慢性病及危险因素监测报告:2018[M]. 北京:人民卫生出版社,2021:1-374.
中华医学会糖尿病学分会. 中国2型糖尿病防治指南:2020年版:上[J]. 中国实用内科杂志,2021,41(8):668-695.
ELRICK H,STIMMLER L,HLAD C J,et al. Plasma insulin response to oral and intravenous glucose administration[J]. J Clin Endocrinol Metab,1964,24(10):1076-1082.
MELONI A R,DEYOUNG M B,LOWE C,et al. GLP-1 receptor activated insulin secretion from pancreatic β-cells:mechanism and glucose dependence[J]. Diabetes Obes Metab,2013,15(1):15-27.
CAMPBELL J E,DRUCKER D J. Pharmacology,phy- siology,and mechanisms of incretin hormone action[J]. Cell Metab,2013,17(6):819-837.
COSENTINO F,GRANT P J,ABOYANS V,et al. 2019 ESC Guidelines on diabetes,pre-diabetes,and cardiovascular diseases developed in collaboration with the EASD[J]. Eur Heart J,2020,41(2):255-323.
VISSEREN F L J,MACH F,SMULDERS Y M,et al. 2021 ESC guidelines on cardiovascular disease prevention in clinical practice:developed by the Task Force for cardiovascular disease prevention in clinical practice with representatives of the European Society of Cardiology and 12 medical societies with the special contribution of the European Association of Preventive Cardiology (EAPC)[J]. Rev Esp Cardiol (Engl Ed),2022,75(5):429.
中华医学会糖尿病学分会微血管并发症学组. 中国糖尿病肾脏病防治指南:2021年版[J]. 中华糖尿病杂志,2021,13(8):762-784.
国家卫生健康委员会能力建设和继续教育中心. 糖尿病患者合并心血管疾病诊治专家共识[J]. 中华内科杂志,2021,60(5):421-437.
中华医学会心血管病学分会,中国康复医学会心脏预防与康复专业委员会,中国老年学和老年医学会心脏专业委员会,等. 中国心血管病一级预防指南[J]. 中华心血管病杂志,2020,48(12):1000-1038.
DAVIES M J,ARODA V R,COLLINS B S,et al. Ma- nagement of hyperglycaemia in type 2 diabetes,2022. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)[J]. Diabetologia,2022,65(12):1925-1966.
中国老年医学学会老年内分泌代谢分会. 中国老年2型糖尿病防治临床指南:2022年版[J]. 中国糖尿病杂志,2022,30(1):2-51.
XU L,YU S Q,GAO L,et al. Effects of incretin-based therapies on weight-related indicators among patients with type 2 diabetes:a network meta-analysis[J]. Biomed Environ Sci,2020,33(1):37-47.
NAUCK M A,MEIER J J,CAVENDER M A,et al. Cardiovascular actions and clinical outcomes with glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors[J]. Circulation,2017,136(9):849-870.
HUSSEIN H,ZACCARDI F,KHUNTI K,et al. Efficacy and tolerability of sodium-glucose co-transporter-2 inhibitors and glucagon-like peptide-1 receptor agonists:a systematic review and network meta-analysis[J]. Diabetes Obes Metab,2020,22(7):1035-1046.
SUN F,WU S S,WANG J,et al. Effect of glucagon-like peptide-1 receptor agonists on lipid profiles among type 2 diabetes:a systematic review and network meta-analysis[J]. Clin Ther,2015,37(1):225-241.e8.
GARBER A,HENRY R,RATNER R,et al. Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 Mono):a randomised,52-week,phase Ⅲ,double-blind,parallel-treatment trial[J]. Lancet,2009,373(9662):473-481.
NAUCK M,FRID A,HERMANSEN K,et al. Efficacy and safety comparison of liraglutide,glimepiride,and placebo,all in combination with metformin,in type 2 diabetes:the LEAD (liraglutide effect and action in diabetes)-2 study[J]. Diabetes Care,2009,32(1):84-90.
GUJA C,FRÍAS J P,SOMOGYI A,et al. Effect of exenatide QW or placebo,both added to titrated insulin glargine,in uncontrolled type 2 diabetes:the DURATION-7 randomized study[J]. Diabetes Obes Metab,2018,20(7):1602-1614.
YU P C,HAN P,LIU X M,et al. Lixisenatide treatment improves glycaemic control in Asian patients with type 2 diabetes mellitus inadequately controlled on metformin with or without sulfonylurea:a randomized,double-blind,placebo-controlled,24-week trial (GetGoal-M-Asia)[J]. Diabetes Metab Res Rev,2014,30(8):726-735.
CHEN Y H,HUANG C N,CHO Y M,et al. Efficacy and safety of dulaglutide monotherapy compared with glimepiride in East-Asian patients with type 2 diabetes in a multicentre,double-blind,randomized,parallel-arm,active comparator,phase Ⅲ trial[J]. Diabetes Obes Metab,2018,20(9):2121-2130.
WANG W Q,NEVÁREZ L,FILIPPOVA E,et al. Efficacy and safety of once-weekly dulaglutide versus insulin glargine in mainly Asian patients with type 2 diabetes mellitus on metformin and/or a sulphonylurea:a 52-week open-label,randomized phase Ⅲ trial[J]. Diabetes Obes Metab,2019,21(2):234-243.
JI L N,DONG X L,LI Y M,et al. Efficacy and safety of once-weekly semaglutide versus once-daily sitagliptin as add-on to metformin in patients with type 2 diabetes in SUSTAIN China:a 30-week,double-blind,phase 3a,randomized trial[J]. Diabetes Obes Metab,2021,23(2):404-414.
SHUAI Y,YANG G Y,ZHANG Q,et al. Efficacy and safety of polyethylene glycol loxenatide monotherapy in type 2 diabetes patients:a multicentre,randomized,double-blind,placebo-controlled phase 3a clinical trial[J]. Diabetes Obes Metab,2021,23(1):116-124.
GAO F,LYU X F,MO Z H,et al. Efficacy and safety of polyethylene glycol loxenatide as add-on to metformin in patients with type 2 diabetes:a multicentre,randomized,double-blind,placebo-controlled,phase 3b trial[J]. Diabetes Obes Metab,2020,22(12):2375-2383.
MARSO S P,DANIELS G H,BROWN-FRANDSEN K,et al. Liraglutide and cardiovascular outcomes in type 2 diabetes[J]. N Engl J Med,2016,375(4):311-322.
GERSTEIN H C,COLHOUN H M,DAGENAIS G R,et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND):a double-blind,randomised placebo-controlled trial[J]. Lancet,2019,394(10193):121-130.
COSMI F,LAINI R,NICOLUCCI A. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes[J]. N Engl J Med,2017,376(9):890.
MENTZ R J,BETHEL M A,GUSTAVSON S,et al. Baseline characteristics of patients enrolled in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL)[J]. Am Heart J,2017,187:1-9.
HOLMAN R R,BETHEL M A,MENTZ R J,et al. Effects of once-weekly exenatide on cardiovascular outcomes in type 2 diabetes[J]. N Engl J Med,2017,377(13):1228-1239.
BENTLEY-LEWIS R,AGUILAR D,RIDDLE M C,et al. Rationale,design,and baseline characteristics in evaluation of lixisenatide in acute coronary syndrome,a long-term cardiovascular end point trial of lixisenatide versus placebo[J]. Am Heart J,2015,169(5):631-638.
PFEFFER M A,CLAGGETT B,DIAZ R,et al. Lixisenatide in patients with type 2 diabetes and acute coronary syndrome[J]. N Engl J Med,2015,373(23):2247-2257.
KRISTENSEN S L,RØRTH R,JHUND P S,et al. Cardiovascular,mortality,and kidney outcomes with GLP-1 receptor agonists in patients with type 2 diabetes:a syste- matic review and meta-analysis of cardiovascular outcome trials[J]. Lancet Diabetes Endocrinol,2019,7(10):776-785.
MANN J F E,ØRSTED D D,BROWN-FRANDSEN K,et al. Liraglutide and renal outcomes in type 2 diabetes[J]. N Engl J Med,2017,377(9):839-848.
GERSTEIN H C,COLHOUN H M,DAGENAIS G R,et al. Dulaglutide and renal outcomes in type 2 diabetes:an exploratory analysis of the REWIND randomised,placebo-controlled trial[J]. Lancet,2019,394(10193):131-138.
MARSO S P,BAIN S C,CONSOLI A,et al. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes[J]. N Engl J Med,2016,375(19):1834-1844.
BETHEL M A,MENTZ R,MERRILL P,et al. Renal outcomes in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL)[J]. Diabetes,2018,67(Suppl 1):552.
MUSKIET M H A,TONNEIJCK L,HUANG Y,et al. Lixisenatide and renal outcomes in patients with type 2 diabetes and acute coronary syndrome:an exploratory analysis of the ELIXA randomised,placebo-controlled trial[J]. Lancet Diabetes Endocrinol,2018,6(11):859-869.
ELSAYED N A,ALEPPO G,ARODA V R,et al. 8. obesity and weight management for the prevention and treatment of type 2 diabetes:standards of care in diabetes:2023[J]. Diabetes Care,2023,46(Suppl 1):S128-S139.
KENDALL D M,CUDDIHY R M,BERGENSTAL R M. Clinical application of incretin-based therapy:therapeutic potential,patient selection and clinical use[J]. Eur J Intern Med,2009,20(Suppl 2):S329-S339.
PENG H,WANT L L,ARODA V R. Safety and tolerabi- lity of glucagon-like peptide-1 receptor agonists utilizing data from the exenatide clinical trial development program[J]. Curr Diab Rep,2016,16(5):44.
FINEMAN M S,MACE K F,DIAMANT M,et al. Clinical relevance of anti-exenatide antibodies:safety,efficacy and cross-reactivity with long-term treatment[J]. Diabetes Obes Metab,2012,14(6):546-554.
BUSE J B,GARBER A,ROSENSTOCK J,et al. Liraglutide treatment is associated with a low frequency and magnitude of antibody formation with no apparent impact on glycemic response or increased frequency of adverse events:results from the Liraglutide Effect and Action in Diabetes (LEAD) trials[J]. J Clin Endocrinol Metab,2011,96(6):1695-1702.
DUNLAY S M,GIVERTZ M M,AGUILAR D,et al. Type 2 diabetes mellitus and heart failure:a scientific statement from the American Heart Association and the Heart Failure Society of America:this statement does not represent an update of the 2017 ACC/AHA/HFSA heart failure guideline update[J]. Circulation,2019,140(7):e294-e324.
WHARTON S,DAVIES M,DICKER D,et al. Managing the gastrointestinal side effects of GLP-1 receptor agonists in obesity:recommendations for clinical practice[J]. Postgrad Med,2022,134(1):14-19.
WILDING J P H,BATTERHAM R L,CALANNA S,et al. Once-weekly semaglutide in adults with overweight or obesity[J]. N Engl J Med,2021,384(11):989-1002.
中华医学会内分泌学分会,中华医学会糖尿病学分会. 中国成人2型糖尿病合并非酒精性脂肪性肝病管理专家共识[J]. 中华内分泌代谢杂志,2021,37(7):589-598.
DONG Y J,LYU Q G,LI S Y,et al. Efficacy and safety of glucagon-like peptide-1 receptor agonists in non-alcoholic fatty liver disease:a systematic review and meta-analysis[J]. Clin Res Hepatol Gastroenterol,2017,41(3):284-295.
ARMSTRONG M J,GAUNT P,AITHAL G P,et al. Liraglutide safety and efficacy in patients with non-alcoholic steatohepatitis (LEAN):a multicentre,double-blind,randomised,placebo-controlled phase 2 study[J]. Lancet,2016,387(10019):679-690.
FLINT A,ANDERSEN G,HOCKINGS P,et al. Randomised clinical trial:semaglutide versus placebo reduced liver steatosis but not liver stiffness in subjects with non-alcoholic fatty liver disease assessed by magnetic resonance imaging[J]. Aliment Pharmacol Ther,2021,54(9):1150-1161.
KUCHAY M S,KRISHAN S,MISHRA S K,et al. Effect of dulaglutide on liver fat in patients with type 2 diabetes and NAFLD:randomised controlled trial (D-LIFT trial)[J]. Diabetologia,2020,63(11):2434-2445.
BODE B W,BRETT J,FALAHATI A,et al. Comparison of the efficacy and tolerability profile of liraglutide,a once-daily human GLP-1 analog,in patients with type 2 diabetes ≥65 and <65 years of age:a pooled analysis from phase Ⅲ studies[J]. Am J Geriatr Pharmacother,2011,9(6):423-433.
KUANG J,ZHU J K,LIU S Y,et al. Efficacy and safety of once-weekly dulaglutide in elderly Chinese patients with type 2 diabetes:a post hoc analysis of AWARD-CHN studies[J]. Diabetes Ther,2020,11(10):2329-2339.
RACCAH D,MIOSSEC P,ESPOSITO V,et al. Efficacy and safety of lixisenatide in elderly (≥65 years old) and very elderly (≥75 years old) patients with type 2 diabetes:an analysis from the GetGoal phase Ⅲ programme[J]. Diabetes Metab Res Rev,2015,31(2):204-211.
0
Views
33
下载量
0
CSCD
Publicity Resources
Related Articles
Related Author
Related Institution