[1]《钠-葡萄糖共转运蛋白抑制剂联合二甲双胍治疗型糖尿病专家共识》专家组.钠-葡萄糖共转运蛋白2抑制剂联合二甲双胍治疗2型糖尿病专家共识[J].国际内分泌代谢杂志,2023,43(05):437-448.[doi:10.3760/cma.j.cn121383-20230725-07036]
　Expert Group for Expert Consensus on Sodium-Glucose Cotransporter- Inhibitors with Metformin in Patients with Type Diabetes Mellitus.Expert consensus on sodium-glucose cotransporter-2 inhibitors with metformin in patients with type 2 diabetes mellitus[J].International Journal of Endocrinology and Metabolism,2023,43(05):437-448.[doi:10.3760/cma.j.cn121383-20230725-07036]
点击复制

钠-葡萄糖共转运蛋白2抑制剂联合二甲双胍治疗2型糖尿病专家共识()
分享到：

《国际内分泌代谢杂志》[ISSN:1673-4157/CN:12-1383/R]

卷:
43
期数:
2023年05期
页码:
437-448
栏目:
指南与共识
出版日期:
2023-09-20

文章信息/Info

Title:
Expert consensus on sodium-glucose cotransporter-2 inhibitors with metformin in patients with type 2 diabetes mellitus
作者:
《钠-葡萄糖共转运蛋白2抑制剂联合二甲双胍治疗2型糖尿病专家共识》专家组
Author(s):
Expert Group for Expert Consensus on Sodium-Glucose Cotransporter-2 Inhibitors with Metformin in Patients with Type 2 Diabetes Mellitus
关键词:
钠-葡萄糖共转运蛋白2抑制剂;  二甲双胍;  糖尿病; 2型;  动脉粥样硬化性心血管疾病;  心力衰竭;  慢性肾脏病;  共识
Keywords:
Sodium-glucose cotransporter-2 inhibitor;  Metformin;  Diabetes mellitus;  Type 2;  Atherosclerotic cardiovascular disease;  Heart failure;  Chronic kidney disease;  Consensus
DOI:
10.3760/cma.j.cn121383-20230725-07036
摘要:
随着2型糖尿病病情进展,传统的阶梯治疗是一种“Treat to failure”的治疗策略。经过治疗理念的发展和变迁,2型糖尿病治疗策略应该由“Treat to failure”转为追求“Treat to Success”的治疗策略。其中,治疗成功更全面的定义应为通过早期/起始联合治疗达到血糖长期稳定控制,心肾并发症综合管理,和更好的治疗依从性,从而最大程度的减缓或阻止疾病进展,减少微血管和大血管并发症及其相关危险因素。为实现追求治疗成功策略,或糖尿病的综合管理目标,应更早地使用更积极的联合治疗方案、提高治疗依从性、减缓或阻止2型糖尿病进展和远期并发症的发生发展。钠-葡萄糖共转运蛋白2抑制剂(SGLT2i)为新型口服降糖药,除降糖外,还具有确切的心血管和肾脏保护作用,并能改善最终临床结局。二甲双胍是国内外指南一致推荐的基础降糖药。SGLT2i联合二甲双胍可针对2型糖尿病不同的病理生理缺陷,发挥机制互补、协同增效的降糖作用,更有助于维持血糖控制,同时还可以带来多重代谢获益,延缓疾病进展,改善糖尿病临床结局,为国内外指南推荐的“双一线”联合治疗方案。SGLT2i/二甲双胍复方制剂具备两种药物的治疗优势,可进一步简化治疗,具有提高治疗依从性和方便性、降低治疗费用等优势,提供了更多选择。为了让临床医生对 SGLT2i联合二甲双胍治疗方案有更全面的认识,根据最新的循证医学证据和研究新进展,制定了本共识。
Abstract:
With the progression of type 2 diabetes mellitus, the traditional stepwise treatment is a futile strategy known as “Treat to failure”. With the evolution of treatment concepts, the approach to managing type 2 diabetes should shift from “Treat to failure” to striving for “Treat to Success”. In this context, a more comprehensive definition of “Treat to Success” involves achieving long-term stable blood glucose control through early/initiation combination therapy, comprehensive management of cardiovascular and renal complications, and improving treatment compliance. This approach aims to significantly slow down or halt disease progression and reduce the occurrence of microvascular and macrovascular complications along with their associated risk factors. To achieve the goal of “Treat to Success” or comprehensive diabetes management, it’s advisable to use combination therapy earlier, enhance treatment compliance, and slow down or prevent the progression of type 2 diabetes and its long-term complications. Sodium-glucose cotransporter 2 inhibitors(SGLT2i)are a novel class of oral antidiabetic medications that not only lower blood glucose levels but also offer definite cardiovascular and renal protection, leading to improved clinical outcomes. Metformin is a recommended foundational antidiabetic drug in guidelines worldwide. Combining SGLT2i with metformin can target various pathological and physiological defects of type 2 diabetes, leveraging complementary mechanisms for synergistic glycemic control. This approach not only aids in maintaining blood glucose control but also provides multiple metabolic benefits, slowing disease progression and enhancing clinical outcomes in diabetes, aligning with the dual first-line combination therapy approach recommended by international guidelines. SGLT2i/metformin combination formulations combine the therapeutic advantages of both medications, further simplifying treatment and increasing treatment compliance, convenience, and cost-effectiveness, providing more options for patients. In order to provide clinicians with a more comprehensive understanding of the SGLT2i combined with metformin treatment regimen, this consensus has been developed based on the latest evidence from evidence-based medicine and recent research advancements.

参考文献/References:

[1] Li Y,Teng D,Shi X,et al.Prevalence of diabetes recorded in mainland China using 2018 diagnostic criteria from the American Diabetes Association: national cross sectional study[J].BMJ,2020,369:m997.DOI:10.1136/bmj.m997.
[2] Ji L,Lu J,Weng J,et al.China type 2 diabetes treatment status survey of treatment pattern of oral drugs users[J].J Diabetes,2015,7(2):166-173.DOI:10.1111/1753-0407.12165.
[3] UK Prospective Diabetes Study(UKPDS)Group.Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes(UKPDS 33)[J].Lancet,1998,352(9131):837-853.
[4] UK Prospective Diabetes Study(UKPDS)Group.Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes(UKPDS 34)[J].Lancet,1998,352(9131):854-865.
[5] Stratton IM,Adler AI,Neil HA,et al.Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes(UKPDS 35):prospective observational study[J].BMJ,2000,321(7258):405-412.DOI:10.1136/bmj.321.7258.405.
[6] Holman RR,Paul SK,Bethel MA,et al.10-year follow-up of intensive glucose control in type 2 diabetes[J].N Engl J Med,2008,359(15):1577-1589.DOI:10.1056/NEJMoa0806470.
[7] ElSayed NA,Aleppo G,Aroda VR,et al.9.Pharmacologic approaches to glycemic treatment:standards of care in diabetes-2023[J].Diabetes Care,2023,46(Suppl 1):S140-S157.DOI:10.2337/dc23-S009.
[8] 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)[J].中华糖尿病杂志,2021,13(4):315-409.DOI:10.3760/cma.j.cn115791-20210221-00095.
[9] Samson SL,Vellanki P,Blonde L,et al.American association of clinical endocrinology consensus statement:comprehensive type 2 diabetes management algorithm-2023 update[J].Endocr Pract,2023,29(5):305-340.DOI:10.1016/j.eprac.2023.02.001.
[10] 代谢中心学术委员会,代谢中心专家顾问委员会,代谢中心理事会,等.国家标准化代谢性疾病管理中心(MMC)代谢病管理指南(第二版)[J].中华内分泌代谢杂志,2023,39(6):538-554.DOI:10.3760/cma.j.cn311282-20230216-00072.
[11] Gallo LA,Wright EM,Vallon V.Probing SGLT2 as a therapeutic target for diabetes:basic physiology and consequences[J].Diab Vasc Dis Res,2015,12(2):78-89.DOI:10.1177/1479164114 561992.
[12] Zinman B,Wanner C,Lachin JM,et al.EMPA-REG OUTCOME Investigators.Empagliflozin,Cardiovascular Outcomes,and Mortality in Type 2 Diabetes[J].N Engl J Med,2015,373(22):2117-2128.DOI:10.1056/NEJMoa1504720.
[13] Neal B,Perkovic V,Mahaffey KW,et al.Canagliflozin and cardiovascular and renal events in type 2 diabetes[J].N Engl J Med,2017,377(7):644-657.DOI:10.1056/NEJMoa1611925.
[14] Wiviott SD, Raz I,Bonaca MP,et al.Dapagliflozin and cardiovascular outcomes in type 2 diabetes[J].N Engl J Med,2019,380(4):347-357.DOI:10.1056/NEJMoa1812389.
[15] Perkovic V,Jardine MJ,Neal B,et al.Canagliflozin and renal outcomes in type 2 diabetes and nephropathy[J].N Engl J Med,2019,380(24):2295-2306.DOI:10.1056/NEJMoa1811744.
[16] Cannon CP,Pratley R,Dagogo-Jack S,et al.Cardiovascular outcomes with Ertugliflozin in type 2 diabetes[J].N Engl J Med,2020,383(15):1425-1435.DOI:10.1056/NEJMoa2004967.
[17] McMurray JJV,Solomon SD,Inzucchi SE,et al.Dapagliflozin in patients with heart failure and reduced ejection fraction[J].N Engl J Med,2019,381(21):1995-2008.DOI:10.1056/NEJMoa1911303.
[18] Forslund K,Hildebrand F,Nielsen T,et al.Disentangling type 2 diabetes and metformin treatment signatures in the human gut microbiota[J].Nature,2015,528(7581):262-266.DOI:10.1038/nature15766.
[19] Morita Y,Nogami M,Sakaguchi K,et al.Enhanced release of glucose into the intraluminal space of the intestine associated with metformin treatment as revealed by [18F]fluorodeoxyglucose PET-MRI[J].Diabetes Care,2020,43(8):1796-1802.DOI:10.2337/dc20-0093.
[20] Ma T,Tian X,Zhang B,et al.Low-dose metformin targets the lysosomal AMPK pathway through PEN2[J].Nature,2022,603(7899):159-165.DOI:10.1038/s41586-022-04431-8.
[21] Araki E,Goto A,Kondo T,et al.Japanese clinical practice guideline for diabetes 2019[J].Diabetol Int,2020,11(3):165-223.DOI:10.1007/s13340-020-00439-5.
[22] 《二甲双胍临床应用专家共识》更新专家组.二甲双胍临床应用专家共识(2023年版)[J].中华内科杂志,2023,62(6):619-630.DOI:10.3760/cma.j.cn112138-20230305-00131.
[23] Kidney Disease:Improving Global Outcomes(KDIGO)Diabetes Work Group.KDIGO 2020 clinical practice guideline for diabetes management in chronic kidney disease[J].Kidney Int,2020,98(4S):S1-S115.DOI:10.1016/j.kint.2020.06.019.
[24] Stumvoll M,Goldstein BJ,van Haeften TW.Type 2 diabetes:principles of pathogenesis and therapy[J].Lancet,2005,365(9467):1333-1346.DOI:10.1016/S0140-6736(05)61032-X.
[25] Laiteerapong N,Ham SA,Gao Y,et al.The legacy effect in type 2 diabetes:impact of early glycemic control on future complications(The diabetes & aging study)[J].Diabetes Care,2019,42(3):416-426.DOI:10.2337/dc17-1144.
[26] Schwartz SS,Katz A.Sodium-glucose cotransporter-2 inhibitor combination therapy to optimize glycemic control and tolerability in patients with type 2 diabetes:focus on dapagliflozin-metformin[J].Diabetes Metab Syndr Obes,2016,9:71-82.DOI:10.2147/DMSO.S65588.
[27] Vlacho B,Mata-Cases M,Mundet-Tudurí X,et al.Analysis of the adherence and safety of second oral glucose-lowering therapy in routine practice from the mediterranean area:a retrospective cohort study[J].Front Endocrinol(Lausanne),2021,12:708372.DOI:10.3389/fendo.2021.708372.
[28] Sherifali D,Nerenberg K,Pullenayegum E,et al.The effect of oral antidiabetic agents on A1C levels:a systematic review and meta-analysis[J].Diabetes Care,2010,33(8):1859-1864.DOI:10.2337/dc09-1727.
[29] Milder TY,Stocker SL,Abdel Shaheed C,et al.Combination therapy with an SGLT2 inhibitor as initial treatment for type 2 diabetes:a systematic review and meta-analysis[J].J Clin Med,2019,8(1):45.DOI:10.3390/jcm8010045.
[30] Zhang Q,Dou J,Lu J.Combinational therapy with metformin and sodium-glucose cotransporter inhibitors in management of type 2 diabetes:systematic review and meta-analyses[J].Diabetes Res Clin Pract,2014,105(3):313-321.DOI:10.1016/j.diabres.2014.06.006.
[31] Del Prato S,Nauck M,Durán-Garcia S,et al.Long-term glycaemic response and tolerability of dapagliflozin versus a sulphonylurea as add-on therapy to metformin in patients with type 2 diabetes:4-year data[J].Diabetes Obes Metab,2015,17(6):581-590.DOI:10.1111/dom.12459.
[32] Leiter LA,Yoon KH,Arias P,et al.Canagliflozin provides durable glycemic improvements and body weight reduction over 104 weeks versus glimepiride in patients with type 2 diabetes on metformin:a randomized,double-blind,phase 3 study[J].Diabetes Care,2015,38(3):355-364.DOI:10.2337/dc13-2762.
[33] Yang T,Lu M,Ma L,et al.Efficacy and tolerability of canagliflozin as add-on to metformin in the treatment of type 2 diabetes mellitus:a meta-analysis[J].Eur J Clin Pharmacol,2015,71(11):1325-1332.DOI:10.1007/s00228-015-1923-y.
[34] 王康丽,洪天配,魏蕊.SGLT2抑制剂对胰岛β细胞的保护作用及潜在机制[J].中华内分泌代谢杂志,2021,37(4):297-300.DOI:10.3760/cma.j.cn311282-20200814-00577
[35] Garvey WT,Van Gaal L,Leiter LA,et al.Effects of canagliflozin versus glimepiride on adipokines and inflammatory biomarkers in type 2 diabetes[J].Metabolism,2018,85:32-37.DOI:10.1016/j.metabol.2018.02.002.
[36] McGuire DK,Shih WJ,Cosentino F,et al.Association of SGLT2 inhibitors with cardiovascular and kidney outcomes in patients with type 2 diabetes:a meta-analysis[J].JAMA Cardiol,2021,6(2):148-158.DOI:10.1001/jamacardio.2020.4511.
[37] Arnott C,Li Q,Kang A,et al.Sodium-Glucose cotransporter 2 inhibition for the prevention of cardiovascular events in patients with type 2 diabetes mellitus:a systematic review and meta-analysis[J].J Am Heart Assoc,2020,9(3):e014908.DOI:10.1161/JAHA.119.014908.
[38] Zannad F,Ferreira JP,Pocock SJ,et al.SGLT2 inhibitors in patients with heart failure with reduced ejection fraction:a meta-analysis of the EMPEROR-Reduced and DAPA-HF trials[J].Lancet,2020,396(10254):819-829.DOI:10.1016/S0140-6736(20)31824-9.
[39] Solomon SD,Vaduganathan M,Claggett BL,et al.Baseline characteristics of patients with HF with mildly reduced and preserved ejection fraction:DELIVER trial[J].JACC Heart Fail,2022,10(3):184-197.DOI:10.1016/j.jchf.2021.11.006.
[40] Packer M,Anker SD,Butler J,et al.Cardiovascular and renal outcomes with empagliflozin in heart failure[J].N Engl J Med,2020,383(15):1413-1424.DOI:10.1056/NEJMoa2022190.
[41] Anker SD,Butler J,Filippatos G,et al.Empagliflozin in heart failure with a preserved ejection fraction[J].N Engl J Med,2021,385(16):1451-1461.DOI:10.1056/NEJMoa2107038.
[42] Neuen BL,Arnott C,Perkovic V,et al.Sodium-glucose co-transporter-2 inhibitors with and without metformin:a meta-analysis of cardiovascular,kidney and mortality outcomes[J].Diabetes Obes Metab,2021,23(2):382-390.DOI:10.1111/dom.14226.
[43] 刘静,肖新华.在“以患者为中心”治疗理念新思考下探讨钠-葡萄糖共转运蛋白2抑制剂的治疗地位[J].中华糖尿病杂志,2022,14(9):987-992.DOI:10.3760/cma.j.cn115791-20211028-00579.
[44] 刘思默,柯静,赵冬.钠-葡萄糖协同转运蛋白2抑制剂改善2型糖尿病患者心血管结局的机制探讨[J].中华糖尿病杂志,2021,13(1):103-106.DOI:10.3760/cma.j.cn115791-20200511-00291.
[45] Hong J,Zhang Y,Lai S,et al.Effects of metformin versus glipizide on cardiovascular outcomes in patients with type 2 diabetes and coronary artery disease[J].Diabetes Care,2013,36(5):1304-1311.DOI:10.2337/dc12-0719.
[46] Hu Y,Lei M,Ke G,et al.Metformin use and risk of all-cause mortality and cardiovascular events in patients with chronic kidney disease-A systematic review and meta-analysis[J].Front Endocrinol(Lausanne),2020,11:559446.DOI:10.3389/fendo.2020.559446.
[47] Zilov AV,Abdelaziz SI,AlShammary A,et al.Mechanisms of action of metformin with special reference to cardiovascular protection[J].Diabetes Metab Res Rev,2019,35(7):e3173.DOI:10.1002/dmrr.3173.
[48] Schernthaner G,Brand K,Bailey CJ.Metformin and the heart:update on mechanisms of cardiovascular protection with special reference to comorbid type 2 diabetes and heart failure[J].Metabolism,2022,130:155160.DOI:10.1016/j.metabol.2022.155160.
[49] Heerspink H,Stefánsson BV,Correa-Rotter R,et al.Dapagliflozin in patients with chronic kidney disease[J].N Engl J Med,2020,383(15):1436-1446.DOI:10.1056/NEJMoa2024816.
[50] Wanner C,Inzucchi SE,Lachin JM,et al.Empagliflozin and progression of kidney disease in type 2 diabetes[J].N Engl J Med,2016,375(4):323-334.DOI:10.1056/NEJMoa1515920.
[51] Cherney DZI,Charbonnel B,Cosentino F,et al.Effects of ertugliflozin on kidney composite outcomes,renal function and albuminuria in patients with type 2 diabetes mellitus:an analysis from the randomised VERTIS CV trial[J].Diabetologia,2021,64(6):1256-1267.DOI:10.1007/s00125-021-05407-5.
[52] Mosenzon O,Raz I,Wiviott SD,et al.Dapagliflozin and prevention of kidney disease among patients with type 2 diabetes:post hoc analyses from the DECLARE-TIMI 58 Trial[J].Diabetes Care,2022,45(10):2350-2359.DOI:10.2337/dc22-0382.
[53] Neuen BL,Young T,Heerspink HJL,et al.SGLT2 inhibitors for the prevention of kidney failure in patients with type 2 diabetes:a systematic review and meta-analysis[J].Lancet Diabetes Endocrinol,2019,7(11):845-854.DOI:10.1016/S2213-8587(19)30256-6.
[54] The EMPA-KIDNEY Collaborative Group; Herrington WG,Staplin N,Wanner C,et al.Empagliflozin in patients with chronic kidney disease[J].N Engl J Med,2023,388(2):117-127.DOI:10.1056/NEJMoa2204233.
[55] Glueck CJ,Fontaine RN,Wang P,et al.Metformin reduces weight,centripetal obesity,insulin,leptin,and low-density lipoprotein cholesterol in nondiabetic,morbidly obese subjects with body mass index greater than 30[J].Metabolism,2001,50(7):856-861.DOI:10.1053/meta.2001.24192.
[56] Salpeter SR,Buckley NS,Kahn JA,et al.Meta-analysis:metformin treatment in persons at risk for diabetes mellitus[J].Am J Med,2008,121(2):149-157.e2.DOI:10.1016/j.amjmed.2007.09.016.
[57] Cai X,Ji L,Chen Y,et al.Comparisons of weight changes between sodium-glucose cotransporter 2 inhibitors treatment and glucagon-like peptide-1 analogs treatment in type 2 diabetes patients:a meta-analysis[J].J Diabetes Investig,2017,8(4):510-517.DOI:10.1111/jdi.12625.
[58] ElSayed NA,Aleppo G,Aroda VR,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.DOI:10.2337/dc23-S008.
[59] Ji L,Li H,Guo X,et al.Impact of baseline BMI on glycemic control and weight change with metformin monotherapy in Chinese type 2 diabetes patients:phase IV open-label trial[J].PLoS One,2013,8(2):e57222.DOI:10.1371/journal.pone.0057222.
[60] Whalen K,Miller S,Onge ES.The Role of sodium-glucose co-transporter 2 inhibitors in the treatment of type 2 diabetes[J].Clin Ther,2015,37(6):1150-1166.DOI:10.1016/j.clinthera.2015.03.004.
[61] Molugulu N,Yee LS,Ye YT,et al.Systematic review of metformin monotherapy and dual therapy with sodium glucose co-transporter 2 inhibitor(SGLT-2)in treatment of type 2 diabetes mellitus[J].Diabetes Res Clin Pract,2017,132:157-168.DOI:10.1016/j.diabres.2017.07.025.
[62] 张洁,郭立新.钠-葡萄糖共转运蛋白2抑制剂改善体重的特点、影响因素及其机制[J].中华糖尿病杂志,2019,11(4):287-290.DOI:10.3760/cma.j.issn.1674-5809.2019.04.012.
[63] Weber MA,Mansfield TA,Cain VA,et al.Blood pressure and glycaemic effects of dapagliflozin versus placebo in patients with type 2 diabetes on combination antihypertensive therapy:a randomised, double-blind, placebo-controlled, phase 3 study[J].Lancet Diabetes Endocrinol,2016,4(3):211-220.DOI:10.1016/S2213-8587(15)00417-9.
[64] Fralick M,Chen SK,Patorno E,et al.Assessing the risk for gout with sodium-glucose cotransporter-2 inhibitors in patients with type 2 diabetes:a population-based cohort study[J].Ann Intern Med,2020,172(3):186-194.DOI:10.7326/M19-2610.
[65] Bailey CJ,Gross JL,Hennicken D,et al.Dapagliflozin add-on to metformin in type 2 diabetes inadequately controlled with metformin:a randomized,double-blind,placebo-controlled 102-week trial[J].BMC Med,2013,11:43.DOI:10.1186/1741-7015-11-43.
[66] Gillani SW,Ghayedi N,Roosta P,et al.Effect of metformin on lipid profiles of type 2 diabetes mellitus:a meta-analysis of randomized controlled trials[J].J Pharm Bioallied Sci,2021,13(1):76-82.DOI:10.4103/jpbs.JPBS_370_20.
[67] Weng S,Luo Y,Zhang Z,et al.Effects of metformin on blood lipid profiles in nondiabetic adults:a meta-analysis of randomized controlled trials[J].Endocrine,2020,67(2):305-317.DOI:10.1007/s12020-020-02190-y.
[68] Neal B,Perkovic V,de Zeeuw D,et al.Efficacy and safety of canagliflozin,an inhibitor of sodium-glucose cotransporter 2,when used in conjunction with insulin therapy in patients with type 2 diabetes[J].Diabetes Care,2015,38(3):403-411.DOI:10.2337/dc14-1237.
[69] Hayashi T,Fukui T,Nakanishi N,et al.Dapagliflozin decreases small dense low-density lipoprotein-cholesterol and increases high-density lipoprotein 2-cholesterol in patients with type 2 diabetes:comparison with sitagliptin[J].Cardiovasc Diabetol,2017,16(1):8.DOI:10.1186/s12933-016-0491-5.
[70] Cheng L,Fu Q,Zhou L,et al.Dapagliflozin,metformin,monotherapy or both in patients with metabolic syndrome[J].Sci Rep,2021,11(1):24263.DOI:10.1038/s41598-021-03773-z.
[71] Oshima M,Neuen BL,Jardine MJ,et al.Effects of canagliflozin on anaemia in patients with type 2 diabetes and chronic kidney disease:a post-hoc analysis from the CREDENCE trial[J].Lancet Diabetes Endocrinol,2020,8(11):903-914.DOI:10.1016/S2213-8587(20)30300-4.
[72] Li WJ,Chen XQ,Xu LL,et al.SGLT2 inhibitors and atrial fibrillation in type 2 diabetes:a systematic review with meta-analysis of 16 randomized controlled trials[J].Cardiovasc Diabetol,2020,19(1):130.DOI:10.1186/s12933-020-01105-5.
[73] Fruci B,Giuliano S,Mazza A,et al.Nonalcoholic Fatty liver:a possible new target for type 2 diabetes prevention and treatment[J].Int J Mol Sci,2013,14(11):22933-22966.DOI:10.3390/ijms141122933.
[74] Kim J,Han K,Kim B,et al.Sodium-glucose cotransporter 2 inhibitors for non-alcoholic fatty liver disease in patients with type 2 diabetes mellitus:a nationwide propensity-score matched cohort study[J].Diabetes Res Clin Pract,2022,194:110187.DOI:10.1016/j.diabres.2022.110187.
[75] Bellanti F,Lo Buglio A,Dobrakowski M,et al.Impact of sodium glucose cotransporter-2 inhibitors on liver steatosis/fibrosis/inflammation and redox balance in non-alcoholic fatty liver disease[J].World J Gastroenterol,2022,28(26):3243-3257.DOI:10.3748/wjg.v28.i26.3243.
[76] Sinha B,Ghosal S.A meta-analysis of the effect of sodium glucose cotransporter-2 inhibitors on metabolic parameters in patients with polycystic ovary syndrome[J].Front Endocrinol(Lausanne),2022,13:830401.DOI:10.3389/fendo.2022.830401.
[77] Garber AJ,Handelsman Y,Grunberger G,et al.Consensus statement by the american association of clinical endocrinologists and american college of endocrinology on the comprehensive type 2 diabetes management algorithm-2020 executive summary[J].Endocr Pract,2020,26(1):107-139.DOI:10.4158/CS-2019-0472.
[78] Ji L,Chan JCN,Yu M,et al.Early combination versus initial metformin monotherapy in the management of newly diagnosed type 2 diabetes:an east asian perspective[J].Diabetes Obes Metab,2021,23(1):3-17.DOI:10.1111/dom.14205.
[79] Han S,Iglay K,Davies MJ,et al.Glycemic effectiveness and medication adherence with fixed-dose combination or coadministered dual therapy of antihyperglycemic regimens:a meta-analysis[J].Curr Med Res Opin,2012,28(6):969-77.DOI:10.1185/03007995.2012.684045.
[80] B?m AK,Schneider U,Aberle J,et al.Regimen simplification and medication adherence:fixed-dose versus loose-dose combination therapy for type 2 diabetes[J].PLoS One,2021,16(5):e0250993.DOI:10.1371/journal.pone.0250993.
[81] Egede LE,Gebregziabher M,Dismuke CE,et al.Medication nonadherence in diabetes:longitudinal effects on costs and potential cost savings from improvement[J].Diabetes Care,2012,35(12):2533-2539.DOI:10.2337/dc12-0572.
[82] Rojas C,Link J,Meinicke T,et al.Pharmacokinetics of fixed-dose combinations of empagliflozin/metformin compared with individual tablets in healthy subjects[J].Int J Clin Pharmacol Ther,2016,54(4):282-292.DOI:10.5414/CP202425.
[83] Khomitskaya Y,Tikhonova N,Gudkov K,et al.Bioequivalence of dapagliflozin/metformin extended-release fixed-combination drug product and single-component dapagliflozin and metformin extended-release tablets in healthy russian subjects[J].Clin Ther,2018,40(4):550-561.e3.DOI:10.1016/j.clinthera.2018.02.006.
[84] Timmins P,Donahue S,Meeker J,et al.Steady-state pharmacokinetics of a novel extended-release metformin formulation[J].Clin Pharmacokinet,2005,44(7):721-729.DOI:10.2165/00003088-200544070-00004.
[85] 王博,张来华,李苑新,等.亲水凝胶骨架缓释片释药机制评价方法的研究进展[J].中国医药工业杂志,2009(10):5.
[86] Guillausseau PJ.Influence of oral antidiabetic drugs compliance on metabolic control in type 2 diabetes.A survey in general practice[J].Diabetes Metab,2003,29(1):79-81.DOI:10.1016/s1262-3636(07)70011-3.
[87] Donnan K,Segar L.SGLT2 inhibitors and metformin:dual antihyperglycemic therapy and the risk of metabolic acidosis in type 2 diabetes[J].Eur J Pharmacol,2019,846:23-29.DOI:10.1016/j.ejphar.2019.01.002.
[88] Osterberg L,Blaschke T.Adherence to medication[J].N Engl J Med.2005, 353(5):487-497.DOI:10.1056/NEJMra050100.
[89] 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.DOI:10.3760/cma.j.cn115791-20210706-00369.
[90] Guo L,Wang J,Li L,et al.A multicentre,prospective,non-interventional study evaluating the safety of dapagliflozin in patients with type 2 diabetes in routine clinical practice in China(DONATE)[J].BMC Med,2023,21(1):212.DOI:10.1186/s12916-023-02906-7.
[91] LiXin Guo,Jing Wang,Li Li,et al.1811-PUB: Real-World Safety of the Combined Use of Dapagliflozin and Metformin in Type 2 Diabetes Mellitus Patients in China—Post Hoc Analysis of the DONATE Study[G/OL].Diabetes,2023,72(Supplement_1):1811-PUB.https://doi.org/10.2337/db23-1811-PUB
[92] Kawalec P,Mikrut A,opuch S.The safety of dipeptidyl peptidase-4(DPP-4)inhibitors or sodium-glucose cotransporter 2(SGLT-2)inhibitors added to metformin background therapy in patients with type 2 diabetes mellitus:a systematic review and meta-analysis[J].Diabetes Metab Res Rev,2014,30(4):269-283.DOI:10.1002/dmrr.2494.
[93] Nabrdalik K,Skonieczna-Z·ydecka K,Irlik K,et al.Gastrointestinal adverse events of metformin treatment in patients with type 2 diabetes mellitus:a systematic review,meta-analysis and meta-regression of randomized controlled trials[J].Front Endocrinol(Lausanne),2022,13:975912.DOI:10.3389/fendo.2022.975912.
[94] Qiu M,Ding LL,Zhang M,et al.Safety of four SGLT2 inhibitors in three chronic diseases:a meta-analysis of large randomized trials of SGLT2 inhibitors[J].Diab Vasc Dis Res,2021,18(2):14791641211011016.DOI:10.1177/14791641211011016.
[95] Li D,Wang T,Shen S,et al.Urinary tract and genital infections in patients with type 2 diabetes treated with sodium-glucose co-transporter 2 inhibitors:a meta-analysis of randomized controlled trials[J].Diabetes Obes Metab,2017,19(3):348-355.DOI:10.1111/dom.12825.
[96] Liu J,Li L,Li S,et al.Effects of SGLT2 inhibitors on UTIs and genital infections in type 2 diabetes mellitus:a systematic review and meta-analysis[J].Sci Rep,2017,7(1):2824.DOI:10.1038/s41598-017-02733-w.
[97] Figueiredo IR,Rose SCP,Freire NB,et al.Use of sodium-glucose cotransporter-2 inhibitors and urinary tract infections in type 2 diabetes patients:a systematic review[J].Rev Assoc Med Bras(1992),2019,65(2):246-252.DOI:10.1590/1806-9282.65.2.246.
[98] Puckrin R,Saltiel MP,Reynier P,et al.SGLT-2 inhibitors and the risk of infections:a systematic review and meta-analysis of randomized controlled trials[J].Acta Diabetol,2018,55(5):503-514.DOI:10.1007/s00592-018-1116-0.
[99] 纪立农,郭立新,郭晓蕙,等.钠-葡萄糖共转运蛋白2(SGLT2)抑制剂临床合理应用中国专家建议[J].中国糖尿病杂志,2016,24(10):865-870.DOI:10.3969/j.issn.1006-6187.2016.10.01.
[100] Liew A,Lydia A,Matawaran BJ,et al.Practical considerations for the use of SGLT-2 inhibitors in the Asia-Pacific countries-an expert consensus statement[J].Nephrology(Carlton),2023,28(8):415-424.DOI:10.1111/nep.14167.
[101] Unnikrishnan AG,Kalra S,Purandare V,et al.Genital infections with sodium glucose cotransporter-2 inhibitors:occurrence and management in patients with type 2 diabetes mellitus[J].Indian J Endocrinol Metab,2018,22(6):837-842.DOI:10.4103/ijem.IJEM_159_17.
[102] Li X,Li T,Cheng Y,et al.Effects of SGLT2 inhibitors on fractures and bone mineral density in type 2 diabetes:an updated meta-analysis[J].Diabetes Metab Res Rev,2019,35(7):e3170.DOI:10.1002/dmrr.3170.
[103] Zhang J,Huan Y,Leibensperger M,et al.Comparative effects of sodium-glucose cotransporter 2 inhibitors on serum electrolyte levels in patients with type 2 diabetes:a pairwise and network meta-analysis of randomized controlled trials[J].Kidney360,2022,3(3):477-487.DOI:10.34067/KID.0006672021.
[104] U.S.Food and Drug Administration.FDA Drug Safety Communication: FDA revises warnings regarding use of the diabetes medicine metformin in certain patients with reduced kidney function[EB/OL].(2017-11-14)[2023-6-17].https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-revises-warnings-regarding-use-diabetes-medicine-metformin-certain.
[105] Sheu WHH,Chan SP,Matawaran BJ,et al.Use of SGLT-2 inhibitors in patients with type 2 diabetes mellitus and abdominal obesity:an asian perspective and expert recommendations[J].Diabetes Metab J,2020,44(1):11-32.DOI:10.4093/dmj.2019.0208.
[106] 姬秋和,陈莉明,郗光霞,等.2型糖尿病患者体重管理专家共识[J].国际内分泌代谢杂志,2022,42(1):78-86.DOI:10.3760/cma.j.cn121383-20211102-11004.
[107] Stolar MW.Defining and achieving treatment success in patients with type 2 diabetes mellitus[J].Mayo Clin Proc,2010,85(12 Suppl):S50-59.DOI:10.4065/mcp.2010.0471.

相似文献/References:

[1]孟旭英,范振迁,郭剑超.利拉鲁肽与格列美脲治疗2型糖尿病的系统评价[J].国际内分泌代谢杂志,2016,36(06):380.[doi:10.3760/cma.j.issn.1673-4157.2016.06.05]
　Meng Xuying,Fan Zhenqian,Guo Jianchao..Effects of liraglutide versus glimepiride for type 2 diabetes mellitus: a systematic review[J].International Journal of Endocrinology and Metabolism,2016,36(05):380.[doi:10.3760/cma.j.issn.1673-4157.2016.06.05]
[2]韩秀丹 朱凌燕 徐积兄.二甲双胍对糖尿病视网膜病变的作用及机制[J].国际内分泌代谢杂志,2019,39(01):53.[doi:10.3760/cma.j.issn.1673-4157.2019.01.013]
　Han Xiudan,Zhu Lingyan,Xu Jixiong.Effects of metformin on diabetic retinopathy and its mechanism[J].International Journal of Endocrinology and Metabolism,2019,39(05):53.[doi:10.3760/cma.j.issn.1673-4157.2019.01.013]
[3]谢叶红 黄明春.二甲双胍降低T2DM血清维生素B12的研究进展[J].国际内分泌代谢杂志,2020,40(01):35.[doi:10.3760/cma.j.issn.1673-4157.2020.01.008]
　Xie Yehong,Huang Mingchun.Progress of metformin in reducing serum vitamin B12 in T2DM[J].International Journal of Endocrinology and Metabolism,2020,40(05):35.[doi:10.3760/cma.j.issn.1673-4157.2020.01.008]
[4]廖英宏,庄晓婷,白越,等.钠-葡萄糖共转运蛋白2抑制剂在血管衰老中的作用[J].国际内分泌代谢杂志,2022,42(05):373.[doi:10.3760/cma.j.cn121383-20210715-07038]
　Liao Yinghong,Zhuang Xiaoting,Bai Yue,et al.Roles of sodium glucose cotransporter 2 inhibitor in vascular aging[J].International Journal of Endocrinology and Metabolism,2022,42(05):373.[doi:10.3760/cma.j.cn121383-20210715-07038]
[5]《恩格列净/二甲双胍复方制剂临床应用专家指导意见》编写组.恩格列净/二甲双胍复方制剂临床应用专家指导意见[J].国际内分泌代谢杂志,2022,42(05):451.[doi:10.3760/cma.j.cn121383-20220530-05068]
　Expert Group for Guidance of EMPA/MET FDC.Expert opinion on empagliflozin/metformin fixed-dose combination for treatment of type 2 diabetes[J].International Journal of Endocrinology and Metabolism,2022,42(05):451.[doi:10.3760/cma.j.cn121383-20220530-05068]

备注/Memo

备注/Memo:
通信作者:陈莉明,Email:xfx22081@vip.163.com; 赵家军,Email:jjzhao@sdu.edu.cn
更新日期/Last Update: 2023-10-10