临床荟萃 ›› 2023, Vol. 38 ›› Issue (11): 1042-1047.doi: 10.3969/j.issn.1004-583X.2023.11.016
收稿日期:
2023-06-20
出版日期:
2023-11-20
发布日期:
2024-01-17
通讯作者:
陈珺
E-mail:694500182@qq.com
Received:
2023-06-20
Online:
2023-11-20
Published:
2024-01-17
摘要:
钠-葡萄糖转运蛋白2抑制剂(SGLT2i)是治疗2型糖尿病(T2DM)的新型口服降糖药,其通过抑制肾脏对葡萄糖近端小管的重吸收,增加尿糖排泄以降低血糖。但该药在发挥稳定疗效的同时,可能带来一些特定的风险,如糖尿病酮症酸中毒、泌尿生殖系统感染、骨折、截肢、肿瘤,以及急性肾损伤等。本文根据最新的文献和临床研究对T2DM患者使用SGLT2i相关的安全性问题进行综述,旨在为临床用药提供参考。
中图分类号:
陈珺. 钠-葡萄糖转运蛋白2抑制剂在2型糖尿病患者中用药安全性的研究进展[J]. 临床荟萃, 2023, 38(11): 1042-1047.
[1] | 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. |
[2] | Forouhi NG, Misra A, Mohan V, et al. Dietary and nutritional approaches for prevention and management of type 2 diabetes[J]. BMJ, 2018, 13(361):2234. |
[3] | 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. |
[4] | 梁欢, 刘建凤. 盘点钠-葡萄糖协同转运蛋白2抑制剂临床研究新进展[J]. 临床荟萃, 2020, 35(9):861-864. |
[5] | Musso G, Saba F, Cassader M, et al. Diabetic ketoacidosis with SGLT2 inhibitors[J]. BMJ, 2020, 12(371):m4147. |
[6] | 杨晓德, 谢晓竞. 钠-葡萄糖共转运蛋白2抑制剂致非高血糖性酮症酸中毒研究进展[J]. 实用药物与床, 2022, 25(10):925-928. |
[7] |
Fralick M, Schneeweiss S, Redelmeier DA, et al. Comparative effectiveness and safety of sodium-glucose cotransporter-2 inhibitors versus metformin in patients with type 2 diabetes: An observational study using data from routine care[J]. Diabetes Obes Metab, 2021, 23(10): 2320-2328.
doi: 10.1111/dom.v23.10 URL |
[8] |
Lin DS, Lee JK, Chen WJ. Clinical adverse events associated with sodium-glucose cotransporter 2 inhibitors: A meta-analysis involving 10 randomized clinical trials and 71 553 individuals[J]. J Clin Endocrinol Metab, 2021, 106(7): 2133-2145.
doi: 10.1210/clinem/dgab274 URL |
[9] | 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. |
[10] |
Kaku K, Chin R, Naito Y, et al. Safety and effectiveness of empagliflozin in Japanese patients with type 2 diabetes: Interim analysis from a post-marketing surveillance study[J]. Expert Opin Drug Saf, 2020, 19(2): 211-221.
doi: 10.1080/14740338.2020.1694659 pmid: 31769309 |
[11] |
Dutta S, Kumar T, Singh S, et al. Euglycemic diabetic ketoacidosis associated with SGLT2 inhibitors: A systematic review and quantitative analysis[J] .J Family Med Prim Care, 2022, 11(3): 927-940.
doi: 10.4103/jfmpc.jfmpc_644_21 pmid: 35495849 |
[12] |
He Z, Lam K, Zhao W, et al. SGLT-2 inhibitors and euglycemic diabetic ketoacidosis/diabetic ketoacidosis in FAERS: A pharmacovigilance assessment[J]. Acta Diabetol, 2023, 60(3): 401-411.
doi: 10.1007/s00592-022-02015-6 |
[13] | Blau JE, Tella SH, Taylor SI, et al. Ketoacidosis associated with SGLT2 inhibitor treatment: Analysis of FAERS data[J]. Diabetes Metab Res Rev, 2017, 33(8):10. |
[14] |
Kuchay MS, Mishra SK, Mehta Y, et al. Empagliflozin induced euglycemic diabetic ketoacidosis in a patient undergoing coronary artery bypass graft despite discontinuation of the drug 48 hours prior to the surgery[J] .Diabetes Metab Syndr, 2021, 15(3): 909-911.
doi: 10.1016/j.dsx.2021.04.016 pmid: 33915345 |
[15] | Wang Q, Wu K, Luo X, et al. Dapagliflozin-associated euglycemic diabetic ketoacidosis presenting with severe abdominal pain mimicking acute peritonitis[J]. Cureus, 2022, 14(2): e22229. |
[16] |
Alkabbani W, Zongo A, Minhas-Sandhu JK, et al. Five comparative cohorts to assess the risk of genital tract infections associated with sodium-glucose cotransporter-2 inhibitors initiation in type 2 diabetes mellitus[J]. Diabet Med, 2022, 39(8): e14858.
doi: 10.1111/dme.v39.8 URL |
[17] |
Lin YH, Lin CH, Huang YY, et al. Risk factors of first and recurrent genitourinary tract infection in patients with type 2 diabetes treated with SGLT2 inhibitors: A retrospective cohort study[J]. Diabetes Res Clin Pract, 2022, 186: 109816.
doi: 10.1016/j.diabres.2022.109816 URL |
[18] |
Zhang F, Wang W, Hou X. Effectiveness and safety of ertugliflozin for type 2 diabetes: A meta-analysis of data from randomized controlled trials[J]. J Diabetes Investig, 2022, 13(3): 478-488.
doi: 10.1111/jdi.v13.3 URL |
[19] |
Alkabbani W, Zongo A, Minhas-Sandhu JK, et al. Sodium-glucose cotransporter-2 inhibitors and urinary tract infections: A propensity score-matched population-based cohort study[J]. Can J Diabetes, 2022, 46(3): 392-403,e13.
doi: 10.1016/j.jcjd.2021.12.005 URL |
[20] |
Huayllani MT, Cheema AS, McGuire MJ, et al. Practical review of the current management of fournier's gangrene[J]. Plast Reconstr Surg Glob Open, 2022, 10(3): e4191.
doi: 10.1097/GOX.0000000000004191 pmid: 35295879 |
[21] | Hu Y, Bai Z, Tang Y, et al. Fournier gangrene associated with sodium-glucose cotransporter-2 inhibitors: A pharmacovigilance study with data from the U.S. FDA adverse event reporting system[J]. J Diabetes Res, 2020, 2020: 3695101. |
[22] |
Fadini GP, Sarangdhar M, De Ponti F, et al. Pharmacovigilance assessment of the association between fournier's gangrene and other severe genital adverse events with SGLT-2 inhibitors[J] .BMJ Open Diabetes Res Care, 2019, 7(1): e000725.
doi: 10.1136/bmjdrc-2019-000725 URL |
[23] | Elbeddini A, Gallinger J, Davey M, et al. A case of fournier's gangrene in a patient taking canagliflozin for the treatment of type II diabetes mellitus[J]. Am J Case Rep, 2020, 24(21): e920115. |
[24] | Dong B, Lv R, Wang J, et al. The extraglycemic effect of sglt-2is on mineral and bone metabolism and bone fracture[J]. Front Endocrinol (Lausanne), 2022, 7(13): 918350. |
[25] |
Hidayat K, Du X, Shi BM. Risk of fracture with dipeptidyl peptidase-4 inhibitors, glucagon-like peptide-1 receptor agonists, or sodium-glucose cotransporter-2 inhibitors in real-world use: Systematic review and meta-analysis of observational studies[J] .Osteoporos Int, 2019, 30(10): 1923-1940.
doi: 10.1007/s00198-019-04968-x pmid: 31134305 |
[26] |
Qian BB, Song PC, Nie HX, et al. Association between combined treatment with SGLT2 inhibitors and metformin for type 2 diabetes mellitus on fracture risk: A meta-analysis of randomized controlled trials[J]. Osteoporos Int, 2020, 31(21): 2313-2320.
doi: 10.1007/s00198-020-05590-y |
[27] |
Ha KH, Kim DJ, Choi YJ. Sodium-glucose cotransporter 2 inhibitors do not increase the risk of fractures in real-world clinical practice in korea: A national observational cohort study[J]. J Diabetes Investig, 2022, 13(6): 986-996.
doi: 10.1111/jdi.v13.6 URL |
[28] |
Adimadhyam S, Lee TA, Calip GS, et al. Sodium-glucose co-transporter 2 inhibitors and the risk of fractures: A propensity score-matched cohort study[J] Pharmacoepidemiol Drug Saf, 2019, 28(12): 1629-1639.
doi: 10.1002/pds.4900 pmid: 31646732 |
[29] |
Zhao B, Shen J, Zhao J, et al. Do sodium-glucose cotransporter 2 inhibitors lead to fracture risk? a pharmacovigilance real-world study[J] .J Diabetes Investig, 2021, 12(8): 1400-1407.
doi: 10.1111/jdi.v12.8 URL |
[30] | Lou Y, Yu Y, Duan J, et al. Sodium-glucose cotransporter 2 inhibitors and fracture risk in patients with type 2 diabetes mellitus: A meta-analysis of randomized controlled trials[J] Ther Adv Chronic Dis, 2020, 26(11): 2040622320961599. |
[31] | 中国老年2型糖尿病防治临床指南编写组. 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(01):2-51. |
[32] |
刘少华, 蒋王艳, 郭洁茹, 等. 基于美国FAERS数据库的卡格列净不良反应信号挖掘[J]. 中国医院药学杂志, 2022, 42(13):1365-1370.
doi: 10.13286/j.1001-5213.2022.13.14 |
[33] |
Li CX, Liang S, Gao L, et al. Cardiovascular outcomes associated with SGLT-2 inhibitors versus other glucose-lowering drugs in patients with type 2 diabetes: A real-world systematic review and meta-analysis[J]. PLoS One, 2021, 16(2): e0244689.
doi: 10.1371/journal.pone.0244689 URL |
[34] |
Qiu M, Ding LL, Zhang M, et al. Comparison of the risk of SGLT2is and NonSGLT2is in leading to amputation: A network meta-analysis[J]. J Diabetes Complications, 2021, 35(2): 107803.
doi: 10.1016/j.jdiacomp.2020.107803 URL |
[35] |
Heyward J, Mansour O, Olson L, et al. Association between sodium-glucose cotransporter 2 (SGLT2) inhibitors and lower extremity amputation: A systematic review and meta-analysis[J] .PLoS One, 2020, 15(6): e0234065.
doi: 10.1371/journal.pone.0234065 URL |
[36] |
Zerovnik S, Kos M, Locatelli I. Risk of lower extremity amputations in patients with type 2 diabetes using sodium-glucose co-transporter 2 inhibitors[J]. Acta Diabetol, 2022, 59(2): 233-241.
doi: 10.1007/s00592-021-01805-8 |
[37] |
Mizutani G, Horii T, Oikawa Y, et al. Real-world risk of lower-limb amputation associated with sodium-glucose cotransporter 2 inhibitors versus metformin: A propensity score-matched model analysis in Japan[J]. J Diabetes Investig, 2022, 13(12): 2000-2009.
doi: 10.1111/jdi.v13.12 URL |
[38] |
Du Y, Bai L, Fan B, et al. Effect of SGLT2 inhibitors versus DPP4 inhibitors or GLP-1 agonists on diabetic foot-related extremity amputation in patients with T2DM: A meta-analysis[J] .Prim Care Diabetes, 2022, 16(1): 156-161.
doi: 10.1016/j.pcd.2021.12.007 URL |
[39] |
Rodionov RN, Peters F, Marschall U, et al. Peters frederik, marschall ursula et al. initiation of SGLT2 inhibitors and the risk of lower extremity minor and major amputation in patients with type 2 diabetes and peripheral arterial disease: A health claims data analysis[J] Eur J Vasc Endovasc Surg, 2021, 62(6): 981-990.
doi: 10.1016/j.ejvs.2021.09.031 URL |
[40] |
Copur S, Yildiz A, Basile C, et al. Is there any robust evidence showing that SGLT2 inhibitor use predisposes to acute kidney injury?[J] .J Nephrol, 2023, 36(1): 31-43.
doi: 10.1007/s40620-022-01422-w |
[41] |
Zinman B, Wanner C, Lachin JM, et al. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes[J] .N Engl J Med, 2015, 373(2): 2117-2728.
doi: 10.1056/NEJMoa1504720 URL |
[42] |
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 URL |
[43] |
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 URL |
[44] |
Horii T, Oikawa Y, Kunisada N, et al. Acute kidney injury in Japanese type 2 diabetes patients receiving sodium-glucose cotransporter 2 inhibitors: A nationwide cohort study[J] J Diabetes Investig, 2022, 13(1): 42-46.
doi: 10.1111/jdi.v13.1 URL |
[45] |
Alkabbani W, Zongo A, Minhas-Sandhu JK, et al. Renal effectiveness and safety of the sodium-glucose cotransporter-2 inhibitors: A population-based cohort study[J] .BMJ Open Diabetes Res Care, 2021, 9(2):e002496
doi: 10.1136/bmjdrc-2021-002496 URL |
[46] |
Zhuo M, Paik JM, Wexler DJ, et al. SGLT2 inhibitors and the risk of acute kidney injury in older adults with type 2 diabetes[J] Am J Kidney Dis, 2022, 79(6): 858-867, e1.
doi: 10.1053/j.ajkd.2021.09.015 URL |
[47] |
Chen G, Li X, Cui Q, et al. Acute kidney injury following SGLT2 inhibitors among diabetic patients: A pharmacovigilance study[J] .Int Urol Nephrol, 2022, 54(11): 2949-2957.
doi: 10.1007/s11255-022-03211-7 |
[48] |
Chan YH, Chen SW, Chao TF, et al. Impact of the initial decline in estimated glomerular filtration rate on the risk of new-onset atrial fibrillation and adverse cardiovascular and renal events in patients with type 2 diabetes treated with sodium-glucose co-transporter-2 inhibitors[J]. Diabetes Obes Metab, 2021, 23(9): 2077-2089.
doi: 10.1111/dom.v23.9 URL |
[49] |
Dicembrini I, Nreu B, Mannucci E, et al. Sodium-glucose co-transporter-2 (SGLT-2) inhibitors and cancer: A meta-analysis of randomized controlled trials[J] .Diabetes Obes Metab, 2019, 21(8): 1871-1877.
doi: 10.1111/dom.13745 pmid: 30972917 |
[50] | Shi N, Shi Y, Xu J, et al. SGLT-2i and risk of malignancy in type 2 diabetes: A meta-analysis of randomized controlled trials[J] .Front Public Health, 2021, 7(9): 668368. |
[51] | Rokszin G, Kiss Z, Sütö G, et al. Sodium-glucose co-transporter 2 inhibitors may change the development of urinary tract and hematological malignancies as compared with dipeptidyl peptidase-4 inhibitors: Data of the post-hoc analysis of a nationwide study[J]. Front Oncol, 2021, 28(11): 725465. |
[52] |
García M, Arteche-Martinez U, Lertxundi U, et al. SGLT2 inhibitors and bladder cancer: Analysis of cases reported in the european pharmacovigilance database[J] J Clin Pharmacol, 2021, 61(2): 187-192.
doi: 10.1002/jcph.v61.2 URL |
[53] | Ueda P, Svanström H, Hviid A, et al. Sodium-glucose cotransporter 2 inhibitors and risk of bladder and renal cancer: Scandinavian cohort study[J]. Diabetes Care, 2022, 45(5): e93-e96. |
[54] |
Tang H, Yang K, Li X, et al. Pancreatic safety of sodium-glucose cotransporter 2 inhibitors in patients with type 2 diabetes mellitus: A systematic review and meta-analysis[J]. Pharmacoepidemiol Drug Saf, 2020, 29(2): 161-172.
doi: 10.1002/pds.4943 pmid: 32017292 |
[55] |
Chan RNC, Chan RNF, Chou OHI, et al. Lower risks of incident colorectal cancer in SGLT2i users compared to DPP4i users: A propensity score-matched study with competing risk analysis[J]. Eur J Intern Med, 2023, 110: 125-127.
doi: 10.1016/j.ejim.2023.01.021 pmid: 36732129 |
[1] | 李琛, 李书颖, 阴雨, 剧一. 替罗非班治疗进展性缺血性脑卒中的研究进展[J]. 临床荟萃, 2022, 37(1): 87-91. |
[2] | 冯新梅. 奥氮平治疗精神分裂症对患者症状、安全性评分及相关血清因子的影响[J]. 临床荟萃, 2021, 36(12): 1114-1117. |
[3] | 马进才,马溶智,马珍珍. 利伐沙班对合并心功能不全的高龄非瓣膜性心房颤动疗效及安全性[J]. 临床荟萃, 2020, 35(5): 413-416. |
[4] | 李长青1,2,柴尔青2,姜蕾1. 急性缺血性脑卒中患者支架取栓术中[J]. 临床荟萃, 2018, 33(9): 787-791,795. |
[5] | 景宏菲,王艳芳,王龙. 联合运用尿激酶和替罗非班治疗急性脑梗死的安全性和有效性[J]. 临床荟萃, 2018, 33(5): 409-412. |
[6] | 王贵霞;曾跃;孟黄花. 恩替卡韦分散片治疗慢性乙型肝炎患者48周疗效观察[J]. 临床荟萃, 2015, 30(8): 899-902. |
[7] | 王秋英;李秀彩;冯桂山. 急性心肌梗死患者植入药物洗脱支架疗效与安全性分析[J]. 临床荟萃, 2010, 25(15): 1356-1357. |
[8] | 王连芹;魏玉清;于强;宁海春;赵丽娟;孔咏梅;李国锋. 脑梗死危险分层下小剂量辛伐他汀达标预防再发对照研究[J]. 临床荟萃, 2009, 24(23): 2053-2056. |
[9] | 王战建;肖艳新;GAO Ya-li. 从ACCORD研究中再认识2型糖尿病强化降糖治疗——ACCORD研究介绍[J]. 临床荟萃, 2009, 24(1): 3-4. |
[10] | 刘鹏;周卓宁;钟润芬;杨望荣. 踝臂指数与老年2型糖尿病缺血性脑卒中的危险因素分析[J]. 临床荟萃, 2008, 23(12): 889-890. |
[11] | 田利民;高翠霞;许衍甲;刘静. 2型糖尿病患者瘦素与性激素的关系[J]. 临床荟萃, 2007, 22(6): 406-407. |
[12] | 赵志刚;刘靖;侯永利. 罗格列酮对2型糖尿病尿微量白蛋白的影响[J]. 临床荟萃, 2007, 22(14): 1037-1038. |
[13] | 刘力昌;李妍怡. 活血化瘀在脑出血急性期的应用现状及前景[J]. 临床荟萃, 2006, 21(3): 223-224. |
[14] | 柴小奇;张莹;董劲;王敬;党群;吴先军. β受体阻滞剂在急性冠状动脉综合征中的应用[J]. 临床荟萃, 2005, 20(13): 745-746. |
[15] | 张雅中;房辉;裴玉梅;田金莉;张禾伟;吴卫平;许静. 两种胰岛素强化治疗方案对初诊2型糖尿病患者胰腺β细胞功能的影响[J]. 临床荟萃, 2005, 20(10): 551-554. |
阅读次数 | ||||||
全文 |
|
|||||
摘要 |
|
|||||