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在台湾 2 型糖尿病患者中,钠-葡萄糖共转运蛋白-2 抑制剂与糖尿病性黄斑水肿的风险:一项多机构队列研究。

Risk of diabetic macular oedema with sodium-glucose cotransporter-2 inhibitors in type 2 diabetes patients: A multi-institutional cohort study in Taiwan.

机构信息

Department of Ophthalmology, College of Medicine, National Cheng Kung University, Tainan, Taiwan.

Department of Pharmacy, Keelung Chang Gung Memorial Hospital, Keelung, Taiwan.

出版信息

Diabetes Obes Metab. 2021 Sep;23(9):2067-2076. doi: 10.1111/dom.14445. Epub 2021 Jun 9.

Abstract

AIMS

To investigate the risk of diabetic macular oedema (DMO) associated with the use of sodium-glucose cotransporter-2 (SGLT2) inhibitors in patients with type 2 diabetes mellitus (T2DM).

MATERIALS AND METHODS

We conducted a retrospective cohort study by analysing a large multi-institutional electronic medical records database in Taiwan. We included adult patients with T2DM without DMO newly receiving either SGLT2 inhibitors or glucagon-like peptide-1 receptor agonists (GLP-1RAs) during the period 2016 to 2018. We used propensity scores with inverse probability of treatment weighting to generate comparable groups. The study outcome was incident DMO, determined by clinical diagnosis during outpatient visits or admissions. We followed patients from the index date to either DMO occurrence, last clinical visit, patient death, or December 31, 2020. We performed Cox proportional hazards regression models to estimate hazard ratios (HRs) and 95% confidence intervals (CIs) for the risk of DMO.

RESULTS

We included 9986 new users of SGLT2 inhibitors (mean [SD] age 59.6 (12.1) years, median [interquartile range {IQR}] glycated haemoglobin [HbA1c] 70 (61-81)mmol/mol, estimated glomerular filtration rate [eGFR] 89.1 [71.4-108.7] mL/min/1.73 m and urine albumin-creatinine ratio [UACR] 26.1 [9.7-117.6] mg/g) and 1067 new users of GLP-1RAs (mean [SD] age 58.4 (41.5) years, median [IQR] HbA1c 73 [64-84] mmol/mol, eGFR 91.6 [68.6-114.0] mL/min/1.73 m and UACR 37.6 [11.1-153.2] mg/g) with similar baseline characteristics. Lower DMO risks were observed among patients newly receiving SGLT2 inhibitors (7.9/1000 person-years), compared to those receiving GLP-1RAs (10.7/1000 person-years) with an HR of 0.75 (95% CI 0.64-0.88).

CONCLUSIONS

Our findings suggest use of SGLT2 inhibitors was associated with lower risk of DMO in T2DM patients in clinical practice, compared to use of GLP-1RAs. Future studies are necessary to confirm this observation.

摘要

目的

研究钠-葡萄糖共转运蛋白 2(SGLT2)抑制剂在 2 型糖尿病(T2DM)患者中的使用与糖尿病黄斑水肿(DMO)风险之间的关系。

材料和方法

我们通过分析台湾一个大型多机构电子病历数据库进行了回顾性队列研究。我们纳入了 2016 年至 2018 年期间新接受 SGLT2 抑制剂或胰高血糖素样肽-1 受体激动剂(GLP-1RAs)治疗的无 DMO 的 T2DM 成年患者。我们使用逆概率治疗加权法生成倾向评分以产生可比组。研究结果是通过门诊或住院期间的临床诊断确定的 DMO 新发病例。我们从指数日期开始对患者进行随访,直至发生 DMO、最近一次临床就诊、患者死亡或 2020 年 12 月 31 日。我们使用 Cox 比例风险回归模型估计 DMO 风险的风险比(HR)和 95%置信区间(CI)。

结果

我们纳入了 9986 名新使用 SGLT2 抑制剂的患者(平均[SD]年龄 59.6[12.1]岁,中位[四分位间距{IQR}]糖化血红蛋白[HbA1c]70[61-81]mmol/mol,估计肾小球滤过率[eGFR]89.1[71.4-108.7]mL/min/1.73 m 和尿白蛋白/肌酐比[UACR]26.1[9.7-117.6]mg/g)和 1067 名新使用 GLP-1RAs 的患者(平均[SD]年龄 58.4[41.5]岁,中位[IQR]HbA1c 73[64-84]mmol/mol,eGFR 91.6[68.6-114.0]mL/min/1.73 m 和 UACR 37.6[11.1-153.2]mg/g),具有相似的基线特征。与接受 GLP-1RAs 的患者(10.7/1000 人年)相比,新接受 SGLT2 抑制剂的患者(7.9/1000 人年)的 DMO 风险较低,HR 为 0.75(95%CI 0.64-0.88)。

结论

我们的研究结果表明,与 GLP-1RAs 相比,SGLT2 抑制剂在临床实践中与 T2DM 患者的 DMO 风险降低相关。需要进一步的研究来证实这一观察结果。

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