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钠-葡萄糖共转运蛋白 2 抑制剂在 1 型糖尿病患者中的获益是否超过风险?

Do the benefits of sodium-glucose cotransporter 2 inhibitors exceed the risks in patients with type 1 diabetes?

机构信息

Yuri Ono Clinic, Diabetes, Internal Medicine, Sapporo 060-0001, Japan.

Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo 060-8638, Japan.

出版信息

Endocr J. 2022 May 30;69(5):495-509. doi: 10.1507/endocrj.EJ21-0573. Epub 2021 Nov 25.

Abstract

Sodium-glucose cotransporter 2 inhibitors (SGLT2is) are well-established means of improving glycemia and preventing cardio-renal events in patients with type 2 diabetes. However, their efficacy and safety have yet to be fully characterized in patients with type 1 diabetes (T1D). We studied patients with T1D who regularly attended one of five diabetes centers and treated with an SGLT2i (ipragliflozin or dapagliflozin) for >52 weeks, and the changes in HbA1c, body mass, insulin dose, and laboratory data were retrospectively evaluated and adverse events (AEs) recorded during December 2018 to April 2021. A total of 216 patients with T1D were enrolled during the period. Of these, 42 were excluded owing to short treatment periods and 15 discontinued their SGLT2i. The mean changes in glycated hemoglobin (HbA1c), body mass, and insulin dose were -0.4%, -2.1 kg, and -9.0%, respectively. The change in HbA1c was closely associated with the baseline HbA1c (p < 0.001), but not with the baseline body mass or renal function. The basal and bolus insulin doses decreased by 18.2% and 12.6%, respectively, in participants with a baseline HbA1c <8%. The most frequent AE was genital infection (2.8%), followed by diabetic ketoacidosis (DKA; 1.4%). None of the participants experienced severe hypoglycemic events. In conclusion, the administration of an SGLT2i in addition to intensive insulin treatment in patients with T1D improves glycemic control and body mass, without increasing the incidence of hypoglycemia or DKA.

摘要

钠-葡萄糖共转运蛋白 2 抑制剂(SGLT2i)是改善 2 型糖尿病患者血糖和预防心肾事件的有效方法。然而,它们在 1 型糖尿病(T1D)患者中的疗效和安全性尚未得到充分描述。我们研究了定期在五个糖尿病中心就诊并接受 SGLT2i(依帕格列净或达格列净)治疗超过 52 周的 T1D 患者,回顾性评估了 HbA1c、体重、胰岛素剂量和实验室数据的变化,并记录了 2018 年 12 月至 2021 年 4 月期间的不良事件(AE)。在此期间共纳入 216 例 T1D 患者。其中,由于治疗时间短,42 例被排除在外,15 例患者停止使用 SGLT2i。糖化血红蛋白(HbA1c)、体重和胰岛素剂量的平均变化分别为-0.4%、-2.1kg 和-9.0%。HbA1c 的变化与基线 HbA1c 密切相关(p<0.001),但与基线体重或肾功能无关。HbA1c<8%的患者基础和餐时胰岛素剂量分别降低了 18.2%和 12.6%。最常见的 AE 是生殖器感染(2.8%),其次是糖尿病酮症酸中毒(DKA;1.4%)。无参与者发生严重低血糖事件。总之,在 T1D 患者中,除了强化胰岛素治疗外,还可以使用 SGLT2i 来改善血糖控制和体重,而不会增加低血糖或 DKA 的发生率。

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