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术前使用钠-葡萄糖协同转运蛋白2(SGLT2)抑制剂与术后糖尿病酮症酸中毒

Preoperative SGLT2 Inhibitor Use and Postoperative Diabetic Ketoacidosis.

作者信息

Dixit Anjali A, Bateman Brian T, Hawn Mary T, Odden Michelle C, Sun Eric C

机构信息

Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, California.

Department of Epidemiology and Population Health, Stanford University School of Medicine, Stanford, California.

出版信息

JAMA Surg. 2025 Apr 1;160(4):423-430. doi: 10.1001/jamasurg.2024.7082.

Abstract

IMPORTANCE

Case reports of postoperative diabetic ketoacidosis in patients using sodium-glucose cotransporter 2 inhibitor (SGLT2i) medications underlie guidance by the US Food and Drug Administration to withhold SGLT2i medication for at least 3 days prior to surgery. Given the potential negative consequences associated with preoperative medication withholding, a large-scale evaluation of the risk of diabetic ketoacidosis in this population is needed.

OBJECTIVE

To estimate the association between preoperative SGLT2i medication use and postoperative diabetic ketoacidosis in a population of patients who underwent a variety of emergency surgeries. Emergency surgery was chosen given the assumption that a patient would be unable to withhold their SGLT2i medication per the current guidance.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study was conducted among a nationwide sample of patients aged 18 years or older with type 2 diabetes who were enrolled in commercial or Medicare fee-for-service insurance plans and who underwent 1 of 13 emergency surgeries between January 1, 2016, and December 15, 2022. Emergency surgeries were defined as those occurring on the same day or the 1 to 2 days after an emergency department claim. Data were analyzed from November 2023 through December 2024.

EXPOSURE

SGLT2i medication use.

MAIN OUTCOMES AND MEASURES

Diabetic ketoacidosis, defined by diagnosis codes, in the 0 to 14 days after surgery.

RESULTS

Among 34 671 patients with type 2 diabetes who underwent emergency surgery (mean [SD] age, 63.9 [14.0] years; 19 175 female [55.3%] and 15 496 male [44.7%]), the most common surgeries were laparoscopic cholecystectomy (9385 patients) and transurethral procedures (12 246 patients). There were 2607 patients (7.5%) who used SGLT2i medications and 32 064 patients (92.5%) who did not. Unadjusted incidence of diabetic ketoacidosis was 127 patients (4.9%) for those exposed to SGLT2i medications and 1115 patients (3.5%) for those unexposed. After accounting for covariates, including demographic characteristics, indicators of diabetic severity, comorbidities, and surgery type, the incidence of the outcome was 3.8% for those exposed to SGLT2i medications and 3.5% for those unexposed. The average treatment effect [ATE] was 0.2% (95% CI, -1.7% to 2.2%). Results were robust to alternate specifications (eg, intensive care unit-level care as the outcome: ATE, -1.0%; 95% CI, -2.9% to 1.1%).

CONCLUSIONS AND RELEVANCE

This study found that preoperative use of SGLT2i medications in patients undergoing emergency surgery was not associated with an increased risk for postoperative diabetic ketoacidosis compared with no use of SGLT2i medications. These findings may justify liberalizing current guidance on preoperative SGLT2i medication withholding periods.

摘要

重要性

使用钠-葡萄糖协同转运蛋白2抑制剂(SGLT2i)药物的患者术后发生糖尿病酮症酸中毒的病例报告,是美国食品药品监督管理局(FDA)建议在手术前至少停用SGLT2i药物3天的依据。鉴于术前停药可能带来的潜在不良后果,需要对该人群中糖尿病酮症酸中毒的风险进行大规模评估。

目的

评估接受各类急诊手术的患者术前使用SGLT2i药物与术后糖尿病酮症酸中毒之间的关联。选择急诊手术是因为假定患者无法按照当前指南停用SGLT2i药物。

设计、地点和参与者:这项回顾性队列研究在全国范围内选取了年龄在18岁及以上的2型糖尿病患者样本,这些患者参加了商业或医疗保险按服务收费计划,并在2016年1月1日至2022年12月15日期间接受了13种急诊手术中的一种。急诊手术定义为在急诊科就诊后当天或1至2天内进行的手术。数据于2023年11月至2024年12月进行分析。

暴露因素

使用SGLT2i药物。

主要结局和测量指标

术后0至14天内通过诊断编码确定的糖尿病酮症酸中毒。

结果

在34671例接受急诊手术的2型糖尿病患者中(平均[标准差]年龄为63.9[14.0]岁;女性19175例[55.3%],男性15496例[44.7%]),最常见的手术是腹腔镜胆囊切除术(9385例患者)和经尿道手术(12246例患者)。使用SGLT2i药物的患者有2607例(7.5%),未使用的患者有32064例(92.5%)。SGLT2i药物使用者中糖尿病酮症酸中毒的未调整发病率为127例(4.9%),未使用者为1115例(3.5%)。在考虑了人口统计学特征、糖尿病严重程度指标、合并症和手术类型等协变量后,SGLT2i药物使用者的结局发生率为3.8%,未使用者为3.5%。平均治疗效果[ATE]为0.2%(95%CI,-1.7%至2.2%)。结果在不同的设定下都很稳健(例如,以重症监护病房级别的护理作为结局:ATE,-1.0%;95%CI,-2.9%至1.1%)。

结论和意义

本研究发现,与未使用SGLT2i药物相比,接受急诊手术的患者术前使用SGLT2i药物与术后糖尿病酮症酸中毒风险增加无关。这些发现可能为放宽当前关于术前停用SGLT2i药物时间的指南提供依据。

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