U.S. Food and Drug Administration, Silver Spring, Maryland (S.J.B., C.C., C.C., C.K., W.H.C.).
Ann Intern Med. 2019 Jun 4;170(11):764-769. doi: 10.7326/M19-0085. Epub 2019 May 7.
Use of sodium-glucose cotransporter-2 (SGLT2) inhibitors has been associated with Fournier gangrene (FG), a rare urologic emergency characterized by necrotizing infection of the external genitalia, perineum, and perianal region.
To describe and compare reported cases of FG in diabetic adults receiving treatment with SGLT2 inhibitors or other antiglycemic agents.
Descriptive case series.
U.S. Food and Drug Administration (FDA) Adverse Event Reporting System and published case reports.
Adults receiving SGLT2 inhibitors or other antiglycemic agents.
Clinical and laboratory data.
The FDA identified 55 unique cases of FG in patients receiving SGLT2 inhibitors between 1 March 2013 and 31 January 2019. The patients ranged in age from 33 to 87 years; 39 were men, and 16 were women. Time to onset after initiation of SGLT2-inhibitor therapy ranged from 5 days to 49 months. All patients had surgical debridement and were severely ill. Reported complications included diabetic ketoacidosis (n = 8), sepsis or septic shock (n = 9), and acute kidney injury (n = 4). Eight patients had fecal diversion surgery, 2 patients developed necrotizing fasciitis of a lower extremity that required amputation, and 1 patient required a lower-extremity bypass procedure because of gangrenous toes. Three patients died. For comparison, the FDA identified 19 FG cases associated with other antiglycemic agents between 1984 and 31 January 2019: metformin (n = 8), insulin glargine (n = 6), short-acting insulin (n = 2), sitagliptin plus metformin (n = 2), and dulaglutide (n = 1). These patients ranged in age from 42 to 79 years; 12 were men, and 7 were women. Two patients died.
Inability to establish causality or incidence, variable quality of reports, possible underreporting, and confounding by indication.
FG is a newly identified safety concern in patients receiving SGLT2 inhibitors. Physicians prescribing these agents should be aware of this possible complication and have a high index of suspicion to recognize it in its early stages.
None.
钠-葡萄糖共转运蛋白 2（SGLT2）抑制剂的使用与 Fournier 坏疽（FG）有关，FG 是一种罕见的泌尿科急症，其特征为外生殖器、会阴和肛周区域的坏死性感染。
描述并比较接受 SGLT2 抑制剂或其他降糖药物治疗的糖尿病成人 FG 的报告病例。
描述性病例系列。
美国食品和药物管理局（FDA）不良事件报告系统和已发表的病例报告。
接受 SGLT2 抑制剂或其他降糖药物治疗的成年人。
临床和实验室数据。
在 2013 年 3 月 1 日至 2019 年 1 月 31 日期间，FDA 在接受 SGLT2 抑制剂治疗的患者中发现了 55 例 FG 的独特病例。患者年龄在 33 至 87 岁之间；39 名男性，16 名女性。开始 SGLT2 抑制剂治疗后发病时间为 5 天至 49 个月。所有患者均接受了手术清创，病情严重。报告的并发症包括糖尿病酮症酸中毒（n=8）、脓毒症或感染性休克（n=9）和急性肾损伤（n=4）。8 例患者接受了粪便转流手术，2 例下肢发生坏死性筋膜炎需要截肢，1 例因坏疽脚趾而行下肢旁路手术。3 例患者死亡。相比之下，FDA 在 1984 年至 2019 年 1 月 31 日期间还发现了 19 例 FG 与其他降糖药物相关的病例：二甲双胍（n=8）、甘精胰岛素（n=6）、短效胰岛素（n=2）、西格列汀加二甲双胍（n=2）和度拉糖肽（n=1）。这些患者年龄在 42 至 79 岁之间；12 名男性，7 名女性。2 例患者死亡。
无法确定因果关系或发病率，报告质量存在差异，可能存在漏报，以及混杂因素的影响。
FG 是接受 SGLT2 抑制剂治疗的患者新出现的安全问题。开具这些药物的医生应该意识到这种可能的并发症，并对其早期阶段保持高度怀疑。
无。
