恩格列净和二甲双胍联合西格列汀和二甲双胍在斋月期间的疗效和安全性：一项观察性研究。
Efficacy and safety of combination of empagliflozin and metformin with combination of sitagliptin and metformin during Ramadan: an observational study.
机构信息
Lady Reading Hospital, Soekarno Rd, PTCL Colony, Peshawar, House No 6A, Street 2, Akbar Town Danishabad, Near Academy Hostel, Peshawar, Khyber Pakhtunkhwa, Pakistan.
Shifa International, Pitras Bukhari Road, Sector H-8/4, Islamabad, Pakistan.
出版信息
BMC Endocr Disord. 2022 Oct 13;22(1):247. doi: 10.1186/s12902-022-01168-3.
BACKGROUND
Management of diabetes during fasting is a clinical challenge. Sodium glucose co-transporter -2 inhibitors (SGLT2i) are considered safe with a low risk of hypoglycemia. However, studies on SGLT2i are scarce. This study was designed to compare the efficacy, safety, and tolerability of empagliflozin with metformin during Ramadan in comparison with sitagliptin and metformin.
METHODS
It was a prospective, observational study, conducted at 11 different sites all across Pakistan on an outpatient basis during Ramadan (May 2021-June 2021). including 132 patients, 88 who received metformin and sitagliptin, and 44 patients who received metformin and empagliflozin.
RESULTS
Patients of the SGLT-2i group experienced similar symptomatic hypoglycemic episodes (15.9%) as the sitagliptin group. There was an improvement in blood sugar levels after the use of SGLT-2i (RBS 181 ± 64 before Ramadan vs 162 ± 53 after Ramadan). HbA1c also improved after the use of SGLT-2i before and after Ramadan (7.2 ± 0.8 vs 6.9 ± 0.9 for Metformin + Empagliflozin and 7.8 ± 1.5 vs 7.6 ± 1.6 for Metformin and sitagliptin). Weight and BMI improved after the use of SGLT-2i (BMI 36.5 ± 4.8 before Ramadan and 33.7 ± 2.4 after Ramadan). There were no reported cases of urinary tract infection in the empagliflozin group.
CONCLUSION
SGLT-2 inhibitors combined with metformin for patients with diabetes during Ramadan fasting is as effective, safe and well tolerated as DPP4 combined with metformin.
背景
在禁食期间管理糖尿病是一个临床挑战。钠-葡萄糖协同转运蛋白 2 抑制剂（SGLT2i）被认为是安全的，低血糖风险低。然而，关于 SGLT2i 的研究很少。本研究旨在比较恩格列净联合二甲双胍与西格列汀联合二甲双胍在斋月期间的疗效、安全性和耐受性。
方法
这是一项前瞻性、观察性研究，于 2021 年 5 月至 6 月在巴基斯坦 11 个不同地点的门诊进行，共纳入 132 例患者，其中 88 例接受二甲双胍和西格列汀治疗，44 例接受二甲双胍和恩格列净治疗。
结果
SGLT-2i 组患者出现类似症状性低血糖发作（15.9%）与西格列汀组相似。使用 SGLT-2i 后血糖水平改善（斋月前 RBS 为 181±64，斋月后为 162±53）。使用 SGLT-2i 前后 HbA1c 也得到改善（二甲双胍+恩格列净组为 7.2±0.8，二甲双胍和西格列汀组为 7.8±1.5）。使用 SGLT-2i 后体重和 BMI 改善（斋月前 BMI 为 36.5±4.8，斋月后 BMI 为 33.7±2.4）。恩格列净组未报告尿路感染病例。
结论
在斋月禁食期间，SGLT-2 抑制剂联合二甲双胍治疗糖尿病患者与 DPP4 联合二甲双胍一样有效、安全且耐受良好。
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