目的:一些临床试验报道了钠-葡萄糖协同转运蛋白(SGLT)抑制剂在1型糖尿病患者中的作用。这项荟萃分析旨在评估SGLT抑制剂在1型糖尿病患者中的疗效和安全性。
方法:在PubMed中确定了相关研究,Embase,科克伦图书馆,中国国家知识基础设施和万方数据库至2020年4月1日。差异表示为连续结局的95%置信区间(CI)或加权平均差(WMD)。和不连续结果的风险比(RR)。
结果:共纳入13个RCT,7962例。SGLT抑制剂降低空腹血糖水平(WMD-1.320mmol/L,95%CI-1.609至-1.031,P<0.001),糖化血红蛋白水平(WMD-0.386%,95%CI-0.431至-0.342,P<0.001)和每日总胰岛素剂量(WMD-5.403,95%CI-7.218至-3.859,P<0.001)。然而,糖尿病酮症酸中毒的风险更高(RR5.042,95%CI3.160-8.046,P<0.001),尿路感染(RR1.259,95%CI1.034-1.533,P=0.022)和生殖器感染(RR2.995,95%CI1.953-4.594,P<0.001)与SGLT抑制剂相关,但SGLT抑制剂并未增加低血糖风险(RR0.980,95%CI0.840-1.144,P=0.799).在亚组分析中,随着空腹血糖的显著降低,糖化血红蛋白和每日胰岛素剂量,与安慰剂相比,SGLT1/2抑制剂不会增加泌尿生殖道感染。
结论:SGLT2和SGLT1/2抑制剂可改善1型糖尿病患者的血糖控制。
OBJECTIVE: Several clinical trials reported the effects of sodium-glucose cotransporter (SGLT) inhibitors in type 1 diabetes patients. This meta-analysis aimed to assess the efficacy and safety of SGLT inhibitors in type 1 diabetes patients.
METHODS: Relevant studies were identified in the PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure and Wan Fang databases through 1 April 2020. Differences were expressed as the 95% confidence interval (CI) or weighted mean difference (WMD) for continuous outcomes, and risk ratio (RR) for discontinuous outcomes.
RESULTS: A total of 13 RCTs with 7,962 cases were included. SGLT inhibitors reduced the fasting plasma glucose level (WMD -1.320 mmol/L, 95% CI -1.609 to -1.031, P < 0.001), glycated hemoglobin level (WMD -0.386%, 95% CI -0.431 to -0.342, P < 0.001) and daily total insulin dose (WMD -5.403, 95% CI -7.218 to -3.859, P < 0.001). However, higher risks of diabetic ketoacidosis (RR 5.042, 95% CI 3.160-8.046, P < 0.001), urinary tract infections (RR 1.259, 95% CI 1.034-1.533,P = 0.022) and genital infections (RR 2.995, 95% CI 1.953-4.594, P < 0.001) were associated with SGLT inhibitors, but SGLT inhibitors did not increase the hypoglycemia risk (RR 0.980, 95% CI 0.840-1.144,P = 0.799). In subgroup analysis, with a significant reduction of fasting plasma glucose, glycated hemoglobin and daily insulin doses, SGLT1/2 inhibitor did not increase genitourinary tract infections compared with a placebo.
CONCLUSIONS: SGLT2 and SGLT1/2 inhibitors can improve glycemic control in patients with type 1 diabetes.