Chen Mao-Bing, Xu Rui-Jun, Zheng Qi-Han, Zheng Xu-Wen, Wang Hua
Department of Emergency.
Department of Endocrinology.
Medicine (Baltimore). 2020 Aug 14;99(33):e20875. doi: 10.1097/MD.0000000000020875.
To systematically evaluate the efficacy and safety of sotagliflozin (SOTA) adjuvant therapy for type 1 diabetes mellitus (T1DM).
Through April 2019, the Web of Science, PubMed, Cochrane Library, Embase, and China National Knowledge Infrastructure databases were electronically searched to identify randomized controlled trials exploring SOTA adjuvant therapy for T1DM. Strict screening and quality evaluations of the obtained literature were performed independently by 2 researchers. Outcome indexes were extracted, and a meta-analysis of the data was performed using Revman 5.3 software.
A total of 7 randomized controlled trials were included. The meta-analysis results showed that compared with the patients in the placebo group, the patients in the SOTA group had a lower hemoglobin A1c (mean difference [MD] = -0.28, 95% confidence interval [CI] [-0.34, -0.22], P < .01), lower total daily insulin use (MD = -8.89, 95% CI [-11.64, -6.13], P < .01), faster weight loss (MD = -3.03, 95% CI [-3.79, -2.26], P < .01), better fasting blood glucose and 2-hour postprandial blood glucose control (MD = -0.75, 95% CI [-1.04, -0.45], P < .01; MD = -2.42, 95% CI [-3.17, -1.67], P < .01), and a higher rate of well-controlled glucose levels (relative risk = 1.75, 95% CI [1.55, 1.99], P < .01), while no significant difference in the incidence of severe hypoglycemic events was found between the SOTA and placebo groups (risk difference [RD] = -0.01, 95% CI [-0.02, 0.00], P = .13). The incidence of diabetic ketoacidosis was higher in the SOTA group than in the placebo group (RD = 0.03, 95% CI [0.02, 0.04], P < .01). The incidence of genital mycotic infection was higher in the SOTA group than in the placebo group (RD = 0.06, 95% CI [0.05, 0.08], P < .01). No significant difference in the incidence of urinary tract infections was detected between the SOTA group and the placebo group (RD = 0.00, 95% CI [-0.01, 0.01], P = 0.97).
SOTA is a potential drug for the treatment of T1DM and is effective for controlling blood sugar. The main adverse reactions to SOTA are genital mycotic infections and diabetic ketoacidosis. We must further assess the severity of diabetic ketoacidosis caused by SOTA.
系统评价索格列净（SOTA）辅助治疗1型糖尿病（T1DM）的疗效和安全性。
截至2019年4月，通过电子检索Web of Science、PubMed、Cochrane图书馆、Embase和中国知网数据库，以识别探索SOTA辅助治疗T1DM的随机对照试验。由2名研究人员独立对获得的文献进行严格筛选和质量评估。提取结局指标，并使用Revman 5.3软件对数据进行荟萃分析。
共纳入7项随机对照试验。荟萃分析结果显示，与安慰剂组患者相比，SOTA组患者的糖化血红蛋白水平更低（平均差值[MD]=-0.28，95%置信区间[CI][-0.34，-0.22]，P<.01），每日胰岛素总用量更低（MD=-8.89，95%CI[-11.64，-6.13]，P<.01），体重减轻更快（MD=-3.03，95%CI[-3.79，-2.26]，P<.01），空腹血糖和餐后2小时血糖控制更好（MD=-0.75，95%CI[-1.04，-0.45]，P<.01；MD=-2.42，95%CI[-3.17，-1.67]，P<.01），血糖控制良好率更高（相对危险度=1.75，95%CI[1.55，1.99]，P<.01），而SOTA组和安慰剂组之间严重低血糖事件的发生率无显著差异（风险差值[RD]=-0.01，95%CI[-0.02，0.0]，P=.13）。SOTA组糖尿病酮症酸中毒的发生率高于安慰剂组（RD=0.03，95%CI[0.02，0.04]，P<.01）。SOTA组生殖器霉菌感染的发生率高于安慰剂组（RD=0.06，95%CI[0.05，0.08]，P<.01）。SOTA组和安慰剂组之间尿路感染的发生率无显著差异（RD=0.00，95%CI[-0.01，0.01]，P=0.97）。
SOTA是一种治疗T1DM的潜在药物，对控制血糖有效。SOTA的主要不良反应是生殖器霉菌感染和糖尿病酮症酸中毒。我们必须进一步评估SOTA引起的糖尿病酮症酸中毒的严重程度。
