钠-葡萄糖协同转运蛋白2抑制剂对1型糖尿病成人患者持续葡萄糖监测指标的影响：作为胰岛素辅助治疗的随机对照试验的荟萃分析
Effect of sodium-glucose cotransporter-2 inhibitors on continuous glucose monitoring metrics, as adjunctive to insulin in adults with type 1 diabetes mellitus: a meta-analysis of randomized controlled trials.
作者信息
Popovic Djordje S, Karakasis Paschalis, Koufakis Theocharis, Fragakis Nikolaos, Papanas Nikolaos, Mitrovic Milena, Gouveri Evanthia, Patoulias Dimitrios
机构信息
Clinic for Endocrinology, Diabetes and Metabolic Disorders, Clinical Centre of Vojvodina, Medical Faculty, University of Novi Sad, Novi Sad, Serbia.
Second Department of Cardiology, Aristotle University of Thessaloniki, Hippokration General Hospital, Greece.
出版信息
Metabolism. 2024 Apr;153:155791. doi: 10.1016/j.metabol.2024.155791. Epub 2024 Jan 15.
AIMS
This meta-analysis of randomized controlled trials (RCTs) aimed to evaluate the effect of sodium-glucose cotransporter-2 inhibitors (SGLT2is) on continuous glucose monitoring metrics as adjunctive to insulin in adults with type 1 diabetes mellitus (T1D).
METHODS
A systematic literature search was conducted through Medline (via PubMed), Cochrane Library and Google Scholar until October 25, 2023. Dual-independent study selection, data extraction and quality assessment were conducted. Results were summarized with random effects meta-analysis.
RESULTS
Eight RCTs were identified, involving a total of 2310 T1D patients. The use of SGLT2is on top of standard insulin therapy was associated with a significantly higher time in range (TIR) compared to placebo (mean difference (MD) 9.7 %; 95 % confidence interval (CI) [8.3, 1.11]; P < 0.001). The time above range was significantly lower in patients receiving SGLT2is (MD -8.71 %; 95 % CI [-11.62, -5.79]; P < 0.001), whereas no difference was observed regarding the time below range (TBR) (MD 0.34 %; 95 % CI [-0.17, 0.85]; P = 0.19). A significantly lower sensor-recorded mean daily glucose was noted in the group receiving SGLT2is (MD -16.55 mg/dL; 95 % CI [-19.82, -13.29]; P < 0.001). When considering the metrics of glucose variability, SGLT2is demonstrated a significant favorable effect on the mean amplitude of glucose excursions (MD -16.92 mg/dL; 95 % CI [-25.31, -8.13]; P < 0.001) and the mean standard deviation of weekly glucose levels (MD -7.67 mg/dL; 95 % CI [-11, -4.35]; P < 0.001). No significant effect was observed concerning the coefficient of variation (MD -1 %; 95 % CI [-2.39, 0.4]; P = 0.16). Regarding safety outcomes, SGLT2is were significantly linked to higher odds of diabetic ketoacidosis compared to insulin alone (OR 3.18; 95 % CI [1.79, 5.66]; P < 0.001), with no significant impact on severe hypoglycemia events (OR 1; 95 % CI [0.54, 1.85]; P = 0.1).
CONCLUSION
Our findings suggest that in individuals with T1D, adjunct therapy with SGLT2is provides a significant benefit in terms of TIR and reduced glucose variability, without an increase in TBR.
目的
本随机对照试验（RCT）的荟萃分析旨在评估钠-葡萄糖协同转运蛋白2抑制剂（SGLT2is）作为1型糖尿病（T1D）成人患者胰岛素辅助治疗对连续血糖监测指标的影响。
方法
通过Medline（通过PubMed）、Cochrane图书馆和谷歌学术进行系统的文献检索，直至2023年10月25日。进行了双独立研究选择、数据提取和质量评估。结果采用随机效应荟萃分析进行总结。
结果
共纳入8项RCT，涉及2310例T1D患者。与安慰剂相比，在标准胰岛素治疗基础上加用SGLT2is与更高的血糖达标时间（TIR）显著相关（平均差值（MD）9.7%；95%置信区间（CI）[8.3, 1.11]；P < 0.001）。接受SGLT2is治疗的患者高于目标范围的时间显著更低（MD -8.71%；95% CI [-11.62, -5.79]；P < 0.001），而低于目标范围的时间（TBR）未观察到差异（MD 0.34%；95% CI [-0.17, 0.85]；P = 0.19）。接受SGLT2is治疗的组传感器记录的平均每日血糖显著更低（MD -16.55 mg/dL；95% CI [-19.82, -13.29]；P < 0.001）。在考虑血糖变异性指标时，SGLT2is对血糖波动平均幅度（MD -16.92 mg/dL；95% CI [-25.31, -8.13]；P < 0.001）和每周血糖水平平均标准差（MD -7.67 mg/dL；95% CI [-11, -4.35]；P < 0.001）显示出显著的有益作用。变异系数未观察到显著影响（MD -1%；95% CI [-2.39, 0.4]；P = 0.16）。关于安全性结果，与单独使用胰岛素相比，SGLT2is与糖尿病酮症酸中毒的更高几率显著相关（比值比（OR）3.18；95% CI [1.79, 5.66]；P < 0.001），对严重低血糖事件无显著影响（OR 1；95% CI [0.54, 1.85]；P = 0.1）。
结论
我们的研究结果表明，在T1D患者中，SGLT2is辅助治疗在TIR和降低血糖变异性方面提供了显著益处，且未增加TBR。
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