Dehghani Mohsen, Sadeghi Masoumeh, Barzkar Farzaneh, Khamseh Mohammad Ebrahim, Torshizian Ashkan, Baradaran Hamid Reza
Department of Epidemiology, School of Health, Mashhad University of Medical Sciences, Mashhad, Iran.
Metabolic Syndrome Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.
J Diabetes Investig. 2025 May;16(5):827-841. doi: 10.1111/jdi.70002. Epub 2025 Feb 5.
To estimate the efficacy and safety of the basal-bolus and premixed insulin as intensification regimens in patients with type 2 diabetes mellitus (T2DM).
A comprehensive search of online databases was performed until December 2022 to identify randomized controlled trials (RCTs) comparing premixed insulin versus basal-bolus regimen with treat-to-target intention. The Cochrane ROB-2 tool and GRADE approach were used for quality assessment and certainty of the evidence, respectively. Pooled weighted mean difference (WMD) and odds ratio (OR) were calculated using random-effects meta-analysis models.
Eighteen RCTs were included in the meta-analysis, and 66% had a low risk of bias. We found no significant difference between the two regimens regarding HbA1c reduction (WMD: 0.03% [-0.05%, 0.10%]). The basal-bolus regimen improved fasting plasma glucose (FPG) more than the premixed regimen (WMD: 6.35 mg/dL [0.31, 12.39]). Both had similar effects on weight gain. The odds of developing overall, nocturnal, and severe hypoglycemia were comparable (pooled OR: 0.9, 1.02, and 1.00, respectively) with no heterogeneity. Findings of the model were robust. The certainty of the evidence was moderate to high for all outcomes except FPG.
Two regimens are clinically comparable. Patient preference should be considered when adopting an individualized approach in a real-world setting.
评估基础-餐时胰岛素方案和预混胰岛素方案作为强化治疗方案在2型糖尿病（T2DM）患者中的疗效和安全性。
对在线数据库进行全面检索，直至2022年12月，以识别比较预混胰岛素与基础-餐时胰岛素方案并以达标为治疗目标的随机对照试验（RCT）。分别使用Cochrane ROB-2工具和GRADE方法进行质量评估和证据的确定性评估。采用随机效应荟萃分析模型计算合并加权平均差（WMD）和比值比（OR）。
荟萃分析纳入了18项RCT，66%的研究偏倚风险较低。我们发现两种方案在降低糖化血红蛋白（HbA1c）方面无显著差异（WMD：0.03%[-0.05%，0.10%]）。基础-餐时胰岛素方案在改善空腹血糖（FPG）方面优于预混胰岛素方案（WMD：6.35mg/dL[0.31，12.39]）。两者在体重增加方面的效果相似。发生总体、夜间和严重低血糖的几率相当（合并OR分别为0.9、1.02和1.00），且无异质性。模型结果稳健。除FPG外，所有结局的证据确定性为中等到高。
两种方案在临床上具有可比性。在现实环境中采用个体化方法时应考虑患者的偏好。
