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Diabetes:Teplizumab治疗后3个月内抑制1型糖尿病高危人群的快速代谢下降

2022-01-25 从医路漫漫 MedSci原创

为了更有效地开展1型糖尿病预防试验,需要提供治疗效果早期识别的终点。

   为了更有效地开展1型糖尿病预防试验,需要提供治疗效果早期识别的终点。为此,在TrialNet teplizumab试验中,我们评估了代谢终点是否可用于检测teplizumab对高危个体治疗后3个月内β细胞快速下降的影响。

   葡萄糖和C肽反应曲线(GCRCs)是通过绘制2小时口服葡萄糖耐量试验的平均葡萄糖和C肽值来构建的。观察各组GCRC形状和运动的变化。

    在随机分组的3个月内,安慰剂组的GCRC变化反映了显著的代谢恶化。6个月时,GCRCs与典型GCRCs相似。相比之下,teplizumab组的GCRC变化提示代谢改善。定量比较,包括两个表明GCRC变化的新代谢终点,象限内终点(WQE)和顺序定向终点(ODE),与3个月和6个月时间点的治疗效果明显一致。

    研究人员首先对潜在终点进行了预测1型糖尿病的测试。然后,在DPT-1和净口服胰岛素试验联合队列中,评估1型糖尿病预测者在检测口服胰岛素治疗效果方面的表现(n=208;试验和治疗之间无交互作用)。在研究的终点中,在281名口服胰岛素或非肠外胰岛素对照组的DPT-1参与者中,四分之一内终点(WQE)和顺序定向终点(ODE)可预测1型糖尿病(未调整的WQE p<0.001, ODE p=0.001;在调整了AUC、葡萄糖AUC、c肽AUC、年龄和BMI后,两者的AUC均<0.001)。尽管其他终点也可预测1型糖尿病,但WQE和ODE在检测口服胰岛素效果方面优于其他终点。表1显示了调整基线葡萄糖AUC、c -肽AUC、年龄和BMI后,安慰剂组和口服胰岛素组WQE (p<0.001)和ODE (p=0.005)的比较。基于这些发现,我们利用WQE和ODE对teplizumab的早期疗效进行了统计评估

    总之,研究结果表明,Teplizumab延缓了代谢的快速下降,并在治疗后3个月内改善了代谢状态;这种影响至少持续6个月。

表1 利用从基线到1年随访期间代谢参数变化对安慰剂组和口服胰岛素组终点的比较*

图 葡萄糖c肽反应曲线(GCRCs)可以可视化和量化1型糖尿病发展过程中葡萄糖和c肽之间的演变关系。

原文出处:Sims EK,  Cuthbertson D,  Herold KC,et al.The Deterrence of Rapid Metabolic Decline within 3 Months after Teplizumab Treatment in Individuals at High Risk for Type 1 Diabetes.Diabetes 2021 Sep 22

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