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中国2型糖尿病下肢动脉粥样硬化疾病Ⅰ期患者预测模型的建立与验证

Development and validation of prediction model for stage I patients with lower extremity atherosclerotic disease in type 2 diabetes mellitus in China.

作者信息

Zhu Rong, Cui Weifeng, Zhao Ruixia, Liu Huijuan, Yan Shuxun, Shao Mingyi, Yu Haibin, Fu Yu

机构信息

Department of Endocrinology, The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, 450000, China.

The First School of Clinical Medicine, Henan University of Chinese Medicine, Zhengzhou, 450046, China.

出版信息

Acta Diabetol. 2025 Apr 28. doi: 10.1007/s00592-025-02497-0.

Abstract

AIMS

Lower extremity atherosclerotic disease (LEAD) is the primary cause of ulcers, gangrene, and amputations in patients with type 2 diabetes mellitus (T2DM), stage I is the crucial time for prevention and intervention to improve the prognosis of T2DM-LEAD. The purpose of this study was to develop and validate a personalized predictive model to determine the risk of outcomes in stage I patients with T2DM-LEAD.

METHODS

There were 1603 stage I patients with T2DM-LEAD at baseline in this retrospective study. Least absolute shrinkage and selection operator regression was applied to filter predictive variables. Cox regression was used to construct a nomogram prediction model. The model's 3-year and 5-year predictive performance was evaluated in terms of its discrimination, calibration, and clinical utility using the area under the receiver operating characteristic curve, calibration curve, decision curve analysis, respectively.

RESULTS

Patients were randomly divided into a development cohort (n = 1122) and a validation cohort (n = 481). Age, cerebrovascular diseases, diabetic kidney disease, diabetic retinopathy, low-density lipoprotein cholesterol, fibrinogen, D-dimer and anti-platelet drugs were selected as predictive factors. The model presented moderate discrimination in development and validation sets with AUCs of 70.3 (95% CI: 65.2-75.3) and 70.1 (95% CI: 64.5-75.7) for the 3-year prediction. Andthe AUC values for the 5-year prediction in development and validation sets were 72.8 (95% CI: 67.6-78.1) and 75.9 (95% CI: 69.0-82.8), respectively. The calibration curve for the 3-year and 5-year predictions demonstrated good agreement between the predicted and actual probabilities, and decision curve analysis showed a wide range of beneficial clinical utility.

CONCLUSION

The prediction model can identify the risk of stage I patients with T2DM-LEAD who are likely to develop outcomes events within 3 years and 5 years. It is valuable for clinical decisions and helps healthcare providers and policy makers to develop more personalized clinical treatment strategies, which has significant public health implications.

摘要

目的

下肢动脉粥样硬化疾病(LEAD)是2型糖尿病(T2DM)患者发生溃疡、坏疽和截肢的主要原因,I期是预防和干预以改善T2DM-LEAD患者预后的关键时期。本研究的目的是开发并验证一种个性化预测模型,以确定I期T2DM-LEAD患者的预后风险。

方法

在这项回顾性研究中,共有1603例I期T2DM-LEAD患者作为基线。应用最小绝对收缩和选择算子回归来筛选预测变量。采用Cox回归构建列线图预测模型。分别使用受试者操作特征曲线下面积、校准曲线、决策曲线分析,从区分度、校准度和临床实用性方面评估该模型的3年和5年预测性能。

结果

患者被随机分为开发队列(n = 1122)和验证队列(n = 481)。年龄、脑血管疾病、糖尿病肾病、糖尿病视网膜病变、低密度脂蛋白胆固醇、纤维蛋白原、D-二聚体和抗血小板药物被选为预测因素。该模型在开发集和验证集中表现出中等区分度,3年预测的AUC分别为70.3(95%CI:65.2-75.3)和70.1(95%CI:64.5-75.7)。开发集和验证集中5年预测的AUC值分别为72.8(95%CI:67.6-78.1)和75.9(95%CI:69.0-82.8)。3年和5年预测的校准曲线显示预测概率与实际概率之间具有良好的一致性,决策曲线分析显示具有广泛的有益临床实用性。

结论

该预测模型可以识别I期T2DM-LEAD患者在3年和5年内发生预后事件的风险。它对临床决策具有重要价值,有助于医疗保健提供者和政策制定者制定更个性化的临床治疗策略,具有重大的公共卫生意义。

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