基于中医证候的缺血性中风病复发早期预警模型的构建及验证

Construction and validation of an early warning model for ischemic stroke recurrence based on TCM syndromes

目的:开发和验证中医证候的缺血性中风病复发早期预警模型和风险评估工具。方法:采用多中心、前瞻性的注册登记研究设计,在全国7家临床分中心,纳入2016年11月—2019年2月期间,1741例首发缺血性中风病的住院患者。采用距离相关系数、互信息熵和统计相关性检验进行了单变量分析,变量多因素分析采用多因素的Cox回归模型并结合中风领域的专家意见进行建模变量的确定。使用Cox比例风险回归模型进行不同时间的中风复发预警模型构建和验证。使用ROC曲线下面积(AUC值)评估模型的预警能力。结果:随访时间1~3年,中位随访时间为1.42年(95%CI[1.37,1.47])。175例发生了复发事件,累积复发发生率为10.05%(95%CI[8.64,11.47])。模型训练集的AUC值为0.64±0.02,验证集AUC值为0.70±0.03。结论:中医证候模型可能较早的对中风病复发进行预警,为缺血性中风病的二级预防评估提供一定的参考。

Objective: To develope and validate an early warning model and risk assessment tool for ischemic stroke recurrence based on TCM syndromes. Methods: A prospective, multi-center and registered study was used in this study. A total of 1 741 cases of first-ever ischemic stroke were included in 7 clinical sub centers from November 2016 to February 2019.Univariate analysis was carried out using distance correlation coefficient, mutual information entropy and statistical correlation test. Multivariate analysis adopted multi-factor Cox regression model and combined with expert opinions in the field of stroke to determine modeling variables. The Cox proportional hazard regression model was used to construct and verify the early warning model of stroke recurrence at different times. The area under the ROC curve(AUC value) was used to evaluate the early warning capability of the model. Results: The follow-up time was 1~3 years, and the median follow-up time was 1.42 years(95%CI[1.37, 1.47]). Recurrence events occurred in 175 cases, and the cumulative recurrence rate was 10.05%(95%CI[8.64,11.47]). The AUC value of the model training set was 0.64±0.02, and validation set was 0.70±0.03. Conclusion: The TCM syndrome model can provide early warning of stroke recurrence, which provides a certain reference for the evaluation of secondary prevention of ischemic stroke.