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多学科参与的ICI相关心肌炎风险评估量表的建立及验证

Development and validation of a multidisciplinary risk assessment scale for immune checkpoint inhibitor-associated myocarditis

  • 摘要:
    目的 在多学科合作基础上,建立免疫检查点抑制剂(immune checkpoint inhibitor, ICI)相关心肌炎风险评估量表,并验证其诊断效能。
    方法 通过多学科合作,结合肿瘤科和心内科临床经验、文献数据以及患者实际情况,开发ICI相关心肌炎风险评估量表。纳入2020年10月至2024年10月在复旦大学附属中山医院进行免疫治疗的101例恶性肿瘤患者作为验证队列,根据量表评分将其分为低风险组(0~1分)、中风险组(2~4分)、高风险组(≥5分)。采用Cox比例风险模型评估量表预测风险分层与实际评估结果的相关性。通过ROC曲线评估该量表预测ICI相关心肌炎的价值。通过Cohen’s Kappa系数评估量表评分与实际结果之间的一致性。
    结果 根据量表评分预测为ICI相关心肌炎低风险28例(27.7%)、中风险8例(7.9%)、高风险65例(64.4%);实际评估为ICI相关心肌炎低危46例(45.5%)、中危8例(7.9%)、高危47例(46.5%)。Kaplan-Meier生存曲线显示高风险组累积ICI相关心肌炎发生率高于中低风险组(P<0.05)。多变量调整后Cox比例风险模型显示,高风险组ICI相关心肌炎风险约为低风险组的4倍。ROC曲线分析显示,该量表预测ICI相关心肌炎的AUC平均达0.81,准确度0.74,Cohen’s Kappa系数为0.55。实际高危组中无患者预测为低风险;实际低危组16例患者预测为高风险。
    结论 该ICI相关心肌炎风险评估量表预测效能较高,为肿瘤科医生提供了一个简单且较有效的多学科诊疗参考工具,有助于提高其对ICI相关心肌炎的早期识别能力。

     

    Abstract:
    Objective To develop a risk assessment scale for immune checkpoint inhibitor (ICI)-associated myocarditis based on multidisciplinary collaboration, and to evaluate its diagnostic performance.
    Methods Based on multidisciplinary cooperation, integrating clinical experience from oncology and cardiology, literature data, and patient conditions, a risk assessment scale for ICI-associated myocarditis was developed. A total of 101 patients with malignancies who received immunotherapy at Zhongshan Hospital, Fudan University, from October 2020 to October 2024 were included as the validation cohort. Patients were stratified into low-risk (0-1 point), medium-risk (2-4 points), and high-risk (≥5 points) groups based on their scale scores. The association between pretictive risk stratifications and actual assessment results was assessed using the Cox proportional hazards regression model. The predictive value of the scale for ICI-associated myocarditis was evaluated using receiver operating characteristic (ROC) curve. Agreement between the scale scores and actual assessment results was assessed using Cohen’s Kappa coefficient.
    Results Based on the scale pretictive results, 28(27.7%), 8(7.9%), 65(64.4%) patients were at low risk, medium risk, and high risk for ICI-related myocarditis, respectively; however, 46(45.5%), 8(7.9%), 47(46.5%) were at low risk, medium risk, and high risk actually. Kaplan-Meier survival analysis showed that the cumulative incidence of ICI-related myocarditis in the high-risk group was significantly higher than that in the medium- and low-risk groups (P<0.05). In the multivariable-adjusted Cox proportional hazards model, the ICI-related myocarditis risk in high-risk group was about 4 times that in the low-risk group. ROC curve analysis demonstrated that the average area under the curve (AUC) for predicting ICI-related myocarditis was 0.81, with an accuracy of 0.74. The Cohen’s Kappa coefficient was 0.55, indicating moderate agreement. In the actual high-risk group, no patient was predicted to be at low risk; in the actual low-risk group, 16 patients were predicted to be at high risk.
    Conclusions This risk assessment scale for ICI-associated myocarditis shows high predictive performance. It provides oncologists with a simple yet effective multidisciplinary diagnostic reference tool, potentially enhancing early identification of ICI-associated myocarditis.

     

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