Objective To discuss the predictive value of electrocardiogram (ECG) to trastuzumab-mediated cardiotoxity.Methods The female patients (n=199, average age: 47.47±10.20) with HER2-positive early breast cancer treated with adjuvant trastuzumab therapy were chosen from Jan. 2008 to Jan. 2013. The changes of heart function were observed, and the patients were divided into cardiotoxity group and non-cardiotoxity group. The correlation between abnormal ECG and cardiotoxity was analyzed, and predictive value of ECG to trastuzumab-mediated cardiotoxity was reviewed.Results The eligible cardiotoxity events were in succession occurred in totally 42 patients (21.11%). Compared with non-cardiotoxity group, the percentage of patients with abnormal ECG increased in cardiotoxity group (59.24%vs. 73.81%,P<0.01). From the beginning of the 2nd therapeutic circle, the percentage of patients with abnormal ECG increased significantly in cardiotoxity group compared with non-cardiotoxity group (P<0.05). The risk of cardiotoxity increased by 1.7 times in the patients with 1-time abnormal ECG (HR=1.762, 95%CI:0.914~3.793), and increased by 2.8 times in those with 2-time abnormal ECG (HR=2.881, 96%CI:1.461~5.679). The sensitivity and specificity of 1-time abnormal ECG for predicting cardiotoxity were, respectively, 73% and 41%, and those of 2-time abnormal ECG for predicting cardiotoxity were, respectively, 69% and 58%. The specificity of 5-time or more abnormal ECG for predicting cardiotoxity was as high as 83%.Conclusion ECG has higher sensitivity for finding subclinical cardiotoxity, which maybe one of ideal approaches for monitoring cardiotoxity occurrence in patients with tumor.%目的:探讨心电图改变对曲妥珠单抗介导心脏毒性的预测价值。方法入选军事医学科学院附属医院乳腺肿瘤内科2008年1月~2013年1月收治的采用曲妥珠单抗辅助治疗的HER2阳性早期乳腺癌患者199例。所有患者均为女性,平均年龄为(47.47±10.20)岁。随访观察患者心功能改变,符合心脏毒性定义则归入心脏毒性组,余为无心脏毒性组。分析其心电图异常与心脏毒性发生的相关性,评估心电图在曲妥珠单抗介导心脏毒性中的诊断价值。结果共有42例(21.11%)患者相继出现符合诊断标准的心脏毒性事件。与无心脏毒性组比较,心脏毒性组心电图异常比例增加(59.24%vs.73.81%),差异具有显著统计学意义(P<0.01)。应用曲妥珠单抗第2周期开始,心脏毒性组较无心脏毒性组心电图异常比例显著增加(P<0.05)。一次心电图异常者的心脏毒性风险可能性增加1.7倍(HR=1.762,95%CI:0.914~3.793)。2次心电图异常的患者风险增加2.8倍(HR=2.881,96%CI:1.461~5.679)。心电图异常次数越多,其后出现心脏毒性事件的可能性越大。出现1次心电图异常预测其后心脏毒性发生的敏感性和特异性分别为73%,41%。出现2次心电图异常时,其敏感性与特异性分别为69%,58%。在出现5次以上(包括5次)的心电图异常患者中,其预测心脏毒性的特异性高达83%。结论心电图对于发现亚临床心脏毒性有较高的敏感性,其可能是监测肿瘤患者心脏毒性发生的理想手段之一。
展开▼
机译:曲妥珠单抗在辅助和新辅助乳腺癌中的心脏毒性分析。 IV期药物警戒研究由“ Observatoire desMédicamentset InnovationsThérapeutiques”(OMIT B PL)领导[IV期药物警戒研究涉及曲妥珠单抗作为乳腺癌的新辅助剂和佐剂的心脏毒性。布列塔尼和卢瓦尔河沿岸药物与治疗创新观察所进行的分析(OMIT B PL)]