摘要
目的探讨真实世界中胃癌患者注射信迪利单抗治疗后致甲状腺免疫相关不良反应(irAEs)的发生情况、临床特征及危险因素,并建立预测模型。方法回顾性分析2021年1月至2022年12月就诊于北京大学人民医院胃肠外科应用信迪利单抗注射液治疗胃癌患者的性别、年龄、BMI、ADR发生情况等病历资料,根据患者是否发生甲状腺irAEs分为发生组与未发生组,采用logistic回归分析信迪利单抗致甲状腺irAEs发生的危险因素,并建立预测模型。利用受试者工作特征(ROC)曲线对预测模型进行检验。结果共纳入91例患者,男65例,女26例,年龄(60.62±12.39)岁,均接受常规剂量治疗,6例接受单药治疗,85例接受联合化疗或联合靶向治疗。共有31例(34.07%)出现甲状腺irAEs,其中甲状腺功能减退7例(7.70%),亚临床甲状腺功能减退10例(10.99%),甲状腺功能亢进2例(2.20%),亚临床甲状腺功能亢进12例(13.19%)。31例甲状腺irAEs患者中,27例发生在治疗开始后的4个月内。logistic回归分析显示,经信迪利单抗治疗后,相比于男性胃癌患者,女性胃癌患者发生甲状腺irAEs的风险增加5.160倍(OR=5.160,95%CI:1.578~16.865),相比病程<1年的患者,病程≥1年的患者发生甲状腺irAEs的风险增加8.472倍(OR=8.472,95%CI:2.723~26.366),ROC曲线下面积为0.833±0.048(95%CI:0.739~0.927),阳性预测准确率为71.0%,模型总预测准确率为79.1%。当logit(P)预测模型方程≥0.2533188时,可判定使用信迪利单抗后发生甲状腺irAEs可能性较大。结论免疫相关性甲状腺功能减退是信迪利单抗常见的不良反应,治疗开始后4个月内的发生率较高,但严重程度较低,治疗期间无需中断治疗。女性和病程≥1年是发展为甲状腺irAEs的危险因素,建立的预测模型结果可靠。
Objective To investigate the occurrence,clinical features,and risk factors of thyroid immune-related adverse events(irAEs)in real-world patients with gastric cancer after treatment with sintilimab and establish a prediction model.Methods The clinical data of patients with gastric cancer treated with sintilimab in the Department of Gastrointestinal Surgery of Peking University People's Hospital from January 2021 to December 2022 were retrospectively analyzed,including gender,age,BMI,and occurrence of adverse drug reactions.The patients were divided into the occurrence group and the non-occurrence group according to whether they had thyroid irAEs.Logistic regression was used to analyze the risk factors of sintilimab-induced thyroid irAEs,and a prediction model was established.The receiver operating characteristic(ROC)curve was used to test the prediction model.Results A total of 91 patients were enrolled,including 65 males and 26 females,aged(60.62±12.39)years old.All patients received conventional dose therapy,6 patients received monotherapy,and 85 patients received combined chemotherapy or combined targeted therapy.A total of 31 cases(34.07%)had thyroid irAEs,including 7 cases(7.70%)of hypothyroidism,10 cases(10.99%)of subclinical hypothyroidism,2 cases(2.20%)of hyperthyroidism,and 12 cases(13.19%)of subclinical hyperthyroidism.Of the 31 patients who developed thyroid irAEs,27 occurred within 4 months of treatment initiation.Logistic regression analysis showed that after sintilimab treatment,the risk of thyroid irAEs in female patients with gastric cancer was 5.160 times higher than that in male patients with gastric cancer(OR=5.160,95%CI:1.578 to 16.865).The risk of thyroid irAEs increased by 8.472 times(OR=8.472,95%CI:2.723 to 26.366)in patients with a course of disease greater than or equal to one year compared with patients with a course of disease less than one year.The area under the ROC curve was 0.833±0.048(95%CI:0.739 to 0.927),the positive prediction accuracy was 71.0%,and the total prediction accurac
作者
孙颖丽
刘一
任晓蕾
黄琳
封宇飞
SUN Ying-li;LIU Yi;REN Xiao-lei;HUANG Lin;FENG Yu-fei(College of Life Sciences and Biopharmaceutics,Shenyang Pharmaceutical University,Shenyang 110016,China;Department of Pharmacy,Fuxing Hospital Capital Medical University,Beijing 100038,China;Department of Pharmacy,Peking University People's Hospital,Beijing 100044,China;Clinical Trial Institutions,Peking University People's Hospital,Beijing 100044,China)
出处
《临床药物治疗杂志》
2024年第3期38-42,共5页
Clinical Medication Journal
基金
中国药品监督管理研究会立项课题(药监研〔2021〕043号)。
