首页|纳武利尤单抗相关甲状腺功能异常影响因素分析

纳武利尤单抗相关甲状腺功能异常影响因素分析

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目的 探讨消化道恶性肿瘤患者应用纳武利尤单抗引起免疫性甲状腺功能异常的发生情况及其潜在影响因素。方法 筛选某院2020年12月-2022年12月接受纳武利尤单抗治疗的胃、食管恶性肿瘤患者,按照用药后是否发生甲状腺功能异常分为两组。分别收集其电子病历并记录其一般情况、治疗情况以及接受纳武利尤单抗治疗前后甲状腺功能检查和血常规检查结果。对于治疗后发生甲状腺功能异常的患者,根据《常见不良反应事件评价标准》(5。0版)对其严重程度进行分级。采用单因素分析及二元Logistic回归分析方法分析纳武利尤单抗相关甲状腺功能异常的潜在影响因素。结果 共纳入40例患者,甲状腺功能异常的发生率为20。00%,其中亚临床甲亢/甲亢的发生率为12。50%,甲减的发生率为17。50%。两组患者基线甲状腺自身抗体阳性(P=0。001)和基线淋巴细胞计数(P=0。042)方面有统计学差异。其中,基线甲状腺自身抗体阳性(OR=24。996,95%CI 2。043~305。776)是纳武利尤单抗相关甲状腺功能异常的独立危险因素。结论 甲状腺功能异常是纳武利尤单抗常见的不良反应,基线甲状腺自身抗体阳性是纳武利尤单抗相关甲状腺功能异常的独立风险因素,临床应加强对患者游离甲状腺素、血清促甲状腺激素及甲状腺自身抗体的监测。
Clinical Characteristics and Influencing Factors of Nivolumab-related Thyroid Dysfunction
Objective To find out about the incidence and possible influencing factors of nivolumab-related thyroid dysfunction in patients with digestive tract malignant tumor.Methods Patients with gastric or esophageal malignant tumor who had been treated with nivolumab between December 2020 and Decem-ber 2022 were selected in this study,who were divided into two groups based on whether they had experi-enced thyroid dysfunction during treatment.Their electronic medical records were collected and their demographics,medical history and treatment courses were recorded,especially thyroid function parameters and complete blood count before and after nivolumab treatment.The Common Terminology Criteria for Adverse Events(Version 5.0)were used to determine the severity of adverse events.Univariate analysis was used to compare the variables and binary logistic regression analysis was performed to identify inde-pendent predictors of nivolumab-related thyroid dysfunction.Results Forty patients were enrolled.The incidence of thyroid dysfunction was 20.00%,that of subclinical hyperthyroidism or hyperthyroidism was 12.50%and that of hypothyroidism was 17.50%.Univariate analysis found that baseline thyroid autoantibody positivity(P=0.001)and baseline lymphocyte count(P=0.042)were significantly different between the two groups.In addition,baseline thyroid autoantibody positivity(odds ratio=24.996,95%CI 2.043-305.776)was identified as an independent risk factor for nivolumab-related thyroid dysfunction.Conclusion Nivolumab-related thyroid dysfunction is a very common adverse reaction of nivolumab.Base-line thyroid autoantibody positivity is an independent risk factor for nivolumab-related thyroid dysfunction so that clinical monitoring of FT4,TSH and thyroid autoantibodies is necessary.

nivolumabnivolumab-related thyroid disfuctionadverse drug reaction

白静雯、刘金玉、王天琳

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100853 北京,解放军总医院医疗保障中心

300070 天津,天津医科大学药学院

纳武利尤单抗 纳武利尤单抗相关性甲状腺功能异常 药品不良反应

北京市首都卫生发展科研专项

2022-2-5011

2024

解放军药学学报
中国人民解放军总后勤部卫生部 药品仪器检验所

解放军药学学报

影响因子:0.529
ISSN:1008-9926
年,卷(期):2024.37(3)