信迪利单抗致甲状腺功能异常临床病例分析  

Clinical case analysis of thyroid dysfunction induced by sintilimab

作　　者：郑飞浪[1] 张琳 王怡然 王帅 王珂 刘平[2] Zheng Feilang;Zhang Lin;Wang Yiran;Wang Shuai;Wang Ke;Liu Ping(Department of Pharmacy,Heping Hospital Affiliated to Changzhi Medical College,Shanxi Province,Changzhi 046000,China;Department of Oncology,Heping Hospital Affiliated to Changzhi Medical College,Shanxi Province,Changzhi 046000,China)

机构地区：[1]长治医学院附属和平医院药剂科,长治046000 [2]长治医学院附属和平医院肿瘤科,长治046000

出　　处：《药物不良反应杂志》2024年第1期44-49,共6页Adverse Drug Reactions Journal

基　　金：长治医学院附属和平医院科研基金(HPYJ201927)。

摘　　要：目的分析信迪利单抗致甲状腺功能(甲功)异常的发生情况和临床特征。方法研究对象选自2021年7月1日至2023年6月30日在长治医学院附属和平医院肿瘤科接受信迪利单抗治疗的恶性肿瘤患者。收集符合纳入标准患者的电子病历,记录其一般情况、信迪利单抗用药情况、联合用药情况和应用信迪利单抗前后甲功检查结果。对出现甲功异常的患者,应用Naranjo不良反应因果关系评估量表进行信迪利单抗与甲功异常的因果关系评价;根据评价结果为“肯定”和“很可能”者的病历资料,分析甲功异常的临床特征。结果纳入分析的患者共145例,24例(16.6%)发生信迪利单抗相关甲功异常,因果关系评估结果均为“很可能”。24例患者中,男性14例,女性10例;年龄37~87岁;信迪利单抗单药治疗者5例,联合化疗者16例,联合靶向药物治疗者3例。24例患者均有基线甲功检查结果,其中23例甲功正常,1例为亚临床甲功亢进(甲亢)。24例甲功异常包括甲功减退(甲减)13例、亚临床甲减5例、甲亢2例和亚临床甲亢4例;11例发生在3个用药周期内;严重程度均为1或2级,无明显临床症状,仅4例甲减患者轻度乏力。13例甲减患者给予左甲状腺素钠治疗后9例恢复或好转,4例病情持续但未加重。5例亚临床甲减患者有3例给予左甲状腺素钠治疗,其中2例恢复,1例演变为亚临床甲亢;余2例先行观察未予干预,后演变成甲减,给予左甲状腺素钠治疗后恢复。甲亢或亚临床甲亢的6例患者均未予干预,除1例亚临床甲亢自愈外,5例患者演变为甲减或亚临床甲减,给予左甲状腺素钠治疗后3例甲功恢复或好转,2例持续甲减但未加重。结论甲功异常是信迪利单抗较常见的免疫相关不良事件,以甲减为主;临床症状不明显,严重程度多为1或2级。使用该药时应常规监测甲功,出现甲减时可及时予左甲状腺素钠治疗,预后一般较好。Objective To explore the occurrence and clinical characteristics of thyroid dysfunction caused by sintilimab.Methods The subjects were selected from malignant tumor patients who were treated with sintilimab during hospitalization in the Oncology Department in Heping Hospital Affiliated to Changzhi Medical College from July 1,2021 to June 30,2023.Electronic medical records of patients meeting the inclusion criteria were collected;the general conditions,sintilimab application,combined medication,and the thyroid function test results before and after sintilimab application were recorded.For patients with thyroid dysfunction,the causal analysis between sintilimab application and the dysfunction was conducted using Naranjo′s causality assessment scale.The clinical characteristics of sintilimab‑related thyroid dysfunction were analyzed based on the medical records that had evaluation results of"certainly"or"probably".Results A total of 145 patients were included in the analysis,and 24(16.6%)had sintilimab‑related thyroid dysfunction,with the causality assessment results"probably".Among the 24 patients,14 were male and 10 were female,aged 37‑87 years;5 were treated with sintilimab monotherapy,16 were with combination of chemotherapy drugs,and 3 were with combination of targeted drugs.All 24 patients had baseline thyroid function test results,of which 23 had normal thyroid function and 1 hadsubclinical hyperthyroidism.Twenty‑four patients with thyroid dysfunction included 13 hypothyroidisms,5 subclinical hypothyroidisms,2 hyperthyroidisms,and 4 subclinical hyperthyroidisms;11 occurred within 3 treatment cycles;the severity was grade 1 or 2,without obvious clinical symptoms,except that 4 hypothyroidism patients had mild fatigue.The 13 hypothyroidism patients were treated with levothyroxine sodium tablets(levothyroxine),9 patients recovered or were improved,and 4 patients were with persistent but not worsening condition.Three of the 5 subclinical hypothyroidism patients were treated with levothyroxine,2 patients

关 键 词：免疫检查点抑制剂 甲状腺功能减退 甲状腺功能亢进 信迪利单抗 免疫毒性 

分 类 号：R969.3[医药卫生—药理学]