免疫检查点抑制剂甲状腺免疫相关不良反应分析

Thyroid immune-related adverse reactions of immune checkpoint inhibitors

目的以免疫检查点抑制剂(ICIs)甲状腺免疫相关不良反应为例,初步探索基于中国药物警戒系统(CHPS)开展药品主动监测的可行性,为相关研究提供依据。方法基于2家哨点医院的CHPS数据,提取2020年1月1日至2021年6月30日应用过ICIs的肿瘤患者信息,以及未使用过ICIs的肿瘤患者信息作为对照。基于广义估计方程,对ICIs的甲状腺免疫相关不良反应进行探索。结果共纳入1691名患者,其中ICIs组666名,对照组1025名。应用广义估计方程模型处理患者的随访数据,充分考虑了多次重复测量数据间相关性的问题,发现显性甲状腺毒症有统计学意义(P<0.05),发生率为4.50%,中位时间为41.5 d。结论ICIs的应用可能会导致显性甲状腺毒症,临床医师在给患者应用ICIs时应注意显性甲状腺毒症的发生,确保患者用药安全。

Objective To explore the feasibility of active monitoring of drugs based on the Chinese Pharmacovigilance System(CHPS)in order to provide data for related research.Methods Based on the data from the CHPS of two sentinel hospitals,the information about tumor patients who had used ICIs and those who had not used ICIs between January 1,2020 and June 30,2021 was retrieved as controls.Based on the generalized estimation equation,the thyroid immune-related adverse reactions of ICIs were explored.Results A total of 1691 patients were included,including 666 in the ICIs group and 1025 in the control group.The generalized estimating equation model was used to process the follow-up data of patients while taking into consideration all the correlations between repeated measurement data.Tt was found that overt thyrotoxicosis was statistically significant(P<0.05).The incidence was 4.50%,and the median time to onset(TTO)was 41.5 days.Conclusion ICIs may cause overt thyrotoxicosis.When applying ICIs to patients,clinicians should be alert to the occurrence of overt thyrotoxicosis to ensure the safety of medications.