中国药业2026，Vol.35Issue(2)：28-34,7.DOI:10.3969/j.issn.1006-4931.2026.02.006
替雷利珠单抗真实世界主动监测模型应用评价
Application Evaluation of Active Monitoring Model for Tislelizumab in Real-World
摘要
Abstract
Objective To further reduce the underreporting of adverse drug reactions(ADR)of tislelizumab in clinic.Methods Relevant literatures on tislelizumab were retrieved and ADRs of the drug based on the drug instructions were collated.China Hospital Pharmacovigilance System(CHPS)was utilized to construct an active monitoring model for tislelizumab.Then,the ADR monitoring results using the active monitoring model in Huangshi Central Hospital from 2021 to 2024 were compared with the spontaneous reporting recognition rate of tislelizumab-related ADRs during the same period in the hospital,and the advantages of active monitoring model in improving the ADR reporting rate were evaluated.Results The identification rate of the active monitoring model for ADR was 7.71%,which was significantly higher than 1.77%of the traditional spontaneous reporting method(P<0.05).The positive alarm rate of the active monitoring model for ADR was 37.87%.Classified by involved systems/organs,the main types of ADRs were gastrointestinal damage(135 cases,34.01%)and systemic damage(123 cases,30.98%).Conclusion This model is simple and effective,which not only significantly improves the recognition and reporting rates of tislelizumab ADRs,but also provides a scalable paradigm for pharmacovigilance of immunotherapy in tertiary hospitals.It is helpful to optimize the pharmacovigilance system and enhance the precision and timeliness of drug safety monitoring.关键词
替雷利珠单抗/真实世界研究/药品不良反应/主动监测模型Key words
tislelizumab/real-world study/adverse drug reaction/active monitoring model分类
医药卫生引用本文复制引用
张青,刘小典,江芮,杨琪..替雷利珠单抗真实世界主动监测模型应用评价[J].中国药业,2026,35(2):28-34,7.基金项目
湖北省卫生健康委员会联合基金项目[WJ2019H181] （）
湖北省黄石市中心医院科研立项项目[ZX2023Q10]. （）
