基于主动监测系统的免疫检查点抑制剂免疫相关不良反应研究.

Objective To investigate the characteristics and risk factors of immune-related adverse events (irAEs) induced by immune checkpoint inhibitors (ICIs) . Methods Monitoring conditions were established by using the Chinese Hospital Pharmacovigilance System. The hospitalized cases of camrelizumab, sintilimab, tislelizumab, and pembrolizumab in the hospital from 2020 to 2022 were searched, and positive alarm cases were obtained. The incidence of irAEs was analyzed. The nested case-control study method was used to set up the case group and the control group, and the influencing factors were analyzed by χ2 test. Results Among the 3 653 hospitalized patients, 910 alarm cases were detected, and 107 cases were finally determined to have irAEs by clinical pharmacist evaluation, including 58 cases of common irAEs and 49 cases of severe irAEs. A total of 128 cases of irAEs occurred in 107 patients. The positive detection rate of the monitoring model was 2. 93% (107/3 653) . Endocrine toxicity[18. 75% (24/128) ], pulmonary toxicity [16. 41% (21/18) ], skin toxicity[14. 06% (18/128) ], liver toxicity[10. 94% (14/128) ], and cardiac toxicity[9. 38% (12/128) ]ranked high. Of the 107 patients, 81 were improved, 20 were cured, four were not improved, and 2 died. There was a statistically significant difference in the incidence of irAEs between patients with and without surgery (P＜0. 05) . Conclusion It is feasible to carry out the active monitoring of irAEs induced by ICIs by using the Chinese Hospital Pharmacovigilance System. It can reflect the occurrence of adverse drug reactions to a certain extent, reduce and prevent the risk of clinical medication, and also provide new methods and ideas for drug safety evaluation. [ABSTRACT FROM AUTHOR]