摘要
目的探讨免疫检查点抑制剂(ICIs)所致免疫相关不良反应(irAEs)的发生特点和相关危险因素。方法利用中国医院药物警戒系统创建监测条件,搜索该院2020-2022年使用卡瑞利珠单抗、信迪利单抗、替雷利珠单抗、帕博利珠单抗的住院病例,得到阳性报警病例,分析irAEs发生情况,应用巢式病例对照研究方法设置病例组与对照组,采用χ2检验对影响因素进行分析。结果3653例住院患者中检出报警病例910例,经临床药师评价最终确定107例存在irAEs,其中58例为普通irAEs,49例为严重irAEs,107例患者共发生irAEs 128例次。监测模型阳性发现率为2.93%(107/3653)。内分泌毒性[18.75%(24/128)]、肺毒性[16.41%(21/18)]、皮肤毒性[14.06%(18/128)]、肝脏毒性[10.94%(14/128)]、心脏毒性[9.38%(12/128)]发生率排名靠前。107例患者中好转81例,痊愈20例,未好转4例,死亡2例。是否进行手术患者间irAEs发生率比较,差异有统计学意义(P<0.05)。结论利用中国医院药物警戒系统开展ICIs致irAEs的主动监测可行性良好,可在一定程度上反映药品不良反应发生情况,减少和防范临床用药风险,也为药物安全性评价提供了新的方法和思路。
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 χ^(2) test.Results Among the 3653 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%(107/3653).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.
作者
刘宏尉
赵敏
颜志文
陈叶莉
LIU Hongwei;ZHAO Min;YAN Zhiwen;CHEN Yeli(Department of Pharmacy,the First Affliated Hospital of Xiamen University,Xiamen,Fujian 361000,China;Department of Pharmaceutical Preparation,the First Affliated Hospital of Xiamen University,Xiamen,Fujian 361000,China)
出处
《现代医药卫生》
2024年第9期1462-1466,1472,共6页
Journal of Modern Medicine & Health
关键词
免疫毒性
主动监测系统
免疫检查点抑制剂
药物警戒
Immunotoxicity
Active monitoring system
Immune checkpoint inhibitors
Pharmacovigilance
