真实世界免疫检查点抑制剂相关不良反应监测数据分析

doi:10.19803/j.1672-8629.20220640

中国药物警戒 ›› 2023, Vol. 20 ›› Issue (9): 1035-1038.
DOI: 10.19803/j.1672-8629.20220640

真实世界免疫检查点抑制剂相关不良反应监测数据分析

张立, 汪余嘉, 张玲玲, 陈家鑫, 林敏华, 林小惠, 聂雪坤^*

宁德师范学院附属宁德市医院药学部,福建宁德 352100

收稿日期:2022-11-04 出版日期:2023-09-15 发布日期:2023-09-14
通讯作者: ^*聂雪坤,女, 硕士,主管药师,临床药学。E-mail: 290770875@qq.com
作者简介:张立,女,本科,主管药师,临床药学。
基金资助:
福建省卫生健康青年科研课题（2022QNA108）; 福建省自然科学基金资助项目（2022J011215）

Surveillance data on adverse reactions associated with real-world immune checkpoint inhibitors

ZHANG Li, WANG Yujia, ZHANG Lingling, CHEN Jiaxin, LIN Minhua, LIN Xiaohui, NIE Xuekun^*

Department of Pharmacy, Ningde Municipal Hospital Affiliated to Ningde Normal University, Ningde Fujian 352100, China

Received:2022-11-04 Online:2023-09-15 Published:2023-09-14

摘要/Abstract

摘要： 目的回顾性分析宁德师范学院附属宁德市医院（简称“本院”）免疫检查点抑制剂（ICIs）临床应用中不良反应发生情况。方法通过医院信息系统（HIS）收集2021年1月1日至12月31日本院ICIs治疗的患者,对其不良反应监护及发生情况进行分析。结果 80例使用ICIs的患者中,发生免疫相关甲状腺功能损害7例（8.75%）、免疫相关性肺炎4例（5.00%）、免疫相关性皮肤损害3例（3.75%）;仅67.50%病例有定期评估甲状腺功能,47.50%病例定期评估肾上腺皮质功能,50.00%病例定期评估心脏功能,不良反应监护存在不完善或未监护情况。结论本研究中需临床干预的免疫相关不良反应发生率与既往研究一致,发生不良反应患者的处置基本合理;临床药师通过加强对医院ICIs相关不良反应的监护及分析,可促进临床规范使用ICIs。

关键词: 免疫检查点抑制剂, PD-1单抗, 免疫相关不良反应, 肿瘤, 甲状腺功能减退, 肺炎, 皮肤不良反应, 药品不良反应

Abstract: Objective To analyze the incidence of immune-related adverse reactions (irAEs) caused by immune checkpoint inhibitors (ICIs) in our hospital. Methods The clinical data of patients treated with ICIs in our hospital in 2021 was investigated via the hospital information system. The monitoring and occurrence of irAEs were analyzed. Results A total of 80 patients treated with ICIs were included, including 7 cases (8.75%) of injuries to immune-related thyroid function, 4 cases (5.00%) of checkpoint inhibitor pneumonitis (CIP), and 3 cases (3.75%) of immune-related cutaneous adverse events (ircAEs). Only 67.50% of the patients regularly had their thyroid function evaluated, 47.50% regularly had their adrenal cortical function assessed and 50.00% regularly had their heart function evaluated. Adverse reactions were poorly monitored or left unmonitored. Conclusion The incidence of irAEs that require clinical treatment in our hospital is consistent with what has been reported, and the treatment of patients with adverse reactions is generally acceptable. Oncology pharmacists can promote the standardized clinical use of ICIs by enhancing the monitoring and analysis of irAEs in hospitals.

Key words: immune checkpoint inhibitors, PD-1 monoclonal antibody, immune-related adverse reaction, tumors, hypothyroidism, pneumonia, immune-related cutaneous adverse reaction, adverse drug reaction

中图分类号:

R979.5
R994

张立, 汪余嘉, 张玲玲, 陈家鑫, 林敏华, 林小惠, 聂雪坤. 真实世界免疫检查点抑制剂相关不良反应监测数据分析[J]. 中国药物警戒, 2023, 20(9): 1035-1038.

ZHANG Li, WANG Yujia, ZHANG Lingling, CHEN Jiaxin, LIN Minhua, LIN Xiaohui, NIE Xuekun. Surveillance data on adverse reactions associated with real-world immune checkpoint inhibitors[J]. Chinese Journal of Pharmacovigilance, 2023, 20(9): 1035-1038.

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真实世界免疫检查点抑制剂相关不良反应监测数据分析

Surveillance data on adverse reactions associated with real-world immune checkpoint inhibitors

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