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广泛期小细胞肺癌患者使用免疫检查点抑制剂发生免疫相关不
良事件的特征及影响因素
Δ
吴 琼 ,黄其春 ,覃忠于 ,廖柳凤 (1.广西医科大学附属肿瘤医院药学部,南宁 530021;2.广西壮族自治区
1 #
1*
2
1
药品不良反应监测中心,南宁 530021)
中图分类号 R979.1 文献标志码 A 文章编号 1001-0408(2024)22-2784-05
DOI 10.6039/j.issn.1001-0408.2024.22.14
摘 要 目的 探讨广泛期小细胞肺癌患者使用免疫检查点抑制剂(ICIs)发生免疫相关不良事件(irAEs)的临床特征及影响因素。
方法 利用中国医院药物警戒系统回顾性收集我院2023年1月1日至5月31日使用ICIs的130例广泛期小细胞肺癌患者的资料,
记录所有患者治疗期间irAEs的发生情况及激素使用情况。采用多因素Logistic回归模型分析影响irAEs发生的因素。结果 纳
入的130例患者中,有32例患者发生了38例次irAEs,发生率为24.6%,严重程度为1~3级;以皮肤症状(8.4%)最为常见,且集中
发生在治疗的第1个周期;5例患者发生多器官系统irAEs。发生irAEs患者的激素使用不合理率为23.1%(甲状腺功能异常患者
除外)。神经元特异性烯醇化酶(NSE)为影响irAEs发生的独立因素(P<0.05)。结论 ICIs 所致的irAEs发生率较高,可累及全身
各个器官系统,以皮肤症状发生最早;NSE是影响irAEs发生的独立因素,可一定程度预测irAEs的发生风险。
关键词 免疫检查点抑制剂;免疫相关不良事件;广泛期小细胞肺癌;神经元特异性烯醇化酶;影响因素
Characteristics and influencing factors of immune-related adverse events in patients with extensive-stage
small cell lung cancer treated with immune checkpoint inhibitors
WU Qiong ,HUANG Qichun ,QIN Zhongyu ,LIAO Liufeng (1. Dept. of Pharmacy, Guangxi Medical
1
2
1
1
University Cancer Hospital, Nanning 530021, China;2. Guangxi Zhuang Autonomous Region Adverse Drug
Reaction Monitoring Center, Nanning 530021, China)
ABSTRACT OBJECTIVE To explore the clinical characteristics and influencing factors of immune-related adverse events
(irAEs) in patients with extensive-stage small cell lung cancer (SCLC) treated with immune checkpoint inhibitors (ICIs).
METHODS The data from 130 patients with extensive-stage SCLC treated with ICIs at our hospital from January 1, 2023, to May
31, 2023 was collected retrospectively using the Chinese Hospital Pharmacovigilance System. The occurrence of irAEs and the use
of corticosteroids during treatment for all patients were recorded. A multifactorial Logistic regression model was used to analyze the
influencing factors for the occurrence of irAEs. RESULTS Among the 130 patients included, 32 patients experienced 38 episodes
of irAEs, with an incidence rate of 24.6% and severity of degree 1-3. Skin symptoms were the most common (8.4%) and
predominantly occurred in the first cycle of treatment. Five patients developed irAEs involving multiple organ systems. The
irrational use rate of corticosteroids in patients with irAEs was 23.1% (excluding patients with thyroid dysfunction). Neuron specific
enolase (NSE) was a independent factor influencing the occurrence of irAEs (P<0.05). CONCLUSIONS The incidence of irAEs
caused by ICIs remains relatively high and can involve various organ systems throughout the body, with skin symptoms occurring
earliest. NSE is an independent influencing factor for the occurrence of irAEs, and could predict the risk of irAEs to a certain
extent.
KEYWORDS immune checkpoint inhibitor; immune-related adverse events; extensive-stage small cell lung cancer; neuron
specific enolase; influence factor
Δ 基金项目 广西壮族自治区药监局直属单位药品安全科研项目
(No. 桂药科〔2022〕自选 14 号);广西药学会医院药学科研项目(No. 肿瘤细胞可利用免疫检查点来抑制 T 细胞的免疫
GXYXH1-202202);中国药学会药物临床评价研究专业委员会研究课
[1]
活性,实现免疫逃逸,从而实现“无限增殖”。针对这一
题(No.CPA-Z06-ZC-2021-004)
*第一作者 副主任药师,硕士。研究方向:肿瘤临床药理。E-mail: 机制,研究人员开发出了新型的免疫治疗药物,即免疫
wuqiong1919@163.com
检 查 点 抑 制 剂(immune checkpoint inhibitors,ICIs)。
# 通信作者 副主任药师,硕士。研究方向:肿瘤临床药理及营养。
E-mail:lcyxllf@163.com ICIs能够有效阻断免疫抑制,恢复免疫细胞对肿瘤细胞
· 2784 · China Pharmacy 2024 Vol. 35 No. 22 中国药房 2024年第35卷第22期