中国新药杂志

卡度尼利单抗相关肝损伤的发生规律及临床特征分析

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李金兰 ¹ , 宋桂玲 ² , 冀承琳 ² , 李星华 ³ , 刘芬 ¹ , 尹桂森 ⁴^,^*

中国新药杂志 | 药物安全与合理应用 2026,35(10): 1082-1087

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中国新药杂志 |药物安全与合理应用 2026 , 35 (10) : 1082 -1087

卡度尼利单抗相关肝损伤的发生规律及临床特征分析

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李金兰¹, 宋桂玲², 冀承琳², 李星华³, 刘芬¹, 尹桂森⁴^,^*

作者信息

¹湖南省肿瘤医院/中南大学湘雅医学院附属肿瘤医院药学部，长沙 410011

²烟台市食品药品检验检测中心，烟台 264000

³滨州医学院半岛肿瘤研究中心，烟台 264003

⁴烟台市中医医院临床药学科，烟台 264000

通讯作者:

^* 尹桂森，男，主管药师，主要从事临床药学工作。联系电话：（0535）6597058，E-mail: ytygs2022@163.com。

作者简介:

李金兰，女，主管药师，主要从事抗肿瘤药物的疗效与安全性研究。联系电话：（0731）89762621，E-mail: lijinlan@hnca.org.cn。

Analysis of the occurrence pattern and clinical characteristics of liver injury related to cadonilimab

Jin-lan LI¹, Gui-ling SONG², Cheng-lin JI², Xing-hua LI³, Fen LIU¹, Gui-sen YIN⁴^,^*

Affiliations

¹Department of Pharmacy, Hunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha 410011, China

²Yantai Center For Food and Drug Control, Yantai 264000, China

³Peninsula Cancer Research Center, Binzhou Medical University, Yantai 264003, China

⁴Department of Pharmacy, Yantai Hospital of Traditional Chinese Medicine, Yantai 264000, China

出版时间: 2026-05-30 doi: 10.20251/j.cnki.1003-3734.2026.10.010

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摘要

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目的：

分析卡度尼利单抗相关肝损伤的发生规律及临床特点，为患者制定个体化用药方案提供参考。

方法：

收集2021年1月—2023年12月期间，在湖南省肿瘤医院接受卡度尼利单抗治疗并出现肝损伤的肿瘤患者病例资料，详细记录患者个人信息、疾病信息、用药信息、肝损伤情况以及不良反应处置转归等信息。

结果：

共纳入14例患者，男性11例、女性3例，中位年龄57岁，原发疾病以肺癌患者为主（57.14%）。从用药情况来看，64.28%的患者按照药品说明书推荐的用法用量，而35.72%的患者存在超说明书用药的情况。11例患者存在联合用药，安罗替尼联合治疗方案占比最高（45.45%），其次为仑伐替尼（18.18%）。卡度尼利单抗相关肝损伤的中位发生时间为65 d，71.43%的患者发生于用药后3个月内，3级及以上肝损伤占比60.00%。从肝损伤的类型来看，多数患者（71.42%）表现为肝细胞损伤型，其中谷丙转氨酶（alanine aminotransferase, ALT）和谷草转氨酶（aspartate aminotransferase, AST）的中位数值分别达到了324.0和430.9 U·L^-1。临床表现以乏力（21.43%）、黄疸（7.14%）为主，71.43%的患者经激素及护肝治疗后好转，28.57%的患者需长期随访监测肝功能。

结论：

卡度尼利单抗相关肝损伤多发生于用药早期，以肝细胞损伤型为主，3级及以上肝损伤占比较高。联合用药（如安罗替尼、铂类）可能增加肝损伤风险。建议治疗初期应加强肝功能监测，对症处理后可明显改善预后。

关键词

卡度尼利单抗 / 肝损伤 / 不良反应 / 发生规律 / 临床特征分析

Abstract

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Objective:

To analyze the occurrence pattern and clinical characteristics of liver injury related to cadonilimab, and provide a reference for formulating individualized medication regimens for patients.

Methods:

The medical data of cancer patients who received cadonilimab treatment and developed liver injury in Hunan Cancer Hospital from January 2021 to December 2023 were collected. Information such as patients' personal information, disease information, medication information, liver injury status, and the outcomes of adverse reaction management were recorded in detail.

Results:

A total of 14 patients were included, with 11 males and 3 females, and the median age was 57 years. The primary disease was mainly lung cancer (57.14%). In terms of medication, 64.28% of the patients used cadonilimab according to the recommended dosage and administration method in the instruction manual, while 35.72% of the patients had off-label medication. A total of 11 patients were treated with combination therapy, and anlotinib combination therapy accounted for the highest proportion (45.45%), followed by lenvatinib (18.18%). The median occurrence time of cadonilimab-related liver injury was 65 days, and 71.43% of the patients developed it within 3 months after medication. Liver injury of grade 3 and above accounted for 60.00%. In terms of the type of liver injury, most patients (71.42%) showed hepatocellular injury type, and the median values of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) reached 324.0 U·L^-1 and 430.9 U·L^-1 respectively. The clinical manifestations were mainly fatigue (21.43%) and jaundice (7.14%). 71.43% of the patients improved after hormone and liver protection treatment, and 28.57% needed long-term follow-up and monitoring of liver function.

Conclusion:

Cadonilimab-related liver injury mostly occurs in the early stage of medication, mainly in the form of hepatocellular injury, and the proportion of liver injury of grade 3 and above is relatively high. Combined medication (such as anlotinib) may increase the risk of liver injury. It is recommended to strengthen the monitoring of liver function in the initial stage of treatment, and the prognosis can be significantly improved after symptomatic treatment.

Key words

cadonilimab / liver injury / adverse drug reaction / incidence pattern / analysis of clinical characteristics

引用本文

李金兰, 宋桂玲, 冀承琳, 李星华, 刘芬, 尹桂森. 卡度尼利单抗相关肝损伤的发生规律及临床特征分析. 中国新药杂志, 2026 , 35 (10) : 1082 -1087 . DOI: 10.20251/j.cnki.1003-3734.2026.10.010

Jin-lan LI, Gui-ling SONG, Cheng-lin JI, Xing-hua LI, Fen LIU, Gui-sen YIN. Analysis of the occurrence pattern and clinical characteristics of liver injury related to cadonilimab[J]. Chinese Journal of New Drugs, 2026 , 35 (10) : 1082 -1087 . DOI: 10.20251/j.cnki.1003-3734.2026.10.010

基金

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中国博士后科学基金资助项目(2023M732333)
烟台市科技局资助项目(2023YD064)
滨州医学院中医药学科融合科技计划专项资助项目(2024ZYYKJ11)
西藏自治区自然基金资助项目(XZ202501ZR0109)

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排序方式：

2026年第35卷第10期

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文章信息

doi: 10.20251/j.cnki.1003-3734.2026.10.010

首发时间：2026-10-26
出版时间：2026-05-30

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出版历史

录用日期：2025-06-17

基金

中国博士后科学基金资助项目(2023M732333)

烟台市科技局资助项目(2023YD064)

滨州医学院中医药学科融合科技计划专项资助项目(2024ZYYKJ11)

西藏自治区自然基金资助项目(XZ202501ZR0109)

作者信息

¹湖南省肿瘤医院/中南大学湘雅医学院附属肿瘤医院药学部，长沙 410011

²烟台市食品药品检验检测中心，烟台 264000

³滨州医学院半岛肿瘤研究中心，烟台 264003

⁴烟台市中医医院临床药学科，烟台 264000

通讯作者:

^* 尹桂森，男，主管药师，主要从事临床药学工作。联系电话：（0535）6597058，E-mail: ytygs2022@163.com。

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https://castjournals.cast.org.cn/joweb/zgxyzz/CN/10.20251/j.cnki.1003-3734.2026.10.010

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2种不同金属材料的力学参数

科 Family	属数 Number of genus	种数 Number of species	占总种数比例 Percentage of total species (%)	属 Genus	种数 Number of species	占总种数比例 Percentage of total species (%)
鹅膏菌科Amanitaceae	2	11	5.26	鹅膏菌属 Amanita	10	4.78
小菇科 Mycenaceae	2	12	5.74	丝盖伞属 Inocybe	5	2.39
多孔菌科 Polyporaceae	8	14	6.70	蜡蘑属 Laccaria	5	2.39
红菇科 Russulaceae	3	23	11.00	小皮伞属 Marasmius	6	2.87
				小菇属 Mycena	11	5.26
				光柄菇属 Pluteus	5	2.39
				红菇属 Russula	17	8.13
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