172例抗肿瘤药品不良反应报告分析

doi:10.19803/j.1672-8629.20240497

摘要/Abstract

摘要： 目的分析本院抗肿瘤药品不良反应（Adverse Drug Reaction,ADR）发生的临床特点与规律,为临床安全合理使用抗肿瘤药物提供参考。方法收集本院2019年1月1日至2023年12月31日报告国家药品不良反应监测系统的ADR报告,对涉及抗肿瘤药物的ADR报告进行回顾性分析。结果 172例抗肿瘤药物ADR中男、女性占比分别为51.16%和48.84%;患者年龄≥60岁的占比54.65%;报告涉及的原患疾病中肺恶性肿瘤、胃恶性肿瘤最多,均为21例（12.21%）;报告涉及的静脉滴注途径给药的ADR占比最多（62.79%）;药品种类最多的为小分子靶向药物55例（31.98%）;ADR常累及的系统-器官为血液系统（24.45%）、全身性损害（17.47%）、肝胆系统损害（16.59%）;骨髓抑制、肝功能异常、畏寒/寒战为较常见的临床表现;新型抗肿瘤药物ADR中,排名前3位的药物为利妥昔单抗21例（19.63%）、信迪利单抗15例（14.02%）、贝伐珠单抗和卡瑞利珠单抗均为8例（7.48%）;一般的ADR 95例、严重的77例,大部分转归为好转。结论应根据患者特点予合适的抗肿瘤治疗方案,同时密切监测相关ADR,保障患者用药安全。

关键词: 抗肿瘤药物, 新型抗肿瘤药物, 小分子靶向药物, 药品不良反应, 用药安全, 药物警戒

Abstract: Objective To analyze the clinical characteristics and patterns of adverse drug reactions (ADR) induced by antineoplastic drugs in our hospital in order to provide a reference for the safe and rational use of antineoplastic drugs. Methods ADR reports related to antineoplastic drugs and submitted by our hospital to the active monitoring and reporting system of the National Adverse Drug Reaction Monitoring Center between 2019 and 2023 were retrospectively analyzed. Results A total of 172 ADR reports of antineoplastic drugs were retrieved, and the percentage of males and females involved in these reports was 51.16% and 48.84% respectively. Patients aged 60 or older accounted for 54.65%. Among the primary diseases mentioned in the reports, malignant tumors of the lung and stomach were dominating, with 21 cases（12.21%）each. The most common route of administration mentioned in these ADR reports was intravenous infusion (62.79%) while the most common antineoplastic drugs found in these ADR reports were small molecule targeted drugs (31.98%). The prevalent ADR of antineoplastic drugs included blood system damage (24.45%), systemic damage (17.47%) , hepatobiliary system damage (16.59%), bone marrow suppression, abnormal liver function, and chills/shivering are common clinical manifestations. Among new antineoplastic drugs, the top three ones responsible were rituximab in 21 cases (19.63%), sintilimab in 15 cases (14.02%), and bevacizumab and camrelizumab in 8 cases (7.48%). There were 95 cases of common ADR and 77 cases of severe ADR, with the majority of patients improved. Conclusion Appropriate anti-tumor treatment regimens should be provided based on the characteristics of patients. Related ADR should be monitored to ensure medication safety.

Key words: Antineoplastic Drugs, New Antineoplastic Drugs, Small Molecule Targeted Drugs, Adverse Drug Reactions, Medication Safety, Pharmacovigilance

中图分类号:

梁洁. 172例抗肿瘤药品不良反应报告分析[J]. 中国药物警戒, 2025, 22(8): 928-932.

LIANG Jie. 172 Cases of Adverse Drug Reactions Induced by Antineoplastic Drugs[J]. Chinese Journal of Pharmacovigilance, 2025, 22(8): 928-932.

导出引用管理器 EndNote|Ris|BibTeX

链接本文: https://zgywjj.magtechjournal.com/CN/10.19803/j.1672-8629.20240497

https://zgywjj.magtechjournal.com/CN/Y2025/V22/I8/928

参考文献

[1] ZHENG RS, ZHANG SW, ZENG HM, et al.Cancer Incidence and Mortality in China(2016)[J]. J Natl Cancer Cent, 2022, 2(1):1-9.
[2] ZHANG SW, SUN KX, ZHENG RS, et al.Cancer Incidence and Mortality in China(2015)[J]. J Natl Cancer Cent, 2021, 1(1): 2-11.
[3] CHEN WQ, ARMSTROG BK, ZHENG RS, et al.Cancer Burden in China: a Bayesian Approach[J]. BMC Cancer, 2013, 13: 458.
[4] ZHENG RS, ZHANG SW, SUN KX, et al.Cancer Statistics in China, 2016[J]. Chin J Oncol(中华肿瘤杂志), 2023,45(3) : 212-220.
[5] CDR, NMPA. Annual Report on National Adverse Drug Reaction Monitoring (2023)[EB/OL]. (2024-03-26)[2024-09-09]. https://www.cdr-adr.org.cn/drug_1/aqjs_1/drug_aqjs_sjbg/202403/t20240326_50614.html.
[6] National Health Commission Medical Affairs Bureau. Notice of the General Office of the National Health Commission on Printing and Distributing the Guiding Principles for the Clinical Application of New Anti-Tumor Drugs (2023 Edition): National Health Office Medical Policy Letter[2024] No.1[EB/OL]. (2024-01-22)[2024-09-09]. http://www.nhc.gov.cn/yzygj/s7659/202401/48be6030a029446c93b852bfd4a5fdf6.shtml.
[7] CHENG J, HAN YX, WANG L, et al.Analysis of 54 Cases of Adverse Drug Reactions Induced by New Antitumor Drugs[J]. Chinese Journal of New Drugs(中国新药杂志), 2021, 30(3): 280-284.
[8] CAI M, LI M, SHEN AZ.Active Monitoring of Adverse Drug Reactions Caused by Anti-Tumor Targeted Drugs[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2021, 18(4): 368-372.
[9] NMPA. Measures for the Reporting and Monitoring of Adverse Drug Reactions[EB/OL]. (2011-05-04)[2024-09-09]. https://www.nmpa.gov.cn/yaopin/ypfgwj/ypfgbmgzh/20110504162501325.html.
[10] CHEN XQ, JIN YY, TANG G. New Pharmacology(新编药物学)[M]. 18th Ed, Beijing: People's Health Publishing House, 2018: 851-929.
[11] CDR, NMPA.Glossary of Adverse Drug Reaction Terms(药品不良反应术语集)[M]. Beijing: China Pharmaceutical Science and Technology Press, 2003.
[12] ZHANG M, XING YB, MA SL.Analysis of 264 Cases of Adverse Reactions Caused by Anticancer Drugs in Children[J]. Chinese Journal of Rational Drug Use(中国合理用药探索), 2020, 17(3): 21-24.
[13] SAWHNEY R, SEHL M, NAEIM A.Physiologic Aspects of Aging: Impact on Cancer Management and Decision Making, Part I[J]. Cancer J, 2005, 11(6): 449-460.
[14] SEHL M, SAWHNEY R, NAEIM A.Physiologic Aspects of Aging: Impact on Cancer Management and Decision Making, Part II[J]. Cancer J, 2005, 11(6): 461-473.
[15] WHO. Global Cancer Burden Growing, Amidst Mounting Need for Services[EB/OL]. (2024-02-02)[2024-09-09]. https://www.who.int/news/item/01-02-2024-global-cancer-burden-growing--amidst-mounting-need-for-services.
[16] HUANG HJ, MAI JH, ZHANG YH, et al.Adverse Drug Reaction Induced by Antineoplastic Drugs in a Cancer Hospital: an Analysis of 613 Cases[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2024, 21(3): 324-328, 334.
[17] WEI LY, QIU XC, ZHOU YL, et al.Analysis of 907 Cases of Adverse Drug Reactions Induced by Antineoplastic Drugs[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2017, 14(4): 242-245.
[18] ZHONG L, LI Y, XIONG L, et al.Small Molecules in Targeted Cancer Therapy: Advances, Challenges, and Future Perspectives[J]. Signal Transduction and Targeted Therapy, 2021, 6(1): 201.
[19] BEDARD PL, HYMAN DM, DAVIDS MS, et al.Small Molecules, Big Impact: 20 Years of Targeted Therapy in Oncology[J]. Lancet (London, England), 2020, 395(10229): 1078-1088.
[20] ROSKOSKI R JR.Properties of FDA-Approved Small Molecule Protein Kinase Inhibitors: a 2023 Update[J]. Pharmacological Research, 2023, 187: 106552.
[21] LIANG YH, HUANG L, LIU HG.Analysis of 618 Cases Reports of Antitumor Drug Adverse Reactions[J]. Northwest Pharmaceutical Journal(西北药学杂志), 2017, 32(5): 670-673.