289例单克隆抗体抗肿瘤药品不良反应报告分析

doi:10.19803/j.1672-8629.20210679

中国药物警戒 ›› 2023, Vol. 20 ›› Issue (4): 444-448.
DOI: 10.19803/j.1672-8629.20210679

289例单克隆抗体抗肿瘤药品不良反应报告分析

罗世书¹, 屈杰², 周楠³, 徐翠香⁴, 刘屹⁵, 张丽洁⁶, 王建华^7,*

¹陕西省食品药品检验研究院,陕西西安 710068;
²延安大学医学院,陕西西安 710068;
³陕西省人民医院药学部,陕西西安 710068;
⁴陕西省人民医院中心实验室,陕西西安 710068;
⁵陕西省人民医院肿瘤内科,陕西西安 710068;
⁶陕西省人民医院血液研究室,陕西西安 710068;
⁷陕西省人民医院普外二科,陕西西安 710068

收稿日期:2022-07-09 出版日期:2023-04-15 发布日期:2023-04-20
通讯作者: ^*王建华,男,博士,主任医师,胃肠道肿瘤。E-mail:894982815@qq.com
作者简介:罗世书,男,硕士,主管药师,药物临床合理使用与不良反应监测。
基金资助:
国家自然科学基金资助项目（81801647）; 陕西省重点研发项目-重点产业创新链（群）（2021ZDLSF01-07）

289 cases of adverse drug reactions associated with monoclonal antibody antitumor drugs

LUO Shishu¹, QU Jie², ZHOU Nan³, XU Cuixiang⁴, LIU Yi⁵, ZHANG Lijie⁶, WANG Jianhua^7,*

¹Shaanxi Institute for Food and Drug Control, Xi'an Shaanxi 710068, China;
²Medical School of Yan'an University, Xi'an Shaanxi 710068, China;
³Department of Pharmacy, Shaanxi Provincial People's Hospital, Xi'an Shaanxi 710068, China;
⁴Department of Scientific Research, Shaanxi Provincial People's Hospital, Xi'an Shaanxi 710068, China;
⁵Interal Medicine-Oncology, Shaanxi Provincial People's Hospital, Xi'an Shaanxi 710068, China;
⁶Blood Laboratory, Shaanxi Provincial People's Hospital, Xi'an Shaanxi 710068, China;
⁷Department of General Surgery, Shaanxi Provincial People's Hospital, Xi'an Shaanxi 710068, China

Received:2022-07-09 Online:2023-04-15 Published:2023-04-20

摘要/Abstract

摘要： 目的分析单克隆抗体类抗肿瘤药品不良反应（ADR）发生的一般规律和特点,为临床合理用药提供依据。方法收集陕西省2016年1月1日至2020年12月31日各级医疗卫生机构上报至陕西省食品药品检验研究院的289例单抗类抗肿瘤ADR报告,从性别、年龄、给药途径、药品种类、临床转归和ADR的临床表现进行分析。结果收集的ADR报告中共涉及5种抗肿瘤药,ADR发生主要以40岁以上人群居多（92.04%）,女性人数大于男性。在289例ADR报告中临床表现为309例次,以血液系统最为常见,其次为消化系统、全身性系统、皮肤及其附件损伤。不同的单抗类抗肿瘤药引起的ADR有相似点,即骨髓抑制均占较高比例。不同的是,贝伐珠单抗、曲妥珠单抗消化道症状出现较多;西妥昔单抗、帕妥珠单抗皮肤毒性明显;利妥昔单抗则是易出现寒战高热。5种抗肿瘤药均以静脉滴注给药为主,但仍有11例静脉推注或胸膜腔内给药。引起严重的ADR最多的是利妥昔单抗（34例）,其ADR主要表现为骨髓抑制和高热。其次为贝伐珠单抗（27例）,其ADR主要表现为骨髓抑制。在转归方面,痊愈和好转占86.51％。另有1例结肠癌老年女性患者使用贝伐珠单抗20 d后出现结肠穿孔,1月后死亡。结论单抗类抗肿瘤ADR的发生与患者年龄、给药途径、药物种类等密切关联,使用存在一些特殊的用法及注意事项,使用时应注意。应充分了解患者病情以及该类药物特点,按时监测患者生理指标,以减少或避免ADR的发生,最大程度利用单克隆抗体抗肿瘤药的优势。

关键词: 抗肿瘤药物, 单克隆抗体, 贝伐珠单抗, 曲妥珠单抗, 西妥昔单抗, 帕妥珠单抗, 利妥昔单抗, 药品不良反应

Abstract: Objective To analyze the patterns and characteristics of adverse drug reactions（ADR）caused by monoclonal antibody anticancer drugs in order to facilitate clinical treatment. Methods A total of 289 cases of ADR induced by monoclonal antibody anticancer drugs between 2016 and 2020 were collected from Shaanxi Province Adverse Drug Reaction Center before being analyzed statistically．Results In these 289 ADR reports, five types of antineoplastic drugs were involved．The majority of the patients with ADR were over 40 years old and female patients outnumbered male ones. Gamage to blood systems was the dominating ADR, followed by damage to the digestive system, systemic reactions, and damage to the skin and accessories. The ADR were similar in that a large proportion of them were induced by bone marrow suppressors. However, many of the symptoms of the digestive tract were caused by bevacizumab and trastuzumab. The skin toxicity of cetuximab and pertuzumab was obvious. Rituximab was likely to cause shivering and high fever. These five types of drugs were mainly given by intravenous drip, but there were still eleven cases of intravenous injection or intrapleural administration. Rituximab caused the large number of severe ADR (34 cases) such as myelosuppression and high fever, followed by bevacizumab (27 cases), the main ADR of which was myelosuppression. 86.51% of the ADR were cured and improved. However, one elderly female patient with colon cancer developed colonic perforation 20 days after bevacizumab treatment and died one month later. Conclusion The incidence of ADR caused by monoclonal antibody anticancer drugs is closely related to the patient's age, route of administration and types of drugs. Some drugs that require special usage and considerations deserve attention. In order to use monoclonal antibody antitumor drugs properly, clinicians should take into account the patient's conditions and the characteristics of drugs in order to prevent ADR.

Key words: anticancer drug, monoclonal antibody, bevacizumab, trastuzumab, cetuximab, pertuzumab, rituximab, adverse drug reaction

中图分类号:

罗世书, 屈杰, 周楠, 徐翠香, 刘屹, 张丽洁, 王建华. 289例单克隆抗体抗肿瘤药品不良反应报告分析[J]. 中国药物警戒, 2023, 20(4): 444-448.

LUO Shishu, QU Jie, ZHOU Nan, XU Cuixiang, LIU Yi, ZHANG Lijie, WANG Jianhua. 289 cases of adverse drug reactions associated with monoclonal antibody antitumor drugs[J]. Chinese Journal of Pharmacovigilance, 2023, 20(4): 444-448.

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289例单克隆抗体抗肿瘤药品不良反应报告分析

289 cases of adverse drug reactions associated with monoclonal antibody antitumor drugs

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