某三级肿瘤专科医院单克隆抗体类新型抗肿瘤药临床使用合理性与安全性分析

doi:10.19803/j.1672-8629.2021.10.14

中国药物警戒 ›› 2021, Vol. 18 ›› Issue (10): 960-964.
DOI: 10.19803/j.1672-8629.2021.10.14

某三级肿瘤专科医院单克隆抗体类新型抗肿瘤药临床使用合理性与安全性分析

吴红^1,2, 李歆^2#, 韩峰^2,*

¹连云港市第二人民医院药学部,江苏连云港 222023;
²南京医科大学药学院, 南京 211166

收稿日期:2021-03-07 出版日期:2021-10-15 发布日期:2021-10-27
通讯作者: ^*韩峰,男,二级教授·博导,临床药理学。E-mail：fenghan169@njmu.edu.cn。^#为共同通信作者。
作者简介:吴红,女,硕士,临床药学。
基金资助:
国家自然科学基金资助项目（72074123, 716731471）; 江苏省政策引导类计划（软科学研究）（BR2020043）

Rationality and Safety of New Monoclonal Antibody Antitumor Drugs Used Clinically in a Tertiary Tumor Hospital

WU Hong^1,2, LI Xin^2#, HAN Feng^2*

¹Deptartment of Pharmacy, Lianyungang Second People's Hospital, Lianyungang Jiangsu 222023, China;
²School of Pharmacy, Nanjing Medical University, Nanjing 211166, China

Received:2021-03-07 Online:2021-10-15 Published:2021-10-27

摘要/Abstract

摘要： 目的调查某院单克隆抗体类新型抗肿瘤药临床使用情况,并进行合理性与安全性分析,为临床规范和安全使用新型抗肿瘤药提供支持。方法随机抽取某院2019年1月1日~2020年12月31日临床使用单克隆抗体类新型抗肿瘤药的住院病例480例,对其合理性及安全性进行回顾性分析。结果 480例病例中,用药不合理125例（26%）,不合理类别分别为超适应证用药（27.2%）、用法用量不适宜（41.6%）、预处理用药不适宜（20.0%）、溶媒选择及溶媒用量不适宜（11.2%）。发生药品不良反应346例次,不良反应累及系统-器官排名前3位分别是皮肤黏膜损伤（20.8%）、输液相关反应（19.7%）及消化系统损伤（14.7%）。结论某院单克隆抗体类新型抗肿瘤药临床使用存在不合理现象。医院应依据最新临床使用指南,规范临床合理使用新型抗肿瘤药,关注其不良反应,保障患者用药安全有效。

关键词: 单克隆抗体, 抗肿瘤药物, 合理性, 安全性, 临床药师

Abstract: Objective To investigate the clinical applications of new monoclonal antibody antitumor drugs in a hospital and analyze the rationality and safety of related medications in order to provide data for regulation and safe use of novel anticancer drugs. Methods A total of 480 medical records of inpatients who had used novel monoclonal antibody antitumor drugs from January 1, 2019 to December 31, 2020 were randomly chosen from a hospital and the rationality and safety of clinical applications were retrospectively analyzed. Results Among the 480 medical records, there were 125 cases of improper use of medicines, accounting for 26% of the total and involving off-label drug use(27.2%), wrong usage and dosage(41.6%), improper pretreatment drug use(20.0%), and imperfect solvent selection and dosage of solvents (11.2%).There were 362 cases of adverse drug reactions (ADR) found in these medical records. The top three organ-system ADRs were skin mucosal injury (20.8%), infusion related reactions (19.7%) and digestive system injury (14.7%). Conclusion The clinical use of new monoclonal antibody antitumor drugs is imperfect in this hospital. The hospital should regulate and rationally use new antitumor drugs according to the latest clinical guidelines, be alert to their adverse reactions, and ensure the safety and effectiveness of drug use.

Key words: monoclonal antibody, antitumor drugs, rationality, safety, clinical pharmacists

中图分类号:

R73R979.1

吴红, 李歆, 韩峰. 某三级肿瘤专科医院单克隆抗体类新型抗肿瘤药临床使用合理性与安全性分析[J]. 中国药物警戒, 2021, 18(10): 960-964.

WU Hong, LI Xin, HAN Feng. Rationality and Safety of New Monoclonal Antibody Antitumor Drugs Used Clinically in a Tertiary Tumor Hospital[J]. Chinese Journal of Pharmacovigilance, 2021, 18(10): 960-964.

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某三级肿瘤专科医院单克隆抗体类新型抗肿瘤药临床使用合理性与安全性分析

Rationality and Safety of New Monoclonal Antibody Antitumor Drugs Used Clinically in a Tertiary Tumor Hospital

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