北京地区阿帕替尼不良反应调研分析

Investigation and analysis of apatinib-related adverse reactions in Beijing area

摘要:

目的 基于北京市药品不良反应监测中心接收的北京地区医疗机构报告的阿帕替尼相关药品不良反应（ADR）数据，分析阿帕替尼的不良反应特点及用药风险，为临床安全用药提供数据支持。方法 采用回顾性分析方法，对2017年1月1日至2022年12月31日北京地区92例阿帕替尼相关ADR报告进行分析。结果 92例患者中，男女比例为1∶1，年龄11~84岁，平均年龄（56.60±16.33）岁。阿帕替尼主要用于治疗胃癌、肺癌、乳腺癌等疾病，存在超适应证用药情况。用药剂量以小剂量为主，其中500 mg qd （25.00%）和250 mg qd （63.04%）较为常见。8例患者的给药频次存在不合理情况。主要不良反应包括高血压、血液毒性、手足皮肤反应及出血等。79例（85.87%）患者的不良反应发生在初始用药的3个月内。结论 临床应重视阿帕替尼的安全性问题，在合理用药的基础上加强不良反应的监测与及时处理，以确保患者用药安全。

Abstract:

Objective To analyze the adverse drug reaction (ADR) characteristics and medication risks of apatinib based on the data of ADSs which were reported by medical institutions in Beijing and received by Beijing Center for Adverse Drug Reaction Monitoring, so as to provide data support for clinical safe drug use.Methods A retrospective analysis method was used to analyze 92 reports of apatinib-related ADRs in the Beijing area from January 1, 2017 to December 31, 2022.Results The male to female ratio of 92 patients was 1∶1, and their age ranged from 11 to 84 years, with an average age of (56.60±16.33) years. Apatinib was mainly used in the treatment of gastric cancer, lung cancer, breast cancer, etc. There were off-label uses. Low-dose regimens predominated, including 500 mg qd (25.00%) and 250 mg qd (63.04%). The frequency of drug administration was unreasonable in 8 patients. The main ADRs included hypertension, hematological toxicity, hand-foot skin reactions, bleeding, etc. The adverse reactions of 79 patients (85.87%) occurred within 3 months after the initial treatment.Conclusion Clinical attention should be paid to the safety of apatinib. On the basis of rational drug use, enhanced ADR monitoring and timely intervention is crucial to ensure the medication safety of patients.