基于广东省药物警戒与风险管控系统对抗肿瘤药物不良反应分析研究

Analysis and research on adverse drug reactions of anti-tumor drugs based on pharmacovigilance and risk control system in Guangdong Province

目的对抗肿瘤药物不良反应报告的总体情况、特点和规律进行分析,研究其不良反应发生影响因素。方法通过广东省药物警戒与风险管控系统收集统计2020年~2021年江门市抗肿瘤药物不良反应并开展回顾性分析。结果2020年和2021年抗肿瘤药物的严重ADR报告约占全市严重ADR报告40%。相比起传统抗肿瘤药物发生不良反应的女性比例高于男性,新型抗肿瘤药物的不良反应发生男女比例更加均衡。传统抗肿瘤药物和新型抗肿瘤药物在2020年和2021年ADR报告中给药途径的前3位均一致,主要为静脉给药方式。传统抗肿瘤药物例次排名前3位分别是紫杉醇、多西他赛和奥沙利铂,新型抗肿瘤药物例次排名前3位分别是注射用曲妥珠单抗、信迪利单抗注射液和贝伐珠单抗注射液。结论应不断加强抗肿瘤药物不良反应监测工作的开展,关注易发生ADR群体,可采用药学监护措施等,减少ADR的发生,对出现的ADR应尽早采取有效的措施,提高患者的用药安全性。

Objective To analyze the general situation,characteristics and rules of adverse drug reaction(ADR)reports of anti-tumor drugs,and to study the influencing factors of ADR.Methods The adverse reactions of anti-tumor drugs in Jiangmen City from 2020 to 2021 were collected and analyzed retrospectively through the pharmacovigilance and risk control system of Guangdong Province.Results The serious ADR reports of anti-tumor drugs in 2020 and 2021 accounted for about 40%of the city's serious ADR reports.Compared with traditional anti-tumor drugs,the proportion of women is higher than that of men,and the proportion of men and women in new anti-tumor drugs is more balanced.The top three routes of administration of traditional anti-tumor drugs and new anti-tumor drugs in the ADR reports of 2020 and 2021 were consistent,mainly intravenous administration.The top three traditional anti-tumor drugs were paclitaxel,docetaxel and oxaliplatin,and the top three new anti-tumor drugs were trastuzumab injection,sintilizumab injection and bevacizumab injection.Conclusion It is necessary to continuously strengthen the monitoring of adverse reactions of anti-tumor drugs,pay attention to the groups prone to ADR,and adopt pharmaceutical care measures to reduce the occurrence of ADR.Effective measures should be taken as soon as possible to improve the safety of patients.