我院贝伐珠单抗生物类似药与原研药相关不良反应回顾性分析  

Retrospective analysis of adverse drug reactions of bevacizumab biosimilar and original drug in our hospital

作　　者：丁年羊[1] 李莉 方攀奇 徐思露 赵敏[1] 燕丹[1] DING Nianyang;LI Li;FANG Panqi;XU Silu;ZHAO Min;YAN Dan(Dept.of Pharmacy,Jiangsu Cancer Hospital/The Affiliated Cancer Hospital of Nanjing Medical University/Jiangsu Institute of Cancer Research,Nanjing 210009,China;Nanjing Institute for Food and Drug Control,Nanjing 211198,China)

机构地区：[1]江苏省肿瘤医院/南京医科大学附属肿瘤医院/江苏省肿瘤防治研究所药学部,南京210009 [2]南京市食品药品监督检验院,南京211198

出　　处：《中国药房》2024年第4期472-475,共4页China Pharmacy

基　　金：南京市药品不良反应重点监测项目。

摘　　要：目的分析某院贝伐珠单抗生物类似药与原研药相关药物不良反应(ADR)的发生情况,为临床合理用药提供数据支持。方法对江苏省肿瘤医院2022年1-12月上报的贝伐珠单抗生物类似药和原研药相关ADR报告进行回顾性分析。结果我院使用贝伐珠单抗的患者共6818人次,上报ADR报告136份,贝伐珠单抗生物类似药的ADR发生率显著高于原研药(2.18%vs.0.71%,P=0.004)。ADR报告中,治疗方案以贝伐珠单抗与其他肿瘤治疗药物的联合治疗方案为主(129人次);痊愈和好转的患者有118人次;一般ADR报告108份,严重ADR报告28份;ADR主要累及系统/器官以心血管系统为主,贝伐珠单抗生物类似药与原研药引起的高血压/血压升高、白细胞/血小板降低、腹泻和发热发生率比较,差异均无统计学意义。结论贝伐珠单抗生物类似药的相关ADR发生率明显高于原研药,但ADR临床表现无明显差异,临床医生可以根据患者及其家属意愿选择使用。OBJECTIVE To analyze the occurrence of adverse drug reactions(ADR)between bevacizumab biosimilars and original drugs,and to provide data support for rational use of drugs in clinical.METHODS ADR reports of bevacizumab biosimilars and original drugs reported by Jiangsu Cancer Hospital from January to December 2022 were retrospectively analyzed.RESULTS A total of 6818 patients were treated with bevacizumab,and 136 ADR patients were reported.The incidence of ADR caused by bevacizumab biosimilars was higher than original drugs(2.18%vs.0.71%,P=0.004).In ADR reports,the main treatment plan was bevacizumab combined with other tumor drugs(129 patients);118 patients were cured and improved;there were 108 general reports and 28 serious reports;the main system/organ involved in ADR was the cardiovascular system;there were no statistical significance in the incidence rates of hypertension/blood pressure increase,leukocyte/platelet decrease,diarrhea and fever caused by bevacizumab biosimilars and original drugs.CONCLUSIONS The incidence of ADR related to bevacizumab biosimilars is significantly higher than that of the original drugs,but there is no significant difference in the clinical manifestation of ADR.Clinicians can use bevacizumab biosimilars or original drugs based on the willingness of patients and their families.

关 键 词：贝伐珠单抗 生物类似药 原研药 药物不良反应 合理使用 

分 类 号：R969.3[医药卫生—药理学]