贝伐珠单抗生物类似药与原研药疗效及不良反应的回顾性分析比较  

Comparison of efficacy and adverse reactions between bevacizumab biosimilar and the reference listed drug

作　　者：黄丽霞 刘基华[1] 刘雪莹 刘澍[1] 黄红兵[1] 刘韬[1] 周捷[1] HUANG Li-xia;LIU Ji-hua;LIU Xueying(Department of Pharmacy,Sun Yat-sen University Cancer Center,State Key Laboratory of Oncology in South China,Collaborative Innovation Center for Cancer Medicine,Guangzhou 510060,China;不详)

机构地区：[1]中山大学肿瘤防治中心药学部,华南肿瘤学国家重点实验室,肿瘤医学协同创新中心,广州510060 [2]东莞黄江医院药剂科,广东东莞523750

出　　处：《中国处方药》2022年第8期1-4,共4页Journal of China Prescription Drug

基　　金：吴阶平医学基金会临床科研专项基金课题(320.6750.2020-10-91)。

摘　　要：目的比较贝伐珠单抗原研药安维汀与国产生物类似药安可达在与化疗药物联用治疗的方案中,两者的疗效和不良反应是否具有显著性差异,为优化抗肿瘤治疗方案提供参考。方法收集接受贝伐珠单抗+培美曲塞+奥沙利铂(方案1)、贝伐珠单抗+卡培他滨+奥沙利铂(贝伐珠单抗+XELOX)(方案2)和贝伐珠单抗+亚叶酸钙+5-氟尿嘧啶+奥沙利铂(贝伐珠单抗+FOLFOX)(方案3)治疗的结直肠癌患者,分别将患者分为安维汀组、安可达组和先后使用过两种药物的更替用药组,收集患者的肿瘤标志物指标、影像学诊断结果、血常规指标和生化指标,用卡方检验分析各组出现的肿瘤学指标异常和不良反应事件的频次是否具有显著性差异。结果在安维汀组、安可达组和更替用药组中,出现肿瘤学指标的异常均没有显著性差异(P>0.05)。在不良反应事件的分析中,使用方案1治疗时,安维汀组胃肠道反应的发生率显著低于安可达组(P<0.017);使用方案3治疗时,安可达组白细胞降低的发生率显著低于安维汀组(P<0.017);而在方案2中,各组各项不良反应发生率并无显著性差异。结论在三个治疗方案中,各组疗效均没有显著性差异,反映出两个厂家的贝伐珠单抗疗效相当。在治疗方案1中,为了降低胃肠道反应的发生率,可尝试选用安维汀进行治疗。在治疗方案3中,为减轻药物骨髓毒性所致的白细胞减少的发生率,可尝试选用安可达进行治疗。Objective To compare the therapeutic efficacy and adverse reactions between bevacizumab biosimilar(Ankeda)and the reference listed drug(Avastin)for optimizing therapy.Methods The colon cancer patients who were treated with bevacizumab+pemetrexed+oxaliplatin,bevacizumab+XELOX and bevacizumab+FOLFOX were divided into three groups based on different treatment schemes.The patients were divided into bevacizumab treated group,biosimilar of bevacizumab treated group and the group treated with both drugs.Tumor markers,imaging diagnosis,hematological examination and biochemical examination were statistical analyzed with Chi square test to compare the proportion of efficacy and adverse events in each group.Results The therapeutic efficacy of three scheme which used bevacizumab or its biosimilar or used both alternatively had no significant difference.The gastrointestinal reaction and bacterial infection in bevacizumab+pemetrexed+oxaliplatin therapeutic scheme which only used Avastin showed higher occurrence significantly(P<0.05).WBC decline in bevacizumab+FOLFOX which only used Ankeda showed higher occurrence significantly(P<0.05).Conclusion The therapeutic effect of Ankeda and Avastin has no obvious difference,which indicated that the two bevacizumab could be used separately or alternatively.In the bevacizumab+pemetrexed+oxaliplatin treatment,to decrease gastrointestinal adverse,Ankeda could be used in priority.In bevacizumab+FOLFOX treatment,Avastin was preferred to decrease leukopenia probably caused by chemotherapeutic drugs.

关 键 词：贝伐珠单抗 生物类似药 原研药 

分 类 号：R969.3[医药卫生—药理学]