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1.上海交通大学医学院附属瑞金医院药剂科,上海 200025
2.河南省人民医院药剂科,郑州 450003
3.上海市第八人民医院药学部,上海 200235
4.青海油田医院药剂科,甘肃 敦煌 736202
主管药师。研究方向:医院药学。E-mail:om40907@rjh.com.cn
主管药师,博士。研究方向:肿瘤药学。E-mail:nhuxiaoni@126.com
收稿日期:2025-03-20,
修回日期:2025-08-14,
录用日期:2025-08-14,
纸质出版日期:2025-09-30
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欧敏,王亚琴,朱志敏,等.贝伐珠单抗生物类似药与原研生物药的临床转换模式及转换原因分析[J].中国药房,2025,36(18):2297-2300.
OU Min,WANG Yaqin,ZHU Zhimin,et al.Clinical switching patterns and reasons between bevacizumab biosimilar and originator drugs[J].ZHONGGUO YAOFANG,2025,36(18):2297-2300.
欧敏,王亚琴,朱志敏,等.贝伐珠单抗生物类似药与原研生物药的临床转换模式及转换原因分析[J].中国药房,2025,36(18):2297-2300. DOI: 10.6039/j.issn.1001-0408.2025.18.14.
OU Min,WANG Yaqin,ZHU Zhimin,et al.Clinical switching patterns and reasons between bevacizumab biosimilar and originator drugs[J].ZHONGGUO YAOFANG,2025,36(18):2297-2300. DOI: 10.6039/j.issn.1001-0408.2025.18.14.
目的
2
分析贝伐珠单抗生物类似药与原研生物药的临床转换模式及转换原因。
方法
2
回顾性收集2018年1月1日至2023年12月31日在上海交通大学医学院附属瑞金医院接受贝伐珠单抗治疗的1 175例肿瘤患者资料,按用药类型分为原研生物药组(
n
=250)和生物类似药组(
n
=925)。比较两组患者的转换率、转换类型及转换原因。
结果
2
两组患者的转换率、转换类型、转换次数比较,差异均无统计学意义(
P
>0.05),转换类型均以单次、单向转换为主。生物类似药组患者因不良事件转换的比例显著高于原研生物药组,因治疗成本转换的比例显著低于原研生物药组(
P
<0.05);两组患者因疗效和药物可及性转换的比例比较,差异均无统计学意义(
P
>0.05)。
结论
2
贝伐珠单抗生物类似药与原研生物药均以单次、单向转换为主;治疗成本和药物可及性是原研生物药使用者转换的主要原因,药物可及性和不良事件是生物类似药使用者转换的主要原因。
OBJECTIVE
2
To analyze clinical switching patterns and reasons between bevacizumab biosimilar and originator drugs.
METHODS
2
The data were collected from 1 175 cancer patients treated with bevacizumab at Ruijin Hospital, Shanghai Jiao Tong University School of Medicine from January 1, 2018, to December 31, 2023. The patients were divided into originator group (
n
=250) and biosimilar group (
n
=925). The switching rate, switching type and reasons of the two groups were compared.
RESULTS
2
There were no statistically significant differences in the switching rate, switching types, and the number of switches between the two groups (
P
>0.05). Single, one-way switches were the switching type in both groups. The proportion of patients in the biosimilar group who switched due to adverse events was significantly higher than originator group, while the proportion of patients who switched due to treatment costs was significantly lower than originator group (
P
<0.05). There were no statistically significant differences in the proportions of patients who switched due to efficacy and drug accessibility between the two groups (
P
>0.05).
CONCLUSIONS
2
The switching between bevacizumab biosimilar and the originator drugs mainly involves single, one-way switches. Treatment costs and drug accessibility are the main factors for the switches among users of originator drugs, while drug accessibility and adverse events are the main factors for the switches among users of biosimilar.
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