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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
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| 篇名： | 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 |
| TITLE： | Clinical switching patterns and reasons between bevacizumab biosimilar and originator drugs |
| 摘要： | 目的 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1175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。 |
| ABSTRACT： | OBJECTIVE To analyze clinical switching patterns and reasons between bevacizumab biosimilar and originator drugs. METHODS 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 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 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. |
| 期刊： | 2025年第36卷第18期 |
| 作者： | 欧敏；王亚琴；朱志敏；张芳芳；朱琼妮 |
| AUTHORS： | OU Min，WANG Yaqin，ZHU Zhimin，ZHANG Fangfang，ZHU Qiongni |
| 关键字： | 贝伐珠单抗；原研生物药；生物类似药；药物转换；安全性；不良反应；可及性 |
| KEYWORDS： | bevacizumab； originator drugs； biosimilar； drug switching； safety； adverse reaction； accessibility |
| 阅读数： | 12 次 |
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