转换从静脉注射到固定剂量皮下配方的珀图祖马布和特拉斯图祖马布安全性研究
Tomoya Abe1, Atsunobu Sagara2, Takayuki Suzuki1
1Department of Pharmacy, Saitama Cancer Center, Ina, Saitama 362-0806, Japan.
Molecular and clinical oncology
|January 31, 2025
概括
在患者从静脉注射配方转换时,固定剂量祖马布和祖马布用于皮下注射 (PHESGO) 的组合显示了较少的输液反应. 最初的PHESGO治疗与更高的输液反应率有关,这表明第一次注射是一个关键时期.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
- 临床药房 临床药房
背景情况:
- 有限的临床数据存在于日本从静脉注射配方切换到皮下输入的珀图祖马布和特拉斯图祖马布 (PHESGO).
- 对于采用PHESGO的犹可能源于缺乏关于配方切换的真实安全信息.
- 本研究涉及PHESGO在日本临床环境中的安全性概况,重点关注从IV转向SC的患者.
研究的目的:
- 评估PHESGO在患有乳腺癌或结直肠癌的患者中的安全性.
- 为了比较输液反应 (IRs) 和皮肤/皮下组织疾病在最初的PHESGO诱导疗法和从静脉输注珀图祖马布和特鲁祖马布切换.
- 提供关于PHESGO管理安全性的临床见解,特别是关于配方变化.
主要方法:
- 在山癌症中心治疗51名PHESGO患者的回顾性分析 (2024年1月至3月).
- 在初始诱导治疗组和从静脉注射到皮下PHESGO切换组之间的安全结果的比较.
- 使用常用术语对不良事件的标准v5.0对输液反应的评估,将IR定义为在给药后24小时内1级+症状.
主要成果:
- 在接受初始PHESGO诱导治疗的患者中,输液反应发生在25% (4/16) 患者中,而在切换组中为0% (P=0.0073).
- 第一次服用PHESGO似乎与输液反应的可能性更高有关,与静脉注射配方一致.
- 在初始使用PHESGO后重新转向静脉注射治疗的5名患者中观察到皮肤和皮肤下组织疾病,治疗方法从剂量调整到停药之间有所不同.
结论:
- 从静脉注射转换为皮下注射的祖马布和祖马布 (PHESGO) 似乎是安全的,与最初的PHESGO治疗相比,输液反应的发生率明显较低.
- 第一次注射PHESGO具有较高的输液反应风险,需要仔细监测.
- 皮肤和皮下组织疾病的治疗可能涉及剂量调整或切换回静脉注射配方,特别是在以前有静脉注射治疗经验的患者中.
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