在患有甲状腺癌的患者中,复合人体甲状腺蛋白加放射性:一种非劣势性随机临床试验
Hui Tan1, Yushen Gu1, Yan Xiu1
1Department of Nuclear Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.
JAMA network open
|November 7, 2024
概括
复合人体甲状腺激素 (SNA001) 在差异化甲状腺癌的放射性治疗中与甲状腺激素撤销一样有效. SNA001显示出更好的安全概况,不良事件较少.
科学领域:
- 内分泌学 在内分泌学.
- 在瘤学瘤学.
- 核医学是一种核医学.
背景情况:
- 放射性 (RAI) 治疗是分化甲状腺癌 (DTC) 手术后的标准治疗方法.
- 对于中等风险的DTC,最优的RAI刺激方法仍在调查中.
研究的目的:
- 为了比较复合人体甲状腺激素 (SNA001) 与甲状腺激素撤销 (THW) 的疗效和安全性,用于中等风险的DTC患者的RAI治疗.
主要方法:
- 一个第三阶段,开放标签,随机临床试验,涉及307名中等风险DTC患者.
- 在3.7 GBq RAI之前,患者接受了SNA001 (0.9毫克每天内服2天) 或THW (3-6周).
- 主要终点:6-8个月后RAI治疗成功率 (全身扫描阴性,刺激性铁血球蛋白<1.0 ng/mL).
主要成果:
- 在不同组之间,RAI治疗的成功率不差:SNA001的43.8%,THW的47.1%.
- 与THW组 (58.8%) 相比,SNA001组 (29.9%) 的不良事件明显较低 (P < .001).
- 对于SNA001.1,没有发生与治疗相关的中止或修改.
结论:
- 在中等风险的DTC中,SNA001在RAI治疗中与THW无差.
- 与THW相比,SNA001提供了有利的安全概况,并减少了不良事件的发生率.
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