USE OF RECOMBINANT HUMAN TSH IN THYROID CANCER PATIENTS

重组人 TSH 在甲状腺癌患者中的应用

• 批准号: 6283096
• 负责人: ANDREA MANNI
• 金额: $ 2.16万
• 依托单位: PENNSYLVANIA STATE UNIV HERSHEY MED CTR
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-12-01 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6283096
• 关键词: clinical research; clinical trials; drug screening /evaluation; hormone therapy; human subject; human therapy evaluation; neoplasm /cancer chemotherapy; recombinant proteins; thyroid function; thyroid neoplasm; thyrotropin

At the present time, patients with well differentiated thyroid cancer who have undergone a near total thyroidectomy are frequently subjected to a total body I131 scan and I131 treatment if thyroid remnants and/or metastasis are identified on the scan. Prior to these treatments, the standard of care requires withrawal of thyroid hormone replacement to stimulate endogenous TSH secretion needed to optimize I131 uptake by residual thyroid tissue and/or metastasis. This approarch may be hazardous in patients with medical consitions such as congestive heart failures, which may be adversely affected by a prolonged state of hypothyroidism. The purpose of this study is to offer patients with thyroid cancer an injection of recombinent TSH (Thyrogen) to avoid prolonged hypothyroidism prior to obtaining a thyroid scan for the direction and treatment of residual thyroid cancer. As a product of recombinent technology, Thryrogen could support TSH-dependent metabolic activities without being recognized as an antigenic entity. Until now, two patients have been successfully treated with thyrogen according to this protocol. Neither experienced any adverse reaction and in both thyrogen administration allowed visualization of residual and/or metastatic thyroid tissue on total body scan and treatment with I131.

目前，高分化甲状腺癌患者 接受过近乎全甲状腺切除术的人经常 对全身进行I131扫描和I131治疗，如果有甲状腺残留和/或 在扫描上发现了转移。在这些治疗之前， 标准护理要求停止甲状腺激素替代治疗 通过以下方式刺激内源性TSH分泌，以优化I131摄取 残留的甲状腺组织和/或转移。此审批人可能是 对患有充血性心脏病等内科疾病的患者来说是危险的 故障，这可能会受到长期的 甲状腺功能减退。这项研究的目的是为患者提供 注射重组促甲状腺激素(THH)预防甲状腺癌 在接受甲状腺扫描前长期甲状腺功能减退 残留甲状腺癌的指导和治疗。作为一种产品 重组技术，Thrygen可支持TSH依赖的代谢 在没有被确认为抗原性实体的情况下进行活动。到目前为止， 两名患者已经成功地接受了胸腺激素的治疗 这个协议。两人都没有经历过任何不良反应，而且 甲状腺激素注射允许显示残留物和/或 全身扫描和131I治疗的转移性甲状腺组织。