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: 6123214
• 负责人: ANDREA MANNI
• 金额: $ 3.26万
• 依托单位: PENNSYLVANIA STATE UNIV HERSHEY MED CTR
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6123214
• 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 withdrawal of thyroid hormone replacement to stimulate endogenous TSH secretion needed to optimize I131 uptake by residual thyroid tissue and/or metastasis. This approach may be hazardous in patients with medical conditions 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 recombinant 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 recombinant 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，已接受近全甲状腺切除术的分化良好的甲状腺癌患者经常接受全身I131扫描和I131治疗，如果在扫描中发现甲状腺残留和/或转移。 在这些治疗之前，标准治疗需要停止甲状腺激素替代治疗，以刺激内源性TSH分泌，从而优化残留甲状腺组织和/或转移灶对I131的摄取。 这种方法对于患有充血性心力衰竭等疾病的患者可能是危险的，这些疾病可能会受到甲状腺功能减退症长期状态的不利影响。本研究的目的是为甲状腺癌患者提供重组TSH（Thyrogen）注射，以避免在获得甲状腺扫描以指导和治疗残留甲状腺癌之前出现长期甲状腺功能减退。 作为重组技术的产物，Thryrogen可以支持TSH依赖性代谢活性，而不被识别为抗原实体。 到目前为止，两名患者已成功地治疗甲状腺根据这一协议。 两者均未出现任何不良反应，并且在两次甲状腺素给药中，全身扫描和I131治疗时均能观察到残留和/或转移性甲状腺组织。