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临床试验/NCT00509483
NCT00509483已完成不适用

Long-Term Follow-up and Outcome of Administering Recombinant Human Thyrotropin as an Adjuvant of Therapy With Radioiodine in the Outpatient Treatment of Multinodular Goitres

University of Sao Paulo0 个研究点目标入组 40 人开始时间: 2002年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40

研究概览

简要总结

Background: Preadministration of recombinant human thyrotropin (rhTSH) increases the amount and homogeneity of thyroid radioiodine uptake, and when used as an adjuvant can augment the efficiency of 131I therapy by allowing multinodular goitre (MNG) volume reduction.

Objective: The investigators aimed to assess low-dose rhTSH-aided fixed-activity radioiodine therapy outcome in MNG patients.

Design: This was a long-term (36 months) observational study. Methods: The investigators measured 24 h thyroid radioiodine uptake (RAIU) of 1.4 µCi (0.5 MBq) of 131-iodine at baseline and 24 h after intramuscular injection of 0.1 mg rhTSH in 42 patients (aged 42-80 years) who subsequently received 30 mCi 131-iodine 24 h after an identical rhTSH injection. Urinary iodine was measured at baseline and at 3 months after following a low iodine diet. TSH, free thyroxine (FT4), T3 (T3) and thyroglobulin (TG) were measured at baseline, 24 h, 48 h, 72 h, 168 h, one month, 3, 6, 9, 12, 18, 24 and 36 months after therapy. Thyroid volume was assessed by computer tomography at baseline and every 6 months thereafter.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with multinodular goitre

排除标准

  • Aversion to any form of treatment
  • Previous radioiodine therapy
  • Being unable to complete a prolonged follow-up; and
  • Having serious cardiovascular disorders.

研究者

申办方类型
Other

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