Department of Endocrinology and Metabolism, Odense University Hospital, Odense, Denmark.
Clin Endocrinol (Oxf). 2010 Mar;72(3):411-6. doi: 10.1111/j.1365-2265.2009.03650.x. Epub 2009 Jun 8.
Recombinant human TSH (rhTSH) is used to augment the effect of radioiodine therapy for nontoxic multinodular goitre. Reports of acute thyroid swelling and hyperthyroidism warrant safety studies evaluating whether these side-effects are dose dependent.
To determine the effects on thyroid size and function of various doses of rhTSH.
In nine healthy male volunteers, the effect of placebo, 0.1, 0.3 and 0.9 mg of rhTSH was examined in a paired design including four consecutive study rounds.
Main outcome measures were evaluated at baseline, 24 h, 48 h, 96 h, 7 days and 28 days after rhTSH and included: Thyroid volume (TV) estimation by planimetric ultrasound, and thyroid function by serum TSH, free T3, free T4 and Tg levels.
Following placebo or 0.1 mg rhTSH, the TV did not change significantly from baseline at any time. At 24 and 48 h after administration of 0.3 mg rhTSH, the TV increased by 37.4 +/- 12.3% (SEM) (P = 0.03) and 45.3 +/- 16.1% (P = 0.05) respectively. After 0.9 mg rhTSH, the TV increased by 23.3 +/- 5.8% (P = 0.008) and 35.5 +/- 18.4% (P = 0.02) respectively. The increase in serum FT3, FT4 and thyroglobulin (Tg) was greater when administering 0.3 mg compared with 0.1 mg (P = 0.02) and when administering 0.9 mg compared with 0.3 mg (P = 0.02). After 0.1 mg rhTSH, the increase in FT3 and Tg was not significantly different from placebo whereas the FT4 increase was significantly higher (P = 0.02 compared with placebo).
In healthy individuals, rhTSH-induced thyroid swelling and hyperthyroidism is rapid and dose dependent. If valid for patients with goitre, our results suggest that these adverse effects are unlikely to be of clinical significance, following doses of rhTSH of 0.1 mg or less.
重组人促甲状腺激素（rhTSH）用于增强放射性碘治疗对非毒性多结节性甲状腺肿的疗效。甲状腺肿胀和甲状腺功能亢进等急性副作用的报告需要进行安全性研究，以评估这些副作用是否与剂量有关。
确定不同剂量 rhTSH 对甲状腺大小和功能的影响。
在 9 名健康男性志愿者中，采用配对设计，包括连续 4 个研究周期，分别评估安慰剂、0.1、0.3 和 0.9mg rhTSH 的作用。
主要观察指标在 rhTSH 后 24 小时、48 小时、96 小时、7 天和 28 天进行评估，包括：甲状腺体积（TV）通过平面超声估计，以及血清 TSH、游离 T3、游离 T4 和 Tg 水平的甲状腺功能。
在给予安慰剂或 0.1mg rhTSH 后，TV 在任何时间均未从基线显著变化。在给予 0.3mg rhTSH 后 24 小时和 48 小时，TV 分别增加了 37.4%±12.3%（SEM）（P=0.03）和 45.3%±16.1%（P=0.05）。给予 0.9mg rhTSH 后，TV 分别增加了 23.3%±5.8%（P=0.008）和 35.5%±18.4%（P=0.02）。与 0.1mg 相比，给予 0.3mg 时，血清 FT3、FT4 和甲状腺球蛋白（Tg）的增加更大（P=0.02），与 0.9mg 相比，增加更大（P=0.02）。给予 0.1mg rhTSH 后，FT3 和 Tg 的增加与安慰剂无显著差异，而 FT4 的增加显著更高（与安慰剂相比，P=0.02）。
在健康个体中，rhTSH 诱导的甲状腺肿胀和甲状腺功能亢进是快速和剂量依赖性的。如果对甲状腺肿患者有效，我们的结果表明，在 0.1mg 或更少的 rhTSH 剂量下，这些不良反应不太可能具有临床意义。
