Wesche M F, Tiel-V Buul M M, Lips P, Smits N J, Wiersinga W M
Department of Endocrinology and Metabolism, Academic Medical Center, University of Amsterdam, 1105 AZ Amsterdam, The Netherlands.
J Clin Endocrinol Metab. 2001 Mar;86(3):998-1005. doi: 10.1210/jcem.86.3.7244.
A randomized clinical trial was performed in consecutive patients with sporadic nontoxic nodular goiter to compare efficacy and side effects of iodine-131 ((131)I) therapy with suppressive levothyroxine (L-thyroxine) treatment. Sixty-four patients were randomized after stratification for sex and menopausal age to receive (131)I (4.44 MBq/g thyroid; group A) or suppressive L-thyroxine treatment aiming at TSH values between 0.01 and 0.1 mU/L (group B). The main outcome measurements after 2 yr were goiter size by ultrasound, serum thyroid function tests, markers of bone turnover, and bone mineral density (BMD). Fifty-seven patients completed the trial. Goiter size was reduced after 2 yr by 44% in group A and by 1% in group B (P< 0.001). Nonresponders (goiter reduction <13%) were 1 of 29 patients in group A and 16 of 28 patients in group B (P = 0.00001). In responders, goiter reduction in group A (46%) was greater than in group B (22%; P< 0.005). In group A, 45% of patients developed hypothyroidism. In group B, 10 patients experienced thyrotoxic symptoms, requiring discontinuation of treatment in 2 (in 1 because of atrial fibrillation). Markers of bone formation and bone resorption increased significantly in group B, related to a mean decrease of 3.6% of BMD at the lumbar spine after 2 yr (from 1.09 +/- 0.22 to 1.05 +/- 0.23 g/cm(2); P< 0.001), both in pre- and postmenopausal women. No changes in BMD were observed in group A. In conclusion, (131)I therapy is more effective and better tolerated than L-thyroxine treatment in patients with sporadic nontoxic goiter. Suppressive L-thyroxine treatment results in significant bone loss.
对连续性散发性非毒性结节性甲状腺肿患者进行了一项随机临床试验，以比较碘-131（¹³¹I）治疗与左旋甲状腺素（L-甲状腺素）抑制治疗的疗效和副作用。64例患者按性别和绝经年龄分层后随机分组，接受¹³¹I治疗（4.44 MBq/g甲状腺；A组）或旨在使促甲状腺激素（TSH）值在0.01至0.1 mU/L之间的L-甲状腺素抑制治疗（B组）。2年后的主要结局指标包括超声检查的甲状腺肿大小、血清甲状腺功能检查、骨转换标志物和骨密度（BMD）。57例患者完成了试验。2年后，A组甲状腺肿大小减少了44%，B组减少了1%（P<0.001）。无反应者（甲状腺肿缩小<13%）在A组29例患者中有1例，在B组28例患者中有16例（P = 0.00001）。在有反应者中，A组甲状腺肿缩小率（46%）高于B组（22%；P<0.005）。A组中45%的患者发生了甲状腺功能减退。B组中有10例患者出现甲状腺毒症症状，其中2例需要停药（1例因房颤）。B组骨形成和骨吸收标志物显著增加，与绝经前和绝经后女性2年后腰椎BMD平均下降3.6%有关（从1.09±0.22降至1.05±0.23 g/cm²；P<0.001）。A组未观察到BMD变化。总之，对于散发性非毒性甲状腺肿患者，¹³¹I治疗比L-甲状腺素治疗更有效且耐受性更好。L-甲状腺素抑制治疗会导致明显的骨质流失。
