Taïeb D, Sebag F, Cherenko M, Baumstarck-Barrau K, Fortanier C, Farman-Ara B, De Micco C, Vaillant J, Thomas S, Conte-Devolx B, Loundou A, Auquier P, Henry J F, Mundler O
Service Central de Biophysique et de Médecine Nucléaire, Centre Hospitalo-Universitaire de la Timone, Marseille Cedex 5, France.
Clin Endocrinol (Oxf). 2009 Jul;71(1):115-23. doi: 10.1111/j.1365-2265.2008.03424.x. Epub 2008 Sep 18.
Recombinant human TSH (rhTSH) has become the modality of choice for radioiodine remnant ablation (RRA) in low-risk thyroid cancer patients.
The aims of the present prospective randomized study were to evaluate the impact of TSH stimulation procedure (hypothyroidism vs. rhTSH) on quality of life (QoL) of thyroid cancer patients undergoing RRA and to evaluate efficacy of both procedures. L-T4 was initiated in both groups after thyroidectomy. After randomization, L-T4 was discontinued in hypothyroid (hypo) group and continued in rhTSH group. A measure of 3.7 GBq of radioiodine was given to both groups. The functional assessment of chronic illness therapy-fatigue (FACIT-F) was administered from the early postoperative period to 9 months. Socio-demographic parameters, anxiety and depression scales were also evaluated (CES-D, BDI and Spielberger state-trait questionnaires). At 9 months, patients underwent an rhTSH stimulation test, diagnostic (131)I whole body scan (dxWBS) and neck ultrasonography.
A total of 74 patients were enrolled for the study. There was a significant decrease in QoL from baseline (t0) to t1 (RRA period) in the hypothyroid group with significant differences in FACIT-F TOI (P < 10(-3)), FACT-G total score (P = 0.005) and FACIT-F total score (P = 0.003). By contrast, QoL was preserved in the rhTSH group. In the multivariate analysis, FACIT-TOI changes were only affected by the modality of TSH stimulation performed for RRA. From 3 to 9 months, changes of QoL scales and subscales were no longer statistically different in both groups of patients. Based on serum rhTSH-stimulated Tg alone (Tg < 0.8 microg/l, BRAHMS Tg Kryptor), no difference in ablation success was observed between rhTSH and hypothyroidism groups, 91.7% and 97.1%, respectively. A higher rate of persistent thyroid remnants was observed in the rhTSH arm, although in most cases uptake was < 0.1% and of no clinical significance.
rhTSH preserves QoL of patients undergoing RRA with similar rates of ablation success compared to hypothyrodism. However, there is a wide heterogeneity in the clinical impact of hypothyroidism.
重组人促甲状腺素（rhTSH）已成为低风险甲状腺癌患者放射性碘残留消融（RRA）的首选方式。
本前瞻性随机研究的目的是评估促甲状腺素刺激程序（甲状腺功能减退与rhTSH）对接受RRA的甲状腺癌患者生活质量（QoL）的影响，并评估两种程序的疗效。两组患者在甲状腺切除术后均开始使用左甲状腺素（L-T4）。随机分组后，甲状腺功能减退（甲减）组停用L-T4，rhTSH组继续使用。两组均给予3.7GBq的放射性碘。从术后早期至9个月进行慢性病治疗-疲劳功能评估（FACIT-F）。还评估了社会人口统计学参数、焦虑和抑郁量表（CES-D、BDI和斯皮尔伯格状态-特质问卷）。在9个月时，患者接受rhTSH刺激试验、诊断性（131）I全身扫描（dxWBS）和颈部超声检查。
共有74例患者纳入研究。甲减组从基线（t0）到t1（RRA期）生活质量显著下降，FACIT-F TOI（P < 10⁻³）、FACT-G总分（P = 0.005）和FACIT-F总分（P = 0.003）有显著差异。相比之下，rhTSH组生活质量得以保留。在多变量分析中，FACIT-TOI变化仅受RRA所采用的促甲状腺素刺激方式影响。从3个月到9个月，两组患者生活质量量表和子量表的变化不再有统计学差异。仅基于血清rhTSH刺激后的Tg（Tg < 0.8μg/l，BRAHMS Tg Kryptor），rhTSH组和甲状腺功能减退组的消融成功率无差异，分别为91.7%和97.1%。rhTSH组持续性甲状腺残留率较高，尽管在多数情况下摄取率<0.1%且无临床意义。
与甲状腺功能减退相比，rhTSH可保留接受RRA患者的生活质量，且消融成功率相似。然而，甲状腺功能减退的临床影响存在广泛异质性。
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