Testori O, Bagnasco M, Banti E, Bombardieri E, Dottorini M E, Fugazzola L, Maffioli L, Perotti G, Rubello D, Seregni E
Struttura Complessa di Medicina Nucleare, A.O.N. SS.Antonio e Biagio e C.Arrigo, Alessandria, Italia.
Minerva Med. 2012 Jun;103(3):209-18.
The established treatment for differentiated thyroid carcinoma (DTC) is founded on total thyroidectomy and subsequent administration of radioiodine (131I) to ablate the thyroid remnant and to treat the metastatic disease. In the case of metastatic or recurrent disease, further cycles of 131I therapy are often necessary. The condition for maximizing the effectiveness of the treatment is to have an adequate stimulation from TSH, which must be >25-30 mIU/L. This elevation is achieved either discontinuing the hormone suppression therapy for an appropriate period, or administering recombinant human TSH (rhTSH). The latter has shown good clinical efficacy in patients with residual thyroid gland and is nowadays commonly employed since it is easy to use and allows to avoid the side effects of hypothyroidism. It thus represents a good alternative to thyroid hormone withdrawal for the remnant ablation, while is still open the question if its efficacy on the management of metastatic disease is superimposable to thyroid hormone withdrawal. To this purpose, a Panel of expert reviewed the literature, assessing the advantages and disadvantages for the patient, as well as the impact in terms of cost and benefit to the National Health Service. The work of the Panel concluded with a proposal for the use of rhTSH in selected patients with metastatic DTC, in which is considered the efficacy and safety of the product and is examined its use in terms of costs; this proposal was accepted by the Italian Drug Agency resulting in an update of the indications for rhTSH.
分化型甲状腺癌(DTC)的既定治疗方法基于全甲状腺切除术以及随后给予放射性碘(131I)以消融甲状腺残余组织并治疗转移性疾病。对于转移性或复发性疾病,通常需要进一步进行131I治疗周期。使治疗效果最大化的条件是要有来自促甲状腺激素(TSH)的充分刺激,TSH必须>25 - 30 mIU/L。这种升高可通过在适当时间段停用激素抑制疗法或给予重组人促甲状腺激素(rhTSH)来实现。后者在有残余甲状腺组织的患者中已显示出良好的临床疗效,并且由于其使用方便且可避免甲状腺功能减退的副作用,如今被广泛应用。因此,它是用于残余组织消融替代甲状腺激素撤药的良好选择,而其对转移性疾病治疗的疗效是否与甲状腺激素撤药相当仍是个问题。为此,一个专家小组查阅了文献,评估了对患者的利弊以及对国家医疗服务体系的成本效益影响。专家小组的工作以一项关于在特定转移性DTC患者中使用rhTSH的提议结束,其中考虑了该产品的疗效和安全性,并审查了其在成本方面的使用情况;该提议被意大利药品管理局接受,从而更新了rhTSH的适应症。