Abstract：
Objectives: Graves\' disease (GD) is the most common cause of hyperthyroidism. Antithyroid drugs (ATDs) are the first-line treatment, but when discontinued, >50% of patients experience relapses. Conventional definitive treatment options include surgery and radioiodine therapy (RAI), each with its own disadvantages. Radiofrequency ablation (RFA) achieved promising short-term remission rates in a previous pilot study. The current study reports our experience of using RFA to treat relapsed GD in the largest cohort of patients with a longer follow-up period. Methods: This single-arm prospective study recruited consecutive patients aged ≥18 with persistent/relapsed GD requiring ATD from two tertiary endocrine surgery centers. Those with compressive goiter, suspected thyroid malignancy, moderate-to-severe Graves\' ophthalmopathy, preference for surgery/RAI, or pregnancy were excluded. Eligible patients received ultrasound-guided RFA to the entire bulk of the thyroid gland. ATDs were discontinued afterward, and thyroid function tests were monitored bimonthly. The primary outcome was the disease remission rate at 24 months follow-up after single-session RFA, defined as being biochemically euthyroid or hypothyroid without ATD. Secondary outcomes were complication rates. Results: Of the 100 patients considered, 30 (30.0%) patients were eligible and received RFA. Most were female patients (93.3%). The median total thyroid volume was 23 mL (15.9-34.5). All completed 24 months follow-up. After single-session RFA, disease remission rates were 60.0% at 12 months and 56.7% at 24 months. Among the 13 patients with relapse after RFA, 9 (69%) required a lower ATD dose than before RFA; 2 received surgery without complications. Total thyroid volume was the only significant factor associated with relapse after RFA (odds ratio 1.054, confidence interval 1.012-1.099, p = 0.012). At 24 months, RFA led to disease remission in 100% of the 9 patients with a total thyroid volume <20 mL and 35% of patients with a total thyroid volume ≥20 mL (p = 0.007). There was no vocal cord palsy, skin burn, hematoma, or thyroid storm after RFA. Conclusions: In a highly selected group of patients with relapsed GD and predominantly small thyroid glands, single-session RFA may achieve disease remission. Smaller total thyroid volume may be a favorable factor associated with disease remission after RFA. The results of this study need to be confirmed with a long-term clinical trial. Clinical Trial Registration: This study is registered at www.clinicaltrial.gov with identifier NCT06418919.
摘要：
目的Graves病(GD)是甲状腺功能亢进最常见的病因。抗甲状腺药物（ATD）是一线治疗，但当停药时，>50%的患者遭受复发。常规的确定性治疗选择包括手术和放射性碘治疗（RAI），每个人都有自己的缺点。在先前的初步研究中，射频消融（RFA）取得了有希望的短期缓解率。当前的研究报告了我们使用RFA治疗复发性GD的经验，该经验来自随访时间较长的最大患者队列。方法这项单臂前瞻性研究从两个三级内分泌手术中心连续招募年龄≥18岁的持续性/复发性GD患者，需要ATD。患有压缩性甲状腺肿的人，疑似甲状腺恶性肿瘤,中度至重度Graves眼病，首选手术/RAI或孕妇被排除.符合条件的患者接受了超声引导的RFA对整个甲状腺。之后停用ATDs，每两个月监测一次甲状腺功能检查。主要结果是单次RFA后24个月随访的疾病缓解率，定义为无ATD的生化甲状腺功能正常或甲状腺功能减退。次要结果是并发症发生率。结果在考虑的100例患者中，30例（30.0％）患者符合条件并接受RFA。大多数为女性患者（93.3%）。中位总甲状腺体积为23mL（15.9-34.5）。全部完成24个月随访。在单会话RFA之后，12个月时疾病缓解率为60.0%,24个月时为56.7%.在RFA后复发的13例患者中，9(69%)所需的ATD剂量低于RFA前；2接收手术无并发症。甲状腺总体积是与RFA后复发相关的唯一重要因素（OR1.054，95％CI1.012-1.099，p=0.012）。24个月时,RFA导致疾病缓解100%的9例患者，甲状腺总体积<20ml，35％的患者甲状腺总体积≥20ml（p=0.007）。没有声带麻痹,皮肤烧伤,血肿,或RFA后的甲状腺风暴。结论在一组高度选择的复发性GD患者中，主要是甲状腺小腺体，单次RFA可实现疾病缓解。甲状腺总体积较小可能是RFA后疾病缓解的有利因素。这项研究的结果需要通过长期的临床试验来证实。
