甲状腺微创治疗的疗效、安全性及反应预测因素：一项前瞻性研究。

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中文摘要

目的： 微创技术（MITs），包括经皮乙醇注射（PEI）和射频消融（RFA），是治疗良性甲状腺结节（BTN）的有效非手术选择。然而，反应预测因素和技术决定因素仍未完全明确。
方法： 我们进行了一项前瞻性单中心研究，纳入2022年至2025年间治疗的120个BTN（45个PEI，75个RFA），随访12个月。本研究的主要目的是确定BTN接受MITs后治疗反应的临床和操作预测因素。主要结局指标是12个月体积缩小率（VRR）。次要终点包括美容和症状评分的变化、自主功能性结节（AFTN）的甲状腺功能以及安全性结局。
结果： 基线平均结节体积为22.06 mL，标准差14.52，美容评分为3.39，标准差0.93，吞咽困难评分为3.33，标准差1.8。在12个月时，平均VRR总体为84.24%，PEI后为95.9%，RFA后为77.4%，96.67%的病例达到治疗成功（p < 0.001）。在AFTN中，MITs（包括3个以囊性为主的结节接受PEI治疗和10个实性结节接受RFA治疗）达到平均VRR为88.17%，TSH从0.12（标准差0.13）升高至2.17（标准差2.47）mIU/L；这些患者中76.9%在消融前使用抗甲状腺药物，所有患者在术后均停药。基线结节体积独立预测VRR（β = -0.237；p = 0.014），而能量密度（kcal/mL）预测RFA疗效（β = 1.416；p = 0.047）。所有不良事件均为轻度且短暂，包括局部疼痛（27.5%）、短暂性发声困难（6.7%）以及短暂性咳嗽或迷走神经反应。未发生永久性并发症。
结论： PEI和RFA是治疗BTN安全有效的微创选择，可实现持久的体积缩小并改善临床结局。较小的结节和较高的每毫升能量输送预测最佳反应。

英文摘要

PURPOSE: Minimally invasive techniques (MITs), including percutaneous ethanol injection (PEI) and radiofrequency ablation (RFA), are effective non-surgical options for benign thyroid nodules (BTN). However, predictors of response and technical determinants remain incompletely defined.
METHODS: We conducted a prospective single-center study including 120 BTNs (45 PEI, 75 RFA) treated between 2022 and 2025, with 12-month follow-up. The primary objective of this study was to identify clinical and procedural predictors of treatment response following MITs for BTNs. The primary outcome measure was the 12-month volume reduction ratio (VRR). Secondary endpoints included changes in cosmetic and symptomatic scores, thyroid function in autonomously functioning nodules (AFTN), and safety outcomes.
RESULTS: Baseline mean nodule volume was 22.06 mL SD 14.52, cosmetic score 3.39 SD 0.93, and dysphagia score 3.33 SD 1.8. At 12 months, mean VRR was 84.24% overall, 95.9% after PEI, and 77.4% after RFA, achieving therapeutic success in 96.67% of cases (p < 0.001). In AFTN, MITs, comprising 3 predominantly cystic nodules treated with PEI and 10 solid nodules treated with RFA, achieved a mean VRR of 88.17%, with TSH increasing from 0.12 SD 0.13 to 2.17 SD 2.47 mIU/L; 76.9% of these patients were on antithyroid medication prior to ablation, all discontinued post-procedure. Baseline nodule volume independently predicted VRR (β = - 0.237; p = 0.014), while energy density (kcal/mL) predicted RFA efficacy (β = 1.416; p = 0.047). All adverse events were mild and transient, including local pain (27.5%), transient dysphonia (6.7%), and transient cough or vagal reaction. No permanent complications occurred.
CONCLUSION: PEI and RFA are safe and effective minimally invasive options for BTN, achieving durable volume reduction with improved clinical outcomes. Smaller nodules and higher energy delivery/ml predict optimal response.