诊室环境下纳秒脉冲场消融治疗症状性良性甲状腺结节的首个临床系列
本研究回顾性分析38例患者（48个症状性良性甲状腺结节）在诊室接受纳秒脉冲场消融（nsPFA）的短期结局。结节体积在1、3、6、12个月平均缩小49.0%、53.5%、51.8%、50.2%，无操作相关并发症，所有患者症状改善，部分抗甲状腺药物成功停用。提示nsPFA是症状性良性甲状腺结节微创治疗的有前景选择。
要点
- nsPFA治疗后结节体积在12个月内平均缩小约50%，症状早期改善。
- 无操作或术后并发症，安全性良好。
- 部分毒性结节患者术后1个月内成功停用抗甲状腺药物。
核心结论
- nsPFA是症状性良性甲状腺结节有前景的微创手术替代方案，可显著缩小体积且安全性良好。
研究设计与样本
- 回顾性病历审查，纳入38例患者共48个症状性良性甲状腺结节，良性细胞学经细针穿刺活检确认。
- 体积缩小分析在结节水平采用重复测量方法，考虑患者内相关性。
主要发现
- 1、3、6、12个月结节平均体积缩小分别为49.0%[CI 42.5-55.4]、53.5%[CI 48.6-58.4]、51.8%[CI 45.2-58.5]、50.2%[CI 34.9-65.5]。
- 主要结节接受中位37次低电压和24次默认电压周期，额外结节所需总周期更少。
- 无操作或术后并发症，所有患者报告症状改善，常早至治疗后2周。
- 3例毒性结节和1例非毒性结节患者初始使用抗甲状腺药物，均在nsPFA后1个月内成功停药。
- 后续甲状腺功能监测显示毒性和非毒性结节患者均无异常。
临床怎么用
- 对于症状性良性甲状腺结节，nsPFA可作为微创治疗选项，尤其适合不宜或不愿手术者。
- 术后需监测甲状腺功能，尤其对毒性结节患者，以评估药物停用可行性。
局限性
- 样本量较小（38例患者，48个结节）。
- 回顾性设计可能影响因果推断。
- 后期随访失访可能影响持续有效性的解读。
- 随访时间有限，需更大规模前瞻性研究验证长期结局。
以上解读依据论文摘要（全文未开放获取或许可不允许翻译转载）。
原文
BACKGROUND: The nPulse™ Vybrance™ Percutaneous Electrode System delivers nanosecond pulsed field ablation (nsPFA), a nonthermal technology that permeabilizes cell membranes while preserving surrounding structures. As a novel therapeutic approach in the United States, nsPFA may offer a nonsurgical alternative for symptomatic benign thyroid nodules (BTNs). This study evaluates the short-term clinical outcomes and safety of nsPFA treatment performed in a clinic setting, focusing on changes in nodule volume and treatment-related complications. METHODS: A retrospective chart review was conducted of 38 patients (48 symptomatic BTNs) treated with nsPFA. Benign cytology was confirmed via fine-needle aspiration biopsy. Since some patients underwent nsPFA of multiple BTNs, analysis of volume reduction was performed at the nodule level using a repeated measures approach, which accounts for within-patient correlation when estimating average changes over time. RESULTS: Average nodule volume reduction at 1, 3, 6, and 12 months was 49.0% [confidence interval (CI) 42.5-55.4], 53.5% [CI 48.6-58.4], 51.8% [CI 45.2-58.5], and 50.2% [CI 34.9-65.5], respectively. Primary nodules received a median of 37 low-voltage and 24 default-voltage cycles, with additional nodules requiring fewer total cycles. No procedural or post-procedural complications were observed. All patients reported symptomatic improvement, often as early as 2 weeks following treatment. Three patients with toxic nodules and one with a nontoxic nodule were initially on antithyroid medication; all successfully discontinued antithyroid medication within 1 month of nsPFA. Subsequent thyroid function monitoring showed no abnormalities across patients with toxic and nontoxic nodules. CONCLUSIONS: This study represents the first reported clinical series of nsPFA outcomes for thyroid nodules in North America and the first in the world in a clinic setting. Early findings suggest that nsPFA is a promising, minimally invasive alternative to surgery for symptomatic BTNs, offering significant volume reduction and an excellent safety profile. The rapid symptomatic improvement and durable volume reductions during limited follow-up support further investigation. The modest sample size, retrospective design, and loss to follow-up at later time points may affect the interpretation of sustained effectiveness. Larger, prospective studies with extended follow-up are warranted to validate these results, assess long-term outcomes, and compare procedural environments.
引用
- Ihrig IC, Mancera C, Moreno M, et al. First Clinical Series of Patients Undergoing Nanosecond Pulsed Field Ablation for Symptomatic Benign Thyroid Nodules in a Clinic Setting. Thyroid. 2026. PMID: 42220239. doi:10.1177/10507256261443630
供执业医师工作参考，不替代临床判断；数值与分级以指南原文为准。