Unit of metabolic diseases, "S. M. Goretti" Hospital, Latina, Italy.
Unit of Endocrinology and Diabetes, Campus Bio-Medico University, Rome, Italy.
J Clin Endocrinol Metab. 2021 May 13;106(6):1692-1701. doi: 10.1210/clinem/dgab102.
Radiofrequency ablation (RFA) seems to achieve a significantly larger nodule volume reduction rate (VRR) than laser ablation (LA) in benign nonfunctioning thyroid nodules (BNTNs).
To compare the efficacy and safety of both treatments at 12-month follow-up in patients with solid or predominantly solid BNTN.
This was a single-center, 12-month, randomized, superiority, open-label, parallel-group trial conducted in an outpatient clinic. Sixty patients with a solitary BNTN or dominant nodule characterized by pressure symptoms/cosmetic problems were randomly assigned (1:1 ratio) to receive either a single session of RFA or LA. Twenty-9 patients per group completed the study. The main outcome measures were VRR and proportion of nodules with more than 50% reduction (technical success rate).
At 12 months, VRR was 70.9 ± 16.9% and 60.0 ± 19.0% in the RFA and LA groups, respectively (P = .024). This effect was confirmed in the linear regression model that was adjusted for age, sex, nodule baseline volume, and proportion of cellular components (RFA treatment: β = .390; P = .009). No significant between-group difference was observed in the technical success rate at 12 months after treatment. A statistically significant improvement was observed from the baseline to the 12-month follow-up for compression (RFA: 4.6 ± 2.6 and 1.3 ± 0.8, P < .001; and LA: 4.6 ± 2.1 and 1.6 ± 0.8, respectively, P < .001) and cosmetic (RFA: 3.4 ± 0.6 and 1.3 ± 0.5, P < .001; and LA: 3.4 ± 0.5 and 1.4 ± 0.6, P < .001) scores although the between-group differences were not significant.
RFA achieved a significantly larger nodule volume reduction at 12 months; however, the technical success rate was similar in the RFA and LA groups.
射频消融(RFA)似乎比激光消融(LA)在良性非功能性甲状腺结节(BNTN)中实现更大的结节体积减少率(VRR)。
比较两种治疗方法在 12 个月随访时对实性或主要实性 BNTN 患者的疗效和安全性。
这是一项单中心、12 个月、随机、优效性、开放标签、平行组试验,在门诊进行。60 例患者患有单发 BNTN 或主要由压迫症状/美容问题引起的结节,随机分为 RFA 或 LA 治疗组(1:1 比例)。每组各有 29 例患者完成了研究。主要观察指标为 VRR 和结节减少 50%以上的比例(技术成功率)。
在 12 个月时,RFA 组和 LA 组的 VRR 分别为 70.9%±16.9%和 60.0%±19.0%(P=0.024)。在调整年龄、性别、结节基线体积和细胞成分比例的线性回归模型中,这一效果得到了确认(RFA 治疗:β=0.390;P=0.009)。治疗 12 个月后,两组之间的技术成功率无显著差异。从基线到 12 个月随访,观察到压迫(RFA:4.6±2.6 和 1.3±0.8,P<0.001;和 LA:4.6±2.1 和 1.6±0.8,分别,P<0.001)和美容(RFA:3.4±0.6 和 1.3±0.5,P<0.001;和 LA:3.4±0.5 和 1.4±0.6,P<0.001)评分均有统计学显著改善,尽管组间差异无统计学意义。
RFA 在 12 个月时实现了更大的结节体积减少,但 RFA 和 LA 两组的技术成功率相似。