Radiofrequency versus Ethanol Ablation for Treating Predominantly Cystic Thyroid Nodules: A Randomized Clinical Trial.
Radiofrequency versus Ethanol Ablation for Treating Predominantly Cystic Thyroid Nodules: A Randomized Clinical Trial.
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DOI：
10.3348/kjr.2015.16.6.1332
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发表时间：
2015-11
影响因子：
4.8
通讯作者：
Shong YK
中科院分区：
文献类型：
--
作者：
Baek JH;Ha EJ;Choi YJ;Sung JY;Kim JK;Shong YK
比较单次射频消融（RFA）和乙醇消融（EA）治疗以囊性为主的甲状腺结节（PCTN）。这项单盲、随机试验得到了两个中心的机构审查委员会的批准，并在入组前获得了所有患者的知情同意书。在两家医院，将50名患有单一PCTN（囊性部分小于90%和大于50%）的患者随机分配接受RFA（25名患者）或EA（25名患者）治疗。主要结局是6个月随访时的肿瘤体积缩小率（%），优效性界值设定为13%（RFA减去EA）。主要以意向治疗方式进行分析。次要结局是治疗成功率、症状和美容问题的改善以及主要并发症的数量。RFA（n = 22）和EA（n = 24）的平均减容率分别为87.5 ± 11.5%和82.4 ± 28.6%（p = 0.710;平均差异[95%置信区间]，5.1% [-8.0至18.2]），表明无显著差异。关于次要结局，治疗成功（p = 0.490）、平均症状（p = 0.205）和美容评分（p = 0.710）无差异。两组均无严重并发症（p > 0.99）。RFA的治疗效果并不上级于EA;因此，EA可能更适合作为PCTN的一线治疗。
To compare single-session radiofrequency ablation (RFA) and ethanol ablation (EA) for treating predominantly cystic thyroid nodules (PCTNs). This single-blind, randomized trial was approved by the Institutional Review Board of two centers and informed consent was obtained from all patients before enrollment. Fifty patients with a single PCTN (cystic portion less than 90% and greater than 50%) were randomly assigned to be treated by either RFA (25 patients) or EA (25 patients) at two hospitals. The primary outcome was the tumor volume reduction ratio (%) at the six-month follow-up and the superiority margin was set at 13% (RFA minus EA). Analysis was performed primarily in an intention-to-treat manner. The secondary outcomes were the therapeutic success rate, improvement of symptomatic and cosmetic problems, and the number of major complications. The mean volume reduction was 87.5 ± 11.5% for RFA (n = 22) and 82.4 ± 28.6% for EA (n = 24) (p = 0.710; mean difference [95% confidence interval], 5.1% [-8.0 to 18.2]), indicating no significant difference. Regarding the secondary outcomes, therapeutic success (p = 0.490), mean symptom (p = 0.205) and cosmetic scores (p = 0.710) showed no difference. There were no major complications in either group (p > 0.99). The therapeutic efficacy of RFA is not superior to that of EA; therefore, EA might be preferable as the first-line treatment for PCTNs.