射频消融治疗良性甲状腺结节的疗效和安全性:一项前瞻性多中心研究。
Efficacy and Safety of Radiofrequency Ablation for Benign Thyroid Nodules: A Prospective Multicenter Study.
机构信息
Department of Radiology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul 06591, Korea.
Department of Radiology and Research Institute of Radiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul 05505, Korea.
出版信息
Korean J Radiol. 2018 Jan-Feb;19(1):167-174. doi: 10.3348/kjr.2018.19.1.167. Epub 2018 Jan 2.
OBJECTIVE
To assess the efficacy and safety of thyroid radiofrequency (RF) ablation for benign thyroid nodules by trained radiologists according to a unified protocol in a multi-center study.
MATERIALS AND METHODS
From 2010 to 2011, 345 nodules from 345 patients (M:F = 43:302; mean age ± SD = 46.0 ± 12.7 years, range = 15-79) who met eligibility criteria were enrolled from five institutions. At pre-ablation, the mean volume was 14.2 ± 13.2 mL (1.1-80.8 mL). For 12 months or longer after treatment, 276 lesions, consisting of 248 solid and 28 predominantly cystic nodules, were followed. All operators performed RF ablation with a cool-tip RF system and two standard techniques (a transisthmic approach and the moving-shot technique). Volume reduction at 12 months after RF ablation (the primary outcome), therapeutic success, improvement of symptoms as well as of cosmetic problems, and complications were evaluated. Multiple linear regression analysis was applied to identify factors that were independently predictive of volume reduction.
RESULTS
The mean volume reduction at 12 months was 80.3% (n = 276) and at the 24-, 36-, 48-, and 60-month follow-ups 84.3% (n = 198), 89.2% (n = 128), 91.9% (n = 57), and 95.3% (n = 6), respectively. Our therapeutic success was 97.8%. Both mean symptom and cosmetic scores showed significant improvements ( < 0.001). The rate of major complications was 1.0% (3/276). Solidity and applied energy were independent factors that predicted volume reduction.
CONCLUSION
Radiofrequency ablation performed by trained radiologists from multiple institutions using a unified protocol and similar devices was effective and safe for treating benign thyroid nodules.
目的
评估根据统一方案由经过培训的放射科医生对良性甲状腺结节进行射频(RF)消融的疗效和安全性,该方案是一项多中心研究。
材料与方法
2010 年至 2011 年,来自五家机构的 345 名患者(M:F=43:302;平均年龄±标准差=46.0±12.7 岁,范围=15-79)的 345 个结节符合入选标准。在消融前,平均体积为 14.2±13.2ml(1.1-80.8ml)。在治疗后 12 个月或更长时间,对 276 个病灶(包括 248 个实性和 28 个主要囊性结节)进行了随访。所有操作者均使用冷尖端 RF 系统和两种标准技术(经峡部入路和移动射击技术)进行 RF 消融。评估消融后 12 个月的体积减少(主要结局)、治疗成功率、症状改善、美容问题改善以及并发症。应用多元线性回归分析确定与体积减少独立相关的因素。
结果
消融后 12 个月的平均体积减少率为 80.3%(n=276),24、36、48 和 60 个月随访时的体积减少率分别为 84.3%(n=198)、89.2%(n=128)、91.9%(n=57)和 95.3%(n=6)。我们的治疗成功率为 97.8%。平均症状和美容评分均显著改善(<0.001)。主要并发症发生率为 1.0%(3/276)。实性和应用能量是预测体积减少的独立因素。
结论
由多个机构的经过培训的放射科医生使用统一方案和类似设备进行射频消融对治疗良性甲状腺结节是有效且安全的。