微波消融与射频消融治疗实性或实性为主良性甲状腺结节的一项随机对照临床试验

Microwave ablation versus radiofrequency ablation for solid or predominantly solid benign thyroid nodules:a randomized controlled clinical trial

目的比较微波消融(MWA)与射频消融(RFA)治疗良性甲状腺结节(BTN)的短期疗效和安全性。方法前瞻性随机对照试验。收集2019年12月至2021年9月南京分中心(南京中医药大学附属中西医结合医院)符合纳入标准并提供书面知情同意书的36例实性或实性为主的BTN患者,采用区组随机化设计,并用随机信封法进行分组隐匿,以1∶1的比例分配到MWA组或RFA组(每组18例患者)。采用独立样本t检验及χ2检验比较两组治疗后1、3、6个月的结节体积缩小率(VRR)、有效率(VRR≥50%)、美观评分及不良事件发生率。结果两组患者临床特征均具有可比性。消融术后,两组的结节体积均较术前明显缩小。术后1、3、6个月两组间结节体积差异均无统计学意义(均P>0.05)。术后3个月,RFA组结节VRR高于MWA组(62.08%±12.46%比46.90%±23.16%;t=-2.45,P=0.021);但在术后1、6个月,两组间结节VRR差异无统计学意义(均P>0.05)。末次随访时两组的有效率差异无统计学意义(14/18比18/18;P=0.104)。RFA组的结节美观评分低于MWA组[(1.78±0.43)分比(2.17±0.51)分;t=-2.47,P=0.019]。两组的不良事件发生率差异无统计学意义(均P>0.05)。结论MWA和RFA都是治疗BTN有效并安全的方法,其短期疗效和安全性无明显差别;在外观改善方面,RFA稍优于MWA。

Objective To compare the short-term efficacy and the safety of microwave ablation(MWA)and radiofrequency ablation(RFA)in the treatment of benign thyroid nodules(BTNs).Methods This prospective randomized controlled trial,performed from December 2019 to September 2021,included 36 patients with solid or predominantly solid BTNs who met the eligibility criteria and provided written informed consent at the Nanjing sub-center(Affiliated Hospital of Integrated Traditional Chinese and Western Medicine,Nanjing University of Chinese Medicine).Patients were assigned to either the MWA group or the RFA group(18 patients in each group)at a ratio of 1∶1 using a block randomization design and allocation concealment using sealed envelope randomization.The independent-sample t-test andχ2 test were used to compare the volume reduction rates(VRRs),effective rates(VRRs≥50%),cosmetic scores,and complication rates at 1,3,and 6 months after treatment between the two groups.Results The clinical characteristics of the two groups of patients were comparable.After ablation,the nodule volume was significantly reduced in both groups.At 1,3,and 6 months,there was no significant difference in the volume between the two groups(all P>0.05).At 3 months,the RFA group had a larger VRRs than that in the MWA group(62.08%±12.46%vs.46.90%±23.16%,t=-2.45,P=0.021).However,at 1 and 6 months,no statistical significance was observed(both P>0.05).No significant difference was observed in the effective rates at the last follow-up(14/18 vs.18/18,P=0.104).However,the RFA group had a lower cosmetic score than that in the MWA group(1.78±0.43 vs.2.17±0.51,t=-2.47,P=0.019).There was no statistically significant difference in the complication rates between the two groups(all P>0.05).Conclusions Both MWA and RFA were effective and safe treatments for BTNs,with no significant differences in short-term efficacy and safety.In addition,the RFA group showed slightly more favorable outcomes than the MWA group in terms of cosmetic improvement.