Lukes Andrea, Green Minda A
Carolina Women's Research and Wellness Center, Durham, North Carolina, USA.
Virtua OB/Gyn, Voorhees, New Jersey, USA.
J Gynecol Surg. 2020 Oct 1;36(5):228-233. doi: 10.1089/gyn.2020.0021.
This article reports on 3-year clinical outcomes of the Sonography Guided Transcervical Ablation of Uterine Fibroids (SONATA) pivotal trial of transcervical fibroid ablation (TFA) in women with symptomatic uterine myomata. The SONATA, prospective, controlled, multicenter interventional trial enrolled 147 premenopausal women with symptomatic uterine fibroids who underwent uterus-preserving, sonography-guided TFA with the Sonata System (Gynesonics, Inc., Redwood City, CA, USA). Clinical outcomes were assessed over 3 years and included surgical reinterventions, Symptom Severity Score (SSS), and Health-Related Quality of Life (HRQoL) subscales of the Uterine Fibroid Symptom and Quality-of-Life Questionnaire, EuroQol 5-Dimension (EQ-5D) questionnaire, Overall Treatment Effect, treatment satisfaction, physical activity, work impairment, pregnancy outcomes, and adverse events. The 3-year rates of surgical reintervention for heavy menstrual bleeding calculated by the binomial and Kaplan-Meier methods were 9.2% and 8.2%, respectively. Compared to baseline, mean SSS decreased from 55 ± 19 to 22 ± 21, HRQoL increased from 40 ± 21 to 83 ± 23, and EQ-5D increased from 0.72 ± 0.21 to 0.88 ± 0.16 (all < 0.001). Treatment benefit on the SSS, HRQoL, and EQ-5Q exceeded the minimal clinically important difference at every follow-up visit over 3 years. At 3 years, 94% of the subjects reported treatment satisfaction, 88% reported reduced fibroid symptoms, work absenteeism due to fibroid symptoms decreased from 2.9% to 1.4%, and impairment due to fibroids decreased from 51% to 12% for work, and 58% to 14% for physical activity (all < 0.001). No late complications occurred. Women treated with sonography-guided TFA in the SONATA pivotal trial experienced significant and durable reduction of fibroid-related symptoms, with low surgical reintervention rates over 3 years of follow-up.
本文报道了超声引导下经宫颈子宫肌瘤消融术（SONATA）关键试验的3年临床结果，该试验针对有症状子宫肌瘤的女性进行经宫颈肌瘤消融术（TFA）。SONATA是一项前瞻性、对照、多中心干预试验，纳入了147例有症状子宫肌瘤的绝经前女性，她们采用Sonata系统（美国加利福尼亚州红木城的Gynesonics公司）接受了保留子宫的超声引导下TFA。对临床结果进行了3年的评估，包括手术再次干预、症状严重程度评分（SSS）、子宫肌瘤症状与生活质量问卷的健康相关生活质量（HRQoL）子量表、欧洲五维健康量表（EQ-5D）问卷、总体治疗效果、治疗满意度、身体活动、工作障碍、妊娠结局和不良事件。采用二项式法和Kaplan-Meier法计算的因月经过多进行手术再次干预的3年发生率分别为9.2%和8.2%。与基线相比，平均SSS从55±19降至22±21，HRQoL从40±21增至83±23，EQ-5D从0.72±0.21增至0.88±0.16（均P<0.001）。在3年的每次随访中，SSS、HRQoL和EQ-5Q的治疗获益均超过了最小临床重要差异。3年时，94%的受试者报告治疗满意，88%的受试者报告肌瘤症状减轻，因肌瘤症状导致的旷工率从2.9%降至1.4%，肌瘤导致的工作障碍率从51%降至12%，身体活动障碍率从58%降至14%（均P<0.001）。未发生晚期并发症。在SONATA关键试验中接受超声引导下TFA治疗的女性，肌瘤相关症状显著且持久减轻，在3年随访期间手术再次干预率较低。
