Garza-Leal Jose Gerardo
Department of Obstetrics and Gynecology, Hospital Universitario "Dr. José Eleuterio González" de Universidad Autonoma de Nuevo León, Monterrey, Mexico.
J Gynecol Surg. 2019 Feb 1;35(1):19-23. doi: 10.1089/gyn.2018.0051. Epub 2019 Jan 29.
The aim of this research was to learn the long-term (> 5 years) clinical outcomes of transcervical radiofrequency ablation of uterine fibroids. For this retrospective, single-arm, long-term data-collection study, 23 women with heavy menstrual bleeding secondary to fibroids were treated with transcervical radiofrequency ablation guided by integrated intrauterine sonography (using the Sonata System, Gynesonics, Redwood City, CA). This study was within the 12-month Fibroid Ablation Study-EU clinical trial in Mexico. Symptoms were assessed using the Uterine Fibroid Symptom and Quality-of-Life's Symptom Severity Score (SSS) and Health-Related Quality of Life (HRQoL) subscales. Patients were queried regarding pregnancy and surgical reinterventions. Seventeen women (73.9%) provided long-term follow-up information, with a mean of 64.4 months ±4.5 months (range: 57-73 months). From baseline, mean SSS decreased significantly from 64.9 ± 16.9 to 27.6 ± 36.1, and mean HRQoL improved significantly from 27.2 ± 22.4 to 76.0 ± 32.6 ( = 0.002, and = 0.0001, respectively). There were no surgical reinterventions through the first 3.5 years post-treatment. There was an 11.8% incidence of surgical reinterventions over 5.4 years of average follow-up, with 2 hysterectomies occurring after 3.5 and 4 years postablation, respectively (event rate: 2.2% per year; 95% confidence interval; 0.3%, 7.9%). Freedom from surgical reintervention at 1, 2, and 3 years was 100%, and, at 4 and 5 years, was 88.2% ± 7.8%. There was a single pregnancy occurring within the first year of treatment leading to a normal-term delivery by elective repeat cesarean section. Transcervical radiofrequency ablation with the Sonata System produced substantial durable clinical benefits beyond 5 years with a low reintervention rate.
本研究的目的是了解经宫颈射频消融治疗子宫肌瘤的长期（>5年）临床结局。在这项回顾性、单臂、长期数据收集研究中，23例因肌瘤导致月经过多的女性接受了经宫腔超声引导下的经宫颈射频消融治疗（使用加利福尼亚州红木城Gynesonics公司的Sonata系统）。本研究属于在墨西哥进行的为期12个月的“子宫肌瘤消融研究-欧盟”临床试验的一部分。使用子宫肌瘤症状与生活质量的症状严重程度评分（SSS）和健康相关生活质量（HRQoL）分量表对症状进行评估。询问患者有关妊娠和再次手术干预的情况。17名女性（73.9%）提供了长期随访信息，平均随访时间为64.4个月±4.5个月（范围：57 - 73个月）。从基线水平来看，平均SSS从64.9±16.9显著降至27.6±36.1，平均HRQoL从27.2±22.4显著提高至76.0±32.6（分别为P = 0.002和P = 0.0001）。治疗后的前3.5年没有再次手术干预。在平均5.4年的随访中，再次手术干预的发生率为11.8%，分别在消融后3.5年和4年进行了2例子宫切除术（事件发生率：每年2.2%；95%置信区间：0.3%，7.9%）。1年、2年和3年无再次手术干预的比例为100%，4年和5年时为88.2%±7.8%。治疗后第一年内有1例妊娠，通过择期再次剖宫产实现足月分娩。使用Sonata系统进行经宫颈射频消融在5年以上产生了显著且持久的临床益处，再次干预率较低。
