Berman Jay M, Guido Richard S, Garza Leal José Gerardo, Pemueller Rodolfo Robles, Whaley Fredrick S, Chudnoff Scott G
Department of Obstetrics and Gynecology, Wayne State University School of Medicine, Detroit, Michigan.
Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh Medical School, Magee-Women's Research Institute, Pittsburgh, Pennsylvania.
J Minim Invasive Gynecol. 2014 Sep-Oct;21(5):767-74. doi: 10.1016/j.jmig.2014.02.015. Epub 2014 Mar 5.
To analyze the clinical success of radiofrequency volumetric thermal ablation (RFVTA) at 3-year follow-up in terms of subject responses to validated questionnaires and surgical repeat intervention to treat myomas.
Prospective follow-up of patients for 36 months after treatment in a multicenter international trial of outpatient, laparoscopic ultrasound-guided RFVTA of symptomatic uterine myomas (Canadian Task Force classification II-1).
University hospitals and private surgical centers.
One hundred thirty-five premenopausal women (mean [SD] age, 42.5 [4.6] years; body mass index, 30.5 [6.1]) with symptomatic uterine myomas and objectively confirmed heavy menstrual bleeding (≥ 160 to ≤ 500 mL).
Laparoscopic ultrasound-guided RFVTA.
One hundred four participants were followed prospectively for 36 months after treatment of myomas via RFVTA. For 104 evaluable participants with 36-month data, change in mean (SD) symptom severity from baseline (60.2 [18.8]) to 36 months was -32.6 (95% confidence interval, -37.5 to -27.8; p < .001). Health-related quality of life also was improved, from the baseline value of 39.2 (19.2) to 38.6 (95% confidence interval, 33.3 to 43.9; p < .001) at 36 months. Patient-reported Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire subscores demonstrated statistically significant improvement from baseline to 36 months in all categories (Concern, Activities, Energy/Mood, Control, Self-consciousness, and Sexual Function) (p < .001). For the 104 participants with 36-month data, mean state of health scores (EuroQOL-5D Health State Index) improved from a baseline value of 71.0 (19.3) to 86.2 (11.7) at 36 months. The cumulative repeat intervention rate of 11% (14 of 135 participants) at 36 months was well below the possible 25% maximum expected at the beginning of the trial.
RFVTA of uterine myomas resulted in sustained relief from myoma symptoms and continued improvement in health-related quality of life through 36 months after ablation. The low repeat intervention data through 36 months is a positive outcome for patient well-being.
根据受试者对有效问卷的回答以及治疗肌瘤的手术重复干预情况，分析射频容积性热消融术（RFVTA）在3年随访期的临床成功率。
在一项针对有症状子宫肌瘤的门诊腹腔镜超声引导下RFVTA的多中心国际试验中，对患者进行治疗后36个月的前瞻性随访（加拿大工作组分类II-1）。
大学医院和私立手术中心。
135名绝经前女性（平均[标准差]年龄42.5[4.6]岁；体重指数30.5[6.1]），患有有症状的子宫肌瘤且经客观证实有月经过多（≥160至≤500 mL）。
腹腔镜超声引导下RFVTA。
104名参与者在通过RFVTA治疗肌瘤后接受了36个月的前瞻性随访。对于104名有36个月数据的可评估参与者，症状严重程度的平均（标准差）变化从基线时的60.2（18.8）降至36个月时的-32.6（95%置信区间，-37.5至-27.8；p<.001）。与健康相关的生活质量也有所改善，从基线值39.2（19.2）提高到36个月时的38.6（95%置信区间，33.3至43.9；p<.001）。患者报告的子宫肌瘤症状和与健康相关的生活质量问卷子评分在所有类别（担忧、活动、能量/情绪、控制、自我意识和性功能）中从基线到36个月均有统计学显著改善（p<.001）。对于104名有36个月数据的参与者，健康状况平均评分（欧洲五维健康量表健康状态指数）从基线值71.0（19.3）提高到36个月时的86.2（11.7）。36个月时11%（135名参与者中的14名）的累积重复干预率远低于试验开始时可能预期的25%最大值。
子宫肌瘤的RFVTA在消融后36个月内可使肌瘤症状持续缓解，与健康相关的生活质量持续改善。36个月时较低的重复干预数据对患者健康是一个积极结果。
