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前瞻性子宫平滑肌瘤射频消融个体化干预试验。

A Prospective Intervention Trial on Tailored Radiofrequency Ablation of Uterine Myomas.

机构信息

Division of Gynaecology, International Evangelical Hospital, 16122 Genoa, Italy.

Division of Radiology, International Evangelical Hospital, 16122 Genoa, Italy.

出版信息

Medicina (Kaunas). 2020 Mar 12;56(3):122. doi: 10.3390/medicina56030122.

DOI:10.3390/medicina56030122
PMID:32178351
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7143923/
Abstract

Investigating the use of radiofrequency myolysis (RFM) for the treatment of fibroids through less invasive access by combining transvaginal ultrasound, hysteroscopy and laparoscopy. Fifty-four premenopausal women with 106 symptomatic uterine myomas. Patients underwent RFM in three ways: Vaginal Ultrasound-guided RFM (VU-RFM), Laparoscopic RFM (L-RFM) and Hysteroscopic-RFM (H-RFM). The mean patient age was 43 years; 52 symptomatic uterine myomas were subserosal, 44 intramural and 10 submucosal. The outcomes evaluated at 1 and 12 months after RFM were myoma size (volume-diameter), "Uterine Fibroid Symptom and Quality of Life (UFS-QOL)" questionnaire and a 10-point Visual Analogue Scale (VAS). The therapy was completed with a single ablation in all patients, no complication was registered. The average number of fibroids treated per intervention was two with the use of different accesses: 64/106 VU-RFMs (60.4%), 32/106 L-RFMs (30.2%) and 10/106 H-RFMs (9.4%). Volume and diameter of fibroids were significantly reduced by, respectively, 51.3% and 20.1% in the first 30 days post-intervention ( < 0.001) up to a maximum of 73.5% and 37.1% after the second follow-up visit at 12 months ( < 0.001). A similar trend was shown in terms of disability with a progressive and significant reduction of symptoms (menorrhagia, dysmenorrhea, dyspareunia and pollakiuria) demonstrated by percentage variation of UFS-QOL Symptom Severity and VAS scores to -74.3% and -45.3% as well as -84.9% and -74.3%, respectively, at 1 and 12 months after RFM ( < 0.001). An overall improvement in the quality of life was also demonstrated by a significant increase in the UFS-QOL total score of +38.2% in the first 30 days post-intervention up to +44.9% after the second follow-up visit at 12 months ( < 0.001). The overall average surgery time of the RFM for each patient was 48 minutes, and the time to treat each fibroid by Vaginal Ultrasound-guided RFM (23 min) was found to be significantly less than those of laparoscopy or hysteroscopy (respectively 35 and 34 min) ( < 0.05). An electromagnetic virtual needle tracking system (VNTS) was successfully tested during the RFM procedures, and real-time contrast-enhanced ultrasound (CEUS) has proven to be effective in determining the duration of myolysis through the identification of eventual residual areas of enhancement within the fibroids. Radiofrequency can be considered a minimally invasive and safe procedure for the treatment of uterine myomas through the customization and possible combination of transvaginal, laparoscopic or hysteroscopic accesses. The standardization of the ablation technique with pre-intervention biopsy and new technologies such as VNTS and CEUS spares healthy uterine tissue and may change the future management of symptomatic uterine fibroids.

摘要

研究通过经阴道超声、宫腔镜和腹腔镜联合微创途径应用射频肌溶解(RFM)治疗肌瘤的效果。 54 名有 106 个有症状的子宫肌瘤的绝经前妇女。患者以三种方式接受 RFM:经阴道超声引导下 RFM(VU-RFM)、腹腔镜 RFM(L-RFM)和宫腔镜 RFM(H-RFM)。患者平均年龄为 43 岁;52 个有症状的子宫肌瘤为浆膜下,44 个为肌壁间,10 个为黏膜下。RFM 后 1 个月和 12 个月评估的结果包括肌瘤大小(体积-直径)、“子宫肌瘤症状和生活质量(UFS-QOL)”问卷和 10 分视觉模拟评分(VAS)。所有患者均完成了单次消融治疗,无并发症发生。每种干预措施平均治疗肌瘤数为 2 个,使用不同的方法:64/106 VU-RFMs(60.4%)、32/106 L-RFMs(30.2%)和 10/106 H-RFMs(9.4%)。 术后 30 天内,肌瘤的体积和直径分别显著减少了 51.3%和 20.1%(<0.001),至 12 个月时第二次随访时最大减少了 73.5%和 37.1%(<0.001)。在残疾方面也表现出类似的趋势,UFS-QOL 症状严重程度和 VAS 评分的症状百分比变化分别显示出渐进性和显著的降低,至 -74.3%和-45.3%以及-84.9%和-74.3%,RFM 后 1 个月和 12 个月(<0.001)。UFS-QOL 总分在术后 30 天内显著增加+38.2%,至 12 个月第二次随访时增加+44.9%,也证明了生活质量的总体改善(<0.001)。每位患者的 RFM 手术总时间平均为 48 分钟,经阴道超声引导下 RFM(23 分钟)治疗每个肌瘤的时间明显少于腹腔镜或宫腔镜(分别为 35 分钟和 34 分钟)(<0.05)。在 RFM 过程中成功测试了电磁虚拟针跟踪系统(VNTS),实时对比增强超声(CEUS)已被证明可通过识别肌瘤内可能残留的增强区域来有效确定肌溶解时间。 射频可被认为是一种微创且安全的治疗子宫肌瘤的方法,可通过经阴道、腹腔镜或宫腔镜联合微创途径进行定制和可能的联合治疗。术前活检和 VNTS 和 CEUS 等新技术的消融技术标准化可保留健康的子宫组织,并可能改变未来对有症状的子宫肌瘤的管理。

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