Portable ultrasound-guided high-intensity focused ultrasound with functions for safe and rapid ablation: prospective clinical trial for uterine fibroids-short-term and long-term results
Portable ultrasound-guided high-intensity focused ultrasound with functions for safe and rapid ablation: prospective clinical trial for uterine fibroids-short-term and long-term results
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DOI：
10.1007/s00330-019-06468-2
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发表时间：
2019-11-08
影响因子：
5.9
通讯作者：
Han, Joon Koo
中科院分区：
文献类型：
--
作者：
Lee, Jae Young;Chung, Hyun Hoon;Han, Joon Koo
目的 探讨采用先进靶向和波束控制技术的新型便携式超声引导高强度聚焦超声系统 (USgHIFU) 治疗子宫肌瘤的有效性和安全性。方法 2013 年 11 月至 2015 年 11 月期间，纳入 36 名参与者（平均年龄 44.9 +/- 4.1 岁）的 59 例子宫肌瘤。所有参与者均接受 HIFU 治疗，并采用 3D 电子转向。 MR成像研究在HIFU前、HIFU后立即、HIFU治疗后1个月和3（或5）个月进行。分析非灌注体积比（NPVR）、肌瘤体积收缩（FVS）、症状改善、量化生活质量评估和安全性。 2017年7月至12月（平均32.2个月）进行长期随访。结果治疗后子宫肌瘤的体积范围为7.5～274.4 cm(3)（平均69.8 cm(3)；标准差64.3 cm(3)）。 HIFU MR 成像后立即的平均 NPVR 为 74.8 +/- 25.2%。 HIFU 治疗后 1 个月、3 个月和 5 个月时的平均 FVS 分别为 17.3%、33.3% 和 45.1%。每个肌瘤的平均治疗时间为 44.6 +/- 28.2 分钟，每个参与者的平均治疗时间为 72.9 +/- 31.4 分钟。 HIFU 治疗后，子宫肌瘤相关症状和生活质量显示出统计学上显着的改善。没有发生与安全或并发症相关的明显症状。在长期随访中，78.8%的受访者对HIFU治疗感到满意。结论本临床试验表明，具有先进功能的便携式USgHIFU可以安全、有效地治疗子宫肌瘤。
Objectives To investigate the efficacy and safety of a new portable ultrasound-guided high-intensity focused ultrasound system (USgHIFU) with advanced targeting and beam steering technology for the treatment of uterine fibroids. Methods Fifty-nine uterine fibroids from 36 participants (mean age, 44.9 +/- 4.1 years) were included from November 2013 to November 2015. All participants were treated with HIFU, with 3D electronic steering. MR imaging studies were performed before HIFU, immediately after HIFU, and 1 month and 3 (or 5) months after the HIFU treatment. The non-perfused volume ratio (NPVR), fibroid volume shrinkage (FVS), symptom improvement, quantified life quality assessment, and safety were analyzed. A long-term follow-up was conducted in July to December 2017 (mean, 32.2 months). Results The volume of the treated uterine fibroids ranged from 7.5 to 274.4 cm(3) (mean, 69.8 cm(3); SD, 64.3 cm(3)). The mean NPVR on the immediate post-HIFU MR imaging was 74.8 +/- 25.2%. The mean FVS was 17.3% at 1 month, 33.3% at 3 months, and 45.1% at 5 months after HIFU treatment. The mean treatment time was 44.6 +/- 28.2 min per fibroid and 72.9 +/- 31.4 min per participant. Uterine fibroid-related symptoms and quality of life showed statistically significant improvement after the HIFU treatment. No significant symptoms related to safety or complications occurred. In the long-term follow-up, 78.8% of those surveyed were satisfied with their HIFU treatment. Conclusion This clinical trial showed that a portable USgHIFU with advanced functions may safely and effectively treat uterine fibroids.