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一种三步法改良操控方案用于 MRI 引导高强度聚焦超声治疗子宫肌瘤的研发与临床评估。

Development and clinical evaluation of a 3-step modified manipulation protocol for MRI-guided high-intensity focused ultrasound of uterine fibroids.

机构信息

Department of Radiology, Isala Hospital, Dokter van Heesweg 2, 8025 AB, Zwolle, The Netherlands.

Department of Gynecology, Isala, Zwolle, The Netherlands.

出版信息

Eur Radiol. 2020 Jul;30(7):3869-3878. doi: 10.1007/s00330-020-06780-2. Epub 2020 Mar 12.

DOI:10.1007/s00330-020-06780-2
PMID:32166489
Abstract

OBJECTIVES

The clinical applicability of magnetic resonance image-guided high-intensity focused ultrasound (MR-HIFU) treatment of uterine fibroids is often limited due to inaccessible fibroids or bowel interference. The aim of this study was to implement a newly developed 3-step modified manipulation protocol and to evaluate its influence on the number of eligible women and treatment failure rate.

METHODS

From June 2016 to June 2018, 165 women underwent a screening MRI examination, 67 women of whom were consecutively treated with MR-HIFU at our institution. Group 1 (n = 20) was treated with the BRB manipulation protocol which consisted of sequential applications of urinary bladder filling, rectal filling, and urinary bladder emptying. Group 2 (n = 47) was treated using the 3-step modified manipulation protocol which included (1) the BRB maneuver with adjusted rectal filling by adding psyllium fibers to the solution; (2) Trendelenburg position combined with bowel massage; (3) the manual uterine manipulation (MUM) method for uterine repositioning. A comparison was made between the two manipulation protocols to evaluate differences in safety, the eligibility percentage, and treatment failure rate due to unsuccessful manipulation.

RESULTS

After implementing the 3-step modified manipulation protocol, our ineligibility rate due to bowel interference or inaccessible fibroids decreased from 18% (16/88) to 0% (0/77). Our treatment failure rate due to unsuccessful manipulation decreased from 20% (4/20) to 2% (1/47). There were no thermal complications to the bowel or uterus.

CONCLUSIONS

Implementation of the 3-step modified manipulation protocol during MR-HIFU therapy of uterine fibroids improved the eligibility percentage and reduced the treatment failure rate.

TRIAL REGISTRATION

Registry number NL56182.075.16 KEY POINTS: • A newly developed 3-step modified manipulation protocol was successfully implemented without the occurrence of thermal complication to the bowel or uterus. • The 3-step modified manipulation protocol increased our eligibility percentage for MR-HIFU treatment of uterine fibroids. • The 3-step modified manipulation protocol reduced our treatment failure rate for MR-HIFU treatment of uterine fibroids.

摘要

目的

由于子宫肌瘤位置不佳或肠道干扰,磁共振引导高强度聚焦超声(MR-HIFU)治疗的临床适用性往往受到限制。本研究旨在实施一种新开发的三步改良操作方案,并评估其对符合条件的女性数量和治疗失败率的影响。

方法

2016 年 6 月至 2018 年 6 月,165 名女性接受了筛查性 MRI 检查,其中 67 名女性连续在我院接受了 MR-HIFU 治疗。第 1 组(n=20)接受了 BRB 操作方案的治疗,该方案包括连续进行膀胱充盈、直肠充盈和膀胱排空。第 2 组(n=47)采用三步改良操作方案治疗,包括(1)BRB 操作,通过向溶液中添加车前子纤维来调整直肠充盈;(2)使用肠道按摩的特伦德伦堡体位;(3)手动子宫复位(MUM)方法。比较两种操作方案在安全性、符合率和因操作失败导致的治疗失败率方面的差异。

结果

实施三步改良操作方案后,由于肠道干扰或子宫肌瘤位置不佳导致的不合格率从 18%(16/88)降至 0%(0/77)。由于操作失败导致的治疗失败率从 20%(4/20)降至 2%(1/47)。未发生肠道或子宫热并发症。

结论

在子宫肌瘤的 MR-HIFU 治疗中实施三步改良操作方案可提高符合率并降低治疗失败率。

试验注册

注册号 NL56182.075.16。

关键点

  • 成功实施了一种新开发的三步改良操作方案,未发生肠道或子宫热并发症。

  • 三步改良操作方案提高了子宫肌瘤 MR-HIFU 治疗的符合率。

  • 三步改良操作方案降低了子宫肌瘤 MR-HIFU 治疗的治疗失败率。

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