超声消融邻近骶尾部子宫肌瘤的临床策略及其安全性的随机对照研究

Clinical strategy on ultrasound ablation for uterine fibroids close to sacrococcyx and its safety: a randomized controlled trial

摘要:

目的：比较2种不同声束投照模式下邻近骶尾骨子宫肌瘤超声消融（Ultrasound ablation，UA）治疗的临床安全性。方法：2008年9月至2009年7月在重庆医科大学附属第一医院接受子宫肌瘤UA治疗患者，MRI影像显示主要肌瘤边缘到骶尾骨距离小于30 mm患者共92例。患者随机分为2组，研究组47例，接受倾斜式声束投照模式下UA治疗；对照组45例，在垂直式声束投照模式下接受UA治疗。研究随访期6个月，观察2组患者不良反应、术中VAS评分及消融率等指标，相关的不良反应评价参照国际介入放射治疗学会SIR标准。结果：92例患者均完成一次性UA治疗。2组患者均未出现主要并发症（SIR C-F 级），对照组患者次要并发症发生率（SIR A-B 级）显著高于研究组（53.3% vs 36.2%；RR 1.71 [1.03-2.82]，P＜0．05）。研究组及对照组VAS分值分别为（2.9±1.4）及（3.6±1.8），差异有统计学意义（P＜0．05）。治疗后1月内MRI显示研究组及对照组肌瘤平均消融率分别为（80.9±18.9）%及（75.3±18.2）%，差异有统计学意义（P＜0．05）。结论：UA治疗邻近骶尾部子宫肌瘤疗效确切，无严重不良反应。倾斜式声束投照的临床治疗策略降低患者不适反应，提高术中耐受性及安全性，有效提高消融效果。

Abstract:

Objective：To compare the clinical safety of ultrasound ablation for uterine fibroids close to sacrococcyx with different models of high intensity focused ultrasound（HIFU） projection. Methods：92 patients with uterine fibroids received ultrasound ablation in our hospital from September 2008 to July 2009，and the distance from leiomyomas border to sacrococcyx was less than 30 mm on MRI images. All the patients were randomly divided into 2 groups. 47 patients in experimental group were treated under oblique HI－FU projection. 45 patients in controlled group were treated under vertical HIFU projection. Adverse events，visual analogue scale （VAS），and non-perfused volume （NPV） of both groups were evaluated in this study within a 6-month follow up.Furthermore，com－plications were assessed according to Society of Cardiovascular and Interventional Radiology（SIR） Classification. Results：92 cases successfully underwent one session of ultrasound ablation.No major complication was observed in all cases.The minor complication rate was significantly higher in the controlled group than in the experimental group（53.3% vs 36.2%；RR 1.71 [1.03-2.82]；P＜0．05）. VAS was also lower for the experimental group（2.9±1.4 vs 3.6±1.8，P＜0．05）. MRI performed 1 month after the treatment suggested that the experimental group obtained a greater NPV value（80.9%±18.9% vs 75.3%±18.2%，P＜0．05）. Conclusions：Ultrasound ablation for uterine fibroids close to sacrococcyx is safety and efficacy. Clinical strategy of oblique HIFU projection protocol reduces uncomfortable responses，pain and complica－tions, and improves tolerance and NPV value.