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非侵入性高强度聚焦超声与骨样骨瘤射频消融的比较

Comparison of Noninvasive High-Intensity Focused Ultrasound with Radiofrequency Ablation of Osteoid Osteoma.

作者信息

Sharma Karun V, Yarmolenko Pavel S, Celik Haydar, Eranki Avinash, Partanen Ari, Smitthimedhin Anilawan, Kim Aerang, Oetgen Matthew, Santos Domiciano, Patel Janish, Kim Peter

机构信息

Sheikh Zayed Institute for Pediatric Surgical Innovation, Children's National Medical Center, Washington, DC; Division of Radiology, Children's National Medical Center, Washington, DC.

Sheikh Zayed Institute for Pediatric Surgical Innovation, Children's National Medical Center, Washington, DC.

出版信息

J Pediatr. 2017 Nov;190:222-228.e1. doi: 10.1016/j.jpeds.2017.06.046. Epub 2017 Aug 17.

Abstract

OBJECTIVE

To evaluate clinical feasibility and safety of magnetic resonance imaging-guided high-intensity focused ultrasound (MR-HIFU) treatment of symptomatic osteoid osteoma and to compare clinical response with standard of care treatment.

STUDY DESIGN

Nine subjects with radiologically confirmed, symptomatic osteoid osteoma were treated with MR-HIFU in an institutional review board-approved clinical trial. Treatment feasibility and safety were assessed. Clinical response was evaluated in terms of analgesic requirement, visual analog scale pain score, and sleep quality. Anesthesia, procedure, and recovery times were recorded. This MR-HIFU group was compared with a historical control group of 9 consecutive patients treated with radiofrequency ablation.

RESULTS

Nine subjects (7 male, 2 female; 16 ± 6 years) were treated with MR-HIFU without technical difficulties or any serious adverse events. There was significant decrease in their median pain scores 4 weeks within treatment (6 vs 0, P < .01). Total pain resolution and cessation of analgesics were achieved in 8 of 9 patients after 4 weeks. In the radiofrequency ablation group, 9 patients (8 male, 1 female; 10 ± 6 years) were treated in routine clinical practice. All 9 demonstrated complete pain resolution and cessation of medications by 4 weeks with a significant decrease in median pain scores (9 vs 0, P < .001). One developed a second-degree skin burn, but there were no other adverse events. Procedure times and treatment charges were comparable between the 2 groups.

CONCLUSION

This pilot study shows that MR-HIFU treatment of osteoid osteoma refractory to medical therapy is feasible and can be performed safely in pediatric patients. Clinical response is comparable with standard of care treatment but without any incisions or exposure to ionizing radiation.

TRIAL REGISTRATION

ClinicalTrials.govNCT02349971.

摘要

目的

评估磁共振成像引导下高强度聚焦超声(MR-HIFU)治疗有症状骨样骨瘤的临床可行性和安全性,并将临床反应与标准治疗方法进行比较。

研究设计

在一项经机构审查委员会批准的临床试验中,对9例经放射学确诊的有症状骨样骨瘤患者进行了MR-HIFU治疗。评估了治疗的可行性和安全性。根据镇痛需求、视觉模拟量表疼痛评分和睡眠质量评估临床反应。记录麻醉、手术和恢复时间。将该MR-HIFU组与连续9例接受射频消融治疗的历史对照组进行比较。

结果

9例患者(7例男性,2例女性;16±6岁)接受了MR-HIFU治疗,未出现技术困难或任何严重不良事件。治疗后4周内,他们的中位疼痛评分显著降低(6分对0分,P<0.01)。9例患者中有8例在4周后疼痛完全缓解且停止使用镇痛药。在射频消融组中,9例患者(8例男性,1例女性;10±6岁)在常规临床实践中接受了治疗。所有9例患者在4周时均显示疼痛完全缓解且停止用药,中位疼痛评分显著降低(9分对0分,P<0.001)。1例患者出现二度皮肤烧伤,但无其他不良事件。两组的手术时间和治疗费用相当。

结论

这项初步研究表明,MR-HIFU治疗药物治疗无效的骨样骨瘤是可行的,并且可以在儿科患者中安全进行。临床反应与标准治疗方法相当,但无需任何切口或暴露于电离辐射。

试验注册

ClinicalTrials.govNCT02349971。

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