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在日本大样本人群中进行的非侵入性磁共振引导聚焦超声治疗子宫肌瘤:学习曲线对患者结局的影响。

Non-invasive magnetic resonance-guided focused ultrasound treatment of uterine fibroids in a large Japanese population: impact of the learning curve on patient outcome.

机构信息

Center of Diagnostic and Interventional Radiology, Iseikai Hospital, Osaka, Japan.

出版信息

Ultrasound Obstet Gynecol. 2009 Nov;34(5):579-83. doi: 10.1002/uog.7454.

Abstract

OBJECTIVES

To describe the learning curve effect of magnetic resonance-guided focused ultrasound surgery (MRgFUS) on the outcomes of patients treated for uterine fibroids in four centers in Japan.

METHODS

The extent of fibroid ablation (often used to measure treatment success) was evaluated using the non-perfused volume (NPV) ratio in 287 Japanese patients. The patients were divided into two equal groups according to the chronological treatment time and results were compared between these groups to estimate the learning curve effect. Results were also compared with published data from clinical trials.

RESULTS

The NPV ratio increased chronologically, from 39.3% to 54.0% (P < 0.001), indicating increasing effectiveness of the treatment with experience. The mean NPV ratios for the entire patient population were over double that of previous clinical trials (46.6% vs. 21.9%; P < 0.001). No serious complications were reported.

CONCLUSION

The learning process and accumulation of data on MRgFUS enable the optimization of treatments in order to safely achieve large NPV ratios and sustained clinical benefit.

摘要

目的

描述磁共振引导聚焦超声手术(MRgFUS)在日本 4 个中心治疗子宫肌瘤患者的结果中的学习曲线效应。

方法

287 名日本患者采用非灌注体积(NPV)比值评估肌瘤消融程度(常用于衡量治疗效果)。根据治疗时间的顺序将患者分为两组,并对两组结果进行比较,以评估学习曲线效应。结果还与临床试验的已发表数据进行了比较。

结果

NPV 比值随时间呈上升趋势,从 39.3%增加到 54.0%(P < 0.001),表明随着经验的积累,治疗效果逐渐增强。整个患者群体的平均 NPV 比值是之前临床试验的两倍以上(46.6%比 21.9%;P < 0.001)。未报告严重并发症。

结论

MRgFUS 的学习过程和数据积累使治疗得以优化,从而安全地实现较大的 NPV 比值和持续的临床获益。

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