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高强度聚焦超声治疗乳腺纤维腺瘤学习曲线的前瞻性临床试验。

Prospective clinical trial on the learning curve of high-intensity-focused ultrasound for the treatment of breast fibroadenoma.

机构信息

Department of Surgery, Li Ka Shing Faculty of Medicine, University of Hong Kong, Hong Kong, China.

出版信息

Surg Today. 2022 Jul;52(7):1048-1053. doi: 10.1007/s00595-021-02421-3. Epub 2022 Jan 9.

DOI:10.1007/s00595-021-02421-3
PMID:35000002
Abstract

INTRODUCTION

High-intensity-focused ultrasound (HIFU) is a safe and feasible treatment option for breast fibroadenoma. However, its learning curve has not been described in the medical literature.

METHODS

All patients with biopsy-proven fibroadenoma considered indicated for HIFU were screened for eligibility for HIFU treatment. A total of 60 patients were recruited according to the pre-defined sample size calculation.

RESULTS

Sixty consecutive patients were divided into three cohorts in chronological order. The mean tumor volume shrinkage rates in cohorts 1, 2, and 3 at 6 months post-HIFU ablation were 38%, 34%, and 59%, respectively. Significant tumor shrinkage was observed from case 41 onward (p < 0.0001). Similarly, the mean tumor volume shrinkage rates in cohorts 1, 2, and 3 at 12 months post-HIFU ablation were 45%, 51%, and 71%, respectively. Significant tumor shrinkage was observed from case 41 onwards (p < 0.0473). The mean procedure time for the first 20 patients was 48.5 (range 45-75) minutes, while that in the second 20 patients was 39.7 (range 20-60) minutes, and that in the last 20 patients was 28.9 (range 15-45) minutes. The treatment time was significantly shorter from case 41 onwards (p = 0.0481).

CONCLUSION

Treatment outcomes and treatment time improved significantly after performing approximately 40 HIFU procedures.

摘要

简介

高强度聚焦超声(HIFU)是一种安全且可行的乳腺纤维腺瘤治疗选择。然而,其学习曲线尚未在医学文献中描述。

方法

所有经活检证实的纤维腺瘤患者均接受高强度聚焦超声治疗的筛选,以确定其是否符合条件。根据预先确定的样本量计算,共招募了 60 名符合条件的患者。

结果

连续 60 例患者按时间顺序分为 3 个队列。HIFU 消融后 6 个月,队列 1、2 和 3 的平均肿瘤体积缩小率分别为 38%、34%和 59%。从第 41 例开始观察到明显的肿瘤缩小(p<0.0001)。同样,HIFU 消融后 12 个月,队列 1、2 和 3 的平均肿瘤体积缩小率分别为 45%、51%和 71%。从第 41 例开始观察到明显的肿瘤缩小(p<0.0473)。前 20 例患者的平均手术时间为 48.5 分钟(范围为 45-75 分钟),而第 20-40 例患者的平均手术时间为 39.7 分钟(范围为 20-60 分钟),最后 20 例患者的平均手术时间为 28.9 分钟(范围为 15-45 分钟)。从第 41 例开始,治疗时间明显缩短(p=0.0481)。

结论

大约完成 40 次 HIFU 治疗后,治疗效果和治疗时间显著改善。

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