BackgroundTo assess the long term efficacy and tolerability of one or two ultrasound (US)-guided high-intensity focused ultrasound (HIFU) treatment in patients with breast fibroadenoma (FA). MethodsTwenty patients with 26 FA were selected for US-guided HIFU. The therapy was performed in one or two sessions. FA volume was assessed before and followed up to 24?months after the last HIFU. After each treatment, adverse events were evaluated. ResultsIn 19/26 FA (73.1%) one HIFU was performed (group 1), whereas 7/26 FA (26.9%) received second HIFU (group 2) 6-9 months (median, 7?months) after the first session. In group 1 and 2, FA volume decreased significantly at 1-month ( p p =?0.005), respectively, and continued to reduce until 24-month follow-up ( p p =?0.003, respectively). At 24?months, mean volume reduction was 77.32% in group 1 and 90.47% in group 2 ( p =?0.025). Mild subcutaneous edema was observed in 4 patients and skin erythema in 3 patients. ConclusionsUS-guided HIFU represents a promising non-invasive method with sustainable FA volume reduction and patient’s tolerability. Although one treatment is highly efficient, the volume reduction can be increased with second treatment. Trial registration NCT01331954 . Registered 07 April 2011.
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机译：背景评估一两次超声（US）引导的高强度聚焦超声（HIFU）治疗乳腺纤维腺瘤（FA）患者的长期疗效和耐受性。方法选择20例26 FA的患者进行美国引导的HIFU。该疗法在一两个疗程中进行。在最后一次HIFU之前和之后的24个月内评估FA量。每次治疗后，评估不良事件。结果在19/26 FA（73.1％）中，进行了一次HIFU（组1），而7/26 FA（26.9％）在第一次疗程后的6-9个月（中位数为7个月）接受了第二次HIFU（组2）。在第1组和第2组中，FA量分别在1个月时显着下降（p p =？0.005），并持续减少直到24个月的随访（p p =？0.003）。在第24个月，第1组的平均体积减少为77.32％，第2组的平均体积减少为90.47％（p =？0.025）。观察到轻度皮下水肿4例，皮肤红斑3例。结论美国指导的HIFU代表了一种有前途的无创方法，具有持续减少FA体积和患者耐受性的特点。尽管一种处理非常有效，但是第二种处理可以增加体积的减少。试用注册号NCT01331954。 2011年4月7日注册。
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