Abstract：
Our study aims at the comprehensive analysis of adverse events (AEs) in patients with symptomatic uterine fibroids (UFs) who underwent magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) in the last 6 years in one of the major Polish centers performing this type of therapy.
The presented retrospective case-control study was conducted in the Department of Obstetrics and Gynecology, Pro-Familia Hospital, Rzeszów in cooperation with the Second Department of Obstetrics and Gynecology, Center of Postgraduate Medical Education, Warsaw. The study enrolled 372 women with symptomatic UFs who underwent MR-HIFU and reported AEs during or after the procedure. The occurrence of particular AEs was analyzed. Statistical comparison of two cohorts (patients with and without AEs) was conducted based on epidemiological factors, UF characteristics, fat layer thickness, the presence of abdominal scars and technical parameters of the procedure.
The overall mean occurrence rate of AEs was 8.9% (n = 33). No major AEs were reported. The only statistically significant risk factor of AEs was the treatment of type II UFs according to Funaki (OR 2.12, CI 95%, p = 0.043). Other investigated factors did not have a statistically significant influence on AE occurrence. Abdominal pain was the most common AE.
Our data showed that MR-HIFU seemed to be a safe procedure. The AE rate after the treatment is relatively low. According to the obtained data it seems that the occurrence of AEs does not depend on the technical parameters of the procedure and the volume, position and location of UFs. Further prospective, randomized studies and with long follow-up are necessary to confirm the final conclusions.
The presented retrospective case-control study was conducted in the Department of Obstetrics and Gynecology, Pro-Familia Hospital, Rzeszów in cooperation with the Second Department of Obstetrics and Gynecology, Center of Postgraduate Medical Education, Warsaw. The study enrolled 372 women with symptomatic UFs who underwent MR-HIFU and reported AEs during or after the procedure. The occurrence of particular AEs was analyzed. Statistical comparison of two cohorts (patients with and without AEs) was conducted based on epidemiological factors, UF characteristics, fat layer thickness, the presence of abdominal scars and technical parameters of the procedure.
The overall mean occurrence rate of AEs was 8.9% (n = 33). No major AEs were reported. The only statistically significant risk factor of AEs was the treatment of type II UFs according to Funaki (OR 2.12, CI 95%, p = 0.043). Other investigated factors did not have a statistically significant influence on AE occurrence. Abdominal pain was the most common AE.
Our data showed that MR-HIFU seemed to be a safe procedure. The AE rate after the treatment is relatively low. According to the obtained data it seems that the occurrence of AEs does not depend on the technical parameters of the procedure and the volume, position and location of UFs. Further prospective, randomized studies and with long follow-up are necessary to confirm the final conclusions.
摘要：
我们的研究旨在全面分析有症状的子宫肌瘤（UFs）患者的不良事件（AE），这些患者在过去6年中在波兰主要中心之一进行磁共振引导的高强度聚焦超声（MR-HIFU）进行了这种类型的治疗。
回顾性病例对照研究是在妇产科进行的，亲家庭医院，Rzeszów与妇产科第二部门合作，研究生医学教育中心，华沙.该研究招募了372名患有有症状的UF的女性，她们接受了MR-HIFU，并在手术期间或之后报告了AE。分析特定AE的发生。根据流行病学因素对两个队列（有和没有AE的患者）进行统计比较，UF特性,脂肪层厚度，腹部疤痕的存在和程序的技术参数。
不良事件的总平均发生率为8.9%(n=33)。未报告重大AE。唯一具有统计学意义的不良事件危险因素是根据Funaki治疗II型UFs（OR2.12，CI95％，p=0.043)。其他调查因素对AE发生没有统计学意义的影响。腹痛是最常见的AE。
我们的数据表明MR-HIFU似乎是一种安全的手术。治疗后的AE率相对较低。根据获得的数据，似乎AE的发生不取决于程序和体积的技术参数，UF的位置和位置。进一步的前瞻性，需要随机研究和长期随访以确认最终结论.
回顾性病例对照研究是在妇产科进行的，亲家庭医院，Rzeszów与妇产科第二部门合作，研究生医学教育中心，华沙.该研究招募了372名患有有症状的UF的女性，她们接受了MR-HIFU，并在手术期间或之后报告了AE。分析特定AE的发生。根据流行病学因素对两个队列（有和没有AE的患者）进行统计比较，UF特性,脂肪层厚度，腹部疤痕的存在和程序的技术参数。
不良事件的总平均发生率为8.9%(n=33)。未报告重大AE。唯一具有统计学意义的不良事件危险因素是根据Funaki治疗II型UFs（OR2.12，CI95％，p=0.043)。其他调查因素对AE发生没有统计学意义的影响。腹痛是最常见的AE。
我们的数据表明MR-HIFU似乎是一种安全的手术。治疗后的AE率相对较低。根据获得的数据，似乎AE的发生不取决于程序和体积的技术参数，UF的位置和位置。进一步的前瞻性，需要随机研究和长期随访以确认最终结论.
