MRI引导的聚焦超声术治疗症状性子宫肌瘤的前瞻性研究

Prospective study on magnetic resonance-guided focused ultrasound surgery for symptomatic uterinefibroid ： short-term follow up

目的探讨MRI引导的聚焦超声术（MRgFUS）治疗育龄期妇女症状性子宫肌瘤的安全性和有效性。方法选择2010年4月至2012年4月在北京协和医院门诊自愿接受MRgFUS治疗的子宫肌瘤患者80例，对其中已完成生育且有症状、可以清晰地表达治疗中的感受、子宫体积〈16孕周、子宫肌瘤直径为2．5±10．0cm、数量〈10个的23例患者进行MRgFUS治疗。记录治疗参数、非灌注体积率（NPVR）和不良反应。并于术后1周，1、3、6个月，1年及2年随访。术前筛查及术后每次随访时均填写子宫肌瘤症状与生命质量问卷（UFS-QOL），该问卷包括症状严重程度评分（SSS）和健康相关生命质量（HRQL）评分两部分，分别比较治疗前后各问卷的评分变化。术后半年及1年时行MRI检查，比较肌瘤及子宫体积变化。术前所有患者均行血常规检查，贫血者于术后3个月、1年时复查血常规。结果（1）治疗参数及不良反应：平均治疗温度为（69±7）℃，平均治疗时间为（144±62）min，平均NPVR为（62±23）％；主要出现的不良反应有皮肤红斑（1／23）、下腹部痉挛性疼痛（8／23）、阴道血性分泌物（5／23）、下肢酸胀或麻木感（4／23），程度均较轻且能自行缓解。（2）治疗后再手术率：1年内选择手术治疗的患者1例，两年内选择手术治疗的患者共4例（包括肌瘤剔除或子宫切除）。（3）治疗前后肌瘤及子宫体积变化：术前、术后半年及1年时子宫肌瘤体积分别为75．6（P25=43．8，P75=128．9）、52．3（Pz5=23．8，P75=111．2）、45．9（P25=26．3，P75=71．7）cm^3，子宫体积分别为270．0（P25=208．4，P75=390．3）、216．4（P25=151．1，P75=290．0）、200．0（P25=149．1，P75=267．6）cm^3，术后肌瘤及子宫体积均呈缩小趋势，差异均有统计学意义（P〈0．01）。（4）治疗前后UFS-QOL测评结果：术前、术后3个月、术后1年的SSS分别为（34±13）、（22±11）、（19±12）分，术后较术前显著降低，差异有统计学意义（P〈0．01）。术前、术后3个月、术后1年的HRQL评分分别为（74±15）、（82±13）、（89±10）分，术后较术前明显提高，差异也有统计学意义（P〈0．01）。（5）治疗前后血红蛋白水平变化：治疗前11例患者贫血，平均血红蛋白为（87±6）g／L，治疗后3个月及1年时的血红蛋白含量分别为（106±14）、（112±10）g／L，术后较术前血红蛋白含量明显升高，差异有统计学意义（P〈0．01）。结论MRgFUS是治疗症状性子宫肌瘤安全的无创疗法，其短期疗效确定，术后1年时子宫肌瘤症状及患者生命质量均明显改善，但两年内有一定的再手术率。

Objective To evaluate the safety and efficacy of magnetic resonance-guided focused ultrasound surgery （ MRgFUS ） in treatment of symptomatic uterine leiomyoma among Chinese reproductive age women. Methods From April 2010 to April 2012, 80 premenopausal women with symptomatic leiomyoma volunteered to participate in this prospective study in Department of Outpatient of Peking UnionMedical College Hospital. Among 23 reproductive aged patients with size of uterus less than 16th gestational weeks, 2. 5 to 10 cm of diameter of myoma, less than 10 myomas and expressing symptoms clearly were treated by MRgFUS. Treatment data, non-perfused volume ratio （NPVR） and adverse events were recorded. After treatment, patients were followed up at 1 week, 1, 3, 6, 12 and 24 months, respectively. Patients at initial screening and each time of the follow-up filled out uterine fibroid symptoms quality of life （UFS-QOL） , which include symptoms severity score （SSS） and health-related quality of life （HRQL）. The volumes of leiomyoma and uterine were evaluated on MRI before and after the treatment （ at 6 and 12 months, respectively）. Before operation, routine blood test were performed on all patients, anemia patients at 3 months and 1 year after treatment were checked with blood test. Results （ 1 ） Treatment data and adverse events：the mean therapeutic temperature was （69 ± 7）℃, the mean treatment time was （ 144 ± 62） rain, the mean NPVR was （62 ± 23）%. Adverse events included mild erythema（1/23）, abdominal cramp （ 8/23 ） , vaginal discharge （ 5/23 ）, and leg numbness （4/23）. （ 2 ） The rate of secondary surgery ： one patient was treated by myoectomy and hysterectomy within one year following up and 4 patients chose surgical treatment during the second-year follow-up. （3） Volume change：the volumes of leiomyoma before the treatment and 6,12 months after the treatment are 75.6（P25 =43.8, P75 = 128.9） ,52.3（P25 =23.8, P75 = 111.2 ） , 45.9 （ P25 = 26. 3, P75 = 71.7 ） cm3, respectively ; and the volumes of uterine before the treatment and 6,12 months after the treatment are 270. 0 （ P25 = 208.4, P75 = 390. 3 ）, 216. 4 （ P25 = 151.1, P75 = 290. 0）, 200. 0 （ P25 = 149. 1, P75 = 267. 6） cm3, respectively. Both leiomyoma and uterine volumes decreased significantly after treatments （P 〈 0. 01 ）. （4） UFS-QOL change： the symptoms severity score （SSS） before the treatment and 3,12 months after the treatment are （34 ± 13）, （22 ± 11 ）, （19 ± 12） , which decreased significantly （P 〈 0. 01 ）. The health-related quality of life （HRQL） before the treatment and 3,12 months after the treatment are （74 ±＋ 15）, （82 ± 13）, （89 ± 10） ,which increased dramatically （ P 〈 0. 01 ）. （ 5 ） Hemoglobin （HGB） change ： eleven patients suffered from anemia before treatments, the mean HGB before treatment was （87±6） g/L and were （ 106 ± 14） g/L 3 months after treatment, （ 112 ± 10） g/L 12 months after treatment. The HGB was increased significantly after treatments （P〈0. 01）. Conclusions MRgFUS is a safe and effective non-invasive management for symptomatic uterine leiomyoma in short-term follow up. But there is additional treatment ratio after MRgFUS.