PROMISe trial: a pilot, randomized, placebo-controlled trial of magnetic resonance guided focused ultrasound for uterine fibroids
PROMISe trial: a pilot, randomized, placebo-controlled trial of magnetic resonance guided focused ultrasound for uterine fibroids
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DOI：
10.1016/j.fertnstert.2015.11.014
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发表时间：
2016-03-01
影响因子：
6.7
通讯作者：
Coakley, Fergus V.
中科院分区：
文献类型：
--
作者：
Jacoby, Vanessa L.;Kohi, Maureen P.;Coakley, Fergus V.
目的：评价磁共振引导下聚焦超声治疗子宫肌瘤的全面安慰剂对照试验的可行性，获得安全性和有效性的评估。设计：先导性、随机、安慰剂对照试验。地点：大学医学中心。患者(S)：患有症状性子宫肌瘤的绝经前妇女。干预(S)：参与者按2：1随机比例接受磁共振引导聚焦超声治疗子宫肌瘤或安慰剂治疗。主要结果(S)：主要结果：用子宫肌瘤症状生活质量问卷评估治疗后4周和12周肌瘤症状的变化；次要结果：12个月和24个月时复发症状的手术或手术的发生率。结果(S)：20名女性，平均年龄44岁(+/-标准差5.4岁)，其中13人被随机分配到MRgFUS组，7人被随机分配到安慰剂组。治疗四周后，所有参与者都报告了UFS-QOL的改善：MRgFUS组的平均分为10分，安慰剂组为9分(两组之间的变化差异)。到12周时，MRgFUS组比安慰剂组改善更多(平均分别为31分和13分)。12周时，MRgFUS组的平均肌瘤体积减少了18%，而安慰剂组没有减少。在MRgFUS两年后，有随访评估的12名女性中有4名(30%)接受了另一次子宫肌瘤手术或程序。结论(S)：患有肌瘤的女性愿意参加MRgFUS的随机、安慰剂对照试验。安慰剂效应可能解释了MRgFUS后前12周观察到的肌瘤相关症状的改善。(C)2016年由美国生殖医学会评选。
Objective: To evaluate the feasibility of a full-scale placebo-controlled trial of magnetic resonance-guided focused ultrasound for fibroids (MRgFUS) and obtain estimates of safety and efficacy.Design: Pilot, randomized, placebo-controlled trial.Setting: University medical center.Patient(s): Premenopausal women with symptomatic uterine fibroids.Intervention(s): Participants randomized in a 2:1 ratio to receive MRgFUS or placebo procedure.Main Outcome Measure(s): Primary outcome: change in fibroid symptoms from baseline to 4 and 12 weeks after treatment assessed by the Uterine Fibroid Symptom Quality of Life Questionnaire (UFS-QOL); secondary outcome: incidence of surgery or procedures for recurrent symptoms at 12 and 24 months.Result(s): Twenty women with a mean age of 44 years (+/- standard deviation 5.4 years) were enrolled, and 13 were randomly assigned to MRgFUS and 7 to placebo. Four weeks after treatment, all participants reported improvement in the UFS-QOL: a mean of 10 points in the MRgFUS group and 9 points in the placebo group (for difference in change between groups). By 12 weeks, the MRgFUS group had improved more than the placebo group (mean 31 points and 13 points, respectively). The mean fibroid volume decreased 18% in the MRgFUS group with no decrease in the placebo group at 12 weeks. Two years after MRgFUS, 4 of 12 women who had a follow-up evaluation (30%) had undergone another fibroid surgery or procedure.Conclusion(s): Women with fibroids were willing to enroll in a randomized, placebo-controlled trial of MRgFUS. A placebo effect may explain some of the improvement in fibroid-related symptoms observed in the first 12 weeks after MRgFUS. (C) 2016 by American Society for Reproductive Medicine.