From St. George's Hospital and Medical School (I.M., A.-M.B.) and Whipps Cross Hospital (F.S.), London, the University of Glasgow, Glasgow (M.-A.L., J.M., O.W.), the University of Birmingham, Birmingham (W.M., L.J.M., V.C.), the University of Nottingham, Nottingham (J.P.D.), and the University of Oxford, Oxford (K.M.) - all in the United Kingdom.
N Engl J Med. 2020 Jul 30;383(5):440-451. doi: 10.1056/NEJMoa1914735.
Uterine fibroids, the most common type of tumor among women of reproductive age, are associated with heavy menstrual bleeding, abdominal discomfort, subfertility, and a reduced quality of life. For women who wish to preserve their uterus and who have not had a response to medical treatment, myomectomy and uterine-artery embolization are therapeutic options.
We conducted a multicenter, randomized, open-label trial to evaluate myomectomy, as compared with uterine-artery embolization, in women who had symptomatic uterine fibroids and did not want to undergo hysterectomy. Procedural options included open abdominal, laparoscopic, or hysteroscopic myomectomy. The primary outcome was fibroid-related quality of life, as assessed by the score on the health-related quality-of-life domain of the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire (scores range from 0 to 100, with higher scores indicating a better quality of life) at 2 years; adjustment was made for the baseline score.
A total of 254 women, recruited at 29 hospitals in the United Kingdom, were randomly assigned: 127 to the myomectomy group (of whom 105 underwent myomectomy) and 127 to the uterine-artery embolization group (of whom 98 underwent embolization). Data on the primary outcome were available for 206 women (81%). In the intention-to-treat analysis, the mean (±SD) score on the health-related quality-of-life domain of the UFS-QOL questionnaire at 2 years was 84.6±21.5 in the myomectomy group and 80.0±22.0 in the uterine-artery embolization group (mean adjusted difference with complete case analysis, 8.0 points; 95% confidence interval [CI], 1.8 to 14.1; P = 0.01; mean adjusted difference with missing responses imputed, 6.5 points; 95% CI, 1.1 to 11.9). Perioperative and postoperative complications from all initial procedures, irrespective of adherence to the assigned procedure, occurred in 29% of the women in the myomectomy group and in 24% of the women in the uterine-artery embolization group.
Among women with symptomatic uterine fibroids, those who underwent myomectomy had a better fibroid-related quality of life at 2 years than those who underwent uterine-artery embolization. (Funded by the National Institute for Health Research Health Technology Assessment program; FEMME Current Controlled Trials number, ISRCTN70772394.).
子宫肌瘤是育龄妇女中最常见的肿瘤类型，与月经过多、腹部不适、不孕和生活质量下降有关。对于希望保留子宫且对药物治疗无反应的妇女，子宫肌瘤切除术和子宫动脉栓塞术是治疗选择。
我们进行了一项多中心、随机、开放标签试验，以评估子宫肌瘤切除术与子宫动脉栓塞术在有症状的子宫肌瘤且不想接受子宫切除术的妇女中的疗效。手术选择包括开腹、腹腔镜或宫腔镜子宫肌瘤切除术。主要结局是通过 Uterine Fibroid Symptom and Quality of Life (UFS-QOL) 问卷健康相关生活质量领域的评分评估的子宫肌瘤相关生活质量，评分范围为 0 到 100，分数越高表示生活质量越好；在调整基线评分后进行。
共有 254 名女性在英国的 29 家医院被招募，随机分为两组：127 名接受子宫肌瘤切除术（其中 105 名接受了子宫肌瘤切除术）和 127 名接受子宫动脉栓塞术（其中 98 名接受了栓塞术）。共有 206 名女性（81%）的主要结局数据可用。在意向治疗分析中，在 2 年时 UFS-QOL 问卷健康相关生活质量领域的平均（±SD）评分在子宫肌瘤切除术组为 84.6±21.5，在子宫动脉栓塞术组为 80.0±22.0（完全案例分析的平均调整差异为 8.0 分；95%置信区间[CI]，1.8 至 14.1；P=0.01；缺失反应的平均调整差异为 6.5 分；95%CI，1.1 至 11.9）。无论是否遵守指定的手术程序，所有初始手术的围手术期和术后并发症在子宫肌瘤切除术组的 29%的女性和子宫动脉栓塞术组的 24%的女性中发生。
在有症状的子宫肌瘤妇女中，接受子宫肌瘤切除术的患者在 2 年内的子宫肌瘤相关生活质量优于接受子宫动脉栓塞术的患者。（由英国国家卫生研究院卫生技术评估计划资助；FEMME 当前对照试验编号，ISRCTN70772394。）
