近日，英国阿伯丁皇家医院Kevin Cooper及其团队比较了腹腔镜下次全子宫切除术和子宫内膜消融术治疗月经过多妇女的疗效。这一研究成果于2019年9月12日在线发表于《柳叶刀》。

英国31家医院进行了这项平行组、多中心、开放标签、随机对照试验，2014年5月21日至2017年3月28日共招募了660名参与者。这些参与者的年龄均小于50岁，月经出血过多，且符合子宫内膜切除术的指征。参与者按1：1随机分配接受腹腔镜下次全子宫切除术或二代子宫内膜消融术。采用月经过多的多属性量表（MMAS）对患者的生活质量进行评分，得分越高生活质量越好。

616名（93%）女性在研究期间接受手术，其中588名（95%）接受随机分组，28名（5%）接受替代手术。15个月后，腹腔镜下次全子宫切除术组中患者对手术的满意度为97%，显著高于子宫内膜消融术组（87%），校正优势比为2.53。腹腔镜下次全子宫切除术组中有69%的患者获得100分的最佳MAAS评分，显著高于子宫内膜消融术组（54%），校正优势比为1.87。腹腔镜下次全子宫切除术组中有14例（5%）患者出现至少一次严重不良事件，而子宫内膜消融术组中有11例（4%）。

总之，腹腔镜下次全子宫切除术的临床疗效优于子宫内膜消融术，术后并发症发生率相差不大，但手术时间较长，康复时间也较长。

据悉，英国有25%的女性遭受月经大出血的折磨，其中多数人需要手术治疗。子宫切除术疗效显著，但与子宫内膜消融术相比并发症更多；子宫内膜消融术创伤小，但最终可导致20%的患者再行子宫切除。

附：英文原文

Title: Laparoscopic supracervical hysterectomy versus endometrial ablation for women with heavy menstrual bleeding (HEALTH): a parallel-group, open-label, randomised controlled trial

Author: Kevin Cooper, Suzanne Breeman, Neil W Scott, Graham Scotland, Justin Clark, Jed Hawe, Robert Hawthorn, Kevin Phillips, Graeme MacLennan, Samantha Wileman, Kirsty McCormack, Rodolfo Hernández, John Norrie, Siladitya Bhattacharya

Issue&Volume: 12 September 2019

Summary: 

Background

Heavy menstrual bleeding affects 25% of women in the UK, many of whom require surgery to treat it. Hysterectomy is effective but has more complications than endometrial ablation, which is less invasive but ultimately leads to hysterectomy in 20% of women. We compared laparoscopic supracervical hysterectomy with endometrial ablation in women seeking surgical treatment for heavy menstrual bleeding.

Methods

In this parallel-group, multicentre, open-label, randomised controlled trial in 31 hospitals in the UK, women younger than 50 years who were referred to a gynaecologist for surgical treatment of heavy menstrual bleeding and who were eligible for endometrial ablation were randomly allocated (1:1) to either laparoscopic supracervical hysterectomy or second generation endometrial ablation. Women were randomly assigned by either an interactive voice response telephone system or an internet-based application with a minimisation algorithm based on centre and age group (<40 years vs ≥40 years). Laparoscopic supracervical hysterectomy involves laparoscopic (keyhole) surgery to remove the upper part of the uterus (the body) containing the endometrium. Endometrial ablation aims to treat heavy menstrual bleeding by destroying the endometrium, which is responsible for heavy periods. The co-primary clinical outcomes were patient satisfaction and condition-specific quality of life, measured with the menorrhagia multi-attribute quality of life scale (MMAS), assessed at 15 months after randomisation. Our analysis was based on the intention-to-treat principle. The trial was registered with the ISRCTN registry, number ISRCTN49013893.

Findings

Between May 21, 2014, and March 28, 2017, we enrolled and randomly assigned 660 women (330 in each group). 616 (93%) of 660 women were operated on within the study period, 588 (95%) of whom received the allocated procedure and 28 (5%) of whom had an alternative surgery. At 15 months after randomisation, more women allocated to laparoscopic supracervical hysterectomy were satisfied with their operation compared with those in the endometrial ablation group (270 [97%] of 278 women vs 244 [87%] of 280 women; adjusted percentage difference 9·8, 95% CI 5·1–14·5; adjusted odds ratio [OR] 2·53, 95% CI 1·83–3·48; p<0·0001). Women randomly assigned to laparoscopic supracervical hysterectomy were also more likely to have the best possible MMAS score of 100 than women assigned to endometrial ablation (180 [69%] of 262 women vs 146 [54%] of 268 women; adjusted percentage difference 13·3, 95% CI 3·8–22·8; adjusted OR 1·87, 95% CI 1·31–2·67; p=0·00058). 14 (5%) of 309 women in the laparoscopic supracervical hysterectomy group and 11 (4%) of 307 women in the endometrial ablation group had at least one serious adverse event (adjusted OR 1·30, 95% CI 0·56–3·02; p=0·54).

Interpretation

Laparoscopic supracervical hysterectomy is superior to endometrial ablation in terms of clinical effectiveness and has a similar proportion of complications, but takes longer to perform and is associated with a longer recovery.

DOI: 10.1016/S0140-6736(19)31790-8

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)31790-8/fulltext