沙特阿拉伯诺拉·宾特·阿卜杜拉赫曼公主大学Shahd Alabdulkader团队研究了减肥手术治疗多囊卵巢综合征（PCOS）肥胖女性对排卵预后的影响。该研究于2024年5月20日发表在《柳叶刀》杂志上。

多囊卵巢综合征（PCOS）是导致无排卵性不孕的最常见原因。肥胖会加重多囊卵巢综合征的生殖并发症；然而，多囊卵巢综合征妇女肥胖的管理仍然是一个巨大的未满足的临床需求。观察性研究表明，减肥手术可以改善排卵周期和生育前景；然而，在一项随机试验中，减肥手术对排卵率的疗效尚未与行为改变和药物治疗进行比较。该研究旨在比较减肥手术与医疗护理对多囊卵巢综合征、肥胖和月经过少或闭经妇女排卵率的安全性和有效性。

在这项多中心、开放标签、随机对照试验中，研究组从两个专业肥胖管理中心和社交媒体招募了80名18岁以上的女性，她们根据2018年国际循证指南评估和管理多囊卵巢综合征，BMI为35 kg/m²或更高。参与者以1:1的比例被随机分配到垂直袖状胃切除术或行为干预和药物治疗，使用计算机生成的随机序列（SAS中的PLAN程序），由一名不参与任何其他临床试验的独立研究人员进行。整个队列的中位年龄为31岁，79%的参与者是白人。主要结局是52周内经生化证实的排卵事件的数量，并使用每周血清孕酮测量进行评估。主要终点包括意向治疗人群，安全性分析按方案人群进行。

参与者招募时间为2020年2月20日至2021年2月1日。每组40名参与者，医疗干预组有7名退出者，手术组有10名退出者。手术组的中位排卵次数为6次（IQR 3.5–10.0），医疗干预组为2次（0.0–4.0）。与医疗干预组相比，手术组的女性自发排卵次数增加了2.5倍（发病率比2.5[95%CI 1.5–4.2]，p＜0.0007）。手术组的并发症比医疗干预组多，尽管没有长期后遗症。手术组有24例（66.7%）不良事件，医疗干预组有12例（30.0%）不良事件。没有与治疗相关的死亡。

研究结果表明，在多囊卵巢综合征、肥胖和月经过少或闭经的女性中，减肥手术比医疗护理可更有效地诱导自发排卵。因此，减肥手术可以提高这一群体妇女自主生育的前景。

附：英文原文

Title: Bariatric surgery for spontaneous ovulation in women living with polycystic ovary syndrome: the BAMBINI multicentre, open-label, randomised controlled trial

Author: Suhaniya N S Samarasinghe, Bianca Leca, Shahd Alabdulkader, Georgios K Dimitriadis, Allan Davasgaium, Puja Thadani, Kate Parry, Migena Luli, Karen ODonnell, Brett Johnson, Ali Abbara, Florian Seyfried, Rachel Morman, Ahmed R Ahmed, Sherif Hakky, Christos Tsironis, Sanjay Purkayastha, Carel W le Roux, Stephen Franks, Vinod Menon, Harpal Randeva, Alexander D Miras

Issue&Volume: 2024-05-20

Abstract:

Background

Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility. Obesity exacerbates the reproductive complications of PCOS; however, the management of obesity in women with PCOS remains a large unmet clinical need. Observational studies have indicated that bariatric surgery could improve the rates of ovulatory cycles and prospects of fertility; however, the efficacy of surgery on ovulation rates has not yet been compared with behavioural modifications and medical therapy in a randomised trial. The aim of this study was to compare the safety and efficacy of bariatric surgery versus medical care on ovulation rates in women with PCOS, obesity, and oligomenorrhoea or amenorrhoea.

Methods

In this multicentre, open-label, randomised controlled trial, 80 women older than 18 years, with a diagnosis of PCOS based on the 2018 international evidence-based guidelines for assessing and managing PCOS, and a BMI of 35 kg/m2 or higher, were recruited from two specialist obesity management centres and via social media. Participants were randomly assigned at a 1:1 ratio to either vertical sleeve gastrectomy or behavioural interventions and medical therapy using a computer-generated random sequence (PLAN procedure in SAS) by an independent researcher not involved with any other aspect of the clinical trial. The median age of the entire cohort was 31 years and 79% of participants were White. The primary outcome was the number of biochemically confirmed ovulatory events over 52 weeks, and was assessed using weekly serum progesterone measurements. The primary endpoint included the intention-to-treat population and safety analyses were per-protocol population. This study is registered with the ISRCTN registry (ISRCTN16668711).

Findings

Participants were recruited from Feb 20, 2020 to Feb 1, 2021. 40 participants were assigned to each group and there were seven dropouts in the medical group and ten dropouts in the surgical group. The median number of ovulations was 6 (IQR 3·5–10·0) in the surgical group and 2 (0·0–4·0) in the medical group. Women in the surgical group had 2.5 times more spontaneous ovulations compared with the medical group (incidence rate ratio 2·5 [95% CI 1·5–4·2], p<0·0007). There were more complications in the surgical group than the medical group, although without long-term sequelae. There were 24 (66·7%) adverse events in the surgical group and 12 (30·0%) in the medical group. There were no treatment-related deaths.

Interpretation

Bariatric surgery was more effective than medical care for the induction of spontaneous ovulation in women with PCOS, obesity, and oligomenorrhoea or amenorrhoea. Bariatric surgery could, therefore, enhance the prospects of spontaneous fertility in this group of women.

DOI: 10.1016/S0140-6736(24)00538-5

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)00538-5/abstract