本文由小咖机器人翻译整理

期刊来源：Lancet

原文链接：https://doi.org/10.1016/S0140-6736(24)00538-5

摘要内容如下：

背景

多囊卵巢综合征（PCOS）是无排卵性不孕最常见的原因。肥胖加重PCOS生殖并发症；然而，多囊卵巢综合征（PCOS）患者的肥胖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，尚未将手术对排卵率的影响与行为改变和药物治疗进行比较。本研究的目的是比较减肥手术与药物治疗对多囊卵巢综合征（PCOS）、肥胖、月经稀发或闭经妇女排卵率的安全性和有效性。

方法

在这项多中心、开放标签、随机对照试验中，从两个专业肥胖管理中心并通过社交媒体招募了80名年龄大于18岁、根据2018年《多囊卵巢综合征评估和管理国际循证指南》诊断为多囊卵巢综合征、BMI为35 kg/m2或更高的女性。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中的计划程序），由独立研究人员进行，不涉及临床试验的任何其他方面。整个队列的平均年龄为31岁，79%的参与者是白人。主要结果是52周内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，安全性分析为符合方案人群。本研究已在ISRCTN注册中心（ISRCTN16668711）注册。

调查结果

受试者招募时间为2020年2月20日至2021年2月1日，每组40人，其中内科手术组7人，外科手术组10人。手术组的中位排卵数为6（IQR 3.5-10.0），药物组为2（0.0-4.0）。与药物组相比，手术组妇女的自发排卵数高2.5倍（发生率比2.5[95%CI 1.5-4.2]，P<0.0007）。尽管没有长期后遗症，但手术组的并发症比药物组多。手术组和药物组分别有24例（66.7%）和12例（30.0%）不良事件。没有与治疗相关的死亡。

解释

对于多囊卵巢综合征（PCOS）、肥胖、月经稀发或闭经的妇女，减肥手术比药物治疗更有效地诱导自发排卵。因此，减肥手术可以提高这类妇女自然生育的可能性。

英文原文如下：

Abstracts

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.

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