补充肌醇预防多囊卵巢综合征妊娠并发症：一项随机临床试验。

Myo-inositol Supplementation to Prevent Pregnancy Complications in Polycystic Ovary Syndrome: A Randomized Clinical Trial.

作者信息

van der Wel Anne W T, Frank Chryselle M C, Bout-Rebel Rebekka, Duijnhoven Ruben G, van Bree Bo E, Valkenburg Olivier, Al-Nasiry Salwan, van Oppenraaij Robbert H F, Vogelvang Tatjana E, Westerhuis Michelle E M H, van de Nieuwenhof Hedwig P, Gielen Susanne C J P, Bandell Myrthe L, Bekker Mireille N, Wouters Maurice G A J, Mijatovic Velja, Franx Arie, Lambalk Cornelis B, Broekmans Frank J M, de Weerd Sabina, Gerards Jet M H, Baalman Jelle H, van Disseldorp Jeroen, Langenveld Josje, Gunning Marlise N, Frederix Geert W J, Painter Rebecca C, Fauser Bart C J M, Laven Joop S E, van Rijn Bas B

机构信息

Department of Obstetrics and Gynecology, Amsterdam University Medical Center location AMC, Amsterdam, the Netherlands.

Amsterdam Reproduction & Development Research Institute, Amsterdam, the Netherlands.

出版信息

JAMA. 2025 Sep 8. doi: 10.1001/jama.2025.13668.

DOI:10.1001/jama.2025.13668

PMID:40920401

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12418221/

Abstract

IMPORTANCE

Pregnant individuals with polycystic ovary syndrome (PCOS) present with a higher risk of pregnancy complications, including gestational diabetes, preeclampsia, and preterm birth. Myo-inositol supplementation may reduce these risks.

OBJECTIVE

To determine whether daily supplementation with myo-inositol during pregnancy among individuals with PCOS reduces the risk of a composite outcome of gestational diabetes, preeclampsia, and preterm birth.

DESIGN, SETTING, AND PARTICIPANTS: This double-blind, placebo-controlled, randomized trial was conducted at 13 hospitals in the Netherlands. Pregnant individuals with PCOS who were between 8 and 16 weeks' gestation were enrolled between June 2019 and March 2023. Final follow-up was complete on December 27, 2023. Analyses were conducted July 2024.

INTERVENTIONS

Participants were randomized on a 1:1 basis to receive sachets with either myo-inositol, 2 g, with 0.2 mg of folic acid twice daily (n = 230) or matching placebo with 0.2 mg of folic acid only (n = 234) until delivery.

MAIN OUTCOMES AND MEASURES

The primary outcome was a composite of gestational diabetes, preeclampsia, or preterm birth (before 37 weeks' gestation).

RESULTS

Among 464 participants, the mean (SD) age was 31.5 (3.8) years; 18 participants (3.9%) reported Asian race and 395 (86.1%) reported White race. The prevalence of biochemical hyperandrogenism was higher at baseline in the myo-inositol group than the placebo group (29.0% [53 of 180] vs 18.5% [37 of 193]). A primary outcome event occurred in 25.0% (n = 56) of participants in the myo-inositol group and 26.8% (n = 61) in the placebo group (relative risk, 0.93 [95% CI, 0.68-1.28]; P = .67).

CONCLUSIONS AND RELEVANCE

Myo-inositol supplementation during pregnancy did not reduce the incidence of a composite of gestational diabetes, preeclampsia, or preterm birth in patients with PCOS.

TRIAL REGISTRATION

onderzoekmetmensen.nl Identifier: NL67329.078.18.

摘要

重要性

患有多囊卵巢综合征（PCOS）的孕妇出现妊娠并发症的风险更高，包括妊娠期糖尿病、先兆子痫和早产。补充肌醇可能会降低这些风险。

目的

确定PCOS患者在孕期每日补充肌醇是否能降低妊娠期糖尿病、先兆子痫和早产这一复合结局的风险。

设计、地点和参与者：这项双盲、安慰剂对照的随机试验在荷兰的13家医院进行。2019年6月至2023年3月招募了妊娠8至16周的PCOS孕妇。最终随访于2023年12月27日完成。分析于2024年7月进行。

干预措施

参与者按1:1随机分组，分别接受每天两次含2克肌醇和0.2毫克叶酸的药包（n = 230）或仅含0.2毫克叶酸的匹配安慰剂（n = 234），直至分娩。

主要结局和测量指标

主要结局是妊娠期糖尿病、先兆子痫或早产（妊娠37周前）的复合情况。

结果

在464名参与者中，平均（标准差）年龄为31.5（3.8）岁；18名参与者（3.9%）报告为亚洲种族，395名（86.1%）报告为白人种族。肌醇组基线时生化性高雄激素血症的患病率高于安慰剂组（29.0%[180人中的53人]对18.5%[193人中的37人]）。肌醇组25.0%（n = 56）的参与者和安慰剂组26.8%（n = 61）的参与者发生了主要结局事件（相对风险，0.93[95%CI，0.68 - 1.28]；P = 0.67）。