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1
Unmasking the risk: clinical trials real-world evidence on dydrogesterone and birth defects.揭示风险：关于炔诺孕酮与出生缺陷的临床试验及真实世界证据
Hum Reprod Open. 2024 Dec 24;2025(1):hoae073. doi: 10.1093/hropen/hoae073. eCollection 2025.
2
Birth defects reporting and the use of dydrogesterone: a disproportionality analysis from the World Health Organization pharmacovigilance database (VigiBase).出生缺陷报告与炔诺孕酮的使用：来自世界卫生组织药物警戒数据库（VigiBase）的不成比例性分析
Hum Reprod Open. 2025 Jan 2;2025(1):hoae072. doi: 10.1093/hropen/hoae072. eCollection 2025.
3
Micronized progesterone plus dydrogesterone versus micronized progesterone alone for luteal phase support in frozen-thawed cycles (MIDRONE): a prospective cohort study.米非司酮联合地屈孕酮与单纯米非司酮用于冻融周期黄体支持（MIDRONE）：一项前瞻性队列研究。
Hum Reprod. 2021 Jun 18;36(7):1821-1831. doi: 10.1093/humrep/deab093.
4
Progestogens for prevention of luteinising hormone (LH) surge in women undergoing controlled ovarian hyperstimulation as part of an assisted reproductive technology (ART) cycle.孕激素在辅助生殖技术（ART）周期中预防接受控制性卵巢超刺激的女性黄体生成素（LH）激增。
Cochrane Database Syst Rev. 2023 Nov 30;11(11):CD013827. doi: 10.1002/14651858.CD013827.pub2.
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Dydrogesterone use during pregnancy: overview of birth defects reported since 1977.孕期使用地屈孕酮：1977年以来报告的出生缺陷概述。
Early Hum Dev. 2009 Jun;85(6):375-7. doi: 10.1016/j.earlhumdev.2008.12.016. Epub 2009 Feb 3.
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Real-World Evidence of Dydrogesterone 20 mg and 30 mg SR Usage in Pregnancy.20毫克和30毫克缓释炔诺酮在孕期使用的真实世界证据。
Cureus. 2024 Oct 21;16(10):e72016. doi: 10.7759/cureus.72016. eCollection 2024 Oct.
7
[Dydrogesterone versus micronized vaginal progesterone as luteal phase support after fresh embryo transfer in IVF].[在体外受精新鲜胚胎移植后，地屈孕酮与微粒化阴道孕酮作为黄体期支持的比较]
Gynecol Obstet Fertil Senol. 2022 Jun;50(6):455-461. doi: 10.1016/j.gofs.2021.12.014. Epub 2022 Jan 6.
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Comparison of vaginal progesterone gel combined with oral dydrogesterone versus intramuscular progesterone for luteal support in hormone replacement therapy-frozen embryo transfer cycle.比较阴道用黄体酮凝胶联合口服地屈孕酮与肌肉注射黄体酮在激素替代治疗-冻融胚胎移植周期中的黄体支持作用。
J Gynecol Obstet Hum Reprod. 2021 Sep;50(7):102110. doi: 10.1016/j.jogoh.2021.102110. Epub 2021 Mar 13.
9
Progestogens for preventing miscarriage: a network meta-analysis.孕激素预防流产的作用：网状荟萃分析。
Cochrane Database Syst Rev. 2021 Apr 19;4(4):CD013792. doi: 10.1002/14651858.CD013792.pub2.
10
A Phase III randomized controlled trial comparing the efficacy, safety and tolerability of oral dydrogesterone versus micronized vaginal progesterone for luteal support in in vitro fertilization.一项比较口服地屈孕酮与微粒化阴道孕酮在体外受精中黄体支持的疗效、安全性和耐受性的III期随机对照试验。
Hum Reprod. 2017 May 1;32(5):1019-1027. doi: 10.1093/humrep/dex023.

引用本文的文献

1
Why does the latest pharmacovigilance data not reflect clinical experience with dydrogesterone?为何最新的药物警戒数据未反映出地屈孕酮的临床使用情况？
Hum Reprod Open. 2025 May 26;2025(3):hoaf030. doi: 10.1093/hropen/hoaf030. eCollection 2025.

本文引用的文献

1
Birth defects reporting and the use of dydrogesterone: a disproportionality analysis from the World Health Organization pharmacovigilance database (VigiBase).出生缺陷报告与炔诺孕酮的使用：来自世界卫生组织药物警戒数据库（VigiBase）的不成比例性分析
Hum Reprod Open. 2025 Jan 2;2025(1):hoae072. doi: 10.1093/hropen/hoae072. eCollection 2025.
2
Real-World Evidence of Dydrogesterone 20 mg and 30 mg SR Usage in Pregnancy.20毫克和30毫克缓释炔诺酮在孕期使用的真实世界证据。
Cureus. 2024 Oct 21;16(10):e72016. doi: 10.7759/cureus.72016. eCollection 2024 Oct.
3
No additional risk of congenital anomalies after first-trimester dydrogesterone use: a systematic review and meta-analysis.孕早期使用醋酸甲羟孕酮后先天性异常无额外风险：一项系统评价和荟萃分析。
Hum Reprod Open. 2024 Jan 23;2024(1):hoae004. doi: 10.1093/hropen/hoae004. eCollection 2024.
4
A critical appraisal of safety data on dydrogesterone for the support of early pregnancy: a scoping review and meta-analysis.对 dydrogesterone 用于支持早期妊娠的安全性数据进行批判性评价：范围审查和荟萃分析。
Reprod Biomed Online. 2022 Aug;45(2):365-373. doi: 10.1016/j.rbmo.2022.03.032. Epub 2022 Apr 10.
5
Dydrogesterone as an oral alternative to vaginal progesterone for IVF luteal phase support: A systematic review and individual participant data meta-analysis.地屈孕酮作为 IVF 黄体期支持的阴道用黄体酮替代口服药物：一项系统评价和个体参与者数据荟萃分析。
PLoS One. 2020 Nov 4;15(11):e0241044. doi: 10.1371/journal.pone.0241044. eCollection 2020.
6
Hypospadias Prevalence and Trends in International Birth Defect Surveillance Systems, 1980-2010.国际出生缺陷监测系统中 1980 至 2010 年尿道下裂的流行率和趋势。
Eur Urol. 2019 Oct;76(4):482-490. doi: 10.1016/j.eururo.2019.06.027. Epub 2019 Jul 9.
7
Dydrogesterone: pharmacological profile and mechanism of action as luteal phase support in assisted reproduction.地屈孕酮：作为辅助生殖中黄体支持的药理学特性和作用机制。
Reprod Biomed Online. 2019 Feb;38(2):249-259. doi: 10.1016/j.rbmo.2018.11.017. Epub 2018 Dec 15.
8
Oral dydrogesterone versus intravaginal micronized progesterone gel for luteal phase support in IVF: a randomized clinical trial.口服地屈孕酮与阴道内给予微粒化黄体酮凝胶用于体外受精中黄体期支持的比较：一项随机临床试验。
Hum Reprod. 2018 Dec 1;33(12):2212-2221. doi: 10.1093/humrep/dey306.
9
Progestogen for preventing miscarriage in women with recurrent miscarriage of unclear etiology.不明病因复发性流产女性预防流产的孕激素治疗
Cochrane Database Syst Rev. 2018 Oct 8;10(10):CD003511. doi: 10.1002/14651858.CD003511.pub4.
10
A Phase III randomized controlled trial comparing the efficacy, safety and tolerability of oral dydrogesterone versus micronized vaginal progesterone for luteal support in in vitro fertilization.一项比较口服地屈孕酮与微粒化阴道孕酮在体外受精中黄体支持的疗效、安全性和耐受性的III期随机对照试验。
Hum Reprod. 2017 May 1;32(5):1019-1027. doi: 10.1093/humrep/dex023.

Unmasking the risk: clinical trials real-world evidence on dydrogesterone and birth defects.

作者信息

Parazzini Fabio, Cantarutti Anna, Esposito Giovanna

机构信息

Department of Clinical Sciences and Community Health, Dipartimento di Eccellenza 2023-2027, University of Milan, Milan, Italy.

Unit of Biostatistics, Epidemiology and Public Health, Department of Statistics and Quantitative Methods, University of Milano-Bicocca, Milan, Italy.

出版信息

Hum Reprod Open. 2024 Dec 24;2025(1):hoae073. doi: 10.1093/hropen/hoae073. eCollection 2025.

DOI:10.1093/hropen/hoae073
PMID:39807113
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11726824/
Abstract
摘要