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Why does the latest pharmacovigilance data not reflect clinical experience with dydrogesterone?

作者信息

Pabuccu Emre, Aguilar Angela, de Azevedo Antunes Roberto, Gefen Eran, Shulman Lee P

机构信息

Ufuk University School of Medicine, Dr. Rıdvan Ege Hospital, Ankara, Turkey.

Centrum Clinic Assisted Reproduction Center, Ankara, Turkey.

出版信息

Hum Reprod Open. 2025 May 26;2025(3):hoaf030. doi: 10.1093/hropen/hoaf030. eCollection 2025.

DOI:10.1093/hropen/hoaf030
PMID:40497085
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12151318/
Abstract
摘要

相似文献

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.
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
Dydrogesterone: metabolism in man.炔诺孕酮：人体代谢
Eur J Drug Metab Pharmacokinet. 1980;5(3):173-84. doi: 10.1007/BF03189462.
4
Dydrogesterone use in early pregnancy.孕早期使用地屈孕酮。
Gynecol Endocrinol. 2016;32(2):97-106. doi: 10.3109/09513590.2015.1121982. Epub 2016 Jan 22.
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Role of Dydrogesterone for Luteal Phase Support in Assisted Reproduction.地屈孕酮在辅助生殖中黄体支持的作用。
Reprod Sci. 2024 Jan;31(1):17-29. doi: 10.1007/s43032-023-01302-z. Epub 2023 Jul 24.
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Cardiovascular risk markers during treatment with estradiol and trimegestone or dydrogesterone.使用雌二醇与屈美孕酮或地屈孕酮治疗期间的心血管风险标志物
Maturitas. 2009 Mar 20;62(3):287-93. doi: 10.1016/j.maturitas.2009.01.004. Epub 2009 Mar 5.
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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.
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Estradiol and dydrogesterone. A review of their combined use as hormone replacement therapy in postmenopausal women.雌二醇和地屈孕酮。关于它们联合用作绝经后女性激素替代疗法的综述。
Drugs Aging. 1997 Oct;11(4):309-32. doi: 10.2165/00002512-199711040-00006.
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Effects of dydrogesterone on the vascular system.炔诺孕酮对血管系统的影响。
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引用本文的文献

1
Reply: Fetal safety of dydrogesterone: clarifying the role of pharmacovigilance.回复：地屈孕酮的胎儿安全性：阐明药物警戒的作用。
Hum Reprod Open. 2025 May 21;2025(3):hoaf031. doi: 10.1093/hropen/hoaf031. eCollection 2025.

本文引用的文献

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
The maternal drug exposure birth cohort (DEBC) in China.中国的母体药物暴露出生队列（DEBC）。
Nat Commun. 2024 Jun 21;15(1):5312. doi: 10.1038/s41467-024-49623-0.
4
Reply: Absence of evidence is not evidence of absence for first trimester dydrogesterone-induced birth defects.回复：对于孕早期服用地屈孕酮是否会导致出生缺陷，缺乏证据并不等同于有证据证明没有影响。
Hum Reprod Open. 2024 May 11;2024(2):hoae031. doi: 10.1093/hropen/hoae031. eCollection 2024.
5
Absence of evidence is not evidence of absence for first trimester dydrogesterone-induced birth defects.对于孕早期地屈孕酮诱导的出生缺陷，缺乏证据并不等同于证据不存在。
Hum Reprod Open. 2024 May 11;2024(2):hoae030. doi: 10.1093/hropen/hoae030. eCollection 2024.
6
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.
7
Global, regional, and national incidence and mortality of congenital birth defects from 1990 to 2019.1990年至2019年全球、区域和国家先天性出生缺陷的发病率和死亡率
Eur J Pediatr. 2023 Apr;182(4):1781-1792. doi: 10.1007/s00431-023-04865-w. Epub 2023 Feb 13.
8
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.
9
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.
10
Association between a Maternal History of Miscarriages and Birth Defects.母亲流产史与出生缺陷的关联。
Birth Defects Res. 2017 Mar 1;109(4):254-261. doi: 10.1002/bdra.23563. Epub 2017 Feb 21.