Institute for Social Medicine and Epidemiology, University of Lübeck, Ratzeburger Allee 160, Lübeck 26536, Germany.
Feinberg School of Medicine of Northwestern University, Chicago, USA.
Reprod Biomed Online. 2022 Aug;45(2):365-373. doi: 10.1016/j.rbmo.2022.03.032. Epub 2022 Apr 10.
No data support the suggestion that first-trimester dydrogesterone use increases the risk of fetal abnormalities; however, two low-quality retrospective studies (one retracted by the journal) have suggested such a link. A scoping review and meta-analysis were carried out to address this discrepancy. The literature was reviewed but it was not possible to identify any evidence of a plausible mechanism for potential causality between dydrogesterone and fetal abnormalities. To investigate whether any evidence existed, a preliminary meta-analysis was undertaken of clinical studies published since 2005 on first-trimester dydrogesterone use with assessment of fetal abnormalities. A fixed effects model was used to determine pooled odds ratios with 95% confidence intervals (95% CI). From 83 articles identified, six randomized controlled trials were included. Pooled risk ratios (RR) for maternal dydrogesterone use and fetal abnormalities gave a RR approaching 1 (RR 0.96; 95% CI 0.57, 1.62), confirming previous conclusions of no causal association between fetal abnormalities and first-trimester dydrogesterone use. Physicians, scientists and journal reviewers should exercise due diligence to prevent promulgation of retracted data. We are confident in using dydrogesterone, if indicated, in the treatment of threatened or recurrent miscarriage, and believe that its favourable safety profile should extend to its appropriate use in assisted reproductive technologies.
没有数据支持在妊娠早期使用地屈孕酮会增加胎儿畸形的风险的说法；然而，两项低质量的回顾性研究（其中一项已被期刊撤回）表明存在这种关联。进行了范围界定审查和荟萃分析以解决这一分歧。虽然对文献进行了回顾，但未能确定地屈孕酮与胎儿畸形之间可能存在因果关系的合理机制的任何证据。为了调查是否存在任何证据，对 2005 年以来发表的关于妊娠早期使用地屈孕酮与胎儿畸形评估的临床研究进行了初步荟萃分析。使用固定效应模型确定汇总优势比及其 95%置信区间（95%CI）。从确定的 83 篇文章中，纳入了六项随机对照试验。母亲使用地屈孕酮与胎儿畸形的汇总风险比（RR）接近 1（RR 0.96；95%CI 0.57, 1.62），证实了先前关于胎儿畸形与妊娠早期使用地屈孕酮之间没有因果关系的结论。医生、科学家和期刊审稿人应谨慎行事，以防止撤回数据的传播。我们有信心在有指征的情况下使用地屈孕酮治疗先兆流产或复发性流产，并且相信其有利的安全性特征应扩展到其在辅助生殖技术中的适当应用。
