Nephrology Department, Clínica Universidad de Navarra, Navarra Institute for Health Research (IdiSNA), Pamplona, Spain.
Nephrology Department, Hospital Clínico Universitario San Carlos, Madrid, Spain.
Clin Transplant. 2021 May;35(5):e14256. doi: 10.1111/ctr.14256. Epub 2021 Feb 27.
The use of mycophenolic acid (MPA) in women during pregnancy causes an increase in miscarriages and birth defects with a typical embryopathy profile. Although epidemiological data does not suggest a greater risk among the offspring of male kidney transplant recipients, the European Medicines Agency and The Spanish Agency of Medicines and Medical Devices introduced the recommendation of using contraceptive methods.
We conducted a national retrospective study in 15 Spanish Kidney Transplant Centers to evaluate the frequency of miscarriages and birth defects between the offspring from male kidney transplants recipients. We included 151 males who had fathered 239 offspring, 225 under MPA and 14 without MPA.
The results of our study showed an incidence of miscarriages in the MPA group of 9.8%, and of birth defects of 4%.
We observed an incidence of miscarriages between the offspring fathered by kidney transplant males under MPA lower than the general population. The incidence of birth defects was similar to the incidence described in other studies and the fact that we did not find the typical embryopathy profile makes it difficult to associate them to the use of MPA. Because of that, we urge the European and Spanish Agencies to reconsider their recommendations for males.
在怀孕期间使用吗替麦考酚酸（MPA）会导致流产和出生缺陷增加，具有典型的胚胎病特征。尽管流行病学数据并未表明男性肾移植受者的后代面临更大的风险，但欧洲药品管理局和西班牙药品和医疗器械管理局提出了使用避孕方法的建议。
我们在 15 家西班牙肾移植中心进行了一项全国性回顾性研究，以评估男性肾移植受者后代的流产和出生缺陷的频率。我们纳入了 151 名男性，他们生育了 239 名后代，其中 225 名在 MPA 下，14 名不在 MPA 下。
我们的研究结果显示，MPA 组的流产发生率为 9.8%，出生缺陷发生率为 4%。
我们观察到 MPA 下男性肾移植后代的流产发生率低于普通人群。出生缺陷的发生率与其他研究中描述的发生率相似，而且我们没有发现典型的胚胎病特征，这使得将其与 MPA 的使用联系起来变得困难。因此，我们敦促欧洲和西班牙机构重新考虑对男性的建议。
