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生物制剂及某些免疫抑制性抗风湿药物孕期安全性的最新情况

Update on safety during pregnancy of biological agents and some immunosuppressive anti-rheumatic drugs.

作者信息

Østensen M, Lockshin M, Doria A, Valesini G, Meroni P, Gordon C, Brucato A, Tincani A

机构信息

Department of Rheumatology and Clinical Immunology and Allergology, University Hospital of Bern, CH-3010 Bern, Switzerland.

出版信息

Rheumatology (Oxford). 2008 Jun;47 Suppl 3:iii28-31. doi: 10.1093/rheumatology/ken168.

DOI:10.1093/rheumatology/ken168
PMID:18504282
Abstract

A consensus paper concerning the interaction of anti-rheumatic drugs and reproduction was published in 2006, representing data collected during the year 2004 and 2005. Because of an increasing use of biological agents in women of fertile age, the information was updated for the years 2006 and 2007. Experts disagree whether TNF-inhibitors should be stopped as soon as pregnancy is recognized or may be continued throughout pregnancy. Pregnancy experience with abatacept and rituximab is still too limited to prove their safety for the developing fetus. They must be withdrawn before a planned pregnancy. LEF has not been proven to be a human teratogen. Registries of transplant recipients have shown that cyclosporin (CsA) and tacrolimus do not increase the rate of congenital anomalies, whereas mycophenolate mofetil (MMF) clearly carries a risk for congenital anomalies. Prophylactic withdrawal of drugs before pregnancy is mandatory for abatacept, rituximab, LEF and MMF. Data remain insufficient for gonadal toxicity of immunosuppressive drugs in men and for excretion of these drugs in human breast milk.

摘要

一篇关于抗风湿药物与生殖相互作用的共识性论文于2006年发表,其中的数据收集于2004年和2005年。由于育龄女性中生物制剂的使用日益增加,该信息于2006年和2007年进行了更新。专家们对于一旦确认怀孕是否应立即停用肿瘤坏死因子抑制剂,还是可以在整个孕期继续使用存在分歧。阿巴西普和利妥昔单抗的妊娠经验仍然非常有限,无法证明它们对发育中的胎儿是安全的。在计划怀孕前必须停用它们。来氟米特尚未被证明是人类致畸剂。器官移植受者登记处的数据表明,环孢素(CsA)和他克莫司不会增加先天性异常的发生率,而霉酚酸酯(MMF)显然存在导致先天性异常的风险。对于阿巴西普、利妥昔单抗、来氟米特和霉酚酸酯,怀孕前必须预防性停药。关于免疫抑制药物对男性性腺毒性以及这些药物在人乳中的排泄情况,数据仍然不足。

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