Pregnancy Research Unit, Department of Rheumatology, Clinical Immunology and Allergology, University Hospital and University of Berne, Berne, Switzerland.
Curr Opin Rheumatol. 2011 May;23(3):293-8. doi: 10.1097/BOR.0b013e328344a732.
Due to limited human pregnancy experience safety issues in regard to children exposed antenatally to biological drugs are still under debate. A survey of new published experience on biological agents during pregnancy is necessary to assist clinicians with adequate counseling and management of patients who desire children.
No controlled study has been published on use of TNFα inhibitors, rituximab, abatacept, tocilizumab or anakinra in pregnancy during the years 2009-2010. New case reports confirm that all monoclonal antibodies expose the child to the full adult dose when administered in late pregnancy with a risk for adverse effects in the newborn and perinatally. Data from a drug registry show that preconceptional and early first-trimester use of rituximab appears to confer no serious side effect to the child. Case reports on abatacept, tocilizumab or anakinra in pregnancy are not conclusive.
Differences in molecular structure of TNFα inhibitors may turn out to favor the use of agents that are not complete monoclonal antibodies in women who consider pregnancy. The very limited experience with abatacept, tocilizumab or anakinra in pregnancy allows no statement as to their compatibility with pregnancy. At present use of biological agents throughout pregnancy cannot be recommended.
由于人类妊娠经验有限，因此对于在产前接触生物药物的儿童的安全性问题仍存在争议。有必要对新发表的关于妊娠期间生物制剂的经验进行调查，以协助临床医生为希望生育的患者提供充分的咨询和管理。
在 2009-2010 年期间，尚无关于 TNFα 抑制剂、利妥昔单抗、阿巴西普、托珠单抗或阿那白滞素在妊娠期间使用的对照研究。新的病例报告证实，所有单克隆抗体在妊娠晚期给予时都会使儿童暴露于全成人剂量，从而使新生儿和围产期存在不良反应的风险。药物登记处的数据表明，在妊娠前和妊娠早期使用利妥昔单抗似乎不会对儿童造成严重的副作用。关于阿巴西普、托珠单抗或阿那白滞素在妊娠期间的病例报告尚无定论。
TNFα 抑制剂的分子结构差异可能有利于在考虑妊娠的女性中使用不完全的单克隆抗体。在妊娠期间使用阿巴西普、托珠单抗或阿那白滞素的经验非常有限，因此无法确定其与妊娠的兼容性。目前不能推荐在整个妊娠期间使用生物制剂。
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