创新链/学科链/研发链/产业链

新药研发前沿动态 / 医药领域趋势进展

哺乳期抗甲状腺药用药的临床证据和指南推荐

Clinical Evidence and Guidelines for Anti-thyroid Drugs during Lactation

  • 摘要: 2018年2月,原国家食品药品监督管理总局(CFDA)要求对甲硫咪唑片说明书的多项内容进行修改,其中有关“哺乳期妇女禁用”的修改与临床实际应用情况大相径庭。考虑到哺乳期抗甲状腺药物用药的特殊性,检索PubMed等数据库,梳理哺乳期抗甲状腺药临床使用证据和指南推荐。大量临床证据认为,哺乳期妇女服用抗甲状腺药物对婴儿的甲状腺功能、身体智力生长发育等方面均无明显影响。最大安全给药剂量为甲硫咪唑30 mg·d-1,丙硫氧嘧啶300 mg·d-1,且甲硫咪唑为哺乳期抗甲状腺首选药物,只有在甲亢危象或重症甲亢、对甲硫咪唑过敏的情况下才推荐使用丙硫氧嘧啶进行治疗。

     

    Abstract: In February 2018, the former China Food and Drug Administration (CFDA) ordered a number of changes to the guidelines for methimidazole tablets, including a change to "ban the drug for lactating women" which was far from clinical practice. Considering the particularity of anti-thyroid drugs (ATDs) for women in lactation, we searched PubMed and other databases and combed the clinical evidence and guidelines for ATDs for women in lactation. A large amount of clinical evidence suggests that ATDs by women during lactation has no obvious effect on the thyroid function, physical intelligence growth and development of the infant. The maximum safe dose was 30 mg·d-1 of methimidazole (MMI) and 300 mg·d-1 of propylthiouracil (PTU). MMI is the first choice of ATD for women in lactation, while PTU is recommended only in the case of hyperthyroidism or severe hyperthyroidism and allergy to MMI.

     

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