Exposure to Hydroxyurea and Pregnancy Outcomes in Patients With Sickle Cell Anemia
Exposure to Hydroxyurea and Pregnancy Outcomes in Patients With Sickle Cell Anemia
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DOI：
10.1016/s0027-9684(15)31072-5
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发表时间：
2009-10-01
影响因子：
3.3
通讯作者：
Waclawiw, Myron A.
中科院分区：
文献类型：
--
作者：
Ballas, Samir K.;McCarthy, William F.;Waclawiw, Myron A.
羟基脲治疗镰状细胞性贫血（MSH）的多中心研究是一项随机双盲安慰剂对照试验，旨在测试羟基脲是否可以降低每年至少有3次疼痛危象的成人的疼痛危象发生率。由于已知羟基脲在动物中具有致癌性、致突变性和致畸性，因此MSH的主要入选标准是雌性和雄性均使用避孕药，以避免胎儿暴露于羟基脲。尽管采取了这一预防措施，但一些妇女在服用羟基脲或其男性伴侣服用羟基脲时怀孕。我们随访了在最初的MSH试验中登记的存活患者，随访时间长达随机化后17年。我们的研究结果表明，胎儿暴露于羟基脲不会导致致畸性变化，在这些妊娠终止活产，无论是足月或早产。无论服用羟基脲的父母是母亲还是父亲，这似乎都是正确的。同样的论点似乎也适用于阿片类药物的暴露。然而，需要对更多暴露于羟基脲的镰状细胞病受试者进行更长时间的随访才能最终确定结果。
The Multicenter Study of Hydroxyurea in Sickle Cell Anemia (MSH) was a randomized double-blind placebo-controlled trial to test whether hydroxyurea could reduce the rate of painful crises in adults who had at least 3 painful crises per year. Because hydroxyurea is known to be carcinogenic, mutagenic, and teratogenic in animals, a major inclusion criterion in MSH was the use of contraceptives both by females and males in order to avoid exposure of the fetus to hydroxyurea. Despite this precautionary measure, some women became pregnant while taking hydroxyurea or their male partners were on hydroxyurea. We followed surviving patients who were enrolled in the original MSH trial for up to 17 years postrandomization. Our findings suggest that exposure of the fetus to hydroxyurea does not cause teratogenic changes in those pregnancies that terminate in live birth whether full term or premature. This seems to be true whether the parent taking hydroxyurea was the mother or the father. The same argument seems to apply for exposure to opioids. However, it will take a much longer follow-up of many more hydroxyurea-exposed sickle cell disease subjects to establish the results conclusively.