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干扰素α的胎儿安全性系统评价。

A systematic review of the fetal safety of interferon alpha.

机构信息

The Motherisk Program, Hospital for Sick Children, University of Toronto, Canada.

出版信息

Reprod Toxicol. 2012 Jun;33(3):265-8. doi: 10.1016/j.reprotox.2011.11.003. Epub 2011 Dec 19.

DOI:10.1016/j.reprotox.2011.11.003
PMID:22200624
Abstract

BACKGROUND

Interferon alpha (IFN) is an effective treatment for a variety of conditions including essential thrombocythemia (ET), chronic myelocytic leukemia, Hepatitis B and C. Because these conditions also occur in women of childbearing age who may become pregnant, information regarding the safety of this medication in pregnancy is essential. This systematic review attempts to summarize all published data on outcome of pregnancies exposed to IFN alpha, trying to differentiate between disease effect and drug effect.

METHODS

Reports on the use of IFN alpha in human pregnancy and reports on essential thrombocythemia (ET) without use of any medication in pregnancy were identified by a systematic search of the medical literature. We were able to locate only case reports of IFN alpha exposure in pregnancy, of whom 40 out of 63 were diagnosed with ET. We also collected randomly 71 cases (more cases were available in the literature) that were diagnosed with ET due to different etiologies, but who had not received any medication in pregnancy.

RESULTS

Among the 63 IFN alpha exposures in pregnancy, the mean maternal age was 30±6 years and the mean full term babies' weight was 3096±463 g. Mean gestational age at delivery was 37±3 weeks. There were 55 single and 4 twin pregnancies. No cases of major malformations or stillbirths were reported. There was one case of spontaneous abortion and 13 preterm deliveries (20% of all exposed cases). Among the 71 cases with untreated ET in pregnancy of different etiologies, 46 (65%) had early (within the first 12 weeks of pregnancy) or late (13-20 weeks of gestation) pregnancy loss. There were also 3 cases (4%) of stillbirth and 4 cases (5.6%) of preterm delivery. Only 18 women (25%) delivered healthy term babies.

CONCLUSIONS

The results of our systematic review suggest that IFN-α does not significantly increase the risk of major malformation, miscarriage, stillbirth or preterm delivery above general population rates. It is also possible that IFN-α may have a protective effect against pregnancy loss in cases of ET.

摘要

背景

干扰素 alpha(IFN)是一种有效的治疗药物,可用于多种疾病,包括原发性血小板增多症(ET)、慢性髓细胞性白血病、乙型肝炎和丙型肝炎。由于这些疾病也发生在育龄妇女中,她们可能会怀孕,因此了解这种药物在怀孕期间的安全性至关重要。本系统评价试图总结所有已发表的 IFN alpha 暴露于妊娠的结局数据,试图区分疾病效应和药物效应。

方法

通过系统搜索医学文献,确定了 IFN alpha 在人类妊娠中的应用报告以及未在妊娠中使用任何药物的原发性血小板增多症(ET)报告。我们仅能找到 IFN alpha 暴露于妊娠中的病例报告,其中 63 例中有 40 例被诊断为 ET。我们还随机收集了 71 例(文献中可获得更多病例)因不同病因而被诊断为 ET 但在妊娠中未使用任何药物的病例。

结果

在 63 例 IFN alpha 暴露于妊娠的病例中,母亲的平均年龄为 30±6 岁,足月婴儿的平均体重为 3096±463g。分娩时的平均妊娠周数为 37±3 周。有 55 例单胎妊娠和 4 例双胎妊娠。未报告重大畸形或死产病例。有 1 例自然流产和 13 例早产(所有暴露病例的 20%)。在 71 例不同病因的妊娠中未接受治疗的 ET 病例中,46 例(65%)发生早孕期(妊娠 12 周内)或晚孕期(妊娠 13-20 周)妊娠丢失。还有 3 例(4%)死产和 4 例(5.6%)早产。只有 18 例妇女(25%)足月分娩健康婴儿。

结论

本系统评价的结果表明,IFN-α 并不会使重大畸形、流产、死产或早产的风险显著高于一般人群。此外,IFN-α 可能对 ET 病例的妊娠丢失有保护作用。

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