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伊马替尼在妊娠和哺乳期的应用:一例病例报告及文献综述

Imatinib use during pregnancy and breast feeding: a case report and review of the literature.

作者信息

Ali Ridvan, Ozkalemkas Fahir, Kimya Yalcin, Koksal Nilgun, Ozkocaman Vildan, Gulten Tuna, Yorulmaz Hakan, Tunali Ahmet

机构信息

Division of Hematology, Department of Internal Medicine, Uludag University School of Medicine, Gorukle, Bursa, Turkey.

出版信息

Arch Gynecol Obstet. 2009 Aug;280(2):169-75. doi: 10.1007/s00404-008-0861-7. Epub 2008 Dec 13.

Abstract

INTRODUCTION

The development of imatinib as a therapeutic agent targeting BCR-ABL has increased the treatment options for chronic myeloid leukemia (CML) by significantly impacting outcomes, and imatinib is recommended by treatment guidelines as the first-line therapy. However, treatment of maternal CML with imatinib during gestation is not recommended because of the potential risk to the fetus.

MATERIALS AND METHODS

We describe the clinical presentation, course and outcome of one pregnant patient with CML who was treated with imatinib. We review all pregnancies associated with imatinib documented in the literature.

CASE PRESENTATION

A 27-year-old pregnant patient was diagnosed to have Philadelphia chromosome positive chronic phase CML in August 2007. Imatinib was administered (400 mg/day) between the 21st and 39th weeks of gestation. The patient tolerated the drug well and achieved complete hematological and cytogenetic remission. There were no imatinib-related maternal complications during the pregnancy. Fetal growth remained normal as well as amniotic fluid volume estimation. Labor was induced at the 39th gestational week, resulting in the uneventful vaginal delivery of a healthy male infant without any congenital anomaly. Umbilical cord blood and infant peripheral blood were collected at delivery. No postnatal complications occurred; however, imatinib was present in the umbilical cord blood (338 ng/mL) and in the infant's peripheral blood (478 ng/mL). Breast milk was collected on different postpartum days, and concentrations of imatinib were detected. At 10 months of age, the baby had normal growth and development.

CONCLUSIONS

In light of reported cases and our experience, treatment of CML during the second and third trimesters of gestation and breast feeding seems to be safe, but the data are still limited and the effects of chronic exposure of infants to imatinib are not known. We think that each case should be examined and considered independently, and decisions should be individualized.

摘要

引言

伊马替尼作为一种靶向BCR-ABL的治疗药物,通过显著改善治疗效果,增加了慢性髓性白血病(CML)的治疗选择,治疗指南推荐伊马替尼作为一线治疗药物。然而,由于对胎儿存在潜在风险,不建议在妊娠期使用伊马替尼治疗孕妇CML。

材料与方法

我们描述了一名接受伊马替尼治疗的妊娠CML患者的临床表现、病程及结局。我们回顾了文献中记录的所有与伊马替尼相关的妊娠病例。

病例报告

一名27岁的妊娠患者于2007年8月被诊断为费城染色体阳性慢性期CML。在妊娠第21周至39周期间给予伊马替尼(400mg/天)治疗。患者对药物耐受性良好,实现了完全血液学和细胞遗传学缓解。孕期未出现与伊马替尼相关的母体并发症。胎儿生长及羊水评估均正常。在妊娠第39周引产,顺利经阴道分娩出一名健康男婴,无任何先天性异常。分娩时采集了脐带血和婴儿外周血。产后未出现并发症;然而,脐带血(338ng/mL)和婴儿外周血(478ng/mL)中均检测到伊马替尼。在产后不同时间采集母乳,并检测伊马替尼浓度。婴儿10个月大时,生长发育正常。

结论

根据已报道的病例及我们的经验,在妊娠中期和晚期以及母乳喂养期间治疗CML似乎是安全的,但数据仍然有限,且婴儿长期接触伊马替尼的影响尚不清楚。我们认为每个病例都应单独检查和考虑,决策应个体化。

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