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目的:观察慢性粒细胞白血病患者(CML)服用伊马替尼期间的生育情况。方法:回顾性搜集服用伊马替尼的CML患者或其配偶妊娠过程中疾病状态、妊娠类型、孕前或孕期服药情况、生产、婴儿及产后治疗等信息。结果:共12例患者或其配偶妊娠12次,其中男5例,女7例,共成功生产6例。7例女性患者妊娠时中位年龄28(25~32)岁,CML中位病程为42(19~97)个月,5例达主要分子学反应(MMR),2例为加速期,目前共成功生产2例,尚未生产2例(分别为孕29周和孕31周),3例流产。5例男性患者配偶妊娠时中位年龄31(22~36)岁,CML中位病程为32(24~84)个月,4例达MMR,1例达部分细胞遗传学反应,共生产4例婴儿,1例在孕9周自然流产。目前共生产6例婴儿的体重、身高等指标均正常,未见先天性畸形,中位年龄24(10~36)个月,2例胎儿行外周血查染色体及定期彩超检查均未发现异常。结论:伊马替尼治疗期间应有效避孕。对有强烈生育要求的女性患者,Sokal评分越低,越早达MMR,且MMR持续时间越长(至少2年),妊娠时停药安全系数越高。受孕前后3个月应避免伊马替尼暴露。男性患者妊娠过程中无需停药。
Objective: To observe the fertility status of patients with chronic myeloid leukemia (CML) taking imatinib. METHODS: We retrospectively collected information on disease status, type of pregnancy, medication taken before or during pregnancy, production, infants and postpartum treatment of CML patients taking imatinib or their spouses during pregnancy. Results: A total of 12 patients or their spouses were pregnant 12 times, including 5 males and 7 females, a total of 6 cases were successfully produced. The median age of pregnancies was 28 (25-32) years in seven women. The median course of CML was 42 (19-97) months. Five patients had major molecular responses (MMR) and two had accelerated phase 2 cases were successfully produced, 2 cases were not yet produced (29 weeks pregnant and 31 weeks pregnant, respectively) and 3 cases were aborted. Five males had a median age of 31 (22-36) at the age of 31 to 22 years old and a median duration of CML of 32 (24-84) months. Four of them reached MMR and one had partial cytogenetic responses, producing a total of 4 One infant was spontaneous abortion at 9 weeks gestation. At present, the total body weight and height of 6 infants were normal. No congenital malformations were found. The median age was 24 (10-36) months. There were no abnormalities in 2 fetuses with peripheral blood chromosomes and regular color Doppler ultrasound examination. Conclusion: Imatinib should be effective during pregnancy. For female patients with strong fertility requirements, the lower the Sokal score, the earlier the MMR, and the longer the MMR duration (at least 2 years), the higher the safety factor for withdrawal during pregnancy. Imatinib exposure should be avoided 3 months before and after conception. Male patients without stopping during pregnancy.