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目的探讨胎儿在子宫内替比夫定暴露后的安全性。方法研究对象为2012年1月1日至11月15日在首都医科大学附属北京地坛医院妇产科进行产前检查并分娩的新生儿。所有新生儿被分为2组:替比夫定组(妊娠期服用替比夫定的HBV感染母亲所生新生儿)和对照组(未服用替比夫定及同类药物的HBV感染母亲所生新生儿)。比较2组新生儿性别、出生体重及其母亲分娩时年龄、产次、孕周数和分娩方式。2组新生儿出生后立即采集静脉血检测丙氨酸转氨酶(ALT)、天冬氨酸转氨酶(AST)、乳酸脱氢酶(LDH)、α-羟基丁酸脱氢酶(α-HBDH)、肌酸激酶(CK)及其同工酶(CK-MB)水平。结果替比夫定组入选31例;对照组入选35例。2组新生儿性别、体重和母亲分娩时年龄、产次、孕周数、分娩方式差异均无统计学意义。2组新生儿ALT、AST、LDH、α-HBDH、CK、CK-MB水平以及CK-MB/CK比值差异均无统计学意义。结论 HBV感染妇女妊娠期服用替比夫定对新生儿肝酶和心肌酶水平无明显影响,未发现替比夫定对胎儿的安全性产生不良影响。
Objective To investigate the safety of fetus after telbivudine exposure in uterus. Methods The study was performed on January 1, 2012 to November 15, 2012 at the Department of Obstetrics and Gynecology, Beijing Ditan Hospital, Capital Medical University. All newborns were divided into two groups: telbivudine group (newborns born to HBV-infected mothers taking telbivudine during pregnancy) and control group (HBV-infected mothers not taking telbivudine and similar drugs) Newborn). The gender, birth weight and birth mothers’ birth age, parity, gestational age and mode of delivery were compared between the two groups. Venous blood was collected immediately after birth in both groups to detect ALT, AST, LDH, α-HBDH, Creatine kinase (CK) and its isoenzyme (CK-MB) levels. Results telbivudine group selected 31 cases; control group selected 35 cases. There was no significant difference in gender, weight and the age, delivery time, gestational age and mode of delivery between the two groups of newborns. There was no significant difference in ALT, AST, LDH, α-HBDH, CK, CK-MB and CK-MB / CK between the two groups. Conclusion The use of telbivudine during pregnancy in HBV-infected women had no significant effect on the levels of liver enzymes and myocardial enzymes in newborns. No adverse effects of telbivudine on fetal safety were found.