替比夫定阻断乙肝病毒宫内感染的临床研究

目的：观察替比夫定阻断乙型肝炎病毒（HBV）宫内感染的疗效和安全性。方法：对2008年1月—2009年5月在杭州六院妇产科分娩的HBsAg、HBeAg双阳性且HBV DNA≥10~5拷贝/mL的孕妇48例,22例孕妇于孕28周开始服用替比夫定600 mg,1次/d,分娩后停药为治疗组,26例孕妇未用药为对照组。两组孕妇于孕28周用药前、分娩前及产后1月行肝功能、血清HBV标记物及HBV DNA定量检测。新生儿出生后注射乙肝免疫球蛋白200 IU和乙肝疫苗10μg。结果：治疗组22例新生儿出生时2例HBsAg阳性（〉0.05 IU/mL）,且HBV DNA均〈10~3拷贝/mL;对照组26例新生儿出生时10例HBsAg阳性,其中HBV DNA阳性4例,治疗组与对照组新生儿宫内感染情况比较差异有统计学意义（P〈0.05）;两组孕妇分娩时HBsAg、HBeAg均未转阴,治疗组孕妇HBV DNA水平分娩前明显下降,较治疗前比较差异有统计学意义（P〈0.05）;两组孕妇及新生儿未发现不良反应,产后1月治疗组HBV DNA回到治疗前水平。结论：HBV感染孕妇孕晚期服用替比夫定可有效减少HBV宫内感染的发生率,且安全性良好。

Clinical study on preventing babby infections in uterine from hepatitis B virus with telbivudine

AIM.To observe the effects and security of telbivudine preventing intrauterine infection from hepatitis B virus.METHODS：48 pregnant women with HBsAg,HBeAg positive and serum levels of HBV DNA were more than 10~5 copies per milliliter in our hospital from January 2008 to May 2009 were divided into treatment group（22 cases）,who began to take telbivudine, 600 mg per day at 28th week after pregnancy and stopped after childbirth,and control group（26 cases）,who did not take telbivudine. The liver functions,serum markers of hepatitis B virus and HBV DNA of two groups were measured on 28th week of pregnancy before taking telbivudine,before childbirth and 1 month after childbirth.The neonatal were all given intramuscular 200 IU of HBIG and 10μg of recombinant hepatitis B vaccine.RESULTS：Two newborns of 22 cases in treatment group were with positive HBsAg when they were born,but the levels of blood HBV DNA were all less than 1000 copies per milliliter.While 10 newborns of 26 cases in control group were with positive HBsAg, and the levels of blood HBV DNA were more than 1000 copies per milliliter in 4 newborns. The difference of the intrauterine infection rate was significantly between the two groups（P〈0.05）.The pregnant women in two groups were all with positive HBsAg and HBeAg before childbirth,but the serum levels of HBV DNA in treatment group were lower before childbirth than before treatment（P〈0.05）.No adverse reactions were found on the pregnant women and newborns in the two groups.The levels of HBV DNA were restored to the levels of before treatment. CONCLUSION：Telbivudine can reduce intrauterine infection rate in pregnant women with hepatitis B virus effectively and safely.