一项关于子宫内阻断乙肝病毒传播的随机对照试验。

A randomized control trial on interruption of HBV transmission in uterus.

作者信息

Zhu Qirong, Yu Guangjun, Yu Hui, Lu Qing, Gu Xinhuan, Dong Zuoquan, Zhang Xiuzhen

机构信息

Department of Infection Diseases, Children's Hospital, Fudan University, Shanghai 200032, China.

出版信息

Chin Med J (Engl). 2003 May;116(5):685-7.

PMID:12875680

Abstract

OBJECTIVE

To study the interruptive effect of hepatitis B virus (HBV) specific immunolobulin (HBIG) before delivery in attempt to prevent intrauterine transmission of HBV.

METHODS

Nine hundred and eighty HBsAg carrier pregnant women were randomly divided into HBIG group and control group. Each subject in the HBIG group received 200 IU or 400 IU of HBIG intramuscularly at 3, 2 and 1 month before delivery. The subjects in the control group did not receive any specific treatment. All newborn infants received 100 IU of HBIG intramascularly after venous blood samples were taken at birth and 2 weeks after birth, followed by 30 micro g plasma-derived HB vaccine or 5 micro g recombinant yeast-derived hepatitis B vaccine at 1, 2 and 7 months of age. Blood tests were performed for all the lying-in women and their neonates. Blood specimens were tested for HBsAg and HBeAg by enzyme immunoassay. All infants were followed up for 1 year.

RESULTS

In the HBIG group, 491 neonates were born to 487 HBV carrier mothers; and in the control group, 496 neonates were born to 493 HBV carrier mothers. The rates of intrauterine transmission in the two groups were 14.3% and 5.7% respectively (chi(2) = 20.280, P < 0.001), and the rates of chronic hepatitis B in the two groups were 2.2% and 7.3% respectively (chi(2) = 13.696, P < 0.001). The high risk factors of intrauterine HBV infection included HBsAg HBeAg double positive and HBV DNA positive in the peripheral blood of pregnant women.

CONCLUSION

HBV infection in the uterus may be interrupted by injecting multiple intramuscular HBIG injections before delivery without causing any side-effects.

摘要

目的

研究分娩前注射乙型肝炎病毒（HBV）特异性免疫球蛋白（HBIG）对预防HBV宫内传播的阻断作用。

方法

将980例HBsAg携带者孕妇随机分为HBIG组和对照组。HBIG组的每位受试者在分娩前3、2和1个月分别肌内注射200 IU或400 IU的HBIG。对照组受试者未接受任何特异性治疗。所有新生儿在出生时及出生后2周采集静脉血样本后，肌内注射100 IU的HBIG，随后在1、2和7月龄时分别接种30μg血浆源性乙肝疫苗或5μg重组酵母源性乙肝疫苗。对所有产妇及其新生儿进行血液检测。采用酶免疫法检测血液标本中的HBsAg和HBeAg。对所有婴儿进行1年的随访。

结果

HBIG组中，487例HBV携带者母亲共分娩491例新生儿；对照组中，493例HBV携带者母亲共分娩496例新生儿。两组的宫内传播率分别为14.3%和5.7%（χ² = 20.280，P < 0.001），两组的慢性乙型肝炎发生率分别为2.2%和7.3%（χ² = 13.696，P < 0.001）。宫内HBV感染的高危因素包括孕妇外周血HBsAg、HBeAg双阳性及HBV DNA阳性。