乙肝疫苗联合乙肝免疫球蛋白对阻断母婴垂直传播乙型肝炎病毒的临床分析

目的探讨孕妇产前用乙肝免疫球蛋白（HBIG）与乙型肝炎疫苗联合免疫阻断母婴传播的效果。方法将504例HBsAg（＋）孕妇分为A（预防组）,B（对照组）两组。A组：246名HBsAg阳性孕妇孕晚期每月分别注射基因重组型乙肝疫苗10μg、HBIG200IU（200IU/ml）,新生儿出生后采股静脉血,同时在出生后24h内注射HBIG200IU,然后在0、1、6月龄接种基因重组型乙肝疫苗,每次10μg。B组：258例产前未注射HBIG和基因重组型乙肝疫苗的HBsAg阳性孕妇,其所生新生儿在0、1、6（30μg、30μg、30μg）月龄只用基因重组型乙肝疫苗免疫。A、B两组婴儿都分别在0、3、6、9、12、24月龄静脉采血,用酶联免疫吸附试验（ELISA）检测HBV标志物,同时随访。结果A组的宫内感染率为3.25%,B组为4.16%,差异无统计学意义（χ^2=1.43,P〉0.05）。A组没有发生慢性HBV感染的婴儿,而B组中有7例婴儿发生慢性HBV感染,B组婴儿发生慢性HBV的感染率显著高于A组（χ^2=4.41,P〈0.05）。结论产前用HBIG和新生儿HBIG联合免疫可降低慢性HBV感染率,阻断宫内感染的慢性化,提高产程感染的阻断效果。     

不同剂量乙肝疫苗与HBIG联合免疫阻断HBV母婴传播的效果对比

目的 探讨10 μg和20 μg乙肝疫苗与HBIG联合免疫阻断HBV母婴传播的效果.方法 124例HBsAg阳性孕妇所生的婴儿随机分为两组,即10 μg乙肝疫苗组和20 μg乙肝疫苗组.婴儿于出生6h内及30 d分别注射200 IU HBIG,同时分别于出生24 h内、1个月及6个月注射3次10 μg或20 μg重组酵母乙肝疫苗.检测婴儿出生时以及1岁时血清HBV标志物.结果 两组新生儿血清HBsAg、HBeAg及抗-HBe阳性率与滴度之间差别均无统计学意义（P＞0.05）.所有新生儿血清HBV DNA水平均小于检测下限（500 U/ml）.出生12个月时,所有124例婴儿血清HBsAg和HBeAg检测结果均为阴性;血清HBV DNA水平均在检测下限以下;10 μg和20 μg乙肝疫苗组血清抗-HBs阳性率分别为90.3％和96.8％,差异无统计学意义（P＞0.05）;抗-HBs水平分别为325.5±342.2 mIU/ml和463.7±353.3 mIU/ml,后者显著高于前者（P=0.01）.而且,20 μg乙肝疫苗组产生高应答抗-HBs（＞ 100 mIU/ml）的比例显著高于10μg乙肝疫苗组（P =0.035）.结论 20 μg乙肝疫苗联合HBIG方案阻断HBV母婴传播的效果优于10 μg乙肝疫苗联合HBIG方案.     

Efficacy of hepatitis-B immunoglobulin and hepatitis-B vaccine in prevention of the HBsAg carrier state in newborn infants of mothers who are chronic carriers of HBsAg and HBeAg

Combined prophylaxis of perinatal transmission of hepatitis B virus (HBV) with hepatitis-B immunoglobulin (HBIG) and hepatitis-B vaccine was investigated in 40 infants born to HBeAg positive carrier mothers. The efficacy of two combined prophylaxis schedules was compared to 78 similar infants in the control group receiving no treatment, by following the HBV markers at regular intervals up to one year of age. In both schedules, the HBIG and HBV vaccine were given at birth, followed by HBV vaccine given at 30 days and 60 days (group I) or 180 days (group II) of age. The incidence of persistent HBsAg carrier in infants born to HBeAg positive carrier mothers was significantly reduced from 92.6 percent at one year of age in the control group to zero percent (group I) and 11.5 percent (group II) in the treated groups. There was no statistical significant difference in the efficacy of these two combined prophylaxis schedules. HBIG given at birth did not interfere with infant immune response to the hepatitis B vaccine. At twelve months of age, anti-HBs could be detected in 77.8 percent of infants in group I and 89.5 percent in group II with mean titre of 621.4 and 1148.0 in group I and group II respectively. It was concluded that combined prophylaxis with HBIG and hepatitis-B vaccine immediately after birth is the best method for prevention of HBV perinatal transmission from HBeAg positive carrier mothers to their infants.     

Hepatitis B immunization in high risk neonates born from HBsAg positive mothers: comparison between plasma derived and recombinant DNA vaccine

A half dose recombinant hepatitis B vaccine (HBVax II, MSD, 5 micrograms) was investigated for efficacy in the prevention of perinatal hepatitis B virus (HBV) transmission in high risk neonates born from e-antigen positive HBsAg carrier mothers as compared to the half-standard dose regimen of plasma derived hepatitis B vaccine (HBVax, MSD, 10 micrograms). Forty infants born to carrier mothers were given hepatitis B immune globulin (HBIG) 100 IU intramuscularly immediately after birth, combined with either the recombinant or plasma derived hepatitis B vaccine. The infants were randomly divided into two groups of 20 infants each. The plasma derived vaccine (10 micrograms) was given to group I, while infants in group II received the recombinant vaccine (5 micrograms) at birth, 1 and 6 months of age. There were no statistically significant differences in the efficacy and the seroconversion rate of these two combined prophylaxis regimens. The protective efficacy rate of both kinds of HBV vaccine was found to be 94.6 and 89.2 percent in group I and group II respectively. At twelve months of age, the anti-HBs seroconversion rates were 95.0 percent in group I and 84.2 percent in group II. However, the geometric mean titres in group I (179.55 mIU/ml) was significantly higher than those in group II (42.2 mIU/ml) but the anti-HBs titre was still above protective level (10 mIU/ml) in most of the infants.(ABSTRACT TRUNCATED AT 250 WORDS)     

Perinatal transmission of hepatitis B virus in Thailand

Perinatal transmission of hepatitis B virus (HBV) from asymptomatic HBsAg carrier mothers to their infants was studied in 78 mother-infant pairs by determination of HBsAg, HBeAg and anti-HBe both in the mothers and in their infants at regular intervals for those children up to the time when they reached at least one year of age. Twenty-five out of the 78 (32.1%) infants born to these mothers were HBsAg-positive 2-6 months after birth and they remained so throughout the observation period of at least one year or more. Perinatal HBV transmission occurred only in infants born to HBsAg carrier mothers who were HBeAg-positive (92.6%) but not in those born to HBsAg carrier mothers who had no detectable HBeAg. This study suggests that preventive measures against HBV transmission during the perinatal period should be taken only for infants born to HBsAg carrier mothers who are HBeAg-positive. In addition, the active immune response to HBV was studied in 75 non-HBsAg carrier infants born to HBsAg carrier mothers by determination of anti-HBs at one year of age or older. Forty-three of these infants were treated with HBIG at birth and 32 infants received no treatment. It was found that infants born to HBsAg carrier mothers who were HBeAg-positive had a better active immune response (84.2% positive for anti-HBs) than infants born to HBsAg carrier mothers who had no detectable HBeAg or anti-HBe (14.3% and 20.4% positive for anti-HBs respectively).     

Perinatal transmission of hepatitis B virus in high-incidence countries

Hepatitis B is a serious public health problem throughout the world. Hepatitis B virus (HBV) induces acute hepatitis with a case-fatality rate of about 1%. Even more important, 5-10% of patients infected with HBV become chronic carries and about 25% of these will die due to cirrhosis and hepatocellular carcinoma. The reservoir of HBV chronic carriers in the world is estimated at more than 200 million people and 80% of them reside in Asia and the western Pacific. In high-incidence areas, such as south-east Asia, perinatal transmission of HBV from carrier mothers to newborns appears to be the most important factor for the high prevalence of HBV infection and 70-90% of infants born to HBsAg/HBeAg-positive mothers become chronic carriers. Three possibilities of transmission of HBV from carrier mothers to newborns are suggested: (a) transplacental transmission in utero - it was estimated that such transmission occurred in 5-15% of newborns; (b) transmission during delivery, which is considered the main mode of perinatal transmission; (c) postnatal transmission from mother to newborn, which is not common. HBeAg is the main maternal factor in determining whether infection of newborns will occur; the expression of this antigen seems to be determined genetically. Recently it has shown that immunoprophylaxis is highly effective in preventing the development of the carrier state in infants born to HBsAg/HBeAg-positive mothers. Only 5-10% of high-risk infants are not protected by vaccination. If it becomes possible to immunize the entire world population including all babies born to carrier mothers at birth, and if our knowledge of the mechanisms of perinatal transmission of HBV is accurate, the carriers and acute cases of HB ought to disappear in two to three generations.     

Multicenter trial on the efficacy of HBIG and vaccine in preventing perinatal hepatitis B. Final report

In an attempt to interrupt perinatal transmission of hepatitis B, 92 infants born to HBsAg carrier mothers (49 to HBeAg-positive mothers, 30 to anti-HBe-positive with abnormally elevated ALT levels, and 13 to HBeAg/anti-HBe-negative mothers) received 0.5 ml/kg BW of HBIG at birth and at 1 month of age. Three IM injections of hepatitis B vaccine were given at 3, 4, and 9 months of life. All babies who were given the three doses of vaccine developed an active anti-HBs response: of these, 53 (62.3%) had antibody titers higher than 1,000 mIU/ml, 29 (34.2%) had levels between 100 and 1,000 mIU/ml, and the other three (3.5%) were below 100 mIU/ml. At the end of the 2-year follow-up, these three poor responders became anti-HBs negative, whereas the others still had antibody. All but three babies were protected by HBIG plus vaccine treatment. Two chronic HBV infections occurred within 6 months of life presumably because the babies were already infected when prophylaxis started. The third baby became an HBsAg carrier at 9 months of age in spite of a previous response to the vaccine. Simultaneous presence of HBsAg of y specificity and anti-HBs (anti-a) was still detectable at 24 months of age. The vaccine was well tolerated. Passive plus active immunization is an effective procedure for preventing perinatally transmitted HBV infection.     

阻断乙型肝炎病毒母婴传播方案探讨

目的探讨阻断乙型肝炎病毒母婴传播的有效方法。方法将乙型肝炎病毒携带孕妇,根据她们的不同情况和就诊的不同时期分为6组,Ms组为乙肝表面抗原阳性乙肝e抗原阴性的孕妇,根据就诊的不同时期分为Ms1组、Ms2组、Ms3组。Mse组为乙肝表面抗原和乙肝e抗原双阳性孕妇。MF组为孕妇与配偶均为乙型肝炎病毒携带者。F组为孕妇为非乙型肝炎病毒携带者配偶为乙型肝炎病毒携带者的孕妇。各组采用不同的方法阻断乙型肝炎病毒的垂直传播。结果 Ms1组230例中有22例母亲孕期用过乙肝免疫球蛋白（占本组总数9.6%）。Ms2组：372例中有37例母亲孕期用过乙肝免疫球蛋白（占本组总数9.9%）。Ms3组287例中有4例母亲孕期检测乙型肝炎病毒脱氧核糖核酸阳性用过HBIG（占本组总数1.4%）,与Ms1组和Ms2组母亲用乙肝免疫球蛋白率9.6%和9.9%比较经统计学处理差异都非常显著（χ2=17.850,P=0.000）;（χ2=20.311,P=0.000）。Mse组32例母亲在孕期都用过乙肝免疫球蛋白（占本组总数100%）。MF组72例中有20例母亲在孕期用过乙肝免疫球蛋白（占本组总数27.7%）。F组：48例中3例母亲在孕期用过乙肝免疫球蛋白（占本组总数6.2%）;32例母亲在孕期用过乙肝疫苗接种（占本组总数66.6%）。各组共1041例新生儿生后24h内静脉血乙肝抗原抗体定性检测：乙肝表面抗原和乙肝e抗原均为阴性。生后3个月至1岁随访检测婴儿静脉血1041例乙肝抗原定性乙肝表面抗原和乙肝e抗原仍均为阴性。结论孕妇或配偶为乙型肝炎病毒携带者,如乙肝e抗原阳性或乙型肝炎病毒脱氧核糖核酸阳性孕妇孕期需要注射乙肝免疫球蛋白阻断乙型肝炎病毒传播,否则不需要。父母为乙型肝炎病毒携带者,如新生儿生后检测乙型肝炎病毒抗原检测阳性需要注射乙肝免疫球蛋白,否则不需要。所有新生儿必须接种乙肝疫苗。     

Hepatitis B immunization in high risk neonates born from HBsAg and HBeAg positive mothers: comparison of standard and low dose regimens

A reduced dose of plasma derived hepatitis B vaccine (Hevac B) was tested for efficacy in the prevention of perinatal hepatitis B virus (HBV) transmission in high risk neonates born from e-antigen positive HBsAg carrier mothers. Forty newborn infants born of these mothers were given hepatitis B immune globulin (HBIG) 100 IU intramuscularly immediately after birth, combined with either standard or reduced doses of HBV vaccine. The infants were divided into two groups of 20 infants each. The standard dose of HBV vaccine (5 micrograms) was given to group I, while infants in group II received reduced dose (2 micrograms) at birth and at 1, 2 and 12 months of age. There was no statistically significant difference in the efficacy and antibody responses of these two combined prophylaxis regimens. The protective efficacy rate of HBV vaccine was found to be 94.0 and 93.2 percent in group I and group II, respectively. At twelve months of age, the anti-HBs seroconversion rates were 80.0 percent in group I and 86.7 percent in group II, with geometric mean titres of 84.57 mlU/ml and 78.56 mlU/ml, in group I and group II, respectively. One month after a booster at one year of age, anti-HBs could be detected in 86.7 percent of the infants in both groups. The geometric mean titres were 429.04 and 664.81 mlU/ml, in group I and group II, respectively. Anti-PreS2 antibody was detected in high titre as early as 4 months after the first dose of HBV vaccine, with a geometric mean titre of 116.30 mlU/ml and 107.97 mlU/ml, in group I and group II, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)     

Efficacy of immunization of high-risk infants against hepatitis B virus evaluated by polymerase chain reaction

The polymerase chain reaction (PCR) is a rapid and very sensitive method to detect viral genomes. In the present study, the efficacy of immunization against hepatitis B virus (HBV) of high-risk infants was evaluated by PCR. Twenty-nine infants born to 24 HBeAg-positive carrier mothers were given hepatitis B immune globulin (HBIG) at birth and thereafter received repeated inoculations of plasma-derived vaccine or HBIG, or both, within 1 year. Serum samples at 1 year following immunization were stored at −40°C for later analysis using PCR to detect HBV-DNA. When HBV genomes were detected in infants, the DNA sequences in the S gene of HBV were determined. Of 29 infants, 2 were positive for HBV-DNA at the 1 year following immunization; one had the HBV containing only the wild-type sequence in the S gene and became negative for HBV-DNA during the follow-up period. In contrast, another had the HBV, which contained nucleotide substitutions that altered the expression of the common group-specific determinant “a” of the S gene and resulted in clinical hepatitis with viral persistence. PCR analysis suggests that immunization against HBV prevents effectively high-risk infants from mother-to-child transmission. Even then, however, it is possible that amino acid substitutions in the “a” determinant of the S gene are associated with failure of conventional immunization against HBV. J. Med. Virol. 53:255–260, 1997. © 1997 Wiley-Liss, Inc.     

新生儿不同时期静脉血HBsAg含量对HBV母婴传播阻断失败的预测研究

目的探讨HBV慢性感染孕妇新生儿出生后不同时期静脉血HBsAg含量变化对ItBV母婴传播阻断失败的预测价值。方法以HBsAg、HBeAg双阳性、血清HBVDNA含量≥10^5拷贝／ml慢性HBV感染孕妇所娩新生儿150例为研究对象,出生后立即注射乙肝免疫球蛋白200Iu,并按0、1和6个月程序接种乙肝疫苗10～20μg。分别于新生儿出生时、生后1个月、生后7个月采取静脉血检测HBV血清学指标,分析新生儿不同时期静脉血HBsAg含量对HBV母婴传播阻断失败的预测。结果共有11例新生儿发生HBV母婴阻断失败。新生儿出生时、生后1个月、生后7个月HBsAg阳性率分别为41．26％、10．49％、7．69％,HBeAg阳性率分别为97．90％、65．75％、13．29％。以出生时I-IBsAg≥O．05和HBsAg≥1IU／ml预测HBV母婴传播阻断失败,阳性预测价值分别为18．64％和70％;生后1个月HBsAg〉~O．05和HBsAg≥1IU／ml的阳性预测价值分别为73．33％和100％。结论出生时静脉血HBsAg含量≥1IU／ml时应高度怀疑HBV母婴传播的失败。生后1个月HBsAg≥1IU／ml对母婴传播阻断失败有高度的预测价值,如何提高出生时和生后1个月静脉血HBsAg阳性新生儿的HBV感染阻断率是以后研究的重点。     

Management of mother-to-child transmission of hepatitis B virus: Propositions and challenges

Chronic hepatitis B virus (HBV) infection due to mother-to-child transmission (MTCT) during perinatal period remains an important global health problem. Despite standard passive–active immunoprophylaxis with hepatitis B immunoglobulin (HBIG) and hepatitis B vaccine in neonates, up to 9% of newborns still acquire HBV infection, especially these from hepatitis B e antigen (HBeAg) positive mothers. Management of HBV infection in pregnancy still need to draw careful attention because of some controversial aspects, including the failure of passive-active immunoprophylaxis in a fraction of newborns, the effect and necessity of periodical hepatitis B immunoglobulin (HBIG) injection to the mothers, the safety of antiviral prophylaxis with nucleoside/nucleotide analogs, the benefit of different delivery ways, and the safety of breastfeeding. In this review, we highlight these unsettled issues of preventive strategies in perinatal period, and we further aim to provide an optimal approach to the management of preventing MTCT of HBV infection.     

不同方案阻断乙型肝炎病毒母婴垂直传播的随访观察

目的探讨阻断乙型肝炎病毒母婴垂直传播的方法.方法将488例HBsAg阳性孕妇分成四组,单纯HBVac治疗组116例,单纯HBIG治疗组116例,左旋咪唑涂布剂加两者联合应用120例,未治疗组136例.治疗组均在孕26周起开始注射,孕妇和新生儿血清HBsAg、抗-HBs、HBeAg、抗-HBe、抗-HBc检测采用ELISA法.随访产妇及新生儿的乙肝标志物(HBVM)变化.结果脐血中HBsAg阳性率:HBVaC治疗组为18.10%,HBIG治疗组为9%,联合治疗组为3.33%,未治疗组为24.26%.随访母亲HBVM多数转为HBSAg、抗-HBC、抗-HBc阳性,所生儿童抗-HBs＞70%.结论携带HBV孕妇于孕晚期给予HBVac、HBIG和左旋咪唑涂布剂联合两者治疗后,可有效阻断HBV母婴之间传播.     

Hepatitis B vaccine alone or in combination with anti-HBs immunoglobulin in the perinatal prophylaxis of babies born to HBsAg carrier mothers.

The efficacy of hepatitis B virus (HBV) vaccine alone (group I) or in combination with hepatitis B immunoglobulin (HBIG) (group II) for prevention of perinatal transmission of the virus was assessed in 21 and 24 neonates, respectively. 58 infants who could not be vaccinated constituted the control group. It was observed that in the unvaccinated group approximately 70% of the infants became infected. In both the vaccinated groups, the seroconversion and seroprotection rates (anti-HBs > or = 10 IU/1) were almost similar at 6 months of follow up, but, at 12 months, infants given HBIG and vaccine showed better seroprotection rate (85%) than those given vaccine alone (58.8%). Immune response to the vaccine was also better in both the groups if the mothers were anti-HBe positive. Despite immunization, 14.2% and 25% infants in group I and II, respectively, became chronic carriers if their mothers were HBeAG positive.     

乙型肝炎病毒母婴阻断长期效果的随访研究

目的观察乙型肝炎病毒母婴阻断长期效果,探讨HBsAg阳性孕妇生产儿童发生慢性HBV感染的相关影响因素。方法随访和收集于2004--2006年在北京地坛医院出生的HBsAg阳性母亲所生,并在出生时进行200单位乙肝免疫球蛋白（HBIG）注射和经过乙肝疫苗10μg,0、1和6个月的完整免疫接种程序的儿童静脉血,采用Abbott微粒子化学发光法检测其HBsAg、抗-HBs抗体、抗-HBc抗体,分析母婴阻断和乙肝疫苗接种的长期效果及其影响因素。结果收集和调查306名儿童年龄3—6（4．84）岁,其母亲生产时HBeAg阳性198人,HBeAg阴性92人。10（3．27％）名儿童发生慢性HBV感染。除慢性HBV感染者外,其余296名儿童,20．27％抗-HBs〈10mlU／ml;44．26％抗-HBs≥10—100mlU／ml;27．03％抗-HBs≥100～1000mlU／ml和8．45％抗-HBs≥1000mlU／m,抗-HBs保护率为79．73％（236／296）。抗-HBc阳性率为7．43％（22／296）。10例感染儿童的母亲生产时HBeAg均为阳性,HBVDNA均在10。拷贝／ml以上,其中8例超过10^8拷贝／ml。结论在进行乙肝疫苗加HBIG注射的HBV母婴传播阻断措施下,HBV母婴阻断失败和慢性H13V感染发生在HBeAg阳性和高病毒载量产妇所生婴儿,在有效阻断后仍需进行抗HBs监测并加强免疫接种。     

Review: hepatitis B immune globulin for prevention of hepatitis B infection

Specific hepatitis B immune globulin (HBIG) contains a high titer of antibody to hepatitis B surface antigens and provides immediate passive protection against infection with hepatitis B virus, after acute exposure to infection. It is now generally combined with active immunization with hepatitis B vaccine. The principal indications for administration of HBIG are: a single acute percutaneous exposure to hepatitis B virus (HBV); mucocutaneous exposure; unprotected sexual exposure; mother-to-infant transmission; prevention of re-infection after liver transplantation; non-responders to hepatitis B vaccine and immunosuppressed patients.     

Field evaluation of the efficacy and immunogenicity of recombinant hepatitis B vaccine without HBIG in newborn Vietnamese infants

A study involving more than 2,000 infants was conducted in Vietnam to assess the field effectiveness and immunogenicity of recombinant hepatitis B vaccine given at birth, 1 month, 2 months, without concomitant hepatitis B immune globulin (HBIG). All received a 5 microg dose of H-B-VAX II at birth. Infants born to non-carrier mothers (Group 1; N = 1798) then received 2.5 microg doses at 1 and 2 months of age, while infants of HBeAg-negative (Group 2; N = 125) or HBeAg-positive (Group 3; N = 88) carrier mothers received 5 microg doses. No Group 1 or 2 vaccinees were infected. In Group 3, 12 (14.6%) of 82 infants did become infected (estimated efficacy 84%). 98.0-98.6% of uninfected infants who were tested for anti-HBs developed a seroprotective concentration > or = 10 IU/L. In hyperendemic Vietnam, where routine maternal screening and passive-active prophylaxis of high-risk infants with vaccine plus HBIG is not feasible, administration of vaccine alone to all newborns may control effectively HBV infection.     

Prevention of perinatal transmission of hepatitis B virus (HBV): a comparison of two prophylactic schedules

Perinatal transmission of hepatitis B virus (HBV) from HBsAg carrier mothers who were HBeAg+, antiHBe+, or negative for both HBe markers, was interrupted using either 4 doses of vaccine, or one dose of hepatitis B immunoglobulin (HBIG) at birth, combined with 4 doses of vaccine. In those infants who received HBIG at birth, the antiHBs titre was significantly higher at 1 and 2 months old, but at 6, 9, and 18 months old, there was no significant difference. Among the infants of carrier mothers who did not display HBeAg (i.e., were antiHBe+, or negative for both HBe markers), a transient subclinical infection would have been expected in around 10% had there been no intervention. No evidence of such infection was detected, and no difference in outcome was found between the two treatment groups. Amongst infants born to HBeAg+ carrier mothers, infection occurred in 1 out of 8 who had received HBIG and vaccine, and in 3 of 8 who had received vaccine only. The difference in outcome was not statistically significant, but the numbers analysed were small. The infections which occurred in spite of prophylaxis may be attributable to in utero infection, poor response to vaccine by the infant, or to the mother having a particularly high HBV-DNA level. HBIG given at birth to infants of HBeAg+ carrier mothers may enhance the protection of infants who are destined to be poor responders to vaccine.     

Reduced doses of hepatitis B immune globulin in the prevention of perinatal transmission of hepatitis B

From October 1982 to May 1983, newborn infants of 79 hepatitis B surface antigen (HBsAg)-positive women were enrolled in a study of the efficacy of hepatitis B immune globulin (HBIG) in the prophylaxis of perinatal transmission of hepatitis B virus (HBV) infection. HBIG 0.5 ml or 0.25 ml was given to the newborn within 15 minutes of birth and at 3 and 6 months. The mother-infant pairs were followed-up every 3 months for at least 9 months. Similar observations of untreated infants were used for comparison. Among infants of hepatitis B e antigen (HBeAg)-positive carrier mothers, the HBsAg carrier rates at 3 months were similar in the 0.5-ml and 0.25-ml HBIG dose groups. At 12 months the difference--17.7% of 17, 40% of 15--did not reach statistical significance, but the differences between these rates and that of the untreated control-85.7% of 35--did. Among infants of HBeAg-negative carrier mothers, HBV infection rates in both dose groups were similar to those of untreated infants. In the treated groups at 12 months about 45% of infants of HBeAg-positive mothers and 90% of infants of HBeAg-negative mothers were still negative for HBsAg and anti-HBs. Vaccination to induce active antibody is necessary to prevent postnatal infection and chronic carriage of HBV. To reduce the cost of combined passive and active hepatitis B immunoprophylaxis in children born to HBeAg-positive carrier mothers, 0.25 ml of HBIG could be used instead of the usually recommended 0.5 ml.     

孕晚期注射HBIG阻断HBV母婴传播的病例对照研究

目的探讨孕晚期注射乙肝免疫球蛋白（HBIG）对阻断HBV母婴传播有无作用。方法选取538例孕晚期注射HBIG和817例未注射HBIG的孕妇及其婴儿,比较两组的宫内感染率。结果（1）HBIG组和对照组的宫内感染率分别为2．2％和1．1％,两组相比差异无统计学意义（P〉0．05）;（2）当母亲同为HBeAg阳性时,两组的宫内感染率相比,差异无统计学意义（4．14％VS．4．92％,P〉0．05）;当母亲同为HBVDNA阳性时,两组的宫内感染率相比,差异仍无统计学意义（3．14％vs．3．10％,P〉0．05）;（3）进一步将孕妇血清HBVDNA按浓度高低进行分层分析,当HBVDNA浓度相同时,两组的宫内感染率相比,差异无统计学意义（P〉0．05）。结论孕期注射HBIG对阻断HBV母婴传播无明显作用,不推荐孕期使用HBIG。