乙肝免疫球蛋白阻断乙肝病毒母婴传播的临床研究

目的 了解乙型肝炎免疫球蛋白(HBIG)阻断乙型肝炎病毒(HBV)母婴传播的效果.方法 将172例HBV阳性孕妇所分娩的新生儿分为3组:A组孕妇及其新生儿联合使用HBIG;B组仅新生儿使用HBIG;C组孕妇及新生儿均未使用HBIG.三组新生儿出生后均在0、1、6个月时肌肉注射乙肝疫苗.结果 7月龄时,A组婴儿HBsAg阳性率(1.72%)低于B组(11.11%),差异有统计学意义;抗-HBs阳性率(81.03%)高于B组(63.89%),差异有统计学意义.结论 HBsAg阳性孕妇及新生儿使用HBIG免疫效果优于未使用者.     

阻断乙型肝炎病毒宫内传播的随机对照研究

目的 最近10多年的研究表明，用乙肝疫苗主被动联合免疫能阻断母婴间乙肝病毒（HBV）传播，保护效果达到70％－90％，而宫内已感染HBV是生后免疫接种失败的主要原因，我们研究用乙肝免疫球蛋白（HBIG）多次产前注射，观察阻断HBV宫内传播的效果。方法 980例携带HBsAg孕妇随机分成两组，一组孕妇产前3个月（妊娠28周起）每4周肌注HBIG 200IU－400IU，直至临产，称HBIG组；另一组不注射为对照，称对照组。所有对象和其所生孩子出生时即采外周血，检测HBsAg、HBeAg，部分测HBV DNA，所有新生儿随访1年。结果 496例新生儿为对照组母亲所生，生后仅接种乙肝疫苗和HBIG；491例新生儿为HBIG组母亲所生，生后同样给予主被动联合免疫。结果显示对照组婴儿的宫内感染率为难4．3％；而HBIG组婴儿的宫内感染率为5．7％（x^2＝20．11，P＜0．001），宫内感染HBV的高危因素是母亲呈HBsAg、HBeAg双阳性或HBV DNA阳性。结论 研究提出产前多次肌注HBIG可有效减少HBV的宫内传播，未发现任何副作用。     

HBsAg阳性母亲的婴儿接种乙肝疫苗后慢性HBV感染相关因素探讨

为探讨HBsAg阳性母亲的婴儿接种乙肝疫苗后慢性HBV感染相关因素及机制,对624名儿童随访了(6.34±1.71)年。结果发现慢性HBV感染89例,其中82.0％始于6月龄前。HBeAg同时阳性母亲的婴儿慢性HBV感染率高于单阳性母亲的婴儿(单用疫苗,P<0.005;HBIG+疫苗,P<0.05),且在6月龄内出现HBsAg阳性时,慢性化率也高(单用疫苗,P<0.025)。联合使用HBIG和疫苗可进一步减少慢性HBV感染率(单阳性组,P<0.025,双阳性组,P<0.005)及在1月～6月HBsAg阳性婴儿慢性化率(双阳性组,P<0.025)。提示HBsAg阳性母亲的婴儿接种乙肝疫苗后慢性HBV感染主要发生于宫内或产程中。双阳性母亲的婴儿更易形成慢性HBV感染,HBIG联合疫苗的预防效果优于单用疫苗。     

国产及进口乙型肝炎免疫球蛋白阻断乙型肝炎病毒母婴垂直传播效果的研究

目的：探讨国产及进口乙型肝炎免疫球蛋白（HBIG）阻断HBeAg/或抗HBe（＋）、HBV－DNA定量PCR（＋）孕妇所生的新生儿宫内乙型肝炎病毒感染的效果。方法：于孕期第6个月起每月给予孕妇进口或国产HBIG2000IU肌注1次，预产期前5－7d再加强注射1次，新生儿娩出后3h内及第15天各肌注1次HBIG，以后按1、2、7、13个月注射基因工程乙肝疫苗10μg。结果：生后13个月时小儿HBsAg阳性率：国产HBIG组、进口HBIG Bayer组与Berna组分别为2．7％、2．2％、2．8％；抗－HBs阳性率分别为94．7％、95．6％、97．2％。13个月龄儿国产HBIG组3例、Bayer组和Berna组各1例检获HBsAg( )，乙型肝炎病毒母婴传播阻断率分别为96．9％、97．4％、96．7％。结论：国产HBIG阻断HBeAg( )孕妇新生儿宫内感染与进口HBIG一样有效，且国产HBIG安全、价廉。     

国产重组酵母疫苗和血源疫苗对乙型肝炎病毒母婴传播阻断效果的比较

目的　以血源乙型肝炎疫苗为对照 ,评估国产重组酵母乙型肝炎疫苗单用或联合乙型肝炎免疫球蛋白 (HBIG)对乙型肝炎病毒 (HBV)母婴传播的阻断效果。方法　以乙型肝炎表面抗原阳性母亲的婴儿为观察对象。其中 117名接种 30 μg血源乙型肝炎疫苗 (血源疫苗组 ) ,99名接种 5 μg酵母重组乙型肝炎疫苗 (基因疫苗组 )。均随机分为单用疫苗或联合免疫 ,单用疫苗者按 0、1、6个月程序接种 ,联合免疫者出生时和出生后 2周时各注射HBIG 10 0IU ,然后于 1、2、7个月龄接种疫苗。结果单用疫苗时 ,1、3、6、12个月龄抗 HBs阳性率在血源疫苗组分别为 11.3%、41.2 %、6 2 .7%、80 .9% ;基因疫苗组为 8.2 %、41.7%、5 8.3%、77.3% ;慢性HBV感染率血源疫苗组为 10 .6 % ,基因疫苗组为 9.1%。联合免疫时 ,1、4、7、12个月龄抗 HBs阳性率在血源疫苗组为 6 7.2 %、6 9.4%、85 .0 %、87.3% ;基因疫苗组为70 .7%、5 3.1%、5 0 .0 %、89.1% ;慢性HBV感染率血源疫苗组为 5 .5 % ,基因疫苗组为 6 .5 % ,两种疫苗间除联合免疫时 7个月龄抗 HBs阳性率差异有显著性 (χ2 =15 .39,P <0 .0 0 5 ) ,其余指标差异无显著性。结论　国产 5 μg重组酵母乙型肝炎疫苗阻断HBV母婴传播的效果和 30 μg血源疫苗相仿。     

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目的探讨采用乙型肝炎免疫球蛋白(HBIG)阻断孕妇乙型肝炎病毒(HBV)感染对新生儿乙型肝炎(简称乙肝)基因疫苗免疫效果的影响。方法对55例HBV标志物阳性孕妇于产前28周、32周和36周分别给予HBIG200IU免疫阻断作为阻断组;31例HBV标志物阳性孕妇未给予HBIG免疫阻断作为未阻断组;同期选择HBV标志物阴性孕妇42例作为对照组。对三组新生儿分别给予乙肝基因疫苗的免疫接种,并分别于1个月、2个月、7个月和12个月龄采集外周血检测HBV标志物及丙氨酸转氨酶(ALT)。结果阻断组、未阻断组和对照组新生儿免疫保护率分别为87.3%(48/55)、77.4%(24/31)和97.6%(41/42);未阻断组与对照组间比较具有统计学意义(P<0.01);对“大三阳”孕妇的阻断效果最好,新生儿抗HBs阳转率从33.3%上升到71.4%。结论对HBV感染孕妇采用HBIG免疫阻断,可以降低宫内感染及母婴传播的发生率;分娩时孕妇HBV感染状态对新生儿抗HBs阳转率可能产生一定程度的影响。     

孕期应用乙型肝炎免疫球蛋白预防乙型肝炎病毒垂直传播的预防作用

目的探讨孕期应用乙肝免疫球蛋白(HBIG)对乙肝表面抗原及e抗原双阳性孕妇乙肝母婴垂直传播的预防作用.方法外周血HBsAg阳性孕妇291例,HBsAg、HBeAg双阳性83例,分为HBIG(A组,59例)及非HBIG(B组,24例)组;所有新生儿在出生24 h内,1、6个月分别注射乙肝疫苗并检验乙肝两对半.结果 1.HBeAg阳性孕妇的外周血HBV-DNA阳性率为76.56%,显著高于HBeAg阴性孕妇(8.22%),P＜0.01;2.孕晚期应用1,2次或3次HBIG的新生儿各月龄HBsAg阳性率及HBsAb阳转率无显著差异;3.A组新生儿出生当天外周血HBsAg阳性率显著低于B组,P＜0.05;B组乙肝疫苗免疫后的6个月龄婴儿外周血HBsAb阳转率仅37.5%,显著低于A组(81.4%),P＜0.001.结论孕晚期应用HBIG可有效降低乙肝宫内感染率,提高6个月龄婴儿HBsAb阳转率.     

乙型肝炎免疫球蛋白阻断HBV宫内感染的疗效及其适应症研究

目的研究乙型肝炎免疫球蛋白(HBIg)阻断HBsAg阳性孕妇HBV宫内感染的疗效并探讨其适应症.方法86例HBsAg阳性孕妇随机分为治疗组(n=40)和对照组(n=46),均在妊娠28周时抽取静脉血检测HBsAg、HBeAg和HBV DNA.治疗组自28周开始每4周肌注一次HBIg(200IU)直至分娩.对照组不给予上述药物.新生儿出生后即取静脉血检测HBsAg.结果治疗组新生儿HBsAg阳性率明显低于对照组.HBeAg阳性和阴性孕妇均可发生宫内感染,但HBeAg阳性孕妇所生新生儿HBeAg阳性率明显高于HBeAg阴性者.而两组中HBV DNA阴性孕妇均未发生宫内感染.结论HBIg能有效降低HBsAg阳性孕妇的宫内感染发生率,HBV DNA检测可以作为是否应用HBIg的指针.     

预防乙型肝炎病毒母婴传播的随机对照研究

目的探讨乙肝免疫球蛋白（HBIG）预防乙型肝炎病毒（HBV）母婴垂直传播的效果。方法以2001年1月至2005年5月在台州医院产科初次进行妊娠健康检查,HBsAg测定阳性或HBsAg、HBeAg均阳性孕妇作为研究对象,共279例。将单纯HBsAg阳性孕妇与HBsAg、HBeAg双阳性孕妇分别应用随机数表方法随机分组,分别为单阳注射组（n=80）、单阳对照组（n=60）、双阳注射组（n=79）、双阳对照组（n=60）。单阳注射组、双阳注射组于妊娠加周开始肌肉注射HBIG 200U,每4周注射1次,直至临产。两对照组不注射HBIG。4组孕妇所产婴儿,除常规接种乙肝疫苗外,均于出生后16h内和2周肌肉注射HBIG。然后随访并测定婴儿HBsAg。结果单阳注射组、单阳对照组、双阳注射组、双阳对照组所生婴儿HBsAg感染率分别为3％、13％、10％、32％。单阳注射组与单阳对照组之间（x^2=6．07,P〈0．05）,以及双阳注射组与双阳对照组之间婴儿HBsAg感染率（x^2=10．11,P〈0．01）均有统计学意义,注射HBIG组,对单纯HBsAg阳性孕妇及HBsAg、HBeAg双阳性孕妇,出生婴儿HBsAg感染率均显著低于对照组;单阳注射组与双阳注射组之间婴儿HBsAg感染率差异亦有统计学意义,说明HBIG对单纯HBsAg阳性孕妇预防效果优于HBsAg、HBeAg双阳性孕妇。结论HBIG能有效预防母婴传播,降低HBV感染率。因此,妊娠妇女应及时进行健康检查,发现HBV感染阳性,及时采取注射HBIG等有效措施,以促进优生优育。     

不同方案HBIG与乙肝疫苗联合应用对阻断HBV母婴传播的效果比较

176例母亲HBsAg 阳性的新生儿分成3组,分别于出生时接种1支和2支乙肝高效价免疫球蛋白(HBIG)及出生时和出生2周时各用1支HBIG。接着在1、2、7个月时接种乙肝疫苗.观察婴儿出现肝功能异常率、抗HBs 阳转率及接种疫苗前外周血抗HBs 浓度.认为出生时和2周时各用1支HBIG 优于其它方案。表明HBIG2支分2次用可发挥更好的保护效果.     

Transient hepatitis B surface antigenemia after neonatal hepatitis B immunization

Following immunization with hepatitis B vaccine, 39 infants were followed prospectively for hepatitis B surface antigen (HBsAg). A total of 69.2% of the infants tested positive for antigenemia at least once. Antigenemia was identified most often at 2–3 days (43.5 %) and 5–6 days (43.5 %) after immunization. The longest documented duration of antigenemia was 21 days. In all cases the antigenemia was transient and cleared by the 28th day post-vaccination.     

Perinatal hepatitis B virus detection by hepatitis B virus-DNA analysis.

Maternal transmission of hepatitis B virus infection in relation to the hepatitis B e antigen/antibody system and serum hepatitis B virus-DNA were evaluated. Results indicate that hepatitis B virus-DNA analysis can identify hepatitis B serum antigen positive mothers who may transmit infection to their offspring.     

Vertical hepatitis B transmission by anti-HBe positive hepatitis B carrier mothers

5 infants (3 boys and 2 girls) were infected vertically with hepatitis B virus by their healthy anti-HBe positive HBsAg carrier mothers. First sign of infection in the infants occurred 1 to 6 months after birth. The course of the disease was as follows: subclinical hepatitis B (1 case), acute hepatitis B with complete resolution (1 case), fatal fulminant hepatitis B (1 case), chronic persistent hepatitis B (1 case), and chronic active hepatitis with rapid progression to cirrhosis. We conclude that anti-HBe positive hepatitis B carrier mothers may be infective and thus may cause serious, eventually fatal disease in their infants. Passive-active immunization must be given to infants of all hepatitis B carrier mothers irrespective if they are anti-HBe positive or not.     

Use of hepatitis B vaccine alone or in combination with hepatitis B immunoglobulin for immunoprophylaxis of perinatal hepatitis B infection.

The efficacy of hepatitis B vaccine alone or in combination with immunoglobulin in neonates born to HBsAG positive mothers was investigated. Twenty-four infants were given three doses (at 0, 1, 2 months) of the vaccine alone, while 27 infants were given hepatitis B immunoglobulin (HBIG) and three doses of the vaccine. Fifty-eight infants born to HBsAg positive mothers who did not agree for vaccination or could not come for follow-up constituted the control group. The overall seroprotection rates (anti-HBS levels > or = 10 IU/l) were almost similar in both the groups at 6 months (81 and 76 per cent, respectively). However, the seroprotection rates in babies born to HBeAg positive mothers were better with combination of HBIG and vaccine (71 v. 57 per cent, respectively). It was also observed that seroprotection rates in babies born to anti-HBe positive mothers were even better (100 and 90 per cent in vaccine alone and combination group, respectively). No chronic carrier was detected in babies born to anti-HBe positive mothers.     

Epidemiology of hepatitis B and hepatitis B virus infection in United States children

Before the era of routine hepatitis B vaccination, an estimated 24,000 children acquired hepatitis B virus (HBV) infection each year in the United States. Childhood hepatitis B immunization has led to significant declines in the incidence and prevalence of HBV infection in U.S. children. Because the greatest burden of hepatitis B is caused by complications of hepatocellular carcinoma and cirrhosis in adults who were infected with HBV as children, most of the benefits of vaccination have yet to be realized. Reaching the goal of eliminating HBV transmission to children likely will require increasing vaccination coverage, ensuring timely administration of postexposure immunoprophylaxis to prevent more perinatal infections, and continued evaluation of the impact of immunization recommendations.     

Overcoming barriers to hepatitis B immunisation by a dedicated hepatitis B immunisation service

AIMS—To determine the effectiveness of a selective hospital based hepatitis B immunisation programme and the barriers to be overcome in obtaining a successful outcome.METHODS—Retrospective case note review of 265 infants born over a five year period to hepatitis B carrier mothers at a university affiliated hospital in Hackney, London.RESULTS—A total of 242 infants (91%) were fully vaccinated; 217 (82%) had serology; 31 required booster doses. Percentages failing to reach second, third vaccinations, and serology on schedule rose exponentially (7%, 18%, 33% respectively). Mobility was high (25%) and significantly affected outcome. A total of 95% Hackney resident babies were fully vaccinated compared with 78% non-residents. Uptake of routine immunisations was higher in Hackney residents than non-residents and greater in those who were eligible for hepatitis B vaccine. Name changes occurred in 35%. Translation requirements were high (85% for Turkish, Vietnamese, and Asian families). Requirements for specific postnatal counselling of mothers and hepatology referral fell significantly during the course of the study. Only seven of 22 babies born in 1995 in Tower Hamlets compared with 53 of 58 Hackney babies received a full vaccination course in non-hospital based primary care.CONCLUSION—In inner city areas with high prevalence of hepatitis B carriage, mobility, and diverse ethnicity, a dedicated centralised immunisation service can be highly effective, provided that adequate support services (translation, counselling, and parental referral) are available.