目的为全国人群乙型病毒性肝炎(乙肝)血清流行病学调查,筛选适宜的抗乙肝病毒表面抗原抗体(Antibody to Hepatitis B Virus Surface Antigen,Anti-HBs)检测试剂。方法选择符合国家质量标准,且在全国销量最大的五种(A、B、C、D、E)酶免...目的为全国人群乙型病毒性肝炎(乙肝)血清流行病学调查,筛选适宜的抗乙肝病毒表面抗原抗体(Antibody to Hepatitis B Virus Surface Antigen,Anti-HBs)检测试剂。方法选择符合国家质量标准,且在全国销量最大的五种(A、B、C、D、E)酶免疫测定法Anti-HBs检测试剂,平行检测由44份阳性和108份阴性品组成的参比系统各5次,将每个检测的s/n值(样品速率值与Index标准品平均速率值之比)做log(s/n+1)转换,计算并比较各试剂的可靠性指标组内相关系数(Intraclass Correlation Coefficient,ICC)、变异系数(Coefficient of Vaviability,CV)和真实性指标曲线下面积(Area Under Curve,AUC)、部分(partial)AUC(pAUC)、固定特异度下的灵敏度等。结果五种试剂ICC、CV从优到劣的排序均为D、E、B、C、A,除CV项目试剂E与B外,其他试剂间差异有统计学意义(Bootstrap法,P<0.05);五种试剂的AUC均在0.980～0.993,pAUC从大到小的排序为C、E、D、B、A,除试剂A明显低外,其余并无明显差别;而特异度为0.97时,试剂E的灵敏度明显高于B、C、D,更高于试剂A。结论综合考虑可靠性和真实性指标,以及试剂的用途,认为试剂D为最佳。展开更多
西藏地区藏族人群乙型肝炎病毒(Hepatitis B virus,HBV)感染率较高,而针对感染者血清中HBV表面抗原(Hepatitis B surface antigen,HBsAg)和HBV表面抗原抗体(Hepatitis B surface antibody,HBsAb)双阳性的研究一直进展缓慢,尚无明确的研...西藏地区藏族人群乙型肝炎病毒(Hepatitis B virus,HBV)感染率较高,而针对感染者血清中HBV表面抗原(Hepatitis B surface antigen,HBsAg)和HBV表面抗原抗体(Hepatitis B surface antibody,HBsAb)双阳性的研究一直进展缓慢,尚无明确的研究结论。为探讨西藏地区藏族人群慢性HBV感染者血清中HBsAg和HBsAb双阳性与基因组核苷酸/氨基酸突变的关系,本研究在西藏选取7个地区作为研究区域,进行多阶段抽样,选取样本进行HBV血清五项指标检测,筛选HBsAg和HBsAb均为阳性的患者血清共24份作为双阳性组,以年龄和乙型肝炎e抗原(HBeAg)等感染指标进行匹配,选取96份HBsAg阳性,HBsAb阴性患者血清作为对照组。HBV全基因组序列通过聚合酶链式反应(Polymerase chain reaction,PCR)产物直接测序获得,并进行重组分析和突变分析。852名西藏HBV感染者中,HBsAg/HBsAb双阳性率为2.82%(24/852)。双阳性组在S蛋白N端和主要亲水区(Major hydrophilic region,MHR)的突变率以及PreS缺失发生率均显著高于对照组。T1753C、C1990T和C2002T等核苷酸突变;S蛋白中V224A、PreS区D103E等氨基酸突变在两组内分布存在显著差异。HBV/CD重组型的HBsAg/HBsAb双阳性发生率与中国乙肝主要流行区域接近。HBV感染者血清HBsAg和HBsAb共存可能与S蛋白,特别是MHR内的高氨基酸突变造成的免疫逃逸有关。PreS缺失、S抗原蛋白C端V224A突变和PreS区D103E突变可能对HBsAg/HBsAb双阳性的产生具有协同作用。展开更多
目的比较甲型乙型肝炎联合疫苗(Hepatitis A and B Combined Vaccine,HepAB)与重组乙型肝炎(乙肝)疫苗(酿酒酵母)(Hepatitis B Vaccine Made by Recombinant Deoxyribonucleic Acid Techniques in SaccharomycesCerevisiae Yeast,HepB-S...目的比较甲型乙型肝炎联合疫苗(Hepatitis A and B Combined Vaccine,HepAB)与重组乙型肝炎(乙肝)疫苗(酿酒酵母)(Hepatitis B Vaccine Made by Recombinant Deoxyribonucleic Acid Techniques in SaccharomycesCerevisiae Yeast,HepB-SCY)、甲型肝炎(甲肝)灭活疫苗(Hepatitis A Virus Inactivated Vaccine,HepA-Ⅰ)诱导小鼠细胞免疫和体液免疫应答的特点。方法 4组无特定病原体的BALB/c小鼠(H-2d,6～8周龄,16～18克,雌性),分别皮下接种HepAB[含甲肝抗原150单位(Unit,U)、乙肝抗原3微克(μg)]、HepB-SCY(含乙肝抗原3μg)、HepA-Ⅰ(含甲肝抗原150U)及铝佐剂对照,于免疫后14d分离脾单个核细胞(Mononuclear Cell,MNC),应用酶联免疫斑点试验(Enzyme-linked Immunospot Assay,ELISPOT)测定MNC体外刺激后所产生的细胞因子干扰素(Interferon,IFN)-γ、白细胞介素(Interleukin,IL)-2斑点形成细胞数(Spots-forming Cell,SFC);同时应用酶联免疫吸附试验(Enzyme-linked Immunosorbent Assay,ELISA)检测免疫后脾MNC培养上清中诱导分泌抗原特异性IFN-γ细胞因子的含量;分别于免疫后14d、28d检测小鼠血清抗甲肝病毒抗体(Antibody to Hepatitis AVirus,Anti-HAV)IgG和抗乙肝病毒表面抗原抗体(Antibody to Hepatitis B Virus Surface Antigen,Anti-HBs)水平。结果应用ELISPOT法检测,HepAB免疫小鼠后诱导乙肝抗原特异性IL-2分泌水平(50%)高于HepB-SCY(20%),HepAB组诱导甲肝抗原特异性IFN-γ阳转率(70%)高于HepA-Ⅰ组(30%),且HepAB诱导乙肝抗原特异性IFN-γ分泌水平(80%)均显著高于HepB-SCY组(30%)(P=0.03489)。应用ELISA法检测HepAB免疫后脾MNC培养诱导分泌甲肝抗原特异性IFN-γ阳转率(80%),也显著高于HepA-Ⅰ组(20%)(P=0.01151)。HepAB组于免疫14d、28d诱导的Anti-HBs抗体滴度分别为93.6毫国际单位/毫升(mIU/ml)和476.8 mIU/ml,均高于HepB-SCY组的26.5 mIU/ml和237.8 mIU/ml。结论两种细胞免疫评价方法结果均表明,HepAB诱导抗原特异性细胞免疫应答反应优于HepB-SCY、HepA-Ⅰ;HepAB与HepB-SCY相比较,在诱导Anti-HBs水平方面也同样具有优势。展开更多
目的了解感染乙型肝炎（乙肝）病毒（Hepatitis B Virus，HBV）母亲的新生儿，接种10微克乙肝疫苗（Hepatitis B Vaccine, HepB）加乙肝免疫球蛋白（Hepatitis B Immunoglobulin，HBIG）后，其抗乙肝病毒表面抗原抗体（Antibody to HBV ...目的了解感染乙型肝炎（乙肝）病毒（Hepatitis B Virus，HBV）母亲的新生儿，接种10微克乙肝疫苗（Hepatitis B Vaccine, HepB）加乙肝免疫球蛋白（Hepatitis B Immunoglobulin，HBIG）后，其抗乙肝病毒表面抗原抗体（Antibody to HBV Surface Antigen，Anti—HBs）的阳转率。方法系统检索中国知识基础设施工程、万方、维普和医学文献检索系统（Pubmed）中公开发表的期刊，利用广义倒方差模型对各文献的Anti—HBs阳转率合并。结果共检索文献392篇，最终保留8篇。合并后Anti—HBs阳转率为90．42％（95％可信区间：85．44％～95．69％），，为93．58％（P〈0．0001）。结论HBIG和HepB联合应用Meta分析的Anti．HBs阳转率可信度较高。展开更多
目的观察新生儿及以上人群接种10微克(?g)/0.5毫升(ml)和5?g/0.5ml重组乙型肝炎(乙肝)疫苗(酿酒酵母)(Hepatitis B Vaccine Made by Recombinant Deoxyribonucleic Acid Techniques in Saccharomyces Cereviside Yeast,HepB-SCY)的免疫...目的观察新生儿及以上人群接种10微克(?g)/0.5毫升(ml)和5?g/0.5ml重组乙型肝炎(乙肝)疫苗(酿酒酵母)(Hepatitis B Vaccine Made by Recombinant Deoxyribonucleic Acid Techniques in Saccharomyces Cereviside Yeast,HepB-SCY)的免疫学效果,以及对乙肝病毒表面抗原[Hepatitis B Virus(HBV)Surface Antigen,HBsAg]阳性母亲的新生儿免疫后阻断母婴传播的效果。方法采用随机、对照和盲法的临床试验,各组按1︰1比例分别接种10?g和5?g HepB-SCY。将新生儿分三组:即母亲HBsAg和乙肝病毒e抗原(HBV e Antigen,HBeAg)均为阴性组,母亲HBsAg阳性、HBeAg阴性组,母亲HBsAg和HBeAg均为阳性组。将非新生儿人群分成1月龄~5岁、6~15岁、≥16岁组。检测各组免疫前、后抗乙肝病毒表面抗原抗体(Antibody to HBsAg,Anti-HBs)阳转率和HBsAg阳性母亲的新生儿阻断HBV母婴传播的保护率。结果 10?g HepB-SCY对新生儿及以上人群全程免疫后,Anti-HBs阳转率为95.27%~98.86%,Anti-HBs几何平均浓度(Geometrics Mean Concentration,GMC)为340.87毫国际单位/毫升(mIU/ml)~837.56mIU/ml;与使用5?g HepB-SCY全程免疫后的Anti-HBs阳转率91.3%~98.8%和GMC 220.86 mIU/ml^701.30 mIU/ml相比,各年龄组间Anti-HBs的阳转率差异无统计学意义,GMC除新生儿组(?2=4.012,P=0.045)外,其余各组间差异亦无统计学意义。10?g和5?g HepB-SCY在HBsAg和HBeAg双阳性组全程免疫后,Anti-HBs阳转率分别为90.70%和88.6%,阻断HBV母婴传播保护率分别为92.25%和84.85%,两组间差异无统计学意义。在HBsAg单阳性组中,Anti-HBs阳转率分别为95.7%和100.0%、保护率分别为95.75%和100.0%,两组间差异无统计学意义。结论 10?g和5?g HepB-SCY对新生儿及以上人群均有良好的免疫原性,除新生儿组Anti-HBs阳转率差异有统计学意义外,其余指标的的差异均无统计学意义,且对HBsAg阳性母亲的新生儿阻断HBV母婴传播的保护率的差异亦无统计学意义。临床试验注册国家药品食品监督管理局《药物临床试验》2008L02895号。展开更多
Hepatitis B virus surface antigen （HBsAg）, a specific antigen on the membrane of Hepatitis B virus （HBV）-infected cells, provides a perfect target for therapeutic drugs. The development of reagents with high affin...Hepatitis B virus surface antigen （HBsAg）, a specific antigen on the membrane of Hepatitis B virus （HBV）-infected cells, provides a perfect target for therapeutic drugs. The development of reagents with high affinity and specificity to the HBsAg is of great significance to the early-stage diagnosis and treatment of HBV infection. Herein, we report the selection of RNA aptamers that can specifically bind to HBsAg protein and HBsAg-positive hepatocytes. One high affinity aptamer, HBs-A22, was isolated from an initial 115 met library of -1.1 ×10^15 random-sequence RNA molecules using the SELEX procedure. The selected aptamer HBs-A22 bound specifically to hepatoma cell line HepG2.2.15 that expresses HBsAg but did not bind to HBsAg-devoid HepG2 cells. This is the first reported RNA aptamer which could bind to a HBV specific antigen. This newly isolated aptamer could be modified to deliver imaging, diagnostic, and therapeutic agents targeted at HBV-infected cells.展开更多
Prophylactic strategies against hepatitis B virus(HBV) recurrence after liver transplantation(LT) are essential for patients with HBV-related disease.Before LT, lamivudine(LAM) was proposed to be down-graded from firs...Prophylactic strategies against hepatitis B virus(HBV) recurrence after liver transplantation(LT) are essential for patients with HBV-related disease.Before LT, lamivudine(LAM) was proposed to be down-graded from first-to second-line therapy.In contrast, adefovir dipivoxil(ADV) has been approved not only as first-line therapy but also as rescue therapy for patients with LAM resistance.Furthermore, combination of ADV and LAM may result in lower risk of ADV resistance than ADV monotherapy.Other new drugs such as entecavir, telbivudine and tenofovir, are probably candidates for the treatment of hepatitis-B-surface-antigen-positive patients awaiting LT.After LT, low-dose intramuscular hepatitis B immunoglobulin(HBIG), in combination with LAM, has been regarded as the most cost-effective regimen for the prevention of post-transplant HBV recurrence in recipients without pretransplant LAM resistance and rapidly accepted in many transplant centers.With the introduction of new antiviral drugs, new hepatitis B vaccine and its new adjuvants, post-transplant HBIG-free therapeutic regimens with new oral antiviral drug combinations or active HBV vaccination combined with adjuvants will be promising, particularly in those patients with low risk of HBV recurrence.展开更多
Hepatitis B surface antigen (HBsAg) is produced and secreted through a complex mechanism that is still not fully understood. In clinical fields, HBsAg has long served as a qualitative diagnostic marker for hepatitis B...Hepatitis B surface antigen (HBsAg) is produced and secreted through a complex mechanism that is still not fully understood. In clinical fields, HBsAg has long served as a qualitative diagnostic marker for hepatitis B virus infection. Notably, advances have been made in the development of quantitative HBsAg assays, which have allowed viral replication monitoring, and there is an opportunity to make maximal use of quantitative HBsAg to elucidate its role in clinical fields. Yet, it needs to be underscored that a further understanding of HBsAg, not only from clinical point of view but also from a virologic point of view, would enable us to deepen our insights, so that we could more widely expand and apply its utility. It is also important to be familiar with HBsAg variants and their clinical consequences in terms of immune escape mutants, issues resulting from overlap with corresponding mutation in the P gene, and detection problems for the HBsAg variants. In this article, we review current concepts and issues on the quantification of HBsAg titers with respect to their biologic nature, method principles, and clinically relevant topics.展开更多
AIM： To assess the prevalence and socio-demographic distribution of hepatitis B virus （HBV） infection in Albania. METHODS： Blood samples from 410 unselected schoolboys, 666 students, 500 military personnel, 1286 c...AIM： To assess the prevalence and socio-demographic distribution of hepatitis B virus （HBV） infection in Albania. METHODS： Blood samples from 410 unselected schoolboys, 666 students, 500 military personnel, 1286 casual blood donors, 378 voluntary blood donors and 640 pregnant women （total 3880 non-vaccinated residents of rural and metropolitan areas from all over Albania; 2354 （60.7%） male and 1526 （39.3%） female; mean age of 26.3 years） were tested during 2004-2006 for hepatitis B surface antigen （HBsAg） and antibodies to hepatitis B virus （anti-HBs） by ELISA. RESULTS： The HBsAg and anti-HBs prevalence were 9.5% and 28.7%, respectively. The highest HI3sAg prevalence was evident in the younger age group, such as in schoolchildren （11.8%） and the military （10.6%）. Consequently, the anti-HBs prevalence increased with age, from 21.2% in schoolchildren （mean age： 15.7 years）, to 36.3% in pregnant women （mean age： 26.3 years） and 29.7% in voluntary blood donors （mean age： 40.1 years）. There were no significant differences between males and females. CONCLUSION： Despite the estimated two-fold reduction of HBsAg prevalence in the general population from about 18%-19% to 9.5%, Albania remains a highly endemic country （i.e. over 8% of HBsAg prevalence rate）.展开更多
文摘目的为全国人群乙型病毒性肝炎(乙肝)血清流行病学调查,筛选适宜的抗乙肝病毒表面抗原抗体(Antibody to Hepatitis B Virus Surface Antigen,Anti-HBs)检测试剂。方法选择符合国家质量标准,且在全国销量最大的五种(A、B、C、D、E)酶免疫测定法Anti-HBs检测试剂,平行检测由44份阳性和108份阴性品组成的参比系统各5次,将每个检测的s/n值(样品速率值与Index标准品平均速率值之比)做log(s/n+1)转换,计算并比较各试剂的可靠性指标组内相关系数(Intraclass Correlation Coefficient,ICC)、变异系数(Coefficient of Vaviability,CV)和真实性指标曲线下面积(Area Under Curve,AUC)、部分(partial)AUC(pAUC)、固定特异度下的灵敏度等。结果五种试剂ICC、CV从优到劣的排序均为D、E、B、C、A,除CV项目试剂E与B外,其他试剂间差异有统计学意义(Bootstrap法,P<0.05);五种试剂的AUC均在0.980～0.993,pAUC从大到小的排序为C、E、D、B、A,除试剂A明显低外,其余并无明显差别;而特异度为0.97时,试剂E的灵敏度明显高于B、C、D,更高于试剂A。结论综合考虑可靠性和真实性指标,以及试剂的用途,认为试剂D为最佳。
文摘西藏地区藏族人群乙型肝炎病毒(Hepatitis B virus,HBV)感染率较高,而针对感染者血清中HBV表面抗原(Hepatitis B surface antigen,HBsAg)和HBV表面抗原抗体(Hepatitis B surface antibody,HBsAb)双阳性的研究一直进展缓慢,尚无明确的研究结论。为探讨西藏地区藏族人群慢性HBV感染者血清中HBsAg和HBsAb双阳性与基因组核苷酸/氨基酸突变的关系,本研究在西藏选取7个地区作为研究区域,进行多阶段抽样,选取样本进行HBV血清五项指标检测,筛选HBsAg和HBsAb均为阳性的患者血清共24份作为双阳性组,以年龄和乙型肝炎e抗原(HBeAg)等感染指标进行匹配,选取96份HBsAg阳性,HBsAb阴性患者血清作为对照组。HBV全基因组序列通过聚合酶链式反应(Polymerase chain reaction,PCR)产物直接测序获得,并进行重组分析和突变分析。852名西藏HBV感染者中,HBsAg/HBsAb双阳性率为2.82%(24/852)。双阳性组在S蛋白N端和主要亲水区(Major hydrophilic region,MHR)的突变率以及PreS缺失发生率均显著高于对照组。T1753C、C1990T和C2002T等核苷酸突变;S蛋白中V224A、PreS区D103E等氨基酸突变在两组内分布存在显著差异。HBV/CD重组型的HBsAg/HBsAb双阳性发生率与中国乙肝主要流行区域接近。HBV感染者血清HBsAg和HBsAb共存可能与S蛋白,特别是MHR内的高氨基酸突变造成的免疫逃逸有关。PreS缺失、S抗原蛋白C端V224A突变和PreS区D103E突变可能对HBsAg/HBsAb双阳性的产生具有协同作用。
文摘目的比较甲型乙型肝炎联合疫苗(Hepatitis A and B Combined Vaccine,HepAB)与重组乙型肝炎(乙肝)疫苗(酿酒酵母)(Hepatitis B Vaccine Made by Recombinant Deoxyribonucleic Acid Techniques in SaccharomycesCerevisiae Yeast,HepB-SCY)、甲型肝炎(甲肝)灭活疫苗(Hepatitis A Virus Inactivated Vaccine,HepA-Ⅰ)诱导小鼠细胞免疫和体液免疫应答的特点。方法 4组无特定病原体的BALB/c小鼠(H-2d,6～8周龄,16～18克,雌性),分别皮下接种HepAB[含甲肝抗原150单位(Unit,U)、乙肝抗原3微克(μg)]、HepB-SCY(含乙肝抗原3μg)、HepA-Ⅰ(含甲肝抗原150U)及铝佐剂对照,于免疫后14d分离脾单个核细胞(Mononuclear Cell,MNC),应用酶联免疫斑点试验(Enzyme-linked Immunospot Assay,ELISPOT)测定MNC体外刺激后所产生的细胞因子干扰素(Interferon,IFN)-γ、白细胞介素(Interleukin,IL)-2斑点形成细胞数(Spots-forming Cell,SFC);同时应用酶联免疫吸附试验(Enzyme-linked Immunosorbent Assay,ELISA)检测免疫后脾MNC培养上清中诱导分泌抗原特异性IFN-γ细胞因子的含量;分别于免疫后14d、28d检测小鼠血清抗甲肝病毒抗体(Antibody to Hepatitis AVirus,Anti-HAV)IgG和抗乙肝病毒表面抗原抗体(Antibody to Hepatitis B Virus Surface Antigen,Anti-HBs)水平。结果应用ELISPOT法检测,HepAB免疫小鼠后诱导乙肝抗原特异性IL-2分泌水平(50%)高于HepB-SCY(20%),HepAB组诱导甲肝抗原特异性IFN-γ阳转率(70%)高于HepA-Ⅰ组(30%),且HepAB诱导乙肝抗原特异性IFN-γ分泌水平(80%)均显著高于HepB-SCY组(30%)(P=0.03489)。应用ELISA法检测HepAB免疫后脾MNC培养诱导分泌甲肝抗原特异性IFN-γ阳转率(80%),也显著高于HepA-Ⅰ组(20%)(P=0.01151)。HepAB组于免疫14d、28d诱导的Anti-HBs抗体滴度分别为93.6毫国际单位/毫升(mIU/ml)和476.8 mIU/ml,均高于HepB-SCY组的26.5 mIU/ml和237.8 mIU/ml。结论两种细胞免疫评价方法结果均表明,HepAB诱导抗原特异性细胞免疫应答反应优于HepB-SCY、HepA-Ⅰ;HepAB与HepB-SCY相比较,在诱导Anti-HBs水平方面也同样具有优势。
文摘目的了解感染乙型肝炎（乙肝）病毒（Hepatitis B Virus，HBV）母亲的新生儿，接种10微克乙肝疫苗（Hepatitis B Vaccine, HepB）加乙肝免疫球蛋白（Hepatitis B Immunoglobulin，HBIG）后，其抗乙肝病毒表面抗原抗体（Antibody to HBV Surface Antigen，Anti—HBs）的阳转率。方法系统检索中国知识基础设施工程、万方、维普和医学文献检索系统（Pubmed）中公开发表的期刊，利用广义倒方差模型对各文献的Anti—HBs阳转率合并。结果共检索文献392篇，最终保留8篇。合并后Anti—HBs阳转率为90．42％（95％可信区间：85．44％～95．69％），，为93．58％（P〈0．0001）。结论HBIG和HepB联合应用Meta分析的Anti．HBs阳转率可信度较高。
文摘目的观察新生儿及以上人群接种10微克(?g)/0.5毫升(ml)和5?g/0.5ml重组乙型肝炎(乙肝)疫苗(酿酒酵母)(Hepatitis B Vaccine Made by Recombinant Deoxyribonucleic Acid Techniques in Saccharomyces Cereviside Yeast,HepB-SCY)的免疫学效果,以及对乙肝病毒表面抗原[Hepatitis B Virus(HBV)Surface Antigen,HBsAg]阳性母亲的新生儿免疫后阻断母婴传播的效果。方法采用随机、对照和盲法的临床试验,各组按1︰1比例分别接种10?g和5?g HepB-SCY。将新生儿分三组:即母亲HBsAg和乙肝病毒e抗原(HBV e Antigen,HBeAg)均为阴性组,母亲HBsAg阳性、HBeAg阴性组,母亲HBsAg和HBeAg均为阳性组。将非新生儿人群分成1月龄~5岁、6~15岁、≥16岁组。检测各组免疫前、后抗乙肝病毒表面抗原抗体(Antibody to HBsAg,Anti-HBs)阳转率和HBsAg阳性母亲的新生儿阻断HBV母婴传播的保护率。结果 10?g HepB-SCY对新生儿及以上人群全程免疫后,Anti-HBs阳转率为95.27%~98.86%,Anti-HBs几何平均浓度(Geometrics Mean Concentration,GMC)为340.87毫国际单位/毫升(mIU/ml)~837.56mIU/ml;与使用5?g HepB-SCY全程免疫后的Anti-HBs阳转率91.3%~98.8%和GMC 220.86 mIU/ml^701.30 mIU/ml相比,各年龄组间Anti-HBs的阳转率差异无统计学意义,GMC除新生儿组(?2=4.012,P=0.045)外,其余各组间差异亦无统计学意义。10?g和5?g HepB-SCY在HBsAg和HBeAg双阳性组全程免疫后,Anti-HBs阳转率分别为90.70%和88.6%,阻断HBV母婴传播保护率分别为92.25%和84.85%,两组间差异无统计学意义。在HBsAg单阳性组中,Anti-HBs阳转率分别为95.7%和100.0%、保护率分别为95.75%和100.0%,两组间差异无统计学意义。结论 10?g和5?g HepB-SCY对新生儿及以上人群均有良好的免疫原性,除新生儿组Anti-HBs阳转率差异有统计学意义外,其余指标的的差异均无统计学意义,且对HBsAg阳性母亲的新生儿阻断HBV母婴传播的保护率的差异亦无统计学意义。临床试验注册国家药品食品监督管理局《药物临床试验》2008L02895号。
基金National Mega Research Program of China(2008ZX10002-011)National Natural Science Foundation of China(30700701)National High Tech-nology Research and Development program of China(2006AA02Z128)
文摘Hepatitis B virus surface antigen （HBsAg）, a specific antigen on the membrane of Hepatitis B virus （HBV）-infected cells, provides a perfect target for therapeutic drugs. The development of reagents with high affinity and specificity to the HBsAg is of great significance to the early-stage diagnosis and treatment of HBV infection. Herein, we report the selection of RNA aptamers that can specifically bind to HBsAg protein and HBsAg-positive hepatocytes. One high affinity aptamer, HBs-A22, was isolated from an initial 115 met library of -1.1 ×10^15 random-sequence RNA molecules using the SELEX procedure. The selected aptamer HBs-A22 bound specifically to hepatoma cell line HepG2.2.15 that expresses HBsAg but did not bind to HBsAg-devoid HepG2 cells. This is the first reported RNA aptamer which could bind to a HBV specific antigen. This newly isolated aptamer could be modified to deliver imaging, diagnostic, and therapeutic agents targeted at HBV-infected cells.
文摘Prophylactic strategies against hepatitis B virus(HBV) recurrence after liver transplantation(LT) are essential for patients with HBV-related disease.Before LT, lamivudine(LAM) was proposed to be down-graded from first-to second-line therapy.In contrast, adefovir dipivoxil(ADV) has been approved not only as first-line therapy but also as rescue therapy for patients with LAM resistance.Furthermore, combination of ADV and LAM may result in lower risk of ADV resistance than ADV monotherapy.Other new drugs such as entecavir, telbivudine and tenofovir, are probably candidates for the treatment of hepatitis-B-surface-antigen-positive patients awaiting LT.After LT, low-dose intramuscular hepatitis B immunoglobulin(HBIG), in combination with LAM, has been regarded as the most cost-effective regimen for the prevention of post-transplant HBV recurrence in recipients without pretransplant LAM resistance and rapidly accepted in many transplant centers.With the introduction of new antiviral drugs, new hepatitis B vaccine and its new adjuvants, post-transplant HBIG-free therapeutic regimens with new oral antiviral drug combinations or active HBV vaccination combined with adjuvants will be promising, particularly in those patients with low risk of HBV recurrence.
基金Supported by The Grant of the Bilateral International Collaborative R&D Program from the Ministry of Knowledge Economythe Good Health R&D Project from the Ministry for Health,Welfare and Family Affairs,South Korea (A050021)
文摘Hepatitis B surface antigen (HBsAg) is produced and secreted through a complex mechanism that is still not fully understood. In clinical fields, HBsAg has long served as a qualitative diagnostic marker for hepatitis B virus infection. Notably, advances have been made in the development of quantitative HBsAg assays, which have allowed viral replication monitoring, and there is an opportunity to make maximal use of quantitative HBsAg to elucidate its role in clinical fields. Yet, it needs to be underscored that a further understanding of HBsAg, not only from clinical point of view but also from a virologic point of view, would enable us to deepen our insights, so that we could more widely expand and apply its utility. It is also important to be familiar with HBsAg variants and their clinical consequences in terms of immune escape mutants, issues resulting from overlap with corresponding mutation in the P gene, and detection problems for the HBsAg variants. In this article, we review current concepts and issues on the quantification of HBsAg titers with respect to their biologic nature, method principles, and clinically relevant topics.
文摘AIM： To assess the prevalence and socio-demographic distribution of hepatitis B virus （HBV） infection in Albania. METHODS： Blood samples from 410 unselected schoolboys, 666 students, 500 military personnel, 1286 casual blood donors, 378 voluntary blood donors and 640 pregnant women （total 3880 non-vaccinated residents of rural and metropolitan areas from all over Albania; 2354 （60.7%） male and 1526 （39.3%） female; mean age of 26.3 years） were tested during 2004-2006 for hepatitis B surface antigen （HBsAg） and antibodies to hepatitis B virus （anti-HBs） by ELISA. RESULTS： The HBsAg and anti-HBs prevalence were 9.5% and 28.7%, respectively. The highest HI3sAg prevalence was evident in the younger age group, such as in schoolchildren （11.8%） and the military （10.6%）. Consequently, the anti-HBs prevalence increased with age, from 21.2% in schoolchildren （mean age： 15.7 years）, to 36.3% in pregnant women （mean age： 26.3 years） and 29.7% in voluntary blood donors （mean age： 40.1 years）. There were no significant differences between males and females. CONCLUSION： Despite the estimated two-fold reduction of HBsAg prevalence in the general population from about 18%-19% to 9.5%, Albania remains a highly endemic country （i.e. over 8% of HBsAg prevalence rate）.
