国产甲型肝炎病毒总抗体检测试剂的评价

目的比较国内常用抗甲型肝炎(甲肝)病毒总抗体(Total Antibody to Hepatitis A Virus,Anti-HAV)酶免疫测定(Enzyme Immunoassay,EIA)试剂的性能,为甲肝血清流行病学调查试剂的选择提供参考。方法以雅培(Abbott)HAVAb2.0试剂的检测结果作为金标准,确定参比系统的总Anti-HAV含量。用A、B两种国产总Anti-HAVEIA试剂,平行检测参比系统8遍,记录CO/S值并作ln(CO/S+0.1)转换,通过广义线性化估计方程(Generalized Estimating Equation,GEE)模型估计各次测试样本的阳性概率,计算比较两种试剂的可靠性指标和真实性指标:组内相关系数(Intraclass Correlation Coefficient,ICC)、变异系数(Coefficient of Variability,CV)和全部受试者工作特征(Receive Operation Characteristic,ROC)曲线下面积和部分ROC曲线下面积,以及固定特异度下的灵敏度[Sensitivityata Particular False-Positive-Rate(1-Specificity),Se(FPR=e)],对比阐明两者之优劣。结果 A试剂的ICC和CV分别为0.9971和5.7840%,B试剂的为0.9952和6.2931%(Bootstrap法,P<0.05);A试剂的ROC曲线下面积(Areaunder Curve,AUC)和部分(Partial)ROC曲线(特异度为0.9～1)下面积(pAUC)分别为0.9557和0.0717,B试制的为0.9404和0.0663(Bootstrap法,P<0.05);在特异度为0.920～0.970时,间隔0.005计算的Se(FPR=e),在特异度为0.945、0.950、0.955、0.960几个观察点时,A试剂的灵敏度>B试剂(Bootstrap法,P<0.05);而在特异度为其他观察点时,对应灵敏度的差异尚无统计学意义(Bootstrap法,P>0.05)。结论 A、B两种试剂均表现出良好的诊断能力,虽然某些指标的差异有统计学意义,但差异有无实际意义,值得进一步探讨。在实际应用时,可根据具体情况进行选择。     

免疫层析法与酶联免疫吸附法检测血中HBsAg、抗-HCV、抗-HIV的比较

〔目的〕分析比较乙型肝炎表面抗原(HBsAg)、丙型肝炎病毒抗体(抗-HCV)、HIV抗体(抗-HIV)的免疫层析快速试剂在实际应用中的灵敏度、特异度和准确度,为今后的工作提供参考。〔方法〕对502份健康体检血清标本同时用快速免疫层析法和酶联免疫吸附法(ELISA)检测HBsAg、抗-HCV、抗-HIV,对其灵敏度和特异度进行比较。〔结果〕与ELISA相比,502份血清标本中HBsAg金标法有2份假阴性,5份假阳性,灵敏度为99.6%,特异度为99.0%,准确度为98.6%;抗-HCV金标法无假阴性,有9份假阳性,灵敏度为100%,特异度为98.2%,准确度为98.2%;抗-HIV硒标法有2份假阳性,灵敏度为100%,特异度为99.6%,准确度为99.6%。〔结论〕金标法检测HBsAg灵敏度和特异度稍低于ELISA,有漏检和误检现象,而抗-HCV、抗-HIV快速法与ELISA比较灵敏度相当,而特异度稍低,因此,都要结合ELISA结果才可出具最终检测报告,抗-HIV的检测任何一种方法出现阳性时都要进行确认试验。     

反转录聚合酶链反应检测水产品中甲型肝炎病毒的研究

目的：建立一种特异、灵敏的RT-PCR方法检测水产品中甲肝病毒。方法：采用抗体捕获RT-PCR和直接RNA提取RT-PCR对细胞传代的甲肝病毒、模拟染毒水产品中甲肝病毒、上海农贸市场水产品中的甲肝病毒进行检测。结果：2种RT-PCR检测细胞传代的甲肝病毒，检测灵敏度无明显区别；而对模拟染毒水产品中甲肝病毒的检测，两者检测灵敏度有显著差异。对农贸市场94份水产品中的甲肝病毒检测，检出率分别为2．13％、13．83％。结论：对于水产品中的甲肝病毒的检测，直接RNA提取RT-PCR要比抗体捕获RT-PCR方法灵敏。     

北京市昌平区自然人群甲型肝炎血清流行病学调查结果分析

本研究旨在探讨北京市昌平区自然人群甲型肝炎(甲肝)病毒(HAV)血清学感染状况。采用多阶段整群随机抽样的方法抽取昌平区1岁以上自然人群538名,采集外周静脉血5ml,利用雅培微粒子酶免疫分析法检测抗-HAV IgG抗体。共检测538人,其中男性247人,女性291人,年龄1～91岁。城区276人,农村262人。HAV IgG抗体阳性率为86.43%(95%CI:83.54～89.32),标化阳性率为75.30%。男性HAV IgG抗体阳性率81.38%,女性阳性率90.72%,差异有统计学意义(χ2=9.949,P=0.002),随年龄增长,HAV抗体阳性率呈增长趋势(χ2=136.423,P=0.000),不同职业(χ2=75.442,P=0.000)及文化程度(χ2=10.961,P=0.004)间HAV抗体阳性率的差异有统计学意义,城乡间差异无统计学意义。研究显示,北京市昌平区自然人群甲肝感染率总体较高,14岁以下儿童为甲肝防控的重点人群。     

无偿献血者血液病原体ELISA与核酸检测结果分析

目的分析酶联免疫吸附试验(ELISA)和核酸检测(NAT)筛查血液HBV/HCV/HIV感染的结果。方法对绍兴市2015年1月—2016年2月采集的52 339份无偿献血者血液标本进行谷丙转氨酶(ALT)检测,并采用2家不同公司生产的ELISA试剂(A/B)进行HBs Ag、梅毒、HCV抗体、HIV抗体检测,排除ALT和梅毒阳性标本后进行HBV/HCV/HIV核酸检测。结果共有52 228份标本用ELISA和NAT作平行检测。以NAT检测结果为金标准,HBV检测阳性169份,阳性率3.24‰;A试剂灵敏度为55.62%,特异度为99.95%;B试剂灵敏度为59.76%,特异度为99.97%。HCV检测阳性11份,阳性率0.21‰;A试剂灵敏度为100.00%,特异度为99.83%;B试剂灵敏度为100.00%,特异度为99.93%。HIV检测阳性5份,阳性率0.10‰;A试剂灵敏度为80.00%,特异度为99.98%;B试剂灵敏度为80.00%,特异度为99.95%;A、B试剂均有1例窗口期漏诊。结论 ELISA联合NAT检测可进一步提高血液病毒检测结果的准确性。     

乙型肝炎病毒（HBV）的ELISA检测及化学发光法检测的诊断价值

目的 本研究探讨化学发光法与酶联免疫吸附法在(HBV)中的诊断价值。方法 收集本院2020年6月—2023年4月收治的300例乙型病毒性肝炎病例的血标本为观察组,另随机选择同期住院的300例非乙型病毒性肝炎病例的血标本为对照组。两组均采用HBV的ELISA检测及化学发光法检测,对比两组检测结果。结果化学发光法对HBV的标准曲线相关系数R²=0.998,平均批内变异系数2.98%,批间变异系数4.20%,优于ELISA检测的平均批内变异系数6.27%及平均批间变异系数7.74%;化学发光法的最低检出浓度为2.5ng/mL,ELISA检测乙型肝炎病毒最低检出浓度为25ng/mL,化学发光法灵敏度优于ELISA检测法。ELISA检测阳性率明显低于化学发光法检测结果,阴性率高于化学发光法。结论 化学发光法有利于早期诊断乙型病毒性肝炎,较ELISA检测具有很高的灵敏度与特异度。     

巨细胞病毒IgG抗体亲和力检测试剂盒的临床应用评估

目的对巨细胞病毒(CMV)IgG抗体亲和力检测试剂进行临床应用评估,为临床资料提供参考依据。方法收集医院364例CMV IgG阳性标本,同时用被考核试剂(罗氏公司生产)和参考试剂[意大利索灵诊断医疗设备(上海)有限公司生产]进行CMV IgM和IgG抗体亲和力检测,计算被考核试剂IgG抗体亲和力检测的相对灵敏度、相对特异度、相对总符合率。结果参考试剂检测为高亲和力抗体的350例、低亲和力抗体11例、灰区3例,即被考核试剂的相对灵敏度为90.90%、相对特异度为98.25%、相对总符合率为98.02%。结论罗氏公司的巨细胞病毒(CMV)IgG抗体亲和力检测试剂盒的灵敏度、特异性均高(>90.00%),具有临床应用的可行性及检测结果的可靠性。     

乙型肝炎病毒DNA定量试剂检测样本的结果评定与分析

目的对国产乙型肝炎病毒(HBV)DNA定量试剂最低检测限样本进行结果评定与分析,评估国产定量试剂的临床应用性能。方法 2011年6月-2012年6月应用国产HBV-DNA检测试剂检测2 061份临床样本、12份灵敏度试验稀释血清、10份卫生部临床检验中心标准品中HBV-DNA含量,结合实时荧光定量曲线和DNA凝胶电泳对小于最低检测限样本进行结果评定,分别采用化学发光法和全自动生化分析仪检测低病毒载量患者血清学指标和肝功能生化指标,对FX试剂定量结果进行相关性统计分析。结果 2 061份样本中小于最低检测限的样本1 233份占59.9%,其中<1 000IU/ml的低载量阳性样本393份占19.1%;393份低病毒载量样本中有193份样本检出有至少1项肝功能生化指标异常,HBsAg、抗-HBe、抗-HBc 3项阳性的有332份占84.48%,HBsAg、HBeAg、抗-HBc阳性26份占6.62%;10份标准品经检测均能正确检出,其实测值和理论靶值相关性比较差异有统计学意义(R=0.9942,P<0.01);国产试剂检测灵敏度试验稀释血清,检出稀释度样本最低浓度为57.8IU/ml。结论国产HBV-DNA定量试剂结果为小于最低检测限的样本中存在一定比例低病毒载量HBV感染者,建议对小于最低检测限样本采用进口试剂检测确认以避免漏检。     

抗乙型肝炎病毒核心抗原抗体免疫球蛋白M诊断试剂区分急慢性乙型肝炎患者方法的初步探讨

目的调整抗乙型肝炎(乙肝)病毒核心抗原抗体免疫球蛋白M(Immunoglobulin M Antibody to Hepatitis B Virus Core Antigen,Anti-HBc-Ig M)诊断试剂临界值,使该指标能够区分急性乙肝(Acute Hepatitis B,AHB)和慢性乙肝(Chronic Hepatitis B,CHB)急性期患者。方法选择A公司国产和美国雅培(Abbott)公司Anti-HBc-Ig M检测试剂,平行检测2658份疑似AHB患者血清标本。利用R语言程序软件(R Programming Software,R)的VGAM程序包,通过最大似然法求得各自的分布参数和估计的阳性率,采用最大似然法、最大准确率法和固定特异度法,以及试剂说明书提供方法求得两种检测试剂的临界值、估计阳性率、灵敏度及特异度指标进行比较。结果采用最大似然法确定临界值,临界值调整前后A公司试剂阳性率为51.58%、12.23%,雅培试剂为28.37%、10.27%。两种试剂受试者工作特征曲线(Receiver Operating Characteristics Curve,ROC)的曲线下面积(Area Under Curve,AUC)均接近于1,都有较高的灵敏度和特异度。最大似然法、最大准确率法和固定特异度法与试剂说明书参考值比较,前三种方法得到的阳性率较为接近,灵敏度、特异度较高,试剂说明书参考值法,灵敏度均较低,假阳性率过高。结论本研究中调整Anti-HBc-Ig M检测试剂临界值的方法,可以使Anti-HBc-Ig M区分AHB和CHB急性期患者的能力更可靠。     

SYBR Green Ⅰ实时PCR检测甲肝病毒方法的建立与初步应用

目的建立一种快速、特异的SYBR Green Ⅰ实时PCR方法检测甲肝病毒.方法对SYBR Green Ⅰ实时PCR检测甲肝病毒方法的反应条件、反应体系进行优化,同时与传统RT-PCR方法进行灵敏度比较,提高该方法的特异性、灵敏性.并用该方法对甲肝病毒毒株、脊髓灰质炎病毒、柯萨奇病毒(1～6型)毒株、贝类水产品标本进行检测.结果SYBR Green Ⅰ实时PCR与传统RT-PCR检测甲肝病毒方法的灵敏度无明显区别,但检测时间缩短了1/2.该方法能特异检测出甲肝病毒,不能扩增脊髓灰质炎病毒、柯萨奇病毒(1～6型)毒株,对农贸市场40份贝类水产品进行甲肝病毒核酸检测,检出3份.结论建立的SYBR Green Ⅰ实时PCR方法用于甲肝病毒检测具有特异、灵敏、快速等优点,可用于甲肝的病原学监测.     

Comparative immunogenicity and safety of two dosing schedules of a combined hepatitis A and B vaccine in healthy adolescent volunteers: an open, randomised study

An open, randomised study was undertaken to demonstrate the equivalence in immunogenicity and to determine the reactogenicity and safety of two dosing schedules (0, 6 or 0, 12 month) of an adult formulation of a combined hepatitis A and B vaccine containing 720 EL.U. of inactivated hepatitis A antigen and 20 μg of hepatitis B surface antigen (Twinrix™, SmithKline Beecham Biologicals, Belgium) in 240 healthy volunteers aged 12–15 years. The vaccine was well tolerated when administered using either vaccination schedule. At month 7, 98.1% of subjects completing the 0, 6 month vaccination schedule were seroprotected against hepatitis B (anti-hepatitis B surface antigen (anti-HBs)10 mIU/ml) and 100% were seropositive for anti-hepatitis A virus (anti-HAV) antibodies (i.e., 33 mIU/ml). The corresponding geometric mean titres (GMTs) were 2791 mIU/ml for anti-HBs and 5992 mIU/ml for anti-HAV antibodies. At month 13, 97% of subjects assigned to the 0, 12 month vaccination schedule were protected against hepatitis B and 99% were seropositive for anti-HAV antibodies. The corresponding GMTs were 4340 and 8472 mIU/ml, respectively. A combined response (i.e., subjects, who were seropositive for anti-HAV antibodies and seroprotected for anti-HBs antibodies) was achieved in 98% of subjects vaccinated according to the 0, 6 month interval and in 96% of subjects vaccinated using the 0, 12 month schedule. The reactogenicity of both vaccination schedules was also equivalent. The results thus show that the combined hepatitis A and B vaccine can be administered using flexible vaccination intervals, which make it suitable for use in large-scale hepatitis immunisation programmes.     

Randomized, cross-over, controlled comparison of two inactivated hepatitis A vaccines

The immunogenicity, tolerability and interchangeability of two hepatitis A vaccines, Vaqta (Merck and Co.) and Havrix (SmithKline) were studied in a randomized, crossover, controlled clinical trial. Vaccine was administered to 201 volunteers at 0 and 26 weeks in one of four vaccine regimens: Havrix-Havrix; Havrix-Vaqta; Vaqta-Havrix or Vaqta-Vaqta. Seroconversion rates (>/=10 mIU/ml) for those whose first dose was Vaqta or Havrix, respectively, were: 41/96 (43%) versus 30/95 (32%) (P=0.15) at 2 weeks and 91/98 (93%) versus 84/97 (87%) (P=0.43) at 4 weeks, and 100% at 26 weeks. Geometric mean concentrations (GMC) of total antibody to hepatitis A virus (anti-HAV) for Vaqta and Havrix were 189 and 114 mIU/ml (P=0.011) at 4 weeks and 234 and 136 mIU/ml (P<0.001) at 26 weeks. At 30 weeks, the GMC after two doses of Havrix was 2612 mIU/ml compared with 5497 after two doses of Vaqta (P<0.001). The GMC in the Havrix-Vaqta group was 5672 mIU/ml compared with 3077 mIU/ml in the Vaqta-Havrix group (P<0.001). Less than half of vaccine recipients reported tenderness or pain. In this study, seroconversion rates of the two vaccines were similar. Vaqta produces significantly higher anti-HAV antibody than Havrix. Crossover immunization is well tolerated and results in high antibody concentrations, especially when Vaqta is the booster dose. The significance of higher anti-HAV antibody concentrations in terms of long-term protection is unknown.     

A new accelerated vaccination schedule for rapid protection against hepatitis A and B.

BACKGROUND: Increasing travel stresses the requirement for rapid protection against infections such as hepatitis A and B. METHODS: This randomised, multicentre study investigated an accelerated vaccination schedule using a combined hepatitis A and B vaccine (Twinrix, Smithkline Beecham Biologicals) compared with simultaneous administration of the two corresponding monovalent vaccines. The combined vaccine was administered on days 0, 7 and 21, whereas the comparison group received hepatitis A vaccine on day 0 and hepatitis B vaccine on days 0, 7 and 21. All subjects received booster vaccination at month 12. RESULTS: At month 1, 100% of subjects in the combined group and 99% of the controls were seropositive for anti-HAV antibodies. The corresponding seroprotection rates for anti-HBs antibodies were 82.0 and 83.9%, respectively. Examination of the 95% confidence intervals (CIs) for the treatment differences showed the two vaccines to be equivalent in terms of immunogenicity 1 week after the initial vaccination course. Just prior to the booster, the seropositivity rate for anti-HAV was 96.2% in the combined group and 95% in the control group. For anti-HBs, this was 94 and 91.6%, respectively. All subjects were seropositive for anti-HAV and seroprotected against hepatitis B at month 13. The anti-HAV GMCs were 9571mIU/ml with the combined vaccine and 5206mIU/ml in control subjects. The anti-HBs titre was 26002 and 29,196mIU/ml, respectively. Both groups had a similar reactogenicity profile. CONCLUSIONS: The accelerated schedule of the combined vaccine provides a good immune response against hepatitis A and B antigens and is suitable for last minute immunisation.     

孩尔来福甲型肝炎灭活疫苗0,12个月免疫程序研究

目的　对孩尔来福 (HealiveR○)甲型肝炎 (甲肝 )灭活疫苗的安全性、免疫原性及适宜儿童的剂量进行研究。方法　在某山区两个农村筛选 4～ 10岁甲肝病毒抗体 (抗 HAV)阴性的 85名易感儿童。以自然村随机分为两组 ,按 0 ,12个月免疫程序分别接种北京科兴生物制品有限公司生产的每剂 2 50U 0 .5ml和 50 0U 1ml甲肝灭活疫苗 ,观察免疫后局部反应和全身反应 ,检测初次免疫 (初免 )后 2 1天、12个月及全程免疫后 1个月抗 HAV阳转率和抗体几何平均滴度 (GMT )。结果　两组均未见严重局部反应和全身反应 ;2 50U 0 .5ml组和 50 0U 1ml组初免后 2 1天 ,抗 HAV阳转率分别为94.4%和 10 0 .0 % ,GMT分别为 195mIU ml和 3 70mIU ml ;初免后 12个月抗 HAV全部阳转 ,GMT分别达 3 61mIU ml和 456mIU ml(P >0 .0 5) ;全程免疫后 1个月 ,GMT分别达 14 893mIU ml和2 1696mIU ml。结论　孩尔来福甲肝灭活疫苗的安全性和免疫原性好 ;每剂 2 50U 0 .5ml适宜儿童 ;0 ,12个月免疫程序更适宜中国儿童     

Long-term antibody persistence induced by a combined hepatitis A and B vaccine in children and adolescents

Two cohorts, comprising of subjects aged 1-6 years and 6-15 years were vaccinated with Twinrix according to a 0-, 1- and 6-month schedule. The 1-6 years cohort was followed up for 7.5 years and the 6-15 years cohort for 10 years. At the latest follow-up time point, all subjects were seropositive for anti-HAV antibodies, while 86.5% (32/37) and 95.5% (21/22) had anti-HBs >or= 10 mIU/ml in the 1-6 years and in the 6-15 years cohort. The geometric mean concentrations (GMCs; mIU/ml) were 233 and 680 for anti-HAV antibodies, and 147 and 165 for anti-HBs antibodies, in the 1-6 years and 6-15 years cohorts, respectively. The high persistence of circulating anti-HAV and anti-HBs antibodies in children and adolescents demonstrates the long-term protection offered by Twinrix in these age groups.     

酶联免疫吸附试验和微粒子酶免疫分析法检测血清甲型肝炎总抗体的比较研究

目的评估酶联免疫吸附试验(ELISA)和微粒子酶免疫分析法(MEIA)检测血清甲型肝炎(甲肝)总抗体的检测性能,从而说明两种方法在各自实际应用中的区别。方法用ELISA和MEIA法检测血清甲肝总抗体,再进行两种方法的互相比较。结果检测同一批血清甲肝总抗体样品,定量检测时ELISA法试剂盒敏感度为57.57毫国际单位/毫升(mIU/ml),变异系数(C V)为10.65%,其结果比MEIA法高;两种方法抗体几何平均浓度(GMC)分别为125.8mIU/ml、58.8mIU/ml;定性检测时,41例标本中ELISA法检测39例阳性,MEIA法40例阳性,两法的符合率为97.56%(40/41)。结论定量检测时,MEIA法比ELISA法更精确;定性检测时,ELISA法试剂盒能客观反映疫苗的免疫原性和保护效果,与MEIA法结合能大大提高敏感性。     

倍尔来福TM甲、乙型肝炎联合疫苗安全性和免疫原性研究

目的 观察倍尔来福~(TM)甲、乙型肝炎(甲、乙肝)联合疫苗的安全性和免疫原性。方法以高中一年级(成人组)和小学1～5年级(儿童组)学生为研究对象,按对甲、乙肝病毒均易感、只对甲肝病毒易感和只对乙肝病毒易感分为AB组、A组和B组,按0、1和6个月三剂程序分别接种甲、乙肝联合疫苗、灭活甲肝疫苗和重组乙肝疫苗。疫苗剂量成人组每剂含甲肝病毒抗原500U和(或)HBsAg10μg,儿童组减半。疫苗接种后72h内观察副反应,免疫后2、7个月采集血清标本检测抗-HAV和抗-HBs。结果 儿童AB组和成人AB组局部副反应发生率分别为0.58％(2/344)和2.56％(8/312),全身副反应发生率分别为9.88％(34/344)和5.45％(17/212),与对照组相比差异无显著性。局部反应主要是轻度疼痛,全身反应主要是低热。免疫后7个月,两组抗-HAV阳转率均为100％,与A组相同;抗体滴度(GMT)分别为33 910mIU/ml和23 435 mIU/ml,显著高于A组;两组抗-HBs阳转率分别为97.30％和96.63％;GMT为103 mIU/ml和102 mIU/ml,抗-HBs阳转率及GMT均与B组差异无显著性。结论 倍尔来福~(TM)甲、乙肝联合疫苗与单价甲肝灭活疫苗和单价重组乙肝疫苗具有相同的安全性和免疫原性。     

Comparison of immunogenicity of two hepatitis A vaccines--VAQTA and HAVRIX--in young adults.

Two new hepatitis A vaccines have been developed, and their immunogenicity tested using different immunoassays. The present study was designed to compare the immunogenicity of these two hepatitis A virus (HAV) vaccines--VAQTA and HAVRIX--as determined by seroconversion rates and anti-HAV titers, and using the same immunoassay. Healthy volunteers (15-30 y), seronegative for anti-HAV, were randomized in an open single center study to four groups of 20-21 vaccinees each, to receive either a 25 U or a 50 U dose of VAQTA, or HAVRIX at 720 EU or 1440 EU/dose, administered at 0, 1 and 6 m or at 0 and 6 m, respectively. Four weeks after primary immunization, seroconversion rates were 100% for VAQTA and 95% for HAVRIX, following injection of 50 U or 1440 EU, respectively (p = NS) and anti-HAV GMTs were 40 and 37 mIU/ml for VAQTA and HAVRIX, respectively. At 6 months, prior to the booster dose, seroconversion rates were 100% for both vaccines, with anti-HAV GMTs of 111 and 70 mIU/ml for VAQTA and HAVRIX, respectively (P < 0.05). At month 7, four weeks after the only booster injection, using the two dose regimen, anti-HAV titers were 2212 and 1511 mIU/ml for VAQTA and HAVRIX, respectively (P < NS). Using three doses of 25 U/dose of VAQTA or 720 EU/dose of HAVRIX at 0, 1 and 6 m did not produce any clinically evaluable advantage over the two dose regimen for either vaccine. No significant adverse events were observed using either vaccine. In summary, both vaccines have similar immunogenicity demonstrated using identical immunoassays for evaluation. These results also confirm the outstanding immunogenicity of a single dose of either of the HAV vaccines and support their use in pre- and possibly postexposure prophylaxis against hepatitis A virus infection.     

成人和儿童接种国产甲型肝炎灭活疫苗的安全性与免疫原性的初步观察

为了评价国产甲型肝炎 (甲肝 )灭活疫苗的安全性和免疫原性 ,将 176名健康易感儿童和 2 0 6名成人随机分为 4组 ,10 7名儿童 (A组 )和 131名成人 (B组 )接种国产甲肝灭活疫苗 ,另 6 9名儿童 (C组 )和 75名成人 (D组 )作为对照接种史克必成公司生产的甲肝灭活疫苗。国产疫苗剂量为儿童 6 4 0EU/1 0ml,成人 12 80EU/1 0ml;对照疫苗剂量儿童 72 0EIU/1 0ml,成人 14 4 0EIU/1 0ml,均采用 0、6个月免疫程序。观察 72h内局部和全身反应 ,免疫后 1、6、7个月的免疫应答水平。结果显示 :所有接种对象均未出现明显的局部和全身副反应 ,亦未发现免疫后丙氨酸氨基转移酶 (ALT)升高。初次免疫后 1个月 ,A组和B组抗体阳转率分别为 94 8%和 96 7% ,几何平均滴度(GMT)为 75 8 6mIU/ml和 36 30 8mIU/ml。全程免疫后 1个月 ,4个组抗体阳转率均为 10 0 % ,A组和B组抗体GMT升至 10 4 71 2mIU/ml和 12 30 2 7mIU/ml,略高于对照的C组和D组 (分别为 30 90 3mIU/ml和3388 4mIU/ml)。表明国产甲肝灭活疫苗具有良好安全性和免疫原性。     

血清hCG、孕酮水平变化对早期诊断妊娠流产特异性分析

目的 探讨血清绒毛膜促性腺激素(hCG)、孕酮(P)水平检测对于早期诊断流产的临床价值.方法 选取2012年3月至2016年9月在十堰市中医医院妇产科门诊进行检查的妊娠妇女490例,追踪其妊娠结局,其中自然流产45例(流产组)、正常妊娠至分娩妇女445例(正常组),对比两组妊娠7～12周时的血清HCG、P水平,并采用受试者工作曲线(receiver operating curve,ROC)求取血清hCG、P水平早期预测自然流产的最佳临界值.结果 孕第7～ 12周,流产组的血清hCG平均值9 368.70±5 958.40mIU/mL、P平均值16.73±3.98μg/L,均显著低于正常组的61 395.50±11 401.70 mIU/mL、27.50±5.54μg/L,差异具有统计学意义(t值分别为73.591、19.788,均P＜0.05);通过绘制ROC曲线:当血清hCG水平为10 156.70 mIU/mL时,对应的灵敏度为72.17％、特异度为78.96％、ROC曲线下面积AUC值为0.753;当血清P水平为18.05 μg/L时,对应的灵敏度为78.43％、特异度为81.60％、ROC曲线下面积AUC值为0.790;血清hCG联合P检测预测妊娠妇女发生流产:灵敏度为84.69％、特异度为89.57％、漏诊率为15.31％、误诊率为10.43％、ROC曲线下面积AUC值为0.873.结论 妊娠早期血清hCG、P水平降低,提示流产风险,血清hCG联合P检测,对预测早期流产具有一定的临床价值.