献血员丙型肝炎病毒抗体酶免疫法检测试剂的测量值与其真阳性的相关性

目的研究丙型肝炎病毒抗体(抗HCV)酶免疫试验(EIA)检测试剂测量值／阳性判定值之比值(S／CO值)与真阳性的相关性，以确定预示≥95％真阳性的S／CO值。方法对采自北京、广州、杭州．昆明、乌鲁木齐等城市抗-HCV EIA初筛阳性的献血员标本159份，用强胜做拓临床诊断有限公司试剂(Ortho)及6种国产抗-HCV EIA试剂(北京华大吉比爱生物技术有限公司，简称华大吉比爱；北京金伟凯医学生物技术有限公司，简称金伟凯；河南华美生物工程有限公司，简称华美；上海实业科华生物技术有限公司，简称科华；厦门英科新创科技有限公司，简称英科新创；北京万泰生物药业有限公司，简称万泰)双孔复检，并用Chiron公司的Procleix HIV-1／HCV检测系统进行HCV RNA核酸扩增检测(NAT)，NAT阴性标本再用Chiron第三代重组免疫斑点试验(RIBA3．0)检测。HCV RNA或RIBA3．0阳性者判为真阳性，分析S／CO值与真阳性的相关性。结果7种抗HCV EIA试剂的S／CO值均与真阳性明显相关，Ortho S／CO≥3．8时，真阳性的预测值为96．1％，华大吉比爱S／CO≥7．0为96．1％，金伟凯S／CO≥10．0为96．1％，华美S／CO≥6．0为97．3％，科华S／CO≥10．0为96．0％，英科新创S／CO≥8．6为96．1％，万泰S／CO≥14．0为96．0％。结论抗HCV EIA试剂的S／CO值与真阳性明显相关，预示95％真阳性的S／CO值分别为Ortho≥3．8，华大吉比爱S／CO≥7．0，金伟凯S／CO≥10．0，华美S／CO≥6．0，科华S／CO≥10．0，英科新创S／CO≥8．6，万泰S／CO≥14．0。     

抗-HCV的ELISA阳性结果与RIBA确证结果比较

目的:比较分析抗丙型肝炎病毒(抗-HCV)酶联免疫吸附试验(ELISA)阳性结果与重组免疫印迹试验(RIBA)确证结果之间的关系。方法:采用2个不同产家ELISA试剂对36 283份无偿献血者血清标本作抗-HCV检测,并收集104份抗-HCV检测不合格血清标本进一步作RIBA确证试验。结果:104份抗-HCV ELISA检测不合格标本中,双试剂呈阳性反应标本32例,RIBA确证阳性15例,不确定12例,阴性5例;单试剂呈阳性反应标本72例,RIBA确证阳性1例,不确定35例,阴性36例。S/CO≥1标本81例,RIBA确证阳性16例,不确定40例,阴性25例;0.7≤S/CO1.0标本23例,RIBA确证不确定7例,阴性16例。结论:简单以ELISA检测S/CO值大于等于或小于1作为判定抗-HCV是否阳性容易产生较多的假阳性甚至假阴性结果,我们在对献血员反馈检测结果信息和进行永久屏蔽时应慎重考虑。     

第1、2代酶联免疫试剂检测重型病毒性肝炎患者抗-HCV结果的比较

目的 比较第1代和第2代酶联免疫(ELISA)检测试剂盒检测重型肝炎患者的抗-HCV阳性率。方法 1984～1990年期间住院的重型肝炎患者78例。治疗前留置血清使用美国Ortho公司的第1代酶联免疫检测试剂盒检测抗-HCV；1997～2003年期间住院的重型肝炎患者251例，于治疗前使用国产第2代酶联免疫检测试剂盒(厦门新创)检测抗-HCV。结果 使用第1代ELISA检测的抗-HCV阳性率为51．9％，使用第2代ELISA试剂检测的抗HCV阳性率为1．2％，两组比较，差异有显著性(x^2=133．68，P≤0．001)。结论 使用第2代ELISA试剂检测重型肝炎患者血清抗-HCV的阳性率明显低于第1代ELISA检测的阳性率。     

静脉吸毒人群丙型肝炎病毒实验室检测结果分析

目的了解静脉吸毒人群中丙型肝炎病毒(HCV)的感染率,并对HCV常见的几种实验室检测结果进行分析。方法对云南芒市172份静脉吸毒人群血样先进行初筛试验检测抗-HCV,抗-HCV反应性样本再进行重组免疫印迹试验(RIBA)和HCV RNA检测,对实验结果进行统计分析。结果 172份样本初筛试验抗体阳性率80.81%(139/172),RIBA抗体阳性率为79.65%(137/172),HCV-RNA阳性率为74.42%(128/172)。当抗-HCV酶免疫法(EIA)S/CO比值20时,抗-HCV EIA与核酸检测的符合率达到95.87%。EAI与RIBA的符合率为98.56%(137/139)。RIBA检测阳性结果进行各区段统计,core区出现的概率最高,为98.54%(135/137),NS3区次之,而NS4区出现的概率最低,为16.06%(22/137)。结论对静脉吸毒人群样本进行实验室检测时,利用国产第三代EIA试剂盒作筛查试验,阳性样本直接进行核酸检测,可以考虑不需要进一步做RIBA,降低其检测的成本效益比。     

抗-HCVELISA间接法与双抗原夹心法试剂的应用对比评价

目的:对比研究国产抗-HCV ELISA间接法和双抗原夹心法试剂的检测效能,探讨血站抗-HCV检测模式。方法:选择1种双抗原夹心法酶联免疫试剂、2种间接法酶联免疫试剂分别检测34 593名无偿献血者血样,采用重组免疫印迹试验(RIBA)对其中有反应性的44份标本进行确认,并用BBI血清盘对这2种检测试剂进行考核评价。结果:科华、新创和万泰3个厂家的抗-HCV有反应性及灰区标本经RIBA实验确证后,假阳性率分别为31%、63%、13%。万泰双抗原夹心法与间接法相比,增加了反应强度、降低了假阳性率且缩短了窗口期。结论:为确保血液质量,血筛实验室应选择灵敏度和特异性双优的试剂,采用间接和双抗原夹心2种不同的ELISA试剂检测HCV抗体优于2种间接ELISA试剂,不仅提高抗-HCV有反应性标本的检出率,而且减少血液因假阳性造成的浪费。     

丙型肝炎病毒在献血者中的交叉感染

目的观察血站在采血（浆）过程中致丙型肝炎病毒在献血者中的交叉感染．方法采用酶联免疫吸附试验（ELISA法），对2601名职业献血者进行抗-HCV检测．其中对检测抗-HCV阳性者，重复用两种不同生产厂家的丙肝抗体检测试剂再次化验，加以确认结果发现曾接受手工分离法单采血浆史的献血者2388人（单采血浆组），有159人再次化验证实抗-HCV阳性，阳性率占单系血浆组献血者的6．66％，其中单采血浆超过5次的献血者123人，5次以下36人，而从未单采血浆的213名献血者（非单采血浆组）中，仅有6人抗-HCV阳性，占2．18％．两组结果有显著差异；另外通过对正常人群（样本为淄博市公民无偿献血者）抗-HCV测定调查发现，有单采血浆史的献血者抗-HCV阳性率远高于正常人群中抗-HCV阳性率为2．03％的比例，而没有单采血浆史的献血者抗-HCV阳性率接近正常的群调查结果．结论手工分离法单采血浆过程中存在着HCV病毒交叉感染问题．     

无偿献血者标本血清学和核酸检测情况分析

目的:分析无偿献血者标本血清学检测和核酸检测情况,为制定血液筛查策略提供依据,降低输血传播性病原体漏检率。方法:分别用2种ELISA试剂对无偿献血者标本进行HBsAg、抗-HCV、HIV抗原/抗体检测,用荧光定性PCR方法对HBsAg、抗-HCV、HIV抗原/抗体ELISA检测结果阴性、0.5≤S/CO≤5.0、S/CO5.0的标本进行HBV-DNA、HCV-RNA、HIV-RNA检测。对190份HBsAg(-)/HBV-DNA(+)献血者标本进行化学发光补充实验。结果:187 791例血清学检测阴性的无偿献血者标本中检出1例HIV-RNA病毒,194例HBV-DNA病毒,未检出HCV RNA病毒。科华和罗氏核酸检测系统拆分阳性率和阳性检出率差异无统计学意义(P0.05)。HBsAg、抗-HCV、HIV抗原/抗体ELISA双试剂阳性(S/CO10.0)标本HBV-DNA、HCV-RAN和HIV-RNA阳性检出率分别为88.89%、84.62%和100%,0.5≤S/CO≤10.0 ELISA双试剂阳性标本的HBV-DNA、HCV-RAN和HIV-RNA阳性检出率分别为69.44%(25/36)、0和0;HBsAg ELISA检测双试剂阳性结果不同组间(S/CO10.0和0.7≤S/CO≤10.0)核酸阳性检出率差异无统计学意义(P0.05)。对194例HBsAg(-)/HBV-DNA(+)中的190例标本进行化学发光补充实验,检出1例HBsAg阳性,HBcAb阳性检出率为90.00%。结论:HBsAg ELISA检测后HBV输血风险仍然较高(103/10万)。NAT技术的应用,降低了血液病毒窗口期、OBI等输血残余风险。HBsAg、抗-HCV、HIV抗原/抗体ELISA阳性反应的HBV-DNA、HCV-RAN、HIV-RNA检出率与ELISA检测S/CO值的高低及2种ELISA试剂检测结果一致程度有一定关联。采用灵敏度高的血清学方法和核酸检测技术,可进一步降低输血传播病原体的漏检率,保障输血安全。     

试剂盒平衡时间对抗-HCV检测结果的影响因素分析

目的：探讨ELISA试剂盒平衡时间对抗-HCV检测结果的影响;研究抗-HCV灰区献血者再次献血的可行性和必要性。方法：变化试剂盒平衡时间,测定不同平衡时间的S/Co值。对部分灰区标本进行重组免疫印迹试验（RIBA）;应用荧光定量-聚合酶链反应（FQ-PCR）检测灰区标本HCVRNA;应用速率法检测灰区和抗-HCV阴性血清ALT。结果：ELISA试剂盒平衡时间在30min内,1NCU/ml抗-HCV质控、抗-HCV灰区标本的S/CO值随着平衡时间的延长而增加（P〈0.05）,但30min后变化不明显（P〉0.05）。32份灰区标本经Murex试剂筛选后的5份标本进行了RIBA检测,结果为2份可疑,3份阴性。FQ-PCR定量检测均为阴性;速率法ALT检测抗-HCV灰区和抗-HCV阴性标本结果分别为（19.20±7.38）U/L、（16.58±7.08）U/L。2者结果均〈40U/L,差异有统计学意义（t=1.48,P〉0.05）。结论：抗-HCV试剂盒在检测前应先在室温下平衡30min以上,否则会降低标本的S/Co值,影响结果判断;抗-HCV灰区标本ALT检测结果正常;抗-HCV灰区的献血者在核酸检测结果为阴性的前提下可考虑再次献血。     

抗-HCV ELISA试剂评价体系的建立及检测结果

目的:建立丙型肝炎病毒抗体(抗-HCV)酶联免疫吸附试验(ELISA)诊断试剂评价参考系统,筛选出适合本地区的献血员抗-HCV检测策略。方法:使用Chiron的RIBA HCV 3.0试剂确认献血员中筛查出抗-HCV阳性和阴性的血清标本,建立抗-HCV参比血清,评价8种国内外抗-HCV EIA试剂的灵敏度、特异度、符合率等指标。结果:构建了抗-HCV诊断试剂评价质控体系,分别包括24份抗-HCV阳性标本、24份抗-HCV阴性标本及8份用于灵敏度评价的系列稀释标本;8种抗-HCV EIA试剂对参比血清的检测结果 Kappa值分别为0.67、0.71、0.75、0.75、0.88、0.79、0.58。结论:自制抗-HCV试剂评价体系更适合各地的试剂评价工作,在制定筛查策略时,双抗原夹心法试剂优于间接法试剂。     

日本丙肝病毒感染的流行病学和长期预后

1990年12月起日本开始对助血员用第一代ELISA筛检抗-HCV,1992年2月后应用核心区c22、非结构区c 33 c和c 100-3等抗原加上RIBA作补充使敏感性和特异性均有提高。检测结果显示,日本抗-HCV的血清阳性率与年龄显著相关:20岁以下者抗-HCV血清阳性率为0.2％,其后每10岁年龄段分别为0.7％、1.9％、2.6％,50岁以上则达到3.9％。估计全日本有230万人通过污染血液感染HCV,事实上真正数字还要高,因为65岁以上者未计入而这些人的阳性率则更高。作者观察537例医务人员中有16例抗-HCV阳性。其中,3例仅ELISA法检出c 100-3阳性,而用RIBA法检测抗-HCV和用PCR法检测HCV RNA     

胰岛素瘤的解剖分布特点分析

目的胰岛素瘤是最常见的胰腺神经内分泌肿瘤，因其临床表现多样，导致诊断困难。影像学诊断尤其是超声内镜(EUS)在胰岛素瘤的诊断中起着重要作用，拥有较高的敏感性和特异性。本研究拟通过明确胰岛素瘤的解剖分布特点，以期有助于提高影像学的诊断准确率和降低漏诊率，尤其是在教育和培训实践中对于EUS的学习者更具有指导价值。 方法回顾性分析解放军总医院第一医学中心病案资料数据库1993年1月至2019年11月经外科手术、病理确诊为胰岛素瘤的患者的临床资料，检索方法采取搜索术后病理诊断为"胰岛素瘤"的病例，通过查阅病例的方法，提取出胰岛素瘤的大小和解剖分布等数据，进一步分析其特点。 结果共检索到确诊为胰岛素瘤的患者116例，其中，男45例、女71例，年龄13～76岁，平均年龄(44.4±14.85)岁。胰岛素瘤单发110例(94.8%)、多发6例(5.2%)。位置分布：头颈部46例(39.7%)，单发45例、多发1例；体尾部68例(58.6%)，单发65例、多发3例；全胰腺多发2例(1.7%)。病变大小特点：最大径0.4～3.4 cm，平均大小(1.53±0.58)cm。≤1 cm 29例、>1 cm而≤1.5 cm41例、>1.5 cm而≤2.0 cm28例，≤3 cm 15例，>3 cm 3例。年龄与肿瘤的大小相关，≤44岁患者肿瘤平均大小为(1.36±0.51)cm、>44岁患者肿瘤平均大小为(1.70±0.60)cm，P<0.05。头颈部的肿瘤大于体尾部的肿瘤，头颈部肿瘤平均大小(1.66±0.63)cm，体尾部(1.42±0.52)cm，P<0.05。 结论胰岛素瘤在胰腺体尾部较头颈部更好发；绝大多数单发，但可以全胰腺多发；多数小于1.5 cm，肿瘤的大小与患者年龄和肿瘤的解剖分布相关。     

Pathogenesis of carcinoma of the papilla of Vater

Most adenomas and carcinomas of the small intestine and extrahepatic bile ducts arise in the region of the papilla of Vater. In familial adenomatous polyposis (FAP) it is the main location for carcinomas after proctocolectomy. In many cases symptoms due to stenosis lead to diagnosis at an early tumor stage. In about 80%, curative intended resection is possible. Operability is the most relevant prognostic factor. Most ampullary carcinomas resp. carcinomas of the papilla of Vater develop from adenomatous or flat dysplastic precursor lesions. They can be sited in the ampulloduodenal part of the papilla of Vater, which is lined by intestinal mucosa. They also can develop in deeper parts of the ampulla, which are lined by pancreaticobiliary duct mucosa. Intestinal-type adenocarcinoma and pancreaticobiliary-type adenocarcinoma represent the main histological types of ampullary carcinoma. Furthermore, there exist unusual types and undifferentiated carcinomas. Many carcinomas of intestinal type express the immunohistochemical marker profile of intestinal mucosa (keratin 7?, keratin 20+, MUC2+). Carcinomas of pancreaticobiliary type usually show the immunohistochemical profile of pancreaticobiliary duct mucosa (keratin 7+, keratin 20?, MUC2?). Even poorly differentiated carcinomas, as well as unusual histological types, may conserve the marker profile of the mucosa they developed from. These findings underline the concept of histogenetically different carcinomas of the papilla of Vater which develop either from intestinal- or from pancreaticobiliary-type mucosa of the papilla of Vater. Molecular alterations in ampullary carcinomas are similar to those of colorectal as well as pancreatic carcinomas, although they appear at different frequencies. In future studies, molecular alterations in ampullary carcinomas should be correlated closely with the different histologic tumor types. Consequently, the histologic classification should reflect the histogenesis of ampullary tumors from the two different types of papillary mucosa.     

Demonstration of the mechanism of action of biguanides

Summary Palmitic acid oxidation in rat diaphragm homogenate is depressed by biguanide concentrations that are still incapable of inhibiting oxidative phosphorylation. Glucose oxidation is not directly effected by the same biguanide concentrations: however, the inhibitory effect of palmitic acid on glucose oxidation is partly removed by biguanides. Inhibition of fatty acid oxidation, which accounts for most of the metabolic effects caused by these drugs, can be regarded as the fundamental mechanism of action of biguanides. There is some evidence suggesting that these drugs might interact with carnitine, thus preventing long-chain fatty acids from being transported across the mitochondrial membrane to the site of oxidation. Traduzione a cura degli AA.     

Lack of correlation of degree of villous atrophy with severity of clinical presentation of coeliac disease

BACKGROUND AND AIM: Both the clinical presentation and the degree of mucosal damage in coeliac disease vary greatly. In view of conflicting information as to whether the mode of presentation correlates with the degree of villous atrophy, we reviewed a large cohort of patients with coeliac disease. PATIENTS AND METHODS: We correlated mode of presentation (classical, diarrhoea predominant or atypical/silent) with histology of duodenal biopsies and examined their trends over time. RESULTS: The cohort consisted of 499 adults, mean age 44.1 years, 68% females. The majority had silent coeliac disease (56%) and total villous atrophy (65%). There was no correlation of mode of presentation with the degree of villous atrophy (p=0.25). Sixty-eight percent of females and 58% of males had a severe villous atrophy (p=0.052). There was a significant trend over time for a greater proportion of patients presenting as atypical/silent coeliac disease and having partial villous atrophy, though the majority still had total villous atrophy. CONCLUSIONS: Among our patients the degree of villous atrophy in duodenal biopsies did not correlate with the mode of presentation, indicating that factors other than the degree of villous atrophy must account for diarrhoea in coeliac disease.     

血吸虫童虫生长发育及其机制的研究进展

血吸虫童虫是宿主免疫系统攻击的重要靶标,包括皮肤型、肺型和肝门型童虫。宿主分子对童虫生长发育具有重要作用。童虫生长发育机制包括免疫调节、信号转导、性别发育及凋亡等。肌动蛋白、组织蛋白酶、烯醇化酶和葡萄糖基转移酶等分子为血吸虫童虫生长发育的重要分子。本文对血吸虫童虫生长发育及其机制的研究进展做一综述。     

氯硝柳胺悬浮剂的毒性评价

目的评价氯硝柳胺悬浮剂的毒性，为现场大规模应用灭螺提供依据。方法按照中华人民共和国国家标准GB 15670-1995《农药登记毒理学试验方法》和鱼类毒性试验方法进行。结果经口、经皮肤的LDso雌、雄性大鼠均>5 000 mg/kg，经呼吸道的LCso雌、雄性大鼠均>5 000mg/m3，该药经口、经皮肤、经呼吸道毒性均属微毒类药物；兔眼用药后，观察期内无不良反应，对眼无刺激性；皮肤用药后对皮肤无刺激性。与氯硝柳胺原药、氯硝柳胺乙醇胺盐原药和氯硝柳胺乙醇胺盐可湿性粉剂相比，氯硝柳胺悬浮剂对鱼急性毒性最低。结论氯硝柳胺悬浮剂属微毒类药物，对鱼的毒性低于其乙醇胺盐可湿性粉剂，适合于现场应用。     

124例耐多药结核分枝杆菌基因突变特征分析

目的对临床分离的耐多药结核分枝杆菌相关基因的突变特征进行分析。方法对124例耐多药结核分枝杆菌以及50株敏感株的耐药相关基因(包括异烟肼inh A、kat G、oxyR-ahp C间隔区以及利福平rpo B)进行序列测定,分析其基因突变情况。结果异烟肼耐药inh A基因突变率为14.5%;kat G基因突变率为70.2%(87/124),主要位于315位;oxyR-ahp C间隔区突变率为15.3%;inh A、kat G两种基因同时突变率75.0%,三种基因同时突变率为89.5%。利福平rpo B基因突变的检出率高达95.2%,突变主要发生在531、526、516位点。结论我省耐多药菌异烟肼耐药相关基因最常见突变为kat G 315、inh A C-T(-15)、axyR-ahp C间隔区(-10)C-T,利福平为rpo B531、526、516。结合MDR-TB耐药相关基因的特征分析,可以建立一种快速、准确、特异的适合于我省的检测结核菌耐多药性的新方法。     

Assessment of quality of life of parents of children with juvenile chronic arthritis

The aim of the study was to assess the quality of life (QOL) and the psychological status of parents of children with juvenile chronic arthritis (JCA). The QOL, anxiety and depression of the parents of 28 children with JCA were evaluated and compared to those of the parents of 28 healthy children. Mothers of JCA children and mothers of healthy children reported similar QOL. The reported anxiety and depression levels were similar for mothers and fathers in both groups. The parents of children with pauciarticular-type JCA reported lower QOL and higher levels of anxiety and depression than the parents of children with other types, namely polyarticular and systemic JCA. These findings may be explained by the fact that the pauciarticular patients had shorter disease duration and were less frequently seen in the outpatient clinic. The QOL of mothers of children with JCA was found to be slightly impaired in the group of children with pauciarticular JCA. Future larger studies are needed to confirm these results, as the number of subjects in the three groups was rather low. Received: 26 September 2001 / Accepted: 8 February 2002     

Numerical Simulation of the Effect of Rate of Change of Glucose on Measurement Error of Continuous Glucose Monitors

Background

A 5-day in-patient study designed to assess the accuracy of the FreeStyle Navigator® Continuous Glucose Monitoring System revealed that the level of accuracy of the continuous sensor measurements was dependent on the rate of glucose change. When the absolute rate of change was less than 1 mg•dl⁻¹•min⁻¹ (75% of the time), the median absolute relative difference (ARD) was 8.5%, with 85% of all points falling within the A zone of the Clarke error grid. When the absolute rate of change was greater than 2 mg•dl⁻¹•min⁻¹ (8% of the time), the median ARD was 17.5%, with 59% of all points falling within the Clarke A zone.

Method

Numerical simulations were performed to investigate effects of the rate of change of glucose on sensor measurement error. This approach enabled physiologically relevant distributions of glucose values to be reordered to explore the effect of different glucose rate-of-change distributions on apparent sensor accuracy.

Results

The physiological lag between blood and interstitial fluid glucose levels is sufficient to account for the observed difference in sensor accuracy between periods of stable glucose and periods of rapidly changing glucose.

Conclusions

The role of physiological lag on the apparent decrease in sensor accuracy at high glucose rates of change has implications for clinical study design, regulatory review of continuous glucose sensors, and development of performance standards for this new technology. This work demonstrates the difficulty in comparing accuracy measures between different clinical studies and highlights the need for studies to include both relevant glucose distributions and relevant glucose rate-of-change distributions.     

Study of constancy of hydrogen-consuming flora of human colon

The constancy of the hydrogen consuming flora of the human colon was studied in 15 healthy subjects via two measurements obtained 18 to 36 months apart. Hydrogen disappearance rate and the major products of H₂-consuming bacteria, methane and sulfide, were measured during incubation of fecal homogenates with excess hydrogen and sulfate. In 11/15, the hydrogen consumption rate and the predominant hydrogen-consuming pathway (methanogenesis, sulfate reduction, or neither) remained constant. However, major shifts in these pathways were observed in four subjects, with two losing and two gaining the ability to produce methane. Methanogenesis was associated with the highest hydrogen consumption rate. This study demonstrates that clinically unrecognizable, major alterations of the colonic flora occur in healthy subjects. Understanding of the factors responsible for these alterations might allow for therapeutic manipulation of the colonic flora.Supported in part by the Department of Veterans Affairs and NIDDKD RO1 DK 13309-25.