透析用注射用水温度对静注人免疫球蛋白质量的影响

目的：摸索提高静注人免疫球蛋白透析用注射用水温度是否会影响其产品质量。方法：通过逐步提高透析用注射用水温度（但不高于26℃）,比较产品的温度和质量的关系。结果：通过逐步提高透析用注射用水的温度,可以确保产品在配制完成后产品温度不低于23℃。结论：逐步提高透析用注射用水的温度不影响静注人免疫球蛋白的质量。     

体外循环对患者血清免疫球蛋白和补体的影响

测定了35例体外循环心脏手术患者围术期不同时间血清免疫球蛋白(IgS)和补体水平。结果显示术后IgS和补体水平均较术前显著下降,且持续至术后3～8d。提示:体外循环系统可损害机体体液免疫功能。     

人淋巴结的内源性抗生物素结合活性

目的 论证人淋巴结为具有内源性抗生物素结合活性(EABA)的器官。方法 以LSAB法、EnVision法、实时生物分子相互作用分析技术及椭偏成像生物显微技术，通过肝癌单克隆抗体Hepama-1对人淋巴结的反应，进行实验论证。结果 LSAB法曾对人淋巴结呈强阳性，但EnVision法、实时生物分子相互作用分析技术及椭偏成像生物显微技术对人淋巴结呈阴性。结论 人淋巴结具有内源性抗生物素结合活性。     

白癜风患者血清免疫球蛋白、补体、自身抗体检测及分析

目的 检测白癜风患者血清中免疫球蛋白IgG、IgA、IgM,补体C3、C4,抗核抗体(ANA)、抗甲状腺过氧化物酶抗体(A-TPO)、抗甲状腺球蛋白抗体(A-TG)的水平并进行比较分析.方法 收集门诊确诊为白癜风的患者血清168例和正常体检人群血清88例,性别、年龄分布无统计学差异,采用速率散射比浊法检测白免疫球蛋白IgG、IgA、IgM和补体C3、C4,采用ELISA法检测抗核抗体,采用电化学发光免疫分析法检测A-TPO、A-TG,结果用SPSS19.0统计软件进行分析.结果 白癜风患者组血清中免疫球蛋白IgG、IgA、IgM,补体C3、C4表达水平与正常人对照组差异不具有统计学意义(P＞0.05);白癜风组与正常对照组ANA阳性率分别为8.1％和5.7％,经比较差异不具有统计学意义(P＞0.05);两组间A-TPO的阳性率分别为18.8％和10.2％,差异有统计学意义(P＜0.05);两组A-TG阳性率分别为25.8％和4.5％,经比较差异具有统计学意义(P＜0.01).结论 部分白癜风患者存在体液免疫紊乱,在发病机制上可能与自身免疫性甲状腺疾病有相似之处;免疫球蛋白、补体及抗核抗体等免疫指标的检测在白癜风诊治中评价的意义不大.     

人抗精子抗体,补体及白细胞杀伤精子作用的研究

虽有一些报道认为白细胞在精液中异常增多，对精子活动力有一定的影响，但至今对白细胞精子症中白细胞及其产物抗生育机制的许多环节仍未完全了解，用人外周血白细胞，人抗精子抗体血清，人补体血清以正常人精子按析因试验设计，体外培养观察精子死亡率，实验结果，白细胞具有较强的直接杀伤精子作用，这种作用在抗精子抗体存在下有所加强，但补体存在，杀伤力并不表现增强，抗精子抗体和补体一起则可表现出一定程度细胞毒效应，而抗     

静注人免疫球蛋白(pH4、10%)在治疗成人特发性血小板减少性紫癜中提升血小板速度的研究

目的与静注人免疫球蛋白(pH4)对比,观察静注人免疫球蛋白(pH4、10%)在治疗成人特发性血小板减少性紫癜(ITP)患者时提升血小板的速度。方法将受试者按1∶1的比例随机接受连续2日的静注人免疫球蛋白(pH4、10%)治疗或连续5日的静注人免疫球蛋白(pH4)治疗,同时接受了相同的基础治疗(口服强的松1mg/kg/日,疗程至少1周)。比较两组首次输注7日内血小板计数达到≥100×109/L所用的天数。结果本研究有151例随机化受试者接受了试验药物,139例受试者按方案完成了试验。试验组所用时间的中位数(95%CI)为3日(2.0,3.0),对照组用时4日(4.0,5.0),组间比较存在统计学差异(P0.05)。结论静注人免疫球蛋白(pH4、10%)与静注人免疫球蛋白(pH4)相比,能够更快速地将成人ITP患者的血小板计数升高至100×109/L或以上。     

影响HIV-1整合酶活性因素的探讨

目的：探讨HIV－1整合酶活性的影响因素,优化其活性测定条件。方法 以同位素标记的寡核苷酸链为底物,体外模拟HIV－1病毒DNA整合过程,检测HIV－1整合酶的3‘端加工,链转移和去整合活性,并考察HIV－1整合酶活性测定中,二价高子、酸碱度、温度和时间等的影响。结果 Mn^2 对整合酶活性的辅助作用,明显强于Mg^2 ,而3‘端加工反应对二价离子的依赖性较小。酸碱度对各种反应的影响较大,温度和时间影响较小。结论 整合酶活性检测的最佳反应条件为pH7.0-7.5,37℃,15mmol/L M^2 及反应时间1h。     

人源化抗人肺癌单域抗体基因的构建、表达及活性分析

目的： 构建人源化的抗人肺癌单域抗体hu3D3VH基因, 在大肠杆菌中表达, 对其蛋白活性进行分析.方法： 采用CDR移植技术对mAb3D3的重链可变区进行人源化, 通过重叠PCR获得hu3D3VH的基因.构建pET22（b＋）/hu3D3VH表达载体, 并转化大肠杆菌BL21（DE3）, 在IPTG诱导下表达.表达产物通过Ni亲和层析柱纯化.采用间接ELISA和竞争抑制ELISA法进行活性分析.结果： 通过重叠PCR获得序列正确的目的基因.目的蛋白以包涵体的形式表达, 表达量占菌体总蛋白的30%以上.纯化后, 目的蛋白的纯度达95%以上.hu3D3VH具有与亲本抗体相同的抗原反应性, 并能抑制mAb3D3与L342细胞的结合.结论： 获得的人源化单域抗体hu3D3VH, 保留了与mAb3D3相同的反应性和特异性, 为进一步临床应用奠定了基础.     

人抗动物抗体对免疫学分析的影响

标本中的人抗动物抗体常常给免疫分析带来干扰。人抗小鼠抗体是人抗动物抗体中最常见的类型。本文就人群中人抗动物抗体的发生率、人抗动物抗体对免疫分析的干扰机制以及克服这种干扰的方法作一综述。     

Determination of IgG subclasses of immunoglobulin preparations for intravenous injection and the problems involved

The IgG subclasses of immunoglobulin for intravenous injection (IVIg) were investigated after various different types of treatment. The level of IgG2 was relatively low in preparations treated with pepsin, but by changing the clone producing anti-IgG2 antibody, the level approached that of normal human serum. Though undetectable in sulfonated immunoglobulin preparations, IgG3 was detected after reoxidation. When determining the IgG subclasses of IVIg, it must be kept in mind that the apparent value may subsequently become lower due to the depressed reaction of the antibody.     

Risk factors for failure of initial intravenous immunoglobulin treatment in Kawasaki disease

The aims of this study were to determine the occurrence and variables associated with the initial intravenous immunoglobulin (IVIG) treatment failure in Kawasaki disease (KD) and to categorize differences in clinical characteristics between responders and nonresponders to initial IVIG treatment. Patients were classified into two groups. Group A included 33 patients who received a single dose of IVIG treatment and responded. Group B included 18 patients who received more than two doses of IVIG due to failure of the initial treatment. The mean duration of fever after initial treatment in group B was significantly longer than it was in group A. In group B, we found that higher bilirubin, aspartate aminotransferase (AST), polymorphonuclear cells (PMN) (%), and lower platelet values at baseline were independent predictors of persistent or recurrent fever in patients with KD. Coronary artery abnormalities were found in 8 patients (44.4%) in group B and in two patients (6.1%) in group A. We found that abnormal liver function tests and a lower platelet count at baseline were possible predictors of nonresponders to IVIG in patients with KD. There is a need for a prospective study focused on baseline hepatobiliary parameters.     

Neutralization of disease associated autoantibodies by an immunoglobulin M- and immunoglobulin A-enriched human intravenous immunoglobulin preparation

Immunoglobulin preparations enriched with IgM and IgA are used in the therapy of severe bacterial infections and for the treatment of acute graft-versus-host disease, but not as yet, in the treatment of autoimmune diseases. We investigated the potential of an IgM- and IgA-enriched immunoglobulin preparation to neutralize activity autoantibodies from patients with autoimmune diseases. We demonstrate that Pentaglobin(R) was at least as effective as intravenous immunoglobulin (Sandoglobulin(R)) in inhibiting autoantibody activity. Each of the immunoglobulin isotypes present in Pentaglobin(R) may be responsible for the inhibitory effect. Pentaglobin(R) immobilized on an affinity matrix retained the disease associated autoantibodies and interacted with F(ab')2 fragments of IgG autoantibodies. Suppression of autoantibody activity is dependent, at least in part, on idiotypic interactions. The present findings provide a rationale for considering these preparations for the immunomodulation of autoimmune disease.     

人体可供肌肉与静脉注射部位的探讨

肌肉与静脉注射是临床治疗的主要给药途径,也是护理工作的主要内容之一,但是,目前护理人员掌握的注射部位普遍比较单一,使注射工作受到一定限制。因而,如何使护理人员普遍能掌握更多的注射途径,仍是护理工作一个有价值的课题。笔者通过解剖学观察,认为人体有10处可供肌肉注射部位,16处可供静脉注射(以上包括目前常用的部位),为护理注射工作开辟了新的思路。     

IgG Fc receptor polymorphisms in human disease: implications for intravenous immunoglobulin therapy

Polymorphisms of human Fc receptors (FcRs) have been described that are associated with the development or progression of autoimmune diseases. The FcR polymorphisms affect the affinity with which FcRs interact with immunoglobulin molecules. Intravenous immunoglobulin is administered as therapy for many autoimmune diseases and might exert its effects by interacting with FcRs. Thus, FcR polymorphisms might influence the efficacy of intravenous immunoglobulin therapy for patients with certain autoimmune diseases. In this article we review FcR polymorphisms in relation to autoimmune diseases for which intravenous immunoglobulin is used therapeutically.     

False-positive Aspergillus galactomannan immunoassays associated with intravenous human immunoglobulin administration

ObjectivesEvidence of false-positive galactomannan enzyme immunoassay (GM-EIA) results associated with intravenous immunoglobulin (IVIG) administration is scarce. Here, we aimed to determine the false-positive rate of GM-EIA after IVIG administration and to identify the related factors.MethodsStandard GM-EIA was performed using diluted and pure human IVIG samples with and without heat treatment. We also included adult patients who had at least one GM-EIA result within 1 week of IVIG administration for analysis. Those who had prior invasive aspergillosis within 1 year before IVIG therapy were excluded. The clinical characteristics and galactomannan index (GMI) kinetics between patients with false-positive and true-positive GMI were compared.ResultsAll diluted and pure IVIG samples tested positive for GM. Heat treatment resulted in the considerable elevation of GMI. Of 48 patients with positive GM-EIA results within 1 week of IVIG administration, 22 (45.8%) were considered to have false-positive antigenaemia (false-positive group, FPG). After the completion of IVIG administration, a decline in GMI was observed in all FPG patients but in only 18 out of 26 patients (69.2%) with true-positive results (true-positive group, TPG). By 7, 14, and 18 days of IVIG administration, GMI reverted to negative values in 7/15 (46.7%), 18/20 (90%) and 22/22 (100%) FPG patients, respectively, and 6/24 (25%), 14/24 (58.3%), and 16/26 (61.5%) of TPG patients, respectively. The TPG was more likely to have two or more consecutively positive GMIs after IVIG administration than the FPG (adjusted odds ratio, 9.01; 95% confidence interval, 1.99–40.9).ConclusionsIVIG treatment may produce false-positive GM-EIA results. A positive GMI among patients receiving human IVIG should be interpreted with caution.     

Virus safety of intravenous immunoglobulin

Patients with immunodeficiencies or some types of autoimmune diseases are dependent on safe therapy with intravenous immunoglobulins. State-of-the-art manufacturing processes provide a high safety standard by incorporating virus elimination procedures into the manufacturing process. Based on their mechanism, these procedures are grouped into three classes: partitioning, inactivation, and removal based on size. Because of current socioeconomic and ecological changes, emerging pathogens continue to be expected. Such pathogens may spread very quickly because of increased intercontinental traffic. Severe acute respiratory syndrome-coronavirus and the West Nile virus are recent examples. Currently, it is not possible to predict the impact such a pathogen will have on blood safety because the capacity for a globally coordinated reaction to such a threat is also evolving. The worst-case scenario would be the emergence of a transmissible, small, nonenveloped virus in the blood donor population. Examples of small nonenveloped viruses, which change host and tissue tropism, are discussed, with focus on parvoviridae. Although today’s immunoglobulins are safer than ever, in preparation for future challenges it is a high priority for the plasma industry to proactively investigate such viruses on a molecular and cellular level to identify their vulnerabilities.     

Effects of intravenous immunoglobulin and methylprednisolone on human umbilical vein endothelial cells in vitro

Endothelial cells (ECs) do more than just play a role in distinguishing blood and tissues. These cells are also influenced by various chemical mediators present in the blood and tissues. In addition, they produce diverse cytokines, chemokines, adhesion molecules, and growth factors. Therefore, ECs are actively involved in the inflammatory and immune response. We investigated the effects of intravenous immunoglobulin (IVIG) and methylprednisolone (MP) on activated human ECs, by examining the individual and combined effects of the drugs. Human umbilical vein ECs (HUVECs) obtained from the umbilical cords of healthy newborns were cultured. After the HUVECs were treated with interleukin (IL)-1beta, the effects of IVIG and/or MP on the activated HUVECs were assessed by cell proliferation, mRNA expression, and the production of vascular cell adhesion molecule (VCAM)-1, IL-1beta, and vascular EC growth factor (VEGF). IVIG and MP inhibited HUVEC proliferation. IVIG and MP significantly down regulated mRNA expression and the production of VCAM-1, IL-1beta, and VEGF. The combination of IVIG and MP generally showed a greater suppressive effect on mRNA expression and on the production of VCAM-1, IL-1beta, and VEGF. Our results suggest that some of the corticosteroid-sparing effects of IVIG observed in patients with severe asthma could be related to a decreased ability of ECs to proliferate, and to a down regulation of the expression of molecules involved in the onset and progression of airway inflammation.