LACK OF AN IMMUNE-RESPONSE TO ALBUNEX(R), A NEW ULTRASOUND CONTRAST AGENT BASED ON AIR-FILLED ALBUMIN MICROSPHERES
LACK OF AN IMMUNE-RESPONSE TO ALBUNEX(R), A NEW ULTRASOUND CONTRAST AGENT BASED ON AIR-FILLED ALBUMIN MICROSPHERES
复制标题
DOI：
10.1159/000236694
复制
发表时间：
1994-08-01
影响因子：
2.8
通讯作者：
SKOTLAND, T
中科院分区：
文献类型：
--
作者：
CHRISTIANSEN, C;VEBNER, AJ;SKOTLAND, T
Albunex(R)是一种新型超声造影剂，由充气的热聚合人血清白蛋白微球悬浮在5%(w/v)的人血清白蛋白溶液中输注而成。白蛋白分子在热聚集过程中引起的结构变化可能会导致新的表位的形成，这可能会在受体中引发免疫反应。为了评估造影剂可能的免疫原性，34名健康志愿者被随机分成四组，分别注射Albunex或5%人血清白蛋白(0.01ml/kg)，每隔4周注射一次。对每次注射后3周采集的血液样本的分析显示，在任何受试者中都没有形成针对白蛋白微球蛋白或白蛋白的IgE或Ig G抗体。评价了新开发的酶免疫吸附试验，以检测这些特异性的IgE和抗体的存在。还研究了热聚集的微球白蛋白是否发生了结构改变，使其能够被猫白蛋白特异性IgE识别，该特异性IgE存在于对猫白蛋白过敏的个体的血清中。187个血清样本被证明含有升高的CAT白蛋白特异性IgE水平用于研究。未检测到热聚集的人血清白蛋白与抗猫白蛋白IgE的交叉反应结合。目前的研究没有证据表明Albunex微球的热聚合白蛋白在重复注射时会引起免疫反应，或者当给药到以猫白蛋白为过敏原之一的过敏者时会引起不良反应。
Albunex(R) is a new ultrasound contrast agent consisting of air-filled microspheres of heat-aggregated human albumin suspended in a 5% (w/v) solution of human albumin for infusion. The structural alterations induced in the albumin molecules during heat aggregation may cause the formation of new epitopes that may provoke an immunological response in recipients. To assess the possible immunogenicity of the contrast agent, 34 healthy volunteers were randomized to receive four injections of either Albunex or 5% human serum albumin (0.01 ml/kg) at 4-week intervals. Analysis of blood samples taken 3 weeks after each injection did not reveal any formation of IgE or IgG antibodies directed against the Albunex microsphere protein or albumin in any of the recipients. The evaluation of novel enzyme immunosorbent assays developed to detect the presence of these specific IgE and IgG antibodies is described. It was also investigated whether the heat-aggregated microsphere albumin was structurally altered in such a way that it could be recognized by cat albumin specific IgE, present in the sera of individuals allergic to cat albumin. 187 serum samples shown to contain elevated levels of cat albumin specific IgE were used in the study. No cross-reactive binding of the heat-aggregated human albumin to anticat albumin IgE could be detected. There is no evidence from the present studies that the heat-aggregated albumin of the Albunex microspheres will provoke an immunological reaction upon repeated injections or cause an adverse reaction when administered to allergic individuals having cat albumin as one of their allergens.