McClelland M, Delustro F
Collagen Corporation, Palo Alto, California 94303, USA.
J Urol. 1996 Jun;155(6):2068-73.
Contigen Bard Collagen Implant (CI), made of highly purified bovine dermal type I collagen (BDC), is used as a bulking agent for the treatment of urinary stress incontinence. The humoral immune response to placement of this material in the urinary sphincter was evaluated.
In a prospective clinical study, patients were treated with CI in the urinary sphincter, and blood was collected at various timepoints following injection. Approximately 28% of the patients treated with BDC demonstrated specific antibodies against bovine type I collagen. Serum samples from 27 patients from this cohort were evaluated. The class specificity of circulating antibodies against bovine collagen was characterized by an indirect enzyme-linked immunosorbent assay.
In all patients demonstrating an antibody response to bovine collagen, the predominant immunoglobulin class was IgG, found in 100% of sera samples. Immunoglobulin A was produced in approximately 40% of these patients, and IgM was seen in approximately 0.6%. No specific IgE was detected against bovine collagen in any serum sample. The highest concentrations of IgG and IgA antibody classes were observed 4 to 5 months after the initial treatment with CI. In the multicenter clinical trial, adverse events were reported in approximately 40% of all patients treated with CI (19). There was no correlation found between the production of a specific immunoglobulin class and the onset of any clinical adverse events.
In all sera from patients treated with CI for urinary stress incontinence, antibodies to bovine dermal collagen always were predominantly IgG. Immunoglobulin A was seen in less than half of the sera samples, and IgE was not observed. In addition, no change in the humoral response to CI over time was noted in patients demonstrating presensitization to bovine dermal collagen at the time of initial treatment. Clinical adverse events reported for patients demonstrating pretreatment antibodies against bovine dermal collagen did not differ in type or number when compared with patients having no presensitization.
Contigen Bard胶原蛋白植入物（CI）由高度纯化的牛I型真皮胶原蛋白（BDC）制成，用作治疗压力性尿失禁的填充剂。评估了将该材料植入尿道括约肌后的体液免疫反应。
在一项前瞻性临床研究中，患者接受了CI尿道括约肌植入治疗，并在注射后的不同时间点采集血液。约28%接受BDC治疗的患者表现出针对牛I型胶原蛋白的特异性抗体。对该队列中27名患者的血清样本进行了评估。通过间接酶联免疫吸附测定法对循环中抗牛胶原蛋白抗体的类别特异性进行了表征。
在所有对牛胶原蛋白产生抗体反应的患者中，主要的免疫球蛋白类别为IgG，在所有血清样本中均有发现（100%）。约40%的此类患者产生了免疫球蛋白A，约0.6%的患者出现了IgM。在任何血清样本中均未检测到针对牛胶原蛋白的特异性IgE。在用CI首次治疗后4至5个月观察到IgG和IgA抗体类别的最高浓度。在多中心临床试验中，约40%接受CI治疗的患者报告了不良事件（19）。未发现特定免疫球蛋白类别的产生与任何临床不良事件的发生之间存在相关性。
在接受CI治疗压力性尿失禁的患者的所有血清中，抗牛真皮胶原蛋白抗体始终以IgG为主。不到一半的血清样本中出现了免疫球蛋白A，未观察到IgE。此外，在初始治疗时对牛真皮胶原蛋白致敏的患者中，未发现随着时间推移对CI的体液反应有变化。与未致敏的患者相比，报告有针对牛真皮胶原蛋白的预处理抗体的患者的临床不良事件在类型或数量上没有差异。
