An enzyme-linked immunosorbent assay for measuring type I collagen degradation products in serum (S-ELISA) was developed. The assay uses a high affinity polyclonal antibody which reacts with an isomerized form of an 8 amino acid sequence of the C-telopeptides of type I collagen (EKAHD-beta-GGR). Cross-reactivity to a nonisomerized synthetic peptide form of the 8 amino acid sequence is less than 0.2%. Values obtained in a group of premenopausal women (age, 33.3 +/- 3.11 years) were 69 +/- 24 ng/ml(n = 22). In a group of early postmenopausal women (age, 51.8 +/- 1.88 years) values obtained were 125 +/- 43 ng/ml (n = 46), which represents an increase of 81% (p < 0.001). Values found in untreated patients with Paget's disease were 234 +/- 95 ng/ml (n = 15), and for primary hyperparathyroidism we found 335 +/- 82 ng/ml (n = 10). Intravenous administration of a bisphosphonate (Pamidronate) to Paget's disease patients for 3 days was reflected in the S-ELISA by a decrease in the values of 55% when compared with values before treatment (n = 15). Following treatment with another bisphosphonate (Alendronate) for 6 months, values were decreased to 48 +/- 19 ng/ml (n = 12), which corresponds to a 62% decrease. Clinical results presented in this context support that the assay is a sensitive and specific index of bone resorption. It may, therefore, prove useful in the follow up of treatment of patients with metabolic bone diseases and in the clinical investigation of osteoporosis.

译文

开发了一种用于测量血清中I型胶原蛋白降解产物的酶联免疫吸附测定法 (S-ELISA)。该测定使用高亲和力多克隆抗体,该抗体与I型胶原蛋白 (EKAHD-β-GGR) 的C-端肽的8个氨基酸序列的异构化形式反应。对8个氨基酸序列的非异构化合成肽形式的交叉反应性小于0.2%。在一组绝经前妇女 (年龄,33.3 +/- 3.11岁) 中获得的值为69 +/- 24 ng/ml(n = 22)。在一组绝经后早期妇女 (年龄,51.8 +/- 1.88岁) 中,获得的值为125 +/- 43 ng/ml (n = 46),这表示增加了81% (p <0.001)。在未经治疗的Paget病患者中发现的值为234/- 95 ng/ml (n = 15),对于原发性甲状旁腺功能亢进,我们发现335/- 82 ng/ml (n = 10)。与治疗前的值相比 (n = 15),在S-ELISA中反映了将双膦酸盐 (帕米膦酸盐) 静脉给药至Paget病患者3天的55% 值降低。用另一种双膦酸盐 (阿仑膦酸盐) 治疗6个月后,值降低至48 +/- 19 ng/ml (n = 12),这对应于62% 降低。在这种情况下提出的临床结果支持该测定是骨吸收的敏感且特异性的指标。因此,它可能对代谢性骨病患者的治疗随访和骨质疏松症的临床研究有用。

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