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

开发了一种用于测定血清中I型胶原降解产物的酶联免疫吸附测定(S-ELISA)。该测定法使用高亲和力的多克隆抗体,该抗体与I型胶原C端肽的8个氨基酸序列的异构化形式(EKAHD-β-GGR)反应。与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%。一组绝经前妇女(年龄33.3 / 3.11岁)获得的值为69 /-24 ng / ml(n = 22)。在一组绝经后的早期妇女(年龄为51.8 / 1.88岁)中,其值是125 /-43 ng / ml(n = 46),增加了81%(p <0.001)。在未接受治疗的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症,我们发现的值为335 /-82 ng / ml(n = 10)。在S-ELISA中,与治疗前的值相比降低了55%(n = 15),这反映了向Paget病患者静脉注射双膦酸盐(帕米膦酸)3天。在用另一种双膦酸盐(阿仑膦酸盐)治疗6个月后,其值降低至48±19 ng / ml(n = 12),相当于降低了62%。在这种情况下提出的临床结果支持该测定是骨吸收的灵敏和特异性指标。因此,它可能被证明对代谢性骨病患者的后续治疗以及骨质疏松症的临床研究有用。

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