Boudou Philippe, Ibrahim Fidaa, Cormier Catherine, Chabas Almécinda, Sarfati Emile, Souberbielle Jean-Claude
Department of Hormonal Biology, Saint-Louis University Hospital, Assistance Publique-Hôpitaux de Paris, 1 avenue Claude Vellefaux, 75475 Paris Cedex 10, France.
J Clin Endocrinol Metab. 2005 Dec;90(12):6370-2. doi: 10.1210/jc.2005-0715. Epub 2005 Sep 27.
Since the demonstration that the second-generation PTH assays, also called intact PTH assays, recognize a non-1-84 PTH fragment in addition to the intact 1-84 PTH, new PTH assays defined as third-generation assays have been commercialized. Two previous studies aimed at evaluating whether these third-generation PTH assays improved the diagnostic sensitivity for primary hyperparathyroidism (PHPT), but they yielded opposite results.
In the present study we compared two second-generation PTH assays (the total intact PTH assay from Scantibodies Laboratory, Inc., and the intact PTH assay from Nichols Institute Diagnostics) with two third-generation assays (the cyclase-activating PTH assay also from Scantibodies Laboratory and the bio-intact PTH assay from Nichols Institute) in a series of 145 consecutive PHPT patients operated in our endocrine surgery department over a 10-month period. A group of 74 healthy subjects served as controls.
The diagnostic sensitivities for PHPT of the total intact, the intact, the cyclase-activating, and the bio-intact assays were 93.8%, 97.3%, 84.2%, and 89.0%, respectively, with 95% confidence intervals in the control groups of 10-46, 11-60, 8.4-34, and 9-41 ng/liter, respectively.
Our findings demonstrate that the diagnostic sensitivities of second- and third-generation PTH assays are similar. Third-generation PTH assays do not therefore improve the diagnosis of elevated serum PTH levels in PHPT, although there are numerical differences among the values.
自从第二代甲状旁腺激素（PTH）检测方法（也称为完整PTH检测方法）被证明除了能识别完整的1-84 PTH外，还能识别一种非1-84 PTH片段以来，被定义为第三代检测方法的新型PTH检测方法已实现商业化。此前有两项研究旨在评估这些第三代PTH检测方法是否提高了原发性甲状旁腺功能亢进症（PHPT）的诊断敏感性，但得出了相反的结果。
在本研究中，我们将两种第二代PTH检测方法（来自Scantibodies Laboratory公司的总完整PTH检测方法和来自Nichols Institute Diagnostics的完整PTH检测方法）与两种第三代检测方法（同样来自Scantibodies Laboratory的环化酶激活PTH检测方法和来自Nichols Institute的生物完整PTH检测方法），在我们内分泌外科10个月期间连续收治的145例接受手术的PHPT患者中进行了比较。一组74名健康受试者作为对照。
总完整、完整、环化酶激活和生物完整检测方法对PHPT的诊断敏感性分别为93.8%、97.3%、84.2%和89.0%，对照组的95%置信区间分别为10 - 46、11 - 60、8.4 - 34和9 - 41 ng/升。
我们的研究结果表明，第二代和第三代PTH检测方法的诊断敏感性相似。因此，第三代PTH检测方法并不能改善PHPT患者血清PTH水平升高的诊断，尽管各数值之间存在数字差异。
