Lamster I B, Pope M R
Division of Periodontics, Columbia University School of Dental and Oral Surgery, New York, NY 10032, USA.
Technol Health Care. 1996 Sep;4(3):331-8.
This manuscript reviews the sequence of events surrounding the development of a proposed diagnostic test for periodontal disease based on analysis of a host mediator in gingival crevicular fluid (GCF). The mediator is lysosomal beta-glucuronidase (beta G), a marker of granule release from polymorphonuclear leukocytes. Preliminary studies were conducted to evaluate the most reproducible method of collecting GCF and analyzing the data. This was followed by analysis of the mediator in GCF in a variety of cross-sectional and short-term longitudinal studies, and eventually by a study of the relationship of beta G in GCF to disease progression (probing attachment loss) in a single center longitudinal trial. Development of an academic-industrial collaboration allowed the project to progress, as a rapid, practical assay system was developed, and a multi-center longitudinal trial was conducted. The multicenter trial indicated that patients with elevated beta G in GCF were at 6 to 14 times higher risk for experiencing probing attachment loss. The technical, regulatory, business and marketing issues surrounding the introduction of a diagnostic test for periodontal disease were considered. While technical and regulatory issues were not major impediments, business and marketing concerns contributed to a decision to halt development of the test. Specifically, there was concern about acceptance of the test by practitioners and third party reimbursement. Underlying these issues were the multifactorial nature of periodontal disease, and the lack of a direct cause and effect relationship of test results to disease outcome. While analysis of beta G in GCF is not currently available as a diagnostic test for periodontal disease, the development process has identified important issues for the introduction of diagnostic tests, including consideration of the relationship of test results to treatment, the need to integrate diagnostic tests into dental practice, and an appreciation of the financial and health care benefits derived by practitioners and patients with use of such tests.
本手稿回顾了围绕一种基于龈沟液（GCF）中宿主介质分析的牙周疾病诊断测试开发的一系列事件。该介质是溶酶体β-葡萄糖醛酸酶（βG），是多形核白细胞颗粒释放的标志物。进行了初步研究，以评估收集GCF和分析数据的最可重复方法。随后，在各种横断面和短期纵向研究中对GCF中的介质进行了分析，最终在一项单中心纵向试验中研究了GCF中βG与疾病进展（探诊附着丧失）的关系。学术-产业合作的开展使该项目得以推进，因为开发了一种快速、实用的检测系统，并进行了一项多中心纵向试验。多中心试验表明，GCF中βG升高的患者发生探诊附着丧失的风险高6至14倍。考虑了围绕牙周疾病诊断测试引入的技术、监管、商业和营销问题。虽然技术和监管问题不是主要障碍，但商业和营销方面的担忧导致决定停止该测试的开发。具体而言，人们担心从业者对该测试的接受程度以及第三方报销情况。这些问题的根本原因是牙周疾病的多因素性质，以及测试结果与疾病结局缺乏直接的因果关系。虽然目前GCF中βG的分析不能作为牙周疾病的诊断测试，但开发过程已经确定了引入诊断测试的重要问题，包括考虑测试结果与治疗的关系、将诊断测试整合到牙科实践中的必要性，以及认识到从业者和患者使用此类测试所获得的财务和医疗保健益处。
