1型糖尿病中的生物标志物：在临床试验中的应用。
Biomarkers in type 1 diabetes: application to the clinical trial setting.
作者信息
Tooley James E, Herold Kevan C
机构信息
Department of Immunobiology and Internal Medicine, Yale University, New Haven, Connecticut, USA.
出版信息
Curr Opin Endocrinol Diabetes Obes. 2014 Aug;21(4):287-92. doi: 10.1097/MED.0000000000000076.
PURPOSE OF REVIEW
Biomarkers of type 1 diabetes (T1D) are important for assessing risk of developing disease, monitoring disease progression, and determining responses to clinical treatments. Here we review recent advances in the development of biomarkers of T1D with a focus on their utility in clinical trials.
RECENT FINDINGS
Measurements of autoantibodies and metabolic outcomes have been the foundation of monitoring T1D for the past 20 years. Recent advancements have led to improvements in T-cell-specific assays that have been used in large-scale clinical trials to measure antigen-specific T cell responses. Additionally, new tools are being developed for the measurement of β cell mass and death that will allow for more direct measurement of disease activity. Lastly, recent studies have used both immunologic and nonimmunologic biomarkers to identify responders to treatments in clinical trials.
SUMMARY
Use of biomarkers in the study of T1D has largely not changed over the past 20 years; however, recent advancements in the field are establishing new techniques that allow for more precise monitoring of disease progression. These new tools will ultimately lead to an improvement in understanding of disease and will be utilized in clinical trials.
综述目的
1型糖尿病（T1D）的生物标志物对于评估疾病发生风险、监测疾病进展以及确定临床治疗反应至关重要。在此，我们综述T1D生物标志物开发方面的最新进展，重点关注其在临床试验中的应用。
最新发现
在过去20年里，自身抗体和代谢指标的检测一直是监测T1D的基础。最近的进展使得T细胞特异性检测方法得到改进，这些方法已用于大规模临床试验以测量抗原特异性T细胞反应。此外，正在开发用于测量β细胞质量和死亡情况的新工具，这将使疾病活动的测量更加直接。最后，最近的研究利用免疫和非免疫生物标志物来识别临床试验中的治疗反应者。
总结
在过去20年里，T1D研究中生物标志物的使用基本没有变化；然而，该领域最近的进展正在建立新的技术，能够更精确地监测疾病进展。这些新工具最终将有助于增进对疾病的理解，并将在临床试验中得到应用。
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