中文摘要：

目的检测不同临床阶段2型糖尿病（T2DM）患者胰腺再生蛋白（Reg）水平,分析血清Reg与T2DM及其慢性并发症的关系。方法选取2012年9月—2014年12月东南大学附属中大医院及南京6个社区医院（红山、玄武、莫愁、夫子庙、中华门和徐家巷）收治的门诊、住院患者以及健康体检者,根据诊断标准与排除标准共纳入950名参与者,将其分为5组：健康对照组（HC组,n=97）、高危人群组（HR组,n=209）、糖调节受损组（IGR组,n=292）、初发T2DM组（Onset组,n=188）和长程T2DM无并发症组（LD-无并发症组,n=94）、长程T2DM有并发症组（LD-有并发症组,n=70）。采用酶联免疫吸附法（ELISA）测定受试者清晨空腹状态下的血清Reg水平,分析Reg与T2DM病程及慢性并发症的关系。结果各组年龄、糖尿病家族史、吸烟史、收缩压比较,差异均无统计学意义（P〉0.05）;各组性别、体质指数（BMI）、舒张压、空腹血糖（FPG）、餐后2 h血糖（2 h PG）、糖化血红蛋白（Hb A1c）、Reg比较,差异均有统计学意义（P〈0.05）。T2DM患者血清Reg水平与病程呈正相关（rs=0.284,P〈0.01）。在所有受试者中血清Reg水平与Hb A1c、FPG、2 h PG呈正相关（rs=0.188、0.115、0.111,P〈0.001）。Reg诊断T2DM的ROC曲线下面积为0.640〔95%CI（0.605,0.674）〕,最佳截点为25 ng/ml,其灵敏度为46%,特异度为76%,阳性似然比为1.92,阴性似然比为0.71。Reg诊断T2DM慢性并发症的ROC曲线下面积为0.754〔95%CI（0.694,0.813）〕,最佳截点为27 ng/ml,其灵敏度为65%,特异度为74%,阳性似然比为2.50,阴性似然比为0.47。结论检测血清Reg水平有助于预测T2DM及其慢性并发症,Reg将来可能成为T2DM及其进展的一种预测因子。

英文摘要：

Objective To investigate the level of pancreatic regenerating protein （Reg） of T2DM patients at different clinical stages, and analyze the relationship between serum Reg level and T2DM and its chronic complications. Methods We enrolled outpatients and inpatients who received treatment and healthy people who received physical examination in Zhongda Hospital Southeast University from September 2012 to December 2014. According to diagnostic criteria and exclusion criteria, a total of 950 subjects were enrolled and were divided into five groups ： healthy control group （ HC group, n = 97 ）, high - risk group （ HR group, n =209 ）, impaired glucose regulation group （ IGR group, n = 292 ）, group of the first onset of T2DM （ Onset group, n = 188）, group of long - term T2DM without complication （ LD - no - complication group, n =94） and group of long - term T2DM with complications （ LD - complication group, n = 70 ）. ELISA was used to determine the morning fasting serum Reg level, and the relation between Reg and the length of T2DM was analyzed. Results The five groups were not significantly different in age, history of diabetes, history of smoking and systolic pressure （ P 〉 0.05 for all） ; the five groups were significantly different in gender, BMI, diastolic pressure, FPG, 2 hPG, HbAlo and Reg （P 〈0. 05 for all）. The serum Reg level and the length of disease had positive linear correlation in T2DM patients （rs =0. 284, P 〈0. 01 ）. In all subjects, the serum Reg level, HbAIc, FPG and 2 hPG had positive linear correlation （re =0. 188, 0. 115, 0. 111 ; P 〈0. 001 ）. The AUC of Reg diagnosing T2DM was 0. 640 （95% CI （0. 605, 0. 674）], and the optimum cut -off point, sensitivity, specificity, positive likelihood ratio and negative likelihood ratio were 25 ng/ml, 46% , 76% , 1.92 and 0. 71. The AUC of Reg diagnosing the chronic complications of T2DM was 0. 754 [ 95% CI （ 0. 694, 0. 813 ） ], and the optimum cut - off point, sensitivity, specificity, positive likeli