国产电生理刺激反馈仪用于无创筛查糖代谢异常的安全性和有效性  

Safety and efficacy of Chinese-made electrophysiological stimulation feedback instrument for non-invasive risk assessment of impaired glucose metabolism

作　　者：王柳 朱小鹏 林寰东 颜红梅 常薪霞 夏明锋 孙潇泱 杨心瑜 卞华 高鑫 WANG Liu;ZHU Xiao-peng;LIN Huan-dong;YAN Hong-mei;CHANG Xin-xia;XIA Ming-feng;SUN Xiao-yang;YANG Xin-yu;BIAN Hua;GAO Xin(Department of Endocrinology,Zhongshan Hospital,Fudan University,Shanghai 200032,China)

机构地区：[1]复旦大学附属中山医院内分泌科,上海200032

出　　处：《复旦学报（医学版）》2020年第6期906-910,916,共6页Fudan University Journal of Medical Sciences

基　　金：上海市自然科学基金(20ZR1410200);国家重点研发计划(2017YFC1309801)。

摘　　要：目的初步研究国产电生理刺激反馈仪用于无创筛查糖代谢异常患者的有效性和安全性,并确定筛查临界值。方法纳入95例40岁以上受试者,根据口服葡萄糖耐量试验(oral glucose tolerance test,OGTT)及既往病史分为糖耐量正常(normal glucose tolerance,NGT)组(n=55)和糖代谢异常(impaired glucose metabolism,IGM)组(n=40)。所有受试者接受病史采集、常规体检及生化检查,国产型电生理刺激反馈仪检测受试者四肢的皮肤电导值(electrochemical skin conductance,ESC),比较两组ESC,计算ROC曲线下面积(AUC)及不同阈值下的敏感度和特异度,同时观察不良反应。结果 NGT组的ESC为63.0(58.0,67.0),IGM组的ESC为57.0(55.0,60.0),两组差异有统计学意义(P<0.01)。以NGT组作为对照,区分糖代谢异常的AUC为0.78(95%CI:0.69~0.87);阈值61.0处的灵敏度为77.5%(95%CI:61.6%~89.2%),特异度为61.8%(95%CI:47.7%~74.6%),阳性似然比2.03,阴性似然比2.75。受试者均未发生不良事件。结论国产电生理刺激反馈仪筛查糖代谢异常患者具有一定的安全性和有效性,在阈值61.0处有较高的灵敏度和特异度。Objective To study the efficacy and safety of non-invasive screening of people with impaired glucose metabolism(IGM)by Chinese-made electrophysiological stimulation feedback instrument,and to determine the screening threshold.Methods Ninety-five subjects older than 40 years were enrolled and were divided into normal glucose tolerance(NGT)group,(n=55)and IGM group(n=40)based on oral glucose tolerance test(OGTT)and diabetic history.All subjects underwent history collection,routine check-up and biochemical examination.Electrophysiological stimulation feedback instrument was used to measure electrochemical skin conductance(ESC)of limbs,which were compared between the two groups.Area under curve(AUC)of ROC,sensitivity and specificity at different cut-off points were evaluated,and the adverse reactions were observed.Results The median ESC of NGT group and IGM group was 63.0(58.0,67.0)and 57.0(55.0,60.0).There was a significant difference in ESC between the two groups(P<0.01).The AUC to distinguish impaired glucose metabolism was 0.78(95%CI:0.69-0.87)with NGT as control.The sensitivity at threshold 61.0 was 77.5%(95%CI:61.6%-89.2%),the specificity was 61.8%(95%CI:47.7%-74.6%).The positive likelihood ratio was 2.03,and the negative likelihood ratio was 2.75.No adverse events occurred in the enrolled subjects.Conclusion Chinese-made electrophysiological stimulation feedback instrument might be a safe and effective tool for screening of impaired glucose metabolism with acceptable sensitivity and specificity at the cut-off point of 61.0.

关 键 词：电生理刺激反馈仪 糖代谢异常 无创筛查 

分 类 号：R587.1[医药卫生—内分泌] R444[医药卫生—内科学]