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国产新型电生理刺激反馈仪DS21在无创筛查糖尿病中的初步应用

  • 摘要: 目的:初步评判国内最新研制的电生理刺激反馈仪DS21无创筛查糖尿病的稳定性、有效性及安全性。方法:46例受试者根据口服葡萄糖耐量试验(OGTT)及既往病史分为健康组(n=17)、糖调节受损组(n=15)和糖尿病组(n=14)。受试者签署知情同意书,接受常规体检及采集病史及生化检查,对受试者进行3次电生理刺激反馈仪DS21测试,得到3个电导值,通过计算平均偏差,判断检测结果的稳定性、有效性,同时观察不良反应。结果:46例受试者电导值平均偏差最大值为4.4,最小值为0.2,均小于5.0;46例受试者中健康组、糖调节受损组和糖尿病组受试者的电导值分别为77.9±5.2、70.4±5.7、54.7±11.4,趋势为健康组>糖调节受损组>糖尿病组,组间差异有统计学意义(P<0.01);校正了性别、年龄、体质指数(BMI),3组人群电导值依然存在上述趋势(P<0.01)。入组受试者均未发生不良事件。结论:国产电生理刺激反馈仪DS21在不同糖代谢人群中存在不同的电导值,有助于评判糖尿病风险,且稳定、安全,值得进一步以应用于临床。

     

    Abstract: Objective:To preliminarily assess the stability, effectiveness, and safety of the electrophysiological stimulation feedback instrument DS21 for noninvasive screening diabetes. Methods:Totally 46 cases were selected and divided into health control group (NC,n=17),impaired glucose regulation group(IGR, n=15), and diabetes group (DM, n=14) based on OGTT and diabetic history. All cases signed informed consent, were performed routine checkup and biochemical examination, and collected history, and underwent three times tests by electrophysiological stimulation feedback instrument. Three conductance values of this instrument were recorded for each case, the deviation of average values were calculated, to evaluate its stability and effectiveness, and the adverse reactions were observed. Results:The maximum of the mean conductance value deviation was 4.4, the minimum value was 0.2 in the 46 subjects, which were all less than 5.0, The conductance values were 77.9±5.2,70.4±5.7, and 54.7±11.4 in NC, IGR, and DM group, respectively. The trend of conductance value was NC >IGR > DM group. The difference of conductance values among groups was statistically significant (P<0.01). After adjusting for gender,age, and body mass index (BMI), the difference of conductance values among groups was still statistically significant (P<0.01). There was no adverse event in the test in 46 cases. Conclusions:Electrophysiological stimulation feedback instrument DS21 is stable, reliable. The conductance values are different in subject with different glucose metabolism.

     

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