正葡萄糖钳夹试验的质量评价

刘辉; 喻红玲; 韩丽娜; 张思琴; 柳佳利; 李佳琦; 谭惠文; 余叶蓉

摘要:

目的探讨评估正葡萄糖钳夹试验质量的质控指标，并进行验证评估。

方法从四川大学华西医院2014~2017年实施的正葡萄糖钳夹试验中每年各随机抽取20例(共80例)受试者数据，根据每次试验的血糖值变异系数(coefficient of variation of blood glucose concentrations，CVBG)将80例受试者分为A组(CVBG≤4.5%)、B组(4.5%＜CVBG≤5.0%)、C组(5.0%＜CVBG≤5.5%)、D组(CVBG＞5.5%)，比较各组血糖值“脱靶”点占比、“脱靶”时间、“脱靶”面积、血糖距靶值波动均值及血糖波动面积的差异。绘制受试者工作特征曲线(ROC曲线)，计算质控指标的敏感度、特异度。

结果 A组37例，CVBG均值为3.75%；B组14例，CVBG均值为4.76%；C组9例，CVBG均值为5.28%；D组20例，CVBG中位数为6.07%；A组的“脱靶”点占比、“脱靶”时间、“脱靶”面积、血糖距靶值波动均值及血糖波动面积均低于其他3组(4组间上述指标差异有统计学意义，P＜0.05)，B组和C组上述指标之间的差异无统计学意义，D组的上述各项指标均高于其它3组。CVBG与其它质控指标呈正相关(相关系数r为0.770~0.805)；以CVBG=5%作为钳夹质量好坏的截点，“脱靶”点占比、“脱靶”时间、“脱靶”面积、血糖距靶值波动、血糖波动面积对应的截断值分别为5.8%、14.6 min、22.82 mg/dL×min、3.23 mg/dL、216.25 mg/dL×min/h，各指标敏感度为79.3%~100%，特异度为74.5%~89.7%；采用“脱靶”点占比、“脱靶”时间、“脱靶”面积、血糖距靶值波动、血糖波动面积进行钳夹质控，发现在A组中有8.11%的钳夹质量欠理想，而在C组中有66.67%的钳夹质量尚可接受。

结论 CVBG≤4.5%的正葡萄糖钳夹试验具有良好的质量；而正葡萄糖钳夹试验中4.5%＜CVBG≤5.5%者，建议结合上述质控指标特别是血糖波动面积(截点：216.25 mg/dL×min/h)进行综合质控评价。结合上述质控指标可甄别假高质量正葡萄糖钳夹及假低质量正葡萄糖钳夹。

Abstract:

Objective To explorethe quality of euglycemic glucose clamptest performed in the West China Hospital from 2014 to 2017 and to evaluate whether the quality control indexes are suitable for the quality assessment of the clamp test.

Methods The data collected from 80 euglycemic glucose clamp tests performed between 2014 and2017 were divided into 4 groups according to the coefficient of variation of the blood glucose concentrations (CVBG): group A (CVBG≤4.5%), group B (4.5% < CVBG≤5.0%), group C (5.0% < CVBG≤5.5%) and group D(CVBG > 5.5%).The differences in percentage of glucose excursion from target range (GEFTR), the duration of GEFTR, the area under curve (AUC) of GEFTR, the mean value of excursion from target glucose (GEFT) and the AUC of GEFT were calculated and compared.

Results In group A, the mean value of CVBG was 3.75%. In group B, the mean value of CVBG was 4.76%. In group C, the mean value of CVBG was 5.28%. The median value of CVBG in group D was 6.07%. The percentage of GEFTR, the duration of GEFTR, the AUC of GEFTR, the mean value of GEFT and the AUC of GEFT in group A were all less than those of other groups (P < 0.05).For the same indexes, there were no significant differences between group B and C, while they were higher in group D compared with the other three groups. CVBG was positively correlated with other quality control indexes (correlation coefficient r was 0.770-0.805). Based on the cut-off point 5% of CVBG, the cut-off points of the percentage of GEFTR, the duration of GEFTR, the AUC of GEFTR, the mean value of GEFT and the AUC of GEFT were 5.8%, 14.6 min, 22.82 mg/dL×min, 3.23 mg/dL, 216.25 mg/dL×min/h respectively, with the sensitivity range from 79.3% to 100% and the specificity range from 74.5% to 89.7%.Combined with these indexes, 8.11% of euglycemic clamps were found to havepoor quality in group A, while 66.67% of euglycemic clamps showed acceptable quality in group C.

Conclusion The investigators should provide an estimation of the quality of the clamps when reporting the results of the insulin analogues' PK/PD characteristics using euglycemic clamps. CVBG less than 4.5% indicates a good quality, and the above-mentioned quality control indexes especially the AUC of GEFT(cut-off point: 216.25 mg·/dL×min/h) should be evaluated when CVBG is more than 4.5%.False high quality and false low quality euglycemic clamps will be detected and a more precise estimation of quality assessment should be made by the combination of these indexes.

正葡萄糖钳夹试验的质量评价

Quality Assessment of Euglycemic Glucose Clamp Test