Lartigue S, Bizais Y, Des Varannes S B, Murat A, Pouliquen B, Galmiche J P
Laboratoire Fonctions Digestives et Nutrition, CHU Nord, Nantes, France.
Dig Dis Sci. 1994 Jan;39(1):109-15. doi: 10.1007/BF02090069.
This study was performed to assess: (1) the inter- and intrasubject variability of gastric emptying measurements by a scintigraphic method in 12 healthy subjects and 14 diabetic patients, and (2) the reproducibility of diagnosis of either the presence or absence of gastroparesis. To address this issue, radiolabeled solid-liquid meals were ingested by all subjects on two separate days. High intersubject variability of gastric emptying measurements was shown in both populations. Intrasubject variability was higher in diabetic patients than in healthy subjects. However, there was no significant difference between the means of any parameters obtained on two separate days. The reproducibility of the diagnosis of gastroparesis was excellent for all parameters; the solid half emptying time was the most reproducible parameter (92% in healthy subjects and 93% in diabetic patients). The means +/- SD of the difference between the two separate days' half emptying time results were -10.6 +/- 41.3 min for solids and -4.8 +/- 36.6 min for liquids and were not statistically different from zero. Only one difference between the half emptying time results on two separate days was not in the 95% confidence interval for both solids and liquids; however, this result came from a diabetic patient with obvious gastroparesis on both days. Thus: (1) in spite of high inter- and intrasubject variability, the scintigraphic method of measuring gastric emptying is highly reproducible for the diagnosis of gastroparesis; (2) reproducibility is better in healthy subjects than in diabetic patients; and (3) the knowledge of intrasubject variability allows assessment of the required sample sizes for pharmacological studies using prokinetic medications.
（1）通过闪烁扫描法测量12名健康受试者和14名糖尿病患者胃排空的受试者间及受试者内变异性；（2）胃轻瘫诊断的可重复性。为解决此问题，所有受试者在两个不同日期摄入放射性标记的固体 - 液体餐。在这两个人群中均显示出胃排空测量的高受试者间变异性。糖尿病患者的受试者内变异性高于健康受试者。然而，在两个不同日期获得的任何参数的平均值之间没有显著差异。胃轻瘫诊断的所有参数的可重复性都非常好；固体半排空时间是最具可重复性的参数（健康受试者中为92%，糖尿病患者中为93%）。两个不同日期半排空时间结果之间差异的平均值±标准差，固体为 -10.6±41.3分钟，液体为 -4.8±36.6分钟，且与零无统计学差异。仅两个不同日期半排空时间结果之间的一个差异不在固体和液体的95%置信区间内；然而，该结果来自一名两天均有明显胃轻瘫的糖尿病患者。因此：（1）尽管存在高受试者间及受试者内变异性，但闪烁扫描法测量胃排空对于胃轻瘫的诊断具有高度可重复性；（2）健康受试者中的可重复性优于糖尿病患者；（3）了解受试者内变异性有助于评估使用促动力药物的药理学研究所需的样本量。
