Department of Gastroenterology, Laboratory of Translational Gastroenterology, Qilu Hospital, Shandong University, Jinan, Shandong, China; Department of Gastroenterology, Weihai Municipal Hospital, Weihai, Shandong, China.
Department of Hepatobiliary Surgery, Weihai Municipal Hospital, Weihai, Shandong, China.
Gastrointest Endosc. 2016 Dec;84(6):917-923.e5. doi: 10.1016/j.gie.2016.05.011. Epub 2016 May 14.
Image quality can be guaranteed with the conventional dosage of fluorescein sodium in probe-based confocal laser endomicroscopy (pCLE). However, yellow discoloration of the skin seriously affects daily life and simultaneously increases the risk of adverse events such as allergic reactions. The aim of this study was to test whether a lower dosage of fluorescein sodium can provide satisfactory image quality and to compare the diagnostic accuracy of gastric intestinal metaplasia (GIM) through a randomized blind controlled trial.
Consecutive patients were randomly assigned to different doses of fluorescein sodium. Image quality was determined by the endoscopists' subjective assessments and signal-to-noise ratio (SNR) assessment systems. Skin discoloration was tested using a neonatal transcutaneous jaundice detector. In addition, consecutive patients with a known or suspected diagnosis of GIM were examined by pCLE with the lower dose and the traditional dose.
Only 0.01 mL/kg dose of 10% fluorescein sodium led to a significant decrease in image quality (P < .05), and a dose of 0.02 mL/kg had the highest SNR value (P < .05). There were no significant differences in skin discoloration between the 0.01 mL/kg and 0.02 mL/kg doses (P = .148) and no statistical difference in the diagnostic accuracy of pCLE for GIM between the 0.02 mL/kg and 0.10 mL/kg doses (P > .05). The kappa values for the correlation between pCLE and histopathology were 0.867 (95% confidence interval, 0.782-0.952) and 0.891 (95% confidence interval, 0.811-0.971).
The 0.02 mL/kg dose of 10% fluorescein sodium seems to be the best dose for pCLE in the upper GI tract, with comparable image quality with the conventional dose and insignificant skin discoloration. This dose is also very efficient for the diagnosis of GIM.
在基于探头的共聚焦激光显微内镜检查（pCLE）中，常规剂量的荧光素钠可以保证图像质量。然而，皮肤的黄染严重影响日常生活，同时增加了不良反应（如过敏反应）的风险。本研究旨在测试较低剂量的荧光素钠是否能提供满意的图像质量，并通过随机盲法对照试验比较胃肠化生（GIM）的诊断准确性。
连续患者被随机分配到不同剂量的荧光素钠。图像质量由内镜医师的主观评估和信噪比（SNR）评估系统来确定。皮肤变色采用新生儿经皮黄疸检测仪进行检测。此外，对已知或疑似 GIM 的连续患者进行 pCLE 检查，剂量分别为较低剂量和传统剂量。
只有 0.01 mL/kg 的 10%荧光素钠剂量会导致图像质量显著下降（P<.05），而 0.02 mL/kg 的剂量具有最高的 SNR 值（P<.05）。0.01 mL/kg 和 0.02 mL/kg 剂量之间的皮肤变色无显著差异（P=0.148），0.02 mL/kg 和 0.10 mL/kg 剂量之间 pCLE 对 GIM 的诊断准确性也无统计学差异（P>.05）。pCLE 与组织病理学之间的相关性的 kappa 值分别为 0.867（95%置信区间，0.782-0.952）和 0.891（95%置信区间，0.811-0.971）。
0.02 mL/kg 的 10%荧光素钠剂量似乎是上消化道 pCLE 的最佳剂量，与传统剂量相比具有相当的图像质量，且皮肤黄染不明显。该剂量对 GIM 的诊断也非常有效。
