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羟苯磺酸钙:一种用于治疗糖尿病性视网膜病变的药物,可能会对酶法测定糖化白蛋白产生负干扰。

Calcium dobesilate: A drug treatment for diabetic retinopathy can negatively interfere with the measurement of glycated albumin using the enzymatic method.

机构信息

Department of Laboratory Medicine, Peking Union Medical College Hospital, Chinese Academic Medical Science and Peking Union Medical College, Beijing, PR China.

Department of Laboratory Medicine, Peking Union Medical College Hospital, Chinese Academic Medical Science and Peking Union Medical College, Beijing, PR China.

出版信息

Clin Chim Acta. 2018 Aug;483:1-5. doi: 10.1016/j.cca.2018.04.014. Epub 2018 Apr 10.

DOI:10.1016/j.cca.2018.04.014
PMID:29653084
Abstract

BACKGROUND

We reported that calcium dobesilate, a vasoprotective agent mainly used for diabetic retinopathy (DR), negatively interferes with glycated albumin (GA) assays involving enzymatic methods.

METHODS

A calcium dobesilate standard was added to 3serum pools in vitro to prepare concentration-response series according to Clinical and Laboratory Standards Institute EP7-A2 guidelines. Percentage deviation between each drug concentration and the drug-free sample was calculated for 6 commercially available GA assays. The acceptable limit of deviation for GA was ±5.61%. For in vivo analyses, changes in serum concentrations of GA and calcium dobesilate were monitored in eight healthy participants before and after oral calcium dobesilate administration.

RESULTS

At 16 μg/ml calcium dobesilate, within the therapeutic range, the percentage deviations for Asahi Kasei, Maccura, Leadman, Homa, and Medicalsystem assays were -8.7% to -49.7%, -2.0% to -47.7%, and -10.1% to -35.7% for low-, medium- and high-GA level interference pools, respectively, exhibiting dose-dependent negative interference. In vivo, calcium dobesilate ingestion was associated with statistically significant, falsely decreased measurements in 5 GA assays, 2 h after daily 500 mg administration.

CONCLUSIONS

Calcium dobesilate ingestion was associated with erroneously low measurements in 5 GA assays. The degree of interference varied greatly among the assays examined.

摘要

背景

我们曾报道,主要用于治疗糖尿病视网膜病变(DR)的血管保护剂羟苯磺酸钙会对涉及酶法的糖化白蛋白(GA)检测产生负性干扰。

方法

根据临床和实验室标准协会 EP7-A2 指南,我们将羟苯磺酸钙标准品加入到体外的 3 个血清池,以制备浓度反应系列。对于 6 种市售 GA 检测法,分别计算每个药物浓度与无药物样品之间的百分比偏差。GA 的可接受偏差限值为±5.61%。对于体内分析,在 8 名健康参与者口服羟苯磺酸钙前后,监测其血清 GA 和羟苯磺酸钙浓度的变化。

结果

在 16μg/ml 的羟苯磺酸钙(治疗范围内),对于 Asahi Kasei、Maccura、Leadman、Homa 和 Medicalsystem 检测法,低、中、高 GA 水平干扰池的百分比偏差分别为-8.7%至-49.7%、-2.0%至-47.7%和-10.1%至-35.7%,呈剂量依赖性负性干扰。在体内,每日口服 500mg 羟苯磺酸钙 2 小时后,5 种 GA 检测法的检测结果均出现统计学上显著的、错误的降低。

结论

羟苯磺酸钙的摄入与 5 种 GA 检测法的错误低值结果相关。所检查的检测法之间干扰的程度差异很大。

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