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用于评估胃酸度的新型口服测试剂GA-测试的开发与评估

Development and evaluation of a new peroral test agent GA-test for assessment of gastric acidity.

作者信息

Ogata H, Aoyagi N, Kaniwa N, Ejima A, Suzuki K, Ishioka T, Morishita M, Ohta K, Takagishi Y, Doi Y

出版信息

J Pharmacobiodyn. 1984 Sep;7(9):656-64. doi: 10.1248/bpb1978.7.656.

Abstract

A new peroral test capsule, GA-Test, containing riboflavin (5 mg) granules coated with polyvinylacetal diethylaminoacetate (AEA) for assessing gastric acidity without intubation was developed and evaluated for usefulness. GA-Test is based on the tracing in the urine of riboflavin, which is released in the stomach only in the presence of acidic fluid and is absorbed. Due to the film coating, riboflavin released very quickly at a pH of less than 5, and not at all at a pH of greater than 6. GA-Test gave a significant correlation, quantitatively, with peroral Gastrotest in assessing acidity, a non-intubation method which had been marketed in Japan prior to 1980. GA-Test results allowed division of the subjects into two groups i.e., subjects having low (hypo- or anacidity) gastric acidity and those having high (normal or hyperacidity) gastric acidity, GA-Test results agreed well with results of intubation (around 91.4%; 32 out of 35 cases) and were easily reproduced during the evaluation.

摘要

一种新型口服测试胶囊GA-Test被研发并评估其效用,该胶囊含有包裹着聚乙烯醇缩乙醛二乙胺基乙酸酯(AEA)的核黄素(5毫克)颗粒,用于在无需插管的情况下评估胃酸度。GA-Test基于对尿液中核黄素的追踪,核黄素仅在酸性液体存在时于胃中释放并被吸收。由于有薄膜包衣,核黄素在pH值小于5时释放非常快,而在pH值大于6时则完全不释放。在评估酸度方面,GA-Test与口服Gastrotest在定量上具有显著相关性,Gastrotest是一种在1980年之前已在日本上市的非插管方法。GA-Test的结果可将受试者分为两组,即胃酸度低(低酸或无酸)的受试者和胃酸度高(正常或胃酸过多)的受试者,GA-Test的结果与插管结果吻合良好(约91.4%;35例中的32例),并且在评估过程中易于重现。

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