International Medical Center of Japan Kohnodai Hospital, Ichikawa, Chiba 272-8516, Japan.
Neurogastroenterol Motil. 2010 Jun;22(6):618-e173. doi: 10.1111/j.1365-2982.2009.01449.x. Epub 2010 Jan 5.
Acotiamide is a selective acetylcholinesterase inhibitor and enhances the actions of cholinergic neurons localized in the stomach.
The present two studies were conducted to examine the optimal dosage of acotiamide hydrochloride (Z-338) in patients with functional dyspepsia (FD) in Japan.
The improvement rate of 'subjects global assessment of overall treatment efficacy (OTE)' at the final evaluation was approximately 10% higher in the acotiamide 100 mg group than that in the placebo group with good reproducibility though there was no significant differences at primary endpoint. The elimination rate of postprandial fullness in the acotiamide 100 mg group was significantly higher compared to placebo group. In addition, the post hoc analysis showed that in patients whose main complaints are meal-related symptoms such as postprandial fullness, upper abdominal bloating and/or early satiety, the improvement rate of 'OTE' at final evaluation in acotiamide 100 mg group was significantly superior to that in the placebo group.
CONCLUSIONS & INFERENCES: These results suggest that acotiamide possesses efficacy on FD and more specifically its meal-related symptoms of FD.
阿考替胺是一种选择性乙酰胆碱酯酶抑制剂，可增强胃局部胆碱能神经元的作用。
本研究旨在考察阿考替胺盐酸盐（Z-338）在日本功能性消化不良（FD）患者中的最佳剂量。
在最终评估时，阿考替胺 100mg 组的“受试者整体治疗效果评估（OTE）”改善率比安慰剂组高约 10%，具有良好的重现性，尽管在主要终点没有显著差异。阿考替胺 100mg 组餐后饱胀的消除率明显高于安慰剂组。此外，事后分析显示，在以餐后饱胀、上腹胀满和/或早饱等与进餐相关的症状为主诉的患者中，阿考替胺 100mg 组在最终评估时的“OTE”改善率明显优于安慰剂组。
这些结果表明，阿考替胺对 FD 具有疗效，特别是对 FD 的与进餐相关的症状。
