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j. tack a. masclee † r. heading ‡ a. berstad § h. piessevaux ¶ t. popiela a. vandenberghe †† & h. kato ‡‡ 《Neurogastroenterology and motility》2009,21(3):272-280
Abstract Impaired gastric accommodation, hypersensitivity to distension and delayed gastric emptying are major pathophysiological mechanisms in functional dyspepsia (FD). Acotiamide (Z-338) was well-tolerated in healthy volunteers. To determine the effect of three doses of Acotiamide on major pathophysiological mechanisms, symptoms, quality of life (QOL) and safety in functional dyspeptics. A phase IIa, randomized, double-blind, placebo-controlled study (14, 21 and 28 days, respectively, for run-in, study drug administration and follow-up). Gastric accommodation, sensitivity to distension and gastric emptying were assessed by barostat and 13 C breath test, symptoms by daily diary cards and QOL by SF-36. A total of 71 patients were enrolled (62 evaluable). There was no effect on gastric emptying and sensitivity to distension. 300 mg was better than placebo for meal accommodation ( P = 0.024). 100 mg was better than placebo at week 2 for upper abdominal bloating ( P = 0.001) and overall symptom score ( P = 0.022), and at week 3 for bloating ( P = 0.008) and heartburn ( P = 0.041). 100 mg was also better than placebo for QOL (physical function) ( P = 0.003). Acotiamide was safe and well-tolerated in patients with FD. The involved mechanism could at least in part depend on an effect on meal-induced accommodation. 100 mg Acotiamide exhibited the potential to improve FD symptoms and QOL. Further studies are indicated. 相似文献
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