Translational Research Centre for Gastrointestinal Disorders, University of Leuven, Leuven, Belgium.
Neurogastroenterol Motil. 2019 Apr;31(4):e13540. doi: 10.1111/nmo.13540. Epub 2019 Jan 20.
Acotiamide, a prokinetic agent was shown to be efficacious in the treatment of functional dyspepsia (FD). The exact mechanism of action is incompletely elucidated.
This randomized, placebo-controlled, cross-over study aimed to examine the effect of acotiamide on gastric motility, measured as intragastric pressure, gastric emptying (GE) rate and gastrointestinal (GI) symptom perception in healthy volunteers (HVs). Participants were treated with acotiamide (100 mg tid) and placebo for 3 weeks, separated by a 1-week washout period. A daily symptom diary was collected during both treatments. At the end of each treatment period, GE rate and gastric motility were assessed with a C-octanoic acid breath test and high-resolution manometry during nutrient infusion, respectively. GI symptom levels were scored during high-resolution manometry. Data were analyzed using mixed models. The study was registered as NCT03402984.
Twenty HVs (10 female, 25 ± 4.1 years, 22.58 ± 2.73 kg/m ) participated in the study. There was no difference in GE half time between both treatments (P = 0.92). Acotiamide had no effect on fundic pressures before and after nutrient infusion (P = 0.91). However, postprandial antral pressures remained significantly lower compared to placebo (P = 0.015). There was no significant difference in hunger, satiation and GI symptoms scores assessed during IGP measurement and by the daily diary (P > 0.12 for all).
Acotiamide is associated with lower antral pressures after nutrient intake, whereas it has no effect on fundic pressures, GE rate and symptom perceptions in HVs. Studies in FD need to elucidate whether lower antral pressures induced by acotiamide underlie postprandial symptom improvement in FD.
促动力药阿考替胺已被证明对功能性消化不良（FD）的治疗有效。其确切作用机制尚未完全阐明。
本随机、安慰剂对照、交叉研究旨在观察阿考替胺对健康志愿者（HV）胃动力的影响，胃动力通过胃内压力、胃排空（GE）率和胃肠道（GI）症状感知来衡量。参与者接受阿考替胺（100mg tid）和安慰剂治疗 3 周，洗脱期为 1 周。在两种治疗期间均每天收集症状日记。在每个治疗期末，通过 C-辛酸呼气试验和营养输注期间的高分辨率测压法分别评估 GE 率和胃动力。在高分辨率测压法期间对 GI 症状水平进行评分。使用混合模型分析数据。该研究已在 NCT03402984 注册。
20 名 HV（10 名女性，25±4.1 岁，22.58±2.73kg/m ）参加了研究。两种治疗之间的 GE 半时间无差异（P=0.92）。阿考替胺对营养输注前后的胃底压力没有影响（P=0.91）。然而，与安慰剂相比，餐后胃窦压力仍然显著降低（P=0.015）。在 IGP 测量和日常日记中评估的饥饿、饱腹感和 GI 症状评分无显著差异（所有 P>0.12）。
阿考替胺与营养摄入后胃窦压力降低有关，而对胃底压力、GE 率和 HV 中症状感知无影响。FD 研究需要阐明阿考替胺引起的胃窦压力降低是否是 FD 餐后症状改善的基础。
