Kessing B F, Smout A J P M, Bennink R J, Kraaijpoel N, Oors J M, Bredenoord A J
Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, The Netherlands.
Neurogastroenterol Motil. 2014 Aug;26(8):1079-86. doi: 10.1111/nmo.12359. Epub 2014 May 29.
The 5-HT4 receptor agonist prucalopride is a prokinetic drug which improves colonic motility. Animal data and in vitro studies suggest that prucalopride also affects gastric and esophageal motor function. We aimed to assess the effect of prucalopride on gastric emptying, esophageal motility, and gastro-esophageal reflux in man.
In this double-blind, placebo-controlled, randomized, crossover study, we included 21 healthy volunteers who received 4 mg prucalopride or placebo per day for 6 days. We performed high-resolution manometry (HRM) followed by 120-min HRM-pH-impedance monitoring after a standardized meal, ambulatory 24-h pH-impedance monitoring, and gastric emptying for solids.
Prucalopride decreased (median [IQR]) total acid exposure time (3.4 [2.5-5.6] vs 1.7 [0.8-3.5] %, p < 0.05). The total number of reflux events was unaffected by prucalopride, however, the number of reflux events extending to the proximal esophagus was reduced by prucalopride (15.5 [9.8-25.5] vs 10.5 [5.3-17.5], p < 0.05). Furthermore, prucalopride improved acid clearance time (77.5 [47.8-108.8] vs 44.0 [30.0-67.8] s, p < 0.05). Prucalopride did not affect the number of transient lower esophageal sphincter (LES) relaxations or their association with reflux events. Esophageal motility and basal pressure of the LES were not affected by prucalopride. Prucalopride increased gastric emptying (T1/2 ; 32.7 [27.9-44.6] vs 49.8 [37.7-55.0] min, p < 0.05) and decreased residue after 120 min (8.8 [4.4-14.8] vs 2.7 [1.3-5.4] %, p < 0.05).
CONCLUSIONS & INFERENCES: Prucalopride reduces esophageal acid exposure and accelerates gastric emptying in healthy male volunteers. These findings suggest that the drug could be effective for treatment of patients with reflux disease and functional dyspepsia.
5-羟色胺4（5-HT4）受体激动剂普芦卡必利是一种促动力药物，可改善结肠动力。动物数据和体外研究表明，普芦卡必利还会影响胃和食管的运动功能。我们旨在评估普芦卡必利对人体胃排空、食管动力和胃食管反流的影响。
在这项双盲、安慰剂对照、随机交叉研究中，我们纳入了21名健康志愿者，他们每天接受4毫克普芦卡必利或安慰剂，持续6天。在标准化餐后，我们进行了高分辨率测压（HRM），随后进行了120分钟的HRM-pH阻抗监测、动态24小时pH阻抗监测以及固体食物的胃排空监测。
普芦卡必利降低了（中位数[四分位间距]）总酸暴露时间（3.4[2.5 - 5.6]%对1.7[0.8 - 3.5]%，p < 0.05）。普芦卡必利对反流事件的总数没有影响，然而，延伸至食管近端的反流事件数量因普芦卡必利而减少（15.5[9.8 - 25.5]对10.5[5.3 - 17.5]，p < 0.05）。此外，普芦卡必利改善了酸清除时间（77.5[47.8 - 108.8]秒对44.0[30.0 - 67.8]秒，p < 0.05）。普芦卡必利不影响一过性下食管括约肌（LES）松弛的次数或它们与反流事件的关联。普芦卡必利对食管动力和LES的基础压力没有影响。普芦卡必利增加了胃排空（T1/2；32.7[27.9 - 44.6]分钟对49.8[37.7 - 55.0]分钟，p < 0.05），并减少了120分钟后的残留物（8.8[4.4 - 14.8]%对2.7[1.3 - 5.4]%，p < 0.05）。
普芦卡必利可减少健康男性志愿者的食管酸暴露并加速胃排空。这些发现表明该药物可能对反流性疾病和功能性消化不良患者有效。
