Translational Research Center for Gastrointestinal Disorders (TARGID), University of Leuven, Leuven, Belgium.
Am J Gastroenterol. 2019 Aug;114(8):1265-1274. doi: 10.14309/ajg.0000000000000304.
Prokinetics are considered the preferred treatment option for gastroparesis, but evidence of their efficacy is scarce. Prucalopride, a selective 5-hydroxytryptamine 4 receptor agonist used in the treatment of constipation, is able to enhance the gastric emptying rate. In a double-blind, randomized, placebo-controlled crossover study, we evaluated the efficacy of prucalopride to improve the gastric emptying rate and symptoms in patients with gastroparesis.
Thirty-four patients with gastroparesis (28 idiopathic, 7 men, mean age 42 ± 13 years) were evaluated in a double-blind crossover trial of 4-week treatment periods with placebo or prucalopride 2 mg q.d., separated by 2 weeks of washout. The primary end point was the change in symptom severity, assessed by the Gastroparesis Cardinal Symptom Index; secondary end points comprised the Patient Assessment of Upper Gastrointestinal Disorders-Symptom Severity Index, the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life, and daily diaries, and the gastric emptying rate was assessed by the C-octanoic acid breath test.
Three patients were lost to follow-up. One serious adverse event occurred (small bowel volvulus in the prucalopride group), and 3 patients dropped out because of adverse events of nausea and headache (all prucalopride). For the entire patient group, compared with placebo, prucalopride significantly improved the total Gastroparesis Cardinal Symptom Index (1.65 ± 0.19 vs 2.28 ± 0.20, P < 0.0001) and the subscales of fullness/satiety, nausea/vomiting, and bloating/distention. Prucalopride significantly improved the overall Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life score (1.15 ± 0.16 vs 1.44 ± 0.16, P < 0.05) and the domains of clothing and diet. The gastric half emptying time was significantly enhanced by prucalopride compared with placebo and baseline (98 ± 10 vs 143 ± 11 and 126 ± 13 minutes, P = 0.005 and <0.001, respectively). These significant improvements were also found when considering only the idiopathic gastroparesis subgroup.
In a cohort of patients with predominantly idiopathic gastroparesis, 4 weeks of prucalopride treatment significantly improved symptoms and quality of life and enhanced gastric emptying compared with placebo.
胃肠动力药物被认为是治疗胃轻瘫的首选方法，但它们的疗效证据有限。普芦卡必利是一种选择性 5-羟色胺 4 受体激动剂，用于治疗便秘，能够提高胃排空率。在一项双盲、随机、安慰剂对照的交叉研究中，我们评估了普芦卡必利改善胃轻瘫患者胃排空率和症状的疗效。
34 例胃轻瘫患者（28 例特发性，7 例男性，平均年龄 42±13 岁）接受了为期 4 周的双盲交叉试验，分别接受安慰剂或普芦卡必利 2mg q.d.治疗，间隔 2 周洗脱期。主要终点是通过胃轻瘫 Cardinal 症状指数评估症状严重程度的变化；次要终点包括患者对上消化道疾病症状严重程度的评估、患者对上消化道疾病生活质量的评估以及日常日记，胃排空率通过 C-辛酸呼气试验评估。
3 例患者失访。1 例发生严重不良事件（普芦卡必利组小肠扭转），3 例因恶心和头痛的不良反应退出（均为普芦卡必利）。对于整个患者组，与安慰剂相比，普芦卡必利显著改善了总胃轻瘫 Cardinal 症状指数（1.65±0.19 与 2.28±0.20，P<0.0001）和饱胀/饱腹感、恶心/呕吐和腹胀/扩张的亚量表。普芦卡必利显著改善了整体患者对上消化道疾病生活质量的评估（1.15±0.16 与 1.44±0.16，P<0.05）和服装和饮食领域。与安慰剂和基线相比，普芦卡必利使胃半排空时间显著加快（98±10 与 143±11 和 126±13 分钟，P=0.005 和<0.001）。当仅考虑特发性胃轻瘫亚组时，也发现了这些显著改善。
在一组主要为特发性胃轻瘫的患者中，普芦卡必利治疗 4 周可显著改善症状和生活质量，并与安慰剂相比增强胃排空。
