Prucalopride in Gastroparesis: A Randomized Placebo-Controlled Crossover Study
Prucalopride in Gastroparesis: A Randomized Placebo-Controlled Crossover Study
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DOI：
10.14309/ajg.0000000000000304
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发表时间：
2019-08-01
影响因子：
9.8
通讯作者：
Tack, Jan
中科院分区：
文献类型：
--
作者：
Carbone, Florencia;Van den Houte, Karen;Tack, Jan
目的：促动力疗法被认为是胃轻瘫的首选治疗方案，但其疗效的证据很少。普鲁卡必利是一种选择性的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、安慰剂对照的交叉试验中，我们评估了普鲁卡必利改善胃轻瘫患者胃排空率和症状的疗效。方法：34例胃轻瘫患者(28例特发性，7例男性，平均年龄42+/-13岁)采用双盲交叉试验进行评估，治疗周期为4周，服用安慰剂或普鲁卡必利2 mg，q.d，间隔2周。主要终点是症状严重程度的变化，通过胃轻瘫主要症状指数进行评估；次要终点包括上消化道疾病患者评估-症状严重程度指数、上胃肠道疾病患者评估-生活质量和日常日记，胃排空率通过C-13-辛酸呼吸试验评估。结果：3名患者失去随访。发生1例严重不良反应(普鲁比利组出现小肠扭转)，3例患者因恶心、头痛等不良反应退出治疗(均为普鲁普利)。在整个患者组中，与安慰剂相比，普鲁托必利显著改善了总的胃瘫主要症状指数(1.65+/-0.19vs2.28+/-0.20，P<；0.0001)以及饱腹感/饱腹感、恶心/呕吐和腹胀/膨胀等子量表。普鲁卡必利显著改善了上消化道疾病患者的总体评估--生活质量评分(1.15+/-0.16比1.44+/-0.16，P<；0.05)以及衣着和饮食领域。与安慰剂组和基线组相比，普鲁卡必利组胃半排空时间显著延长(98+/-10分钟比143+/-11分钟和126+/-13分钟，P=0.005和
OBJECTIVES: 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.METHODS: 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-13-octanoic acid breath test.RESULTS: 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