Yan Bing, Wang Shimin, Chen Jian, Zhong Xiaolin, Wang Bangmao, Wu Yumei, Wu Ji, Zhang Nina, Sun Jing, Zou Duowu
Chongqing Medical University, The Second Affiliated Hospital, Department of Gastroenterology - Chongqing, China.
Zhaoqing First People's Hospital, Department of Gastroenterology - Zhaoqing, China.
Rev Assoc Med Bras (1992). 2025 May 2;71(3):e20241628. doi: 10.1590/1806-9282.20241628. eCollection 2025.
Cinitapride, a gastrointestinal prokinetic, is commonly used for treating functional dyspepsia. However, large-scale, real-world data on its efficacy, especially in patients with overlapping symptoms, are limited. The aim of this study was to evaluate the clinical effectiveness and safety of cinitapride in Chinese patients with functional dyspepsia, including those with overlapping symptoms, in a real-world setting.
In this single-arm, prospective, multicentric study, 1,012 Chinese outpatients with functional dyspepsia and functional dyspepsia overlapping with gastroesophageal reflux disease, irritable bowel syndrome, and/or functional constipation were treated with cinitapride (1 mg t.i.d.) from May 2019 to March 2021. Symptom improvement was assessed at weeks 2 and 4, with adverse events recorded.
At weeks 2 and 4, the overall symptom improvement rate was 62.4 and 90.9%, respectively. Subgroup improvement rates were as follows: functional dyspepsia-gastroesophageal reflux disease, 86.8%; functional dyspepsia-irritable bowel syndrome, 96.2%; functional dyspepsia-functional constipation, 91.7%; and functional dyspepsia-gastroesophageal reflux disease-irritable bowel syndrome, 67.6%. functional dyspepsia patients showed statistically significantly higher improvement than those with overlapping symptoms at weeks 2 (p=0.018) and 4 (p=0.009). The dyspepsia symptom score decreased by 51.0% at week 2 and 74.4% at week 4 (p<0.001). The most common adverse event was asymptomatic electrocardiogram abnormalities (n=8).
Cinitapride is effective and well-tolerated in treating functional dyspepsia and functional dyspepsia-overlapping gastroesophageal reflux disease, irritable bowel syndrome, and functional constipation in Chinese patients.
西沙必利作为一种胃肠促动力药，常用于治疗功能性消化不良。然而，关于其疗效的大规模真实世界数据有限，尤其是在有重叠症状的患者中。本研究旨在评估西沙必利在中国功能性消化不良患者（包括有重叠症状的患者）的真实临床疗效和安全性。
在这项单臂、前瞻性、多中心研究中，2019年5月至2021年3月期间，1012例患有功能性消化不良以及功能性消化不良合并胃食管反流病、肠易激综合征和/或功能性便秘的中国门诊患者接受了西沙必利治疗（1毫克，每日三次）。在第2周和第4周评估症状改善情况，并记录不良事件。
在第2周和第4周，总体症状改善率分别为62.4%和90.9%。亚组改善率如下：功能性消化不良-胃食管反流病，86.8%；功能性消化不良-肠易激综合征，96.2%；功能性消化不良-功能性便秘，91.7%；功能性消化不良-胃食管反流病-肠易激综合征，67.6%。在第2周（p=0.018）和第4周（p=0.009），功能性消化不良患者的改善情况在统计学上显著高于有重叠症状的患者。消化不良症状评分在第2周下降了51.0%，在第4周下降了74.4%（p<0.001）。最常见的不良事件是无症状心电图异常（n=8）。
西沙必利在治疗中国患者的功能性消化不良以及功能性消化不良合并胃食管反流病、肠易激综合征和功能性便秘方面有效且耐受性良好。
