Introduction

Pediatric prucalopride studies for treatment of gastrointestinal (GI) disorders have reported mixed results. We aimed to assess the safety and effectiveness of prucalopride in functional constipation (FC) with and without upper GI symptoms.

Methods

Retrospective data on patients with FC receiving combined prucalopride and conventional therapy was compared with those receiving conventional therapy alone within 12 months. Thirty patients on combined therapy and those on conventional therapy were each matched on the basis of age, gender, race, and presence of fecal soiling. Response (complete, partial, or no resolution) was compared. Similarly, response to concurrent functional upper GI symptoms (postprandial pain, bloating, weight loss, vomiting, early satiety, or nausea) and dysphagia, as well as adverse effects, were evaluated in the combined group.

Results

Mean age of 57 cases was 14.7 ± 4.9 years and 68% were female. Comorbidities included functional upper GI (UGI) symptoms (84%), dysphagia (12%), mood disorders (49%), and hypermobility spectrum disorder (37%). Unmatched cases reported 63% improvement to FC; response did not differ between the matched cohorts (70% versus 76.6%, p = 0.84). Cases showed a 56% improvement in functional UGI symptoms and 100% in dysphagia. Adverse effects were reported in 30%, abdominal cramps being most common. Four (7%) patients with a known mood disorder reported worsened mood, of which two endorsed suicidal ideation.

Conclusion

Prucalopride efficaciously treated concurrent UGI symptoms and dysphagia in constipated pediatric patients and was overall well tolerated. Preexisting mood disorders seemed to worsen in a small subset of cases.

中文翻译：

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普卢卡必利对伴有或不伴有上肢症状的功能性便秘儿童的安全性和有效性

介绍

儿科普卡必利治疗胃肠道 (GI) 疾病的研究报告了不同的结果。我们的目的是评估普卡必利治疗有或没有上消化道症状的功能性便秘 (FC) 的安全性和有效性。

方法

将接受普卡必利联合常规治疗的 FC 患者的回顾性数据与 12 个月内单独接受常规治疗的患者进行比较。30 名接受联合治疗的患者和接受常规治疗的患者根据年龄、性别、种族和粪便污染情况进行匹配。比较反应（完全、部分或无解决）。同样，在联合组中评估了对并发功能性上消化道症状（餐后疼痛、腹胀、体重减轻、呕吐、早饱或恶心）和吞咽困难以及不良反应的反应。

结果

57 例患者的平均年龄为 14.7 ± 4.9 岁，其中 68% 为女性。合并症包括功能性上消化道 (UGI) 症状 (84%)、吞咽困难 (12%)、情绪障碍 (49%) 和活动过度谱系障碍 (37%)。未匹配的病例报告 FC 改善 63%；匹配队列之间的反应没有差异（70% 与 76.6%，p = 0.84）。病例显示功能性上消化道症状改善了 56%，吞咽困难改善了 100%。30% 的人报告了不良反应，其中腹部痉挛最为常见。四名（7%）患有已知情绪障碍的患者报告情绪恶化，其中两人有自杀意念。

结论

普卢卡必利可有效治疗便秘儿科患者并发的上消化道症状和吞咽困难，并且总体耐受性良好。在一小部分病例中，先前存在的情绪障碍似乎恶化了。