Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, Nationwide Children's Hospital, Columbus, OH, USA.
Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Pediatric Gastroenterology, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.
Paediatr Drugs. 2021 May;23(3):307-314. doi: 10.1007/s40272-021-00444-4. Epub 2021 Apr 20.
Linaclotide is a well-tolerated and effective agent for adults with functional constipation (FC) or irritable bowel syndrome with constipation (IBS-C). However, data in children are lacking. The aim of this study is to examine the efficacy and safety of linaclotide in children.
We performed a retrospective review of children < 18 years old who started linaclotide at our institution (Nationwide Children's Hospital, Columbus, Ohio). We excluded children already using linaclotide or whom had an organic cause of constipation or abdominal pain. We recorded information on patient characteristics, medical and surgical history, symptoms, clinical response, course of treatment, and adverse events at baseline, first follow-up, and after 1 year of linaclotide use. A positive clinical response was based on the physician's global assessment of symptoms at the time of the visit as documented.
We included 93 children treated with linaclotide for FC (n = 60) or IBS-C (n = 33); 60% were female; median age was 14.7 years (IQR 13.2-16.6). Forty-five percent of patients with FC and 42% with IBS-C had a positive clinical response at first follow-up a median of 2.5 and 2.4 months after starting linaclotide, respectively. Approximately a third of patients experienced adverse events and eventually 27% stopped using linaclotide due to adverse events. The most common adverse events were diarrhea, abdominal pain, nausea, and bloating.
Nearly half of children with FC or IBS-C benefited from linaclotide, but adverse events were relatively common. Further prospective, controlled studies are needed to confirm these findings and to identify which patients are most likely to benefit from linaclotide.
利那洛肽在成人功能性便秘（FC）或便秘型肠易激综合征（IBS-C）中具有良好的耐受性和疗效。但目前缺乏儿童患者的数据。本研究旨在评估利那洛肽在儿童患者中的疗效和安全性。
我们对在我院（哥伦布，俄亥俄州全国儿童医院）开始使用利那洛肽的<18 岁儿童进行了回顾性研究。我们排除了已使用利那洛肽或存在便秘或腹痛的器质性原因的儿童。我们记录了患者特征、医疗和手术史、症状、临床反应、治疗过程和不良反应在基线、首次随访和使用利那洛肽 1 年后的情况。临床反应阳性是基于就诊时医生对症状的总体评估。
我们纳入了 93 名接受利那洛肽治疗 FC（n=60）或 IBS-C（n=33）的儿童；60%为女性；中位年龄为 14.7 岁（IQR 13.2-16.6）。45%的 FC 患者和 42%的 IBS-C 患者在开始利那洛肽治疗后 2.5 和 2.4 个月时首次随访时出现临床反应阳性。约三分之一的患者出现不良反应，最终 27%的患者因不良反应停止使用利那洛肽。最常见的不良反应是腹泻、腹痛、恶心和腹胀。
近一半的 FC 或 IBS-C 儿童患者从利那洛肽中获益，但不良反应较为常见。需要进一步进行前瞻性、对照研究以确认这些发现，并确定哪些患者最有可能从利那洛肽中获益。
