Division of Gastroenterology and Hepatology, Medical College of Georgia, Georgia Regents University, Augusta, GA, USA.
Section of Gastroenterology and Hepatology, Medical College of Georgia, Georgia Regents University, BBR2540, 1120 15th Street, Augusta, GA 30912, USA.
Therap Adv Gastroenterol. 2014 Sep;7(5):193-205. doi: 10.1177/1756283X14537882.
Constipation-predominant irritable bowel syndrome (IBS-C) is a commonly prevalent and clinically challenging disorder to treat. Until recently, most therapeutic agents had limited ability to address the complexity of symptoms inherent to the syndrome. The development of linaclotide provides a physiologically sound approach to treatment of the multiple symptoms of IBS-C. Clinical trials demonstrate the efficacy of linaclotide, and a platform to better understand the symptomatology of IBS-C. Based on recent clinical evidence, linaclotide should be considered for patients with IBS-C because it improves abdominal pain and bowel symptoms. In phase III trials, linaclotide met the US Food and Drug Administration responder endpoint with a number needed to treat (NNT) of 5.1-7.9, and European Medicines Agency coprimary endpoints at 12 weeks with a NNT of 4.39-7.69, and at 26 weeks with a NNT of 4.93-5.68. It is safe and effective, with diarrhea reported as the most common adverse effect, which leads to discontinuation of the medication in approximately 5% of patients.
以便秘为主要症状的肠易激综合征（IBS-C）是一种常见且具有临床挑战性的疾病。直到最近，大多数治疗药物都难以解决该综合征固有症状的复杂性。利那洛肽的开发为治疗 IBS-C 的多种症状提供了一种合理的生理学方法。临床试验证明了利那洛肽的疗效，并为更好地了解 IBS-C 的症状学提供了一个平台。基于最近的临床证据，利那洛肽应该被考虑用于 IBS-C 患者，因为它可以改善腹痛和肠道症状。在 III 期临床试验中，利那洛肽达到了美国食品和药物管理局（FDA）的应答终点，需要治疗的患者数（NNT）为 5.1-7.9，在欧洲药品管理局（EMA）的 12 周主要终点的 NNT 为 4.39-7.69，在 26 周的 NNT 为 4.93-5.68。它是安全有效的，最常见的不良反应是腹泻，导致约 5%的患者停药。
