一个随机的第2阶段研究5-HT4受体激动剂felcisetrag用于术后胃肠功能障碍后肠道手术
Guy Boeckxstaens1, Sabry Ayad2, George Dukes3
1Center of Intestinal Neuroimmune Interaction, Division of Gastroenterology, Translational Research Center for Gastrointestinal Disorders (TARGID), University Hospital Leuven, 3000, Leuven, Belgium.
American journal of surgery
|May 9, 2024
概括
费尔西塞拉格是一种5-基三胺-4受体激动剂,在第二阶段试验中没有显著加速胃肠功能手术后恢复. 药物耐受性很好,但与安慰剂相比,没有显示出临床上有意义的益处.
科学领域:
- 胃肠病学 胃肠病学
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 研究性药物felcisetrag准了5-基三胺-4受体 (5-HT4).
- 5-HT4激动剂正在被探索,以改善外科手术后的胃肠功能.
研究的目的:
- 评估felcisetrag在肠道手术后加速胃肠道恢复的疗效和安全性.
- 为了比较不同剂量方案的felcisetrag与安慰剂.
主要方法:
- 第二阶段,随机化,安慰剂控制,双盲,多中心研究 (NCT03827655).
- 209名成年患者接受开放式或腹腔镜辅助肠道手术.
- 在手术前和/或手术后静脉注射安慰剂或felcisetrag (0.1或0.5毫克).
主要成果:
- 胃肠道功能恢复的中位时间为安慰剂1.9天,而西塞拉格2.6天 (p > 0.05).
- 在felcisetrag和安慰剂组之间没有观察到恢复时间的显著差异.
- 所有治疗手臂的不良事件都是可比的.
结论:
- 在没有新的安全问题的情况下,Felcisetrag表现出良好的耐受性.
- 与安慰剂相比,没有发现胃肠道恢复时间的临床意义上的改善.
- 对复杂的开放腹部手术中5-HT4激动剂的进一步研究可能是有益的.
相关概念视频
Drugs Affecting GI Tract Motility: Serotonin Receptor Agonists
249
Serotonin, a crucial neurotransmitter synthesized by enterochromaffin cells, plays a cardinal role in regulating gastrointestinal (GI) motility. With over 90% of the body's total serotonin in the GI tract, its influence on digestive processes is profound. Serotonin is swiftly released upon various stimuli, such as food boluses or certain drugs, triggering intrinsic sensory neurons in the myenteric plexus and extrinsic vagal and spinal sensory neurons. This leads to the activation of the...
249
Drugs for Treatment of Diarrhea-Predominant IBS
161
Diarrhea-predominant irritable bowel syndrome (IBS-D) is a subtype of IBS characterized primarily by frequent, loose, or watery stools, abdominal pain, and abdominal discomfort. Therapeutic approaches to managing IBS-D include dietary changes, stress management techniques, and pharmaceutical interventions.
Two specific drugs used in the treatment are alosetron (Lotronex) and eluxadoline (Viberzi). Alosetron, a 5-HT3 antagonist, works by slowing the movement of stools in the gut, reducing bowel...
Two specific drugs used in the treatment are alosetron (Lotronex) and eluxadoline (Viberzi). Alosetron, a 5-HT3 antagonist, works by slowing the movement of stools in the gut, reducing bowel...
161
Endoscopic Procedures IV: Sigmoidoscopy and Laproscopy
77
Sigmoidoscopy and laparoscopy are distinct medical procedures that enable physicians to internally inspect different parts of the GI tract. Although they serve different purposes, each is essential for diagnosing and, in some cases, treating various medical conditions.
Sigmoidoscopy
Sigmoidoscopy is a diagnostic procedure that uses a flexible sigmoidoscope equipped with a light source and camera to examine the rectum and sigmoid colon. The procedure involves inserting the tube through the anus...
Sigmoidoscopy
Sigmoidoscopy is a diagnostic procedure that uses a flexible sigmoidoscope equipped with a light source and camera to examine the rectum and sigmoid colon. The procedure involves inserting the tube through the anus...
77
Drugs for Treatment of Constipation-Predominant IBS
160
Pharmacological therapies for IBS-C are designed to alleviate abdominal discomfort and enhance bowel function. In patients with IBS-C, fiber supplements may help soften stools and decrease straining, but may also lead to increased gas production and bloating. Osmotic laxatives like milk of magnesia are frequently used to soften stools and increase stool frequency in IBS-C patients. In addition, two drugs approved for use in severe IBS-C adult cases are linaclotide (Linzess) and lubiprostone...
160
Chemotherapy-Induced Nausea and Vomiting: 5-HT3 Receptor Antagonists
197
5-HT3 receptor antagonists, such as dolasetron, granisetron (Kytril), ondansetron (Zofran), and palonosetron (Axoli), are crucial in managing chemotherapy-induced nausea and vomiting (CINV) and postoperative nausea. These drugs selectively block 5-HT3 receptors in the visceral vagal and spinal afferent nerves, chemoreceptor trigger zone, and the vomiting center. They have a rapid onset of action and can be given as a single dose before chemotherapy. Ondansetron and granisetron, in particular,...
197
Inflammatory Bowel Disease V: Surgical Management
145
Surgical interventions for inflammatory bowel disease (IBD), which includes ulcerative colitis and Crohn's disease, are essential in managing symptoms and addressing complications. The selection of surgical procedures is contingent upon the specific conditions and complications that stem from these illnesses.
Here are some common surgical interventions for IBD:
Here are some common surgical interventions for IBD:
145


