Rodriguez-Stanley Sheila, Zubaidi Sattar, Proskin Howard M, Kralstein Jeffrey R, Shetzline Michael A, Miner Philip B
Oklahoma Foundation for Digestive Research, Oklahoma City, Oklahoma, USA.
Clin Gastroenterol Hepatol. 2006 Apr;4(4):442-50. doi: 10.1016/j.cgh.2006.01.014.
BACKGROUND & AIMS: Tegaserod, a 5-HT4-receptor partial agonist, effectively treats irritable bowel syndrome with constipation. The role of tegaserod in functional disorders of the upper gastrointestinal (GI) tract is unclear. The aims of this study were to determine if tegaserod improves esophageal pain with mechanical and chemical stimuli, GI symptom profile, and global preference in patients with functional heartburn.
Patients with functional heartburn, as defined by Rome II criteria, underwent esophageal barostat and acid-infusion sensory tests. Mechanical hypersensitivity was required for entry. The baseline GI symptom profile was rated before treatment. Patients were blinded to treatment and randomly assigned to tegaserod 6 mg twice daily or placebo for 14 days, and crossed-over to the alternate treatment after 7 to 10 days of washout. Patients underwent sensory tests and rated GI symptoms after each treatment. Global treatment preference was completed at the end of the study.
Forty-two patients (15 men, 27 women; age, 20-68 y) completed the study. The predominant baseline symptoms in addition to heartburn included upper-abdominal pain, upper-abdominal discomfort, regurgitation, chest pain, early satiety, and postmeal bloating. Tegaserod significantly increased balloon pressure to pain (P = .04) and the mean (P = .002) and maximum wall tension at pain (P = .0004). Tegaserod did not alter pain with acid infusion. Tegaserod significantly decreased the frequency of occurrence of heartburn/acid reflux (P = .004), regurgitation (P = .048), and distress from regurgitation (P = .039). The global preference for tegaserod was 63.4% vs 12.2% for placebo.
Tegaserod improved the esophageal pain threshold to mechanical distention, and distressing upper-GI symptoms in patients with functional heartburn.
替加色罗是一种5-羟色胺4（5-HT4）受体部分激动剂，可有效治疗便秘型肠易激综合征。替加色罗在上消化道（GI）功能紊乱中的作用尚不清楚。本研究旨在确定替加色罗是否能改善功能性烧心患者在机械和化学刺激下的食管疼痛、胃肠道症状谱以及总体偏好。
符合罗马II标准定义的功能性烧心患者接受食管压力测定仪和酸灌注感觉测试。入组要求存在机械性超敏反应。在治疗前对基线胃肠道症状谱进行评分。患者对治疗方案不知情，并被随机分配至每日两次服用6毫克替加色罗或安慰剂，疗程为14天，洗脱7至10天后交叉接受另一种治疗。每种治疗后，患者接受感觉测试并对胃肠道症状进行评分。在研究结束时完成总体治疗偏好评估。
42例患者（15例男性，27例女性；年龄20 - 68岁）完成了研究。除烧心外，主要的基线症状包括上腹部疼痛、上腹部不适、反流、胸痛、早饱感和餐后腹胀。替加色罗显著提高了引起疼痛的球囊压力（P = 0.04）以及疼痛时的平均（P = 0.002）和最大壁张力（P = 0.0004）。替加色罗未改变酸灌注引起的疼痛。替加色罗显著降低了烧心/胃酸反流的发生频率（P = 0.004）、反流的发生频率（P = 0.048）以及反流引起的不适（P = 0.039）。对替加色罗的总体偏好为63.4%，而安慰剂为12.2%。
替加色罗提高了功能性烧心患者对机械扩张的食管疼痛阈值，并改善了令人困扰的上消化道症状。
