Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.
J Gastroenterol Hepatol. 2018 Feb;33(2):411-417. doi: 10.1111/jgh.13914.
BACKGROUND AND AIM: Current treatments of functional dyspepsia (FD) are unsatisfied. Tricyclic antidepressants alter visceral hypersensitivity and brain-gut interaction. We assessed the efficacy and safety of nortriptyline in patients with FD. METHODS: Patients diagnosed with FD according to Rome III criteria who failed to respond to proton pump inhibitor and prokinetic treatment were randomly assigned to either once daily 10-mg nortriptyline or placebo. The primary endpoint was the rate of responders defined as > 50% reduction in dyspepsia symptom score after 8 weeks of treatment. The secondary endpoints were improvement in quality of life as assessed by 36-Item Short Form Health Survey score and safety. RESULTS: Sixty-one patients (nortriptyline 28 and placebo 33) were enrolled. Dyspepsia symptom score and duration of symptoms were balanced at entry between both groups. Eight and seven patients in nortriptyline and placebo groups were lost to follow up. Seven patients withdrew due to mild adverse events (nortriptyline 1 and placebo 6). Overall, 19 with nortriptyline and 20 with placebo completed the study. Patients receiving nortriptyline did not achieve higher response rate than those in placebo in both intention-to-treat (53.6% vs 57.6%, P = 0.75) and per-protocol (76.5% vs 73.7%, P = 1.00) analyses. Nortriptyline did not provide improvement in quality of life. The mean difference was 3.8 (P = 0.36) and 0.88 (P = 0.86) by intention-to-treat and 2.9 (P = 0.57) and 3.5 (P = 0.57) by per-protocol analyses in physical and mental component, respectively. All adverse events were minor and similar in both groups. CONCLUSION: Nortriptyline was not superior to placebo in management of patients with FD.
背景与目的：目前功能性消化不良（FD）的治疗效果并不令人满意。三环类抗抑郁药可以改变内脏高敏性和脑-肠相互作用。我们评估了 10mg 每日一次的去甲替林治疗 FD 的疗效和安全性。
方法：根据罗马 III 标准诊断为 FD 的患者，质子泵抑制剂和促动力治疗失败后，随机分为每日一次 10mg 去甲替林或安慰剂组。主要终点是应答率，定义为治疗 8 周后消化不良症状评分降低≥50%。次要终点是 36 项简短健康调查评分和安全性评估的生活质量改善。
结果：61 例患者（去甲替林 28 例，安慰剂 33 例）入组。两组在入组时消化不良症状评分和症状持续时间平衡。去甲替林和安慰剂组各有 8 例和 7 例失访。因轻度不良反应（去甲替林 1 例，安慰剂 6 例）退出 7 例。共有 19 例（去甲替林）和 20 例（安慰剂）完成了研究。意向治疗（53.6% vs 57.6%，P=0.75）和方案治疗（76.5% vs 73.7%，P=1.00）分析中，去甲替林组的应答率均未高于安慰剂组。去甲替林不能改善生活质量。意向治疗和方案治疗的平均差值分别为 3.8（P=0.36）和 0.88（P=0.86），在生理和心理成分方面分别为 2.9（P=0.57）和 3.5（P=0.57）。所有不良反应均较轻，两组间相似。
结论：去甲替林在 FD 患者的治疗中并不优于安慰剂。
J Gastroenterol Hepatol. 2018-2
Lancet Gastroenterol Hepatol. 2018-10-22
Cochrane Database Syst Rev. 2023-5-10
Neurogastroenterol Motil. 2023-2
Gastroenterol Hepatol (N Y). 2020-2
J Neurogastroenterol Motil. 2020-1-30
Zotero 插件