Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Am J Gastroenterol. 2010 Jul;105(7):1504-12. doi: 10.1038/ajg.2010.82. Epub 2010 Mar 23.
Esophageal hypersensitivity is currently believed to have a crucial role in the pathogenesis of functional chest pain (FCP). The aim of this study was to evaluate the clinical efficacy of venlafaxine, a serotonin-norepinephrine reuptake inhibitor (SNRI), for FCP in young adult patients.
Patients diagnosed with FCP were randomized to either an extended-release formulation of venlafaxine (75 mg hora somni) or a placebo for 4 weeks. After a washout period of 2 weeks, patients crossed over to the other arm of the study. The primary efficacy variable was the number of patients with >50% improvement in symptom scores. The secondary efficacy variables were (i) the symptom intensity score during each week, (ii) quality of life (QOL), (iii) the Beck Depression Inventory (BDI) score, and (iv) side effects.
A total of 43 patients (37 men, mean age 23.5 + or - 1.9 years) completed the study. A positive response was observed in 52.0% of patients during venlafaxine treatment; 4.0% had a positive response with placebo treatment as assessed by the intention-to-treat analysis (venlafaxine vs. placebo: odds ratio 26.0; 95% confidence interval 5.7-118.8; P<0.001). Results of Short-Form 36 (SF-36) indicated that patients who received venlafaxine treatment had a significantly greater improvement in body pain and emotional role compared with those who received placebo treatment (P=0.002 and P=0.002, respectively). No significant change was noted in the depression score after venalafaxine or placebo treatment. One patient withdrew from the study because of sleep disturbance and loss of appetite while receiving venlafaxine.
Venlafaxine, an SNRI antidepressant, significantly improved symptoms in young adult patients with FCP.
食管高敏性目前被认为在功能性胸痛(FCP)的发病机制中起着关键作用。本研究旨在评估 5-羟色胺去甲肾上腺素再摄取抑制剂(SNRI)文拉法辛治疗青年 FCP 患者的临床疗效。
将诊断为 FCP 的患者随机分为文拉法辛缓释片(75 毫克睡前服用)组或安慰剂组,疗程 4 周。2 周洗脱期后,患者交叉至另一组。主要疗效变量是症状评分改善>50%的患者比例。次要疗效变量包括:(i)每周症状严重程度评分,(ii)生活质量(QOL),(iii)贝克抑郁量表(BDI)评分和(iv)不良反应。
共有 43 例患者(37 例男性,平均年龄 23.5±1.9 岁)完成了研究。意向治疗分析显示,文拉法辛治疗组有 52.0%的患者有阳性反应,安慰剂组有 4.0%的患者有阳性反应(文拉法辛与安慰剂:比值比 26.0;95%置信区间 5.7-118.8;P<0.001)。健康调查简表 36 项(SF-36)结果表明,接受文拉法辛治疗的患者在身体疼痛和情绪角色方面的改善明显优于接受安慰剂治疗的患者(P=0.002 和 P=0.002)。文拉法辛或安慰剂治疗后抑郁评分无显著变化。1 例患者因使用文拉法辛时出现睡眠障碍和食欲丧失而退出研究。
SNRI 类抗抑郁药文拉法辛显著改善了青年 FCP 患者的症状。