文拉法辛缓释片与匹维溴铵治疗无明显情绪障碍腹泻型肠易激综合征的初步研究

Preliminary Study on Effect of Venlafaxine Sustained-release Tablet Combined with Pinaverium Bromide in Treating Diarrhea-predominant Irritable Bowel Syndrome without Mood Disorders

背景:目前对选择性5-羟色胺再摄取抑制剂(SSRIs)可用于治疗伴抑郁或焦虑状态的肠易激综合征(IBS)已基本达成共识,但关于SSRIs治疗无明显情绪障碍IBS的研究相对较少。目的:评价5-羟色胺去甲肾上腺素再摄取抑制剂文拉法辛缓释片与匹维溴铵对无明显情绪障碍、长期反复发作腹泻型IBS(IBS-D)的治疗作用。方法:本临床研究协作组前期关于文拉法辛缓释片与匹维溴铵治疗IBS-D的随机对照多中心研究中,376例患者完成观察。23例经汉密尔顿抑郁量表(HAMD)和汉密尔顿焦虑量表(HAMA)评价为无明显抑郁、焦虑状态者中,对照组7例(口服匹维溴铵8周),试验组16例(口服文拉法辛缓释片与匹维溴铵8周)。比较两组患者的症状评分和HAMD、HAMA评分以及总有效率。结果:服药1周后起,试验组腹痛、腹泻评分和症状总评分均显著低于对照组(P<0.05);服药4周后起,试验组HAMD、HAMA评分亦显著低于对照组(P<0.05)。试验组总体症状改善的总有效率显著高于对照组(87.5%对28.6%,P<0.05)。结论:文拉法辛缓释片与匹维溴铵可改善无明显情绪障碍IBS-D患者的核心症状和不良情绪因子,疗效明显优于单用匹维溴铵。

Background： A consensus has been reached on the effect of selective serotonin reuptake inhibitors （SSRIs） in treating irritable bowel syndrome （IBS） patients complicated with depression or anxiety, however, studies on the effect of SSRIs on IBS without mood disorders are not frequently seen. Aims： To assess the efficacy of venlafaxine sustained-release tablet, a serotonin-norepinephrine reuptake inhibitor, combined with pinaverium bromide in treating recurrent diarrheapredominant IBS （IBS-D） without mood disorders. Methods： In a randomized controlled multicentre study conducted for assessing the efficacy of venlafaxine sustained-release tablet combined with pinaverium bromide on IBS-D, 376 patients completed the observational course. Among them, 23 cases were verified as non-depressed and non-anxious by Hamilton depression scale （HAMD） and Hamilton anxiety scale （HAMA） ; 7 were in control group （given oral pinaverium bromide for 8 weeks） and 16 were in study group （given oral venlafaxine sustained-release tablet combined with pinaverium bromide for 8 weeks）. The symptom score, HAMD score, HAMA score and overall efficacy were compared between the two groups. Results： Scores of abdominal pain, diarrhea and global symptom were significantly lower in study group than in control group after the first week treatment （ P 〈 0.05 ） , while scores of HAMD and HAMA were significantly lower in study group than in control group after the fourth week treatment （ P 〈 0.05 ）. Overall efficacies for improving global symptom in study group and control group were 87.5% and 28.6%, respectively. Statistically significant difference was seen between the two groups （P 〈0. 05 ）. Conclusions： Venlafaxine sustained-release tablet combined with pinaverium bromide is superior to pinaverium bromide alone for improving the core symptoms and mood factors of IBS-D patients without mood disorders.