临床表现和人格因素作为功能性消化不良患者的疗效预测指标:一项随机、双盲、安慰剂对照的交叉试验  

Clinical presentation and personality factors are predictors of the response to treatment in patients with functional dyspepsia:A randomized,double-blind placebo-controlled crossover study

作　　者：Holtmann G. Kutscher S.-U. Haag S. 郝筱倩 

机构地区：[1]University of Essen, Department of Internal Medicine,Div. of Gastroenterol. and Hepatol.,Hufelandstr.55, 45122 Essen, Germany

出　　处：《世界核心医学期刊文摘（胃肠病学分册）》2005年第1期10-10,共1页Core Journals in Gastroenterology

摘　　要：The role of psychological factors or symptom pattern for the response to treatment in patients with unexplained (functional)dyspepsia is unknown. We hypothesized that patients with reflux-and ulcerlike symptoms would be more likely to respond to acid-lowering therapy, while psychological disturbances would be associated with a less favorable response to treatment. Seventy-eight patients with a diagnosis of functional dyspepsia were recruited and 75 completed the trial. Patients were treated for 4 weeks in a double-blind, placebo-controlled crossover trial starting in random order with either active drug(ranitidine, 150 mg b.d.) or placebo. Every 7 days, medication was switched from active drug to placebo, or vice versa. At entry, patient characteristics were assessed utilizing a semistructured standardized interview and standardized questionnaires,and weekly intensity of symptoms was assessed utilizing a visual analogue scale. Patients with a greater reduction of the symptom score during active treatment and an overall reduction of the global symptom score by more than 50% at the end of the study period were categorized as responders. Logistic regression analysis was utilized to assess the influence of symptom type and presence of psychological disturbances on the treatment response. During treatment the symptom score decreased significantly, from 32.1 ± 1.44 (SD) to 21.3 ± 1.9 at the end of the trial (P < 0.001). Twenty of 75 were responders.High scores for somatization (OR, 3.6; 95% Cl,1.2-11.4), anxiety (OR, 3.3; 95% Cl, 0.9-11.8), and reflux-like symptoms (OR, 5.3; 95% Cl, 1.7-16.7) were associated with response to treatment, while dysmotility-like symptoms were associated with an unfavorable response (OR, 0.3; 95% Cl,0.1-0.9). Symptom pattern and psychological disturbances are independent predictors of treatment response. Patients with reflux-like symptoms and greater psychological disturbances are more likely to respond to an acid-lowering compound.The role of psychological factors or symptom pattern for the response to treatment in patients with unexplained (functional)dyspepsia is unknown. We hypothesized that patients with reflux-and ulcerlike symptoms would be more likely to respond to acid-lowering therapy, while psychological disturbances would be associated with a less favorable response to treatment. Seventy-eight patients with a diagnosis of functional dyspepsia were recruited and 75 completed the trial. Patients were treated for 4 weeks in a double-blind, placebo-controlled crossover trial starting in random order with either active drug(ranitidine, 150 mg b.d.) or placebo. Every 7 days, medication was switched from active drug to placebo, or vice versa. At entry, patient characteristics were assessed utilizing a semistructured standardized interview and standardized questionnaires,and weekly intensity of symptoms was assessed utilizing a visual analogue scale. Patients with a greater reduction of the symptom score during active treatment and an overall reduction of the global symptom score by more than 50% at the end of the study period were categorized as responders. Logistic regression analysis was utilized to assess the influence of symptom type and presence of psychological disturbances on the treatment response. During treatment the symptom score decreased significantly, from 32.1 ± 1.44 (SD) to 21.3 ± 1.9 at the end of the trial (P < 0.001). Twenty of 75 were responders.High scores for somatization (OR, 3.6; 95% Cl,1.2-11.4), anxiety (OR, 3.3; 95% Cl, 0.9-11.8), and reflux-like symptoms (OR, 5.3; 95% Cl, 1.7-16.7) were associated with response to treatment, while dysmotility-like symptoms were associated with an unfavorable response (OR, 0.3; 95% Cl,0.1-0.9). Symptom pattern and psychological disturbances are independent predictors of treatment response. Patients with reflux-like symptoms and greater psychological disturbances are more likely to respond to an acid-lowering compound.

关 键 词：交叉试验 疗效预测 安慰剂对照 人格因素 动力障碍性 药物制剂 视觉模拟 反应者 隐源性 心理干扰 

分 类 号：R57[医药卫生—消化系统]