Froehlich F, Gonvers J J, Wietlisbach V, Burnand B, Hildebrand P, Schneider C, Saraga E, Beglinger C, Vader J P
Department of Gastroenterology, Medical Outpatient Department Policlinique Médicale Universitaire/Centre Hospitalier Universitaire Vaudois, Switzerland.
Am J Gastroenterol. 2001 Aug;96(8):2329-36. doi: 10.1111/j.1572-0241.2001.04037.x.
The aim of this study was to assess the still controversial role of treatment of Helicobacter pylori (H. pylori) infection in patients with nonulcer dyspepsia.
We conducted a double-blind, randomized, placebo-controlled, multicenter trial comparing the efficacy of 7 days of eradication treatment (lansoprazole 15 mg b.i.d., amoxicillin I g b.i.d., and clarithromycin 500 mg b.i.d.) with a control treatment (lansoprazole 15 mg b.i.d. and placebo) in H. pylori-infected patients with nonulcer dyspepsia. 13C breath tests were performed at baseline and during follow-up. We assessed patient symptoms, health status (based on the SF-12 questionnaire), patient satisfaction, drug consumption, health care consultation behavior, and absenteeism related to dyspepsia over a 1-yr period.
A total of 74 patients randomized to eradication treatment and 70 patients randomized to placebo were compared. The rate of eradication of H. pylori infection was 75% in the active treatment group and 4% in the placebo group (p < 0.005). The symptom score improved to a similar extent in the group receiving active treatment (-4.0; 95% CI = -5.0 to -3.0) and placebo (-3.6; 95% CI = -4.5 to -2.7). Treatment response was not related to the severity or duration of initial symptoms or to the severity of gastritis on histology. Quality of life scores were comparable at 12 months. There was no significant difference in dyspepsia-related absenteeism or satisfaction with management of NUD. Patients receiving active treatment were more likely not to have had to use any dyspepsia treatment over the 12 months (60.8% vs 44.3%; p = 0.047).
This study did not demonstrate any substantial benefit of curing H. pylori infection in patients with nonulcer dyspepsia. The study adds further evidence that H. pylori is not the main pathogenetic or therapeutic target in these patients.
本研究旨在评估幽门螺杆菌（H. pylori）感染治疗在非溃疡性消化不良患者中仍具争议的作用。
我们开展了一项双盲、随机、安慰剂对照、多中心试验，比较了7天根除治疗（兰索拉唑15毫克，每日两次；阿莫西林1克，每日两次；克拉霉素500毫克，每日两次）与对照治疗（兰索拉唑15毫克，每日两次加安慰剂）对幽门螺杆菌感染的非溃疡性消化不良患者的疗效。在基线和随访期间进行了13C呼气试验。我们评估了患者症状、健康状况（基于SF - 12问卷）、患者满意度、药物消耗、医疗咨询行为以及与消化不良相关的1年内缺勤情况。
共比较了74例随机接受根除治疗的患者和70例随机接受安慰剂治疗的患者。活性治疗组幽门螺杆菌感染根除率为75%，安慰剂组为4%（p < 0.005）。接受活性治疗组（-4.0；95%可信区间=-5.0至-3.0）和安慰剂组（-3.6；95%可信区间=-4.5至-2.7）的症状评分改善程度相似。治疗反应与初始症状的严重程度或持续时间以及组织学上胃炎的严重程度无关。12个月时生活质量评分相当。与消化不良相关的缺勤率或对非溃疡性消化不良管理的满意度无显著差异。接受活性治疗的患者在12个月内更有可能无需使用任何消化不良治疗（60.8%对44.3%；p = 0.047）。
本研究未证明根除幽门螺杆菌感染对非溃疡性消化不良患者有任何实质性益处。该研究进一步证明幽门螺杆菌不是这些患者的主要致病或治疗靶点。
