Baysal Birol, Şentürk Hakan, Masri Omar, Tozlu Mukaddes, Kayar Yusuf, Arabacı Elif, Uysal Ömer, Buğdacı Mehmet Sait, İnce Ali Tüzün
Department of Gastroenterology, Bezmialem Vakif University Faculty of Medicine, İstanbul, Turkey.
Turk J Gastroenterol. 2015 Jan;26(1):6-14. doi: 10.5152/tjg.2015.0010.
BACKGROUND/AIMS: This study aimed to test the efficacy of empirical proton pump inhibitor use and Helicobacter pylori therapy for uninvestigated dyspepsia in a population with a high prevalence of H. pylori.
The study had a two-stage design. In the first stage, the efficacy of 4-week pantoprazole treatment was compared with placebo in patients with uninvestigated dyspepsia. In the second stage, the efficacies of 2-week treatment with pantoprazole in H. pylori-negative patients and H. pylori eradication therapy (pantoprazole + amoxicillin + clarithromycin) in H. pylori-positive patients were compared. The primary endpoint was sufficient overall symptom relief (Global Overall Symptom score ≤2; no or minimal symptoms) at the end of treatment.
In the first stage, sufficient overall symptom relief was achieved by 25.2% of patients in the pantoprazole group and 15.5% of patients in the placebo group, a difference that was not statistically significant (p=0.06). In the second stage, the rate of sufficient overall symptom relief was higher in the H. pylori therapy group than in the pantoprazole group (37.1% vs. 23.4%; p=0.02). After untreated follow-up, sufficient overall symptom relief remained significantly higher in the H. pylori therapy group than in the pantoprazole group (39.7% vs. 18%; p<0.001). Almost all patients receiving pantoprazole experienced symptom relapse after treatment.
This study validated the use of a test-and-treat strategy against H. pylori in uninvestigated dyspepsia, which may be an advisable treatment approach for uninvestigated dyspeptic patients in countries with a high prevalence of H. pylori.
背景/目的：本研究旨在测试经验性使用质子泵抑制剂和幽门螺杆菌治疗对幽门螺杆菌高流行人群中未经检查的消化不良的疗效。
本研究采用两阶段设计。在第一阶段，比较了泮托拉唑4周治疗对未经检查的消化不良患者与安慰剂的疗效。在第二阶段，比较了泮托拉唑对幽门螺杆菌阴性患者2周治疗的疗效以及幽门螺杆菌阳性患者的幽门螺杆菌根除治疗（泮托拉唑+阿莫西林+克拉霉素）的疗效。主要终点是治疗结束时总体症状充分缓解（总体症状评分≤2；无或轻微症状）。
在第一阶段，泮托拉唑组25.2%的患者和安慰剂组15.5%的患者实现了总体症状充分缓解，差异无统计学意义（p = 0.06）。在第二阶段，幽门螺杆菌治疗组总体症状充分缓解率高于泮托拉唑组（37.1%对23.4%；p = 0.02）。未经治疗的随访后，幽门螺杆菌治疗组总体症状充分缓解率仍显著高于泮托拉唑组（39.7%对18%；p < 0.001）。几乎所有接受泮托拉唑治疗的患者在治疗后都出现了症状复发。
本研究验证了在未经检查的消化不良中采用检测和治疗幽门螺杆菌策略的有效性，这对于幽门螺杆菌高流行国家中未经检查的消化不良患者可能是一种可取的治疗方法。
