摘要：

DISCLOSURE This work was supported by TAP Pharmaceutical Products, Inc. Lake Forest, Illinois, and Abbott Laboratories, Abbott Park, Illinois. Background: The impact of various Helicobacter pylori eradication regimens in patients with uninvestigated dyspepsia is controversial. Objective: To compare symptom relief, tolerability, and treatment compliance among Hpylori-positive subjects with uninvestigated ulcer-like dyspepsia treated with 2 widely used Hpylori-eradication regimens. Methods: Patients were randomized to a 2-week course of either bismuth subsalicylate, metronidazole, tetracycline, and cimetidine or lansoprazole, amoxicillin, and clarithromycin. Antacid tablets were taken as needed for pain and discomfort. Primary endpoints evaluated were symptom relief, medication compliance, tolerance, and Hpylori eradication rates. Results: Sixty of the 62 patients (mean age 50 years) enrolled completed the study. The patients treated with lansoprazole-based regimen consumed fewer antacid tablets (10.1 versus 27.2 tablets, P=0.013) and were more compliant with their regimen (92.9% versus 62.1%, respectively, P=0.006). A greater incidence of moderate-to-severe adverse events was reported among the patients treated with the bismuth-based regimen when compared with the lansoprazole group (38.7% versus 13.8%, P=0.029). A 7-point gastrointestinal symptom rating scale was used. Symptoms in both groups improved significantly at 8 weeks compared to baseline (1.65 versus 1.18, P=0.0008). Hpylori eradication was achieved in 86.8% of all patients. Conclusions: Treatment with the lansoprazole-based Hpylori-eradication regimen produced higher symptom relief and patient compliance compared with treatment with the bismuth-based regimen in Hpylori-positive patients with uninvestigated dyspepsia. KEY WORDS: lansoprazole, Helicobacter pylori, symptom relief, compliance, tolerability, uninvestigated dyspepsia INTRODUCTION Helicobacter pylori is a common organism that infects approximately one third of all Americans and more than 50% of individuals worldwide. (1) Dyspepsia, defined by the Rome II criteria as "pain or discomfort centered in the upper abdomen," is also common and affects 15% to 20% of the adults, although only a fraction of these seek health care. (2-4) Substantial controversy surrounds the impact of Hpylori eradication on the prevalence of dyspepsia symptoms. (5-8) Although randomized, controlled clinical trials have shown no or marginal benefits for patients with non-ulcer dyspepsia, other studies have suggested a reduction in symptoms and health care costs following the treatment of Hpylori in patients with uninvestigated dyspepsia. (9,10) Numerous regimens have been developed and approved by the Food and Drug Administration for the treatment of patients infected with H pylori. These regimens combine antimicrobial agents (including bismuth compounds) with an antisecretory agent such as a proton pump inhibitor (PPI) or a histamine-2 receptor antagonist (H2RA). While none of these therapies have been shown to produce H pylori eradication in 100% of patients, several regimens, and in particular the PPI-based triple therapy regimen (combination of a PPI with clarithromycin and amoxicillin) and the BMT quadruple regimen (combination of bismuth, metronidazole, tetracycline (BMT) and a H2RA) consistently achieve eradication rates exceeding 85% and 77%, respectively. (11-19) However, due to the complexity of the bismuth-based quadruple regimen, the PPI-based triple therapy regimen represents the current first-line treatment for patients with H pylori. The BMT regimen is often used when cost and/or treatment failure is an...

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