[Effects of different triple therapies on duodenal ulcer-associated Helicobacter pylori infection and a one-year follow-up study].

OBJECTIVE

To evaluate the effects of different triple therapies on healing of duodenal ulcer associated with Helicobacter pylori (Hp) infection; Hp eradication; and ulcer recurrence.

METHOD

248 patients with Hp-associated active duodenal ulcer confirmed by endoscopy, 193 males and 55 females, were randomized to receive OAC(250): omeprazole (0.20 mg bid) + amoxicillin (1000 mg bid) + clarithromycin (250 mg bid), for 1 week (group A1) or 2 weeks (group A2); OAC(500): omeprazole (0.20 mg bid) + amoxicillin (1000 mg bid) + clarithromycin (500 mg bid), for 1 week (group B1) or 2 weeks (group B2); or OAM: omeprazole (0.20 mg bid) + amoxicillin (1000 mg bid) + metronidazole (400 mg bid), for 1 week (group C1) or 2 weeks (group C2) respectively. Endoscopy and biopsy were performed at least 4 weeks after the end of therapy to unde5rgo histological examination. Rapid urease test was performed. Endoscopy and histological examination and rapid urease test were performed twice again on the patients with the ulcer healed 6 months and one year after so as to observe the recurrence rate.

RESULTS

By protocol analysis the ulcer healing rates of the groups A1, A2, B1, B2, C1, and C2 were 93.3% (42/45), 92.7% (38/41); 89.2% (33/37), 94.9% (37/39); 88.4% (38/43), and 93.0% (40/43) respectively without a significant difference between any 2 groups (all P > 0.05); and the Hp eradication rates of the groups A1, A2, B1, B2, C1, and C2 were 86.7% (39/45), 90.2% (37/41); 89.2% (33/37), 92.3% (36/39); 67.4% (29/43), and 86.0% (37/43) respectively. The Hp eradication rate of OAM for 1-week group was significantly lower than the OAC(250)/OAC(250) for 1-week groups (all P < 0.05), and the Hp eradication rate of OAM for 1-week group was significantly lower than that of the OAM for 2-weeks group (P < 0.05). The 6-month follow-up showed an ulcer recurrence rate of 41.2% (7/17) for the patients without successful Hp eradication and an ulcer recurrence rate of 0% (0/130) for the patients with successful Hp eradication (P < 0.001). One-year follow-up showed an ulcer recurrence rate of 58.9% (10/17) for the patients without successful Hp eradication and an ulcer recurrence rate of 2.3% (3/130) for the patients with successful Hp eradication (P < 0.001).

CONCLUSION

Omeprazole-based triple therapy with clarithromycin and amoxicillin for 1-week is the best regimen for the treatment of patient with Hp positive duodenal ulcer disease. Omeprazole-based triple therapies have achieved the highest eradication rates and lowest ulcer recurrence rates.