[The clinical applications of rabeprazole either alone or combined with anti-Helicobacter pylori agents in peptic ulcer patients].

OBJECTIVE

To study the efficacy and safety of rabeprazole in peptic ulcer patients alone or combined with anti-Helicobacter pylori (Hp) agents.

METHODS

An open labeled multi-center clinical trial was designed. Different types peptic ulcer patients identified by endoscopy were recruited from 24 provinces and cities in China. They were given rabeprazole alone 10 mg/d for 7 days continuously (rabeprazole alone group), or combined anti-Hp protocol (including rabeprazole 10 mg, b.i.d., 5 or 7 days) (combination group) respectively by doctors according to their disease situations. Their symptoms and side effects during the therapy were recorded.

RESULTS

This study included 25 609 patients in total with 11 386 in rabeprazol alone group and 14 223 in combination and following diseases as gastric ulcer, duodenal ulcer, complex ulcer, esophageal ulcer, stress ulcer and anastomotic ulcer. The effective rates relieving epigastric pain was 63.0%, 91.2%, 99.2% and 99.7%, respectively, with elimination rates of 16.0%, 47.8%, 80.3%, 94.8%, respectively on the 1st, 2nd, 5th and 7th day. The effective rate to relieve all symptoms on the 1st, 2nd, 5th and 7th day was 42.0%, 78.0%, 93.1% and 98.3%. No statistical differences between rabeprazole alone group and combined group. 476 patients (1.9%) developed mild side effects during the therapy, labeprazole alone group of 147 (1.3%), and combined group of 329 (2.3%), P < 0.01. No severe side effects occurred.

CONCLUSIONS

Whether labeprazole was used alone or combined with anti-Hp agents, it is an effective and safe therapy for the treatment of peptic ulcer.