ABSTRACT
Objective: To investigate the clinical efficacy and safety of compound bismuth potassium citrate capsules(CBPCC) combined with omeprazole capsules in eradication of Helicobacter pylori (H. pylori) infection. Methods: A total of 240 patients with gastric H. pylori infection were enrolled in this double-blinded, randomized controlled study. Patients in group A(control group) were given a combination of bismuth potassium citrate/tinidazole/clarithromycin tablets and ormprazole capsule(n= 120); those in group B(treatment group) were given compound bismuth potassium citrate capsules and ormprazole capsules (n = 120). H. pylori eradication rates and clinical safety of both treatment regimens were analyzed using SAS 6.12 software system. Results: A total of 236 patients from 6 resreach centers completed in this study, with 117 in group A and 119 in group B. Two patients in the contol group and 8 in the treatment group did not complete the experiment; six patients in the control group were excluded due to other reasons. There were 236 patients entered full analysis sets(FAS), 220 entered per protocol set (PPS), and 236 entered safety analysis sets (SS). FAS showed that the eradication rates of H. pylori were 84.87% in group B and 74.36% in group A(P 0.05), with no severe adverse event found in both groups. The treatment regimen in group B was more cost-effective than that in group A(P<0.05). Conclusion: This study demonstrates that compound bismuth potassium citrate capsules combined with omeprazole capsules have a high efficacy in eradication of H. pylori infection, and it is safe, cost-effective and worth popularizing in clinic.