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A randomized clinical trial of ten-day concomitant, sequential and bismuth-based quadruple therapies for Helicobacter pylori
- LI Yueyue, ZUO Xiuli, JI Rui, CHEN Feixue, ZHAO Hongyu, WANG Han, GUO Jing, ZHANG Jingyuan, FU Shanshan, LIU Jianwei, LI Yanqing
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JOURNAL OF SHANDONG UNIVERSITY (HEALTH SCIENCES). 2014, 52(7):
45-49.
doi:10.6040/j.issn.1671-7554.0.2013.750
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Objective To determine the best empiric regimens to eradicate Helicobacter pylori (Hp) in daily clinical work by comparing the efficacy of ten-day concomitant, sequential and bismuth-based quadruple therapies. Methods A total of 226 patients with H.pylori infection proved by rapid urease test (RUT) were randomly divided into 3 groups, and received concomitant therapy (omeprazole 20 mg, amoxicillin 1 000 mg, clarithromycin 500 mg and tinidazole 500 mg), sequential therapy (omeprazole 20 mg, amoxicillin 1 000 mg for the first 5 days, followed by omeprazole 20 mg, clarithromycin 500 mg and tinidazole 500 mg for another 5 days), and bismuth-based therapy (omeprazole 20 mg, amoxicillin 1 000 mg, clarithromycin 500 mg and colloidal bismuth pectin 200 mg), respectively. All regimens were taken twice a day for 10 days. Hp status was confirmed by 13C-urea breath test 6 weeks after completion of treatment, and negative result was considered as successful in Hp eradication. Results In intention-to-treat analysis, the eradication rates of concomitant therapy, sequential therapy and bismuth-based therapy were 85.6%, 70.7%, and 85.3%, respectively. Either concomitant therapy or bismuth-based therapy was significantly superior to sequential therapy (P<0.05). In per-protocol analysis, the eradication rates of the 3 regimens were 87.8%, 82.8% and 88.9%, respectively.And there was no statistic significance between any two of the three groups (P>0.05). Conclusion Ten-day bismuth-based therapy can be adopted as the best empiric regimen to cure Hp infection in clinical work.