| Objective To compare the safety and efficacy of eprazole based bismuth quadruple 14 days,bismuth quadruple 10 days regimen and double therapy 14 days regimen as the first-line treatment for eradication of Helicobacter pylori infection.Methods This is an open,randomized,single center study.450 patients with untreated Helicobacter pylori infection were randomly divided into three groups: bismuth quadruple 14 days group(iprazole 5mg,twice a day,bismuth glycyrrhizinate 220 mg,twice a day,amoxicillin 1.0g,twice a day,furazolidone 0.1g,twice a day,course of 14 days),bismuth quadruple 10 days group(iprazole 5mg,twice a day,Bismuth glycyrrhizinate 220 mg,twice a day,amoxicillin 1.0g,twice a day,furazolidone 0.1g,twice a day,course of 10 days)and double therapy 14 days group(eprazole 5mg,twice a day,amoxicillin 0.75g/day,4 times /day,14 days of treatment).13 C urea breath test was performed 4-6 weeks after drug withdrawal to evaluate the eradication results.For the patients who failed in the first treatment,gastric mucosa tissues(2 antrum and 1 body)were taken under gastroscope to culture Helicobacter pylori,detect drug resistance,CYP2C19 gene and globular degeneration.Results In ITT analysis,the eradication rates of Helicobacter pylori were 84.0%(126 /150;95% CI 78.1%-89.9%),79.3%(119 / 150;95% CI 72.8%-85.9%)and 88.0%(132 /150;95% CI 82.7%-93.3%)in bismuth quadruple 14 days group,bismuth quadruple 10 days group and double therapy 14 days group,respectively.In PP analysis,the eradication rates of the three groups were 94.7%(126 / 133;95% CI 90.9%-98.6%),87.5%(119 / 136;95% CI81.9%-93.1%)and 93.0%(132 / 142;95% CI 88.7%-97.2%)respectively.5%(12 / 142),significantly lower than 23.3%(31 / 133)and 20.6%(28 / 136)in bismuth quadruple 14 days group and bismuth quadruple 10 days group(P < 0.01).There was no significant difference in the compliance among bismuth quadruple 14 days group,bismuth quadruple 10 days group and double therapy 14 days group(88.7% vs 90.7% vs 94.7%,P = 0.171).Smoking reduced the efficacy of the double therapy 14 days group(66.7%(16 / 24)for smokers and 98.3%(116 / 118)for non-smokers.The drug cost of double therapy 14 days group(53.95 US dollars)and bismuth quadruple 10 days group(48.26 US dollars)was lower than that of bismuth quadruple 14 days group(67.56 US dollars).The drug resistance rate of amoxicillin,furazolidone,tetracycline,clarithromycin,metronidazole and levofloxacin was 12.5%(2 / 16),12.5%(2 / 16),0%(0 / 16),75.0%(12 / 16),93.8%(15 / 16)and 81.3%(13 / 16),respectively.The value of CYP2C19 polymorphism was 55.9%(19/34),35.3%(12/34)and8.8%(3/34),respectively.Conclusion Compared with bismuth quadruple therapy for 14 days,eprazole based double therapy 14 days and bismuth quadruple therapy for 10 days newly diagnosed patients with H.pylori have similar therapeutic effect and low cost,which can be considered as the first-line scheme for empirical treatment. |
