Comparative study on eradication therapy of 1 440 newly diagnosed patients with Helicobacter pylori infection

Abstract

Objective To evaluate the efficacy and safety of common therapy and individualized treatment in newly diagnosed patients with Helicobacter pylori (H. pylori) infection. Methods From March 2008 to February 2010, September 2013 to April 2014, January to October 2015, a total of 1 440 patients with H.pylori infection who received eradication therapy and with complete clinical data were retrospectively enrolled. Each was 350 cases in individualized treatment group, clarithromycin and bismuth containing quadruple therapy group and concomitant therapy group. A total of 100 cases were in standard triple therapy group, 90 cases in sequential therapy group, and 200 cases in levofloxacin and bismuth-containing quadruple therapy group. The eradication rate of H.pylori, incidence of adverse events and compliance rate were compared in the six groups. Chi square test was performed for statistical analysis. Results The results of intention-to-treat analysis indicated that there was no statistically significant difference in H.pylori eradication rates among six groups (χ2=0.985, P=0.323). However, the results of modified intention-to-treat analysis showed that H.pylori eradication rate of individualized treatment group was the highest (92.5% (282/305) and 93.3% (278/298)), second was levofloxacin and bismuth-containing quadruple therapy group (90.3% (167/185) and 91.6% (164/179)), and the differences were statistically significant (χ2=11.285 and 13.981, both P<0.01). There was statistically significant difference in indcidence of adverse events among the six groups (χ2=5.692, P=0.018), the incidence of adverse events in levofloxacin and bimuth-containing quadruple therapy group was lowest (16.2% (30/185)), and second was individualized treatment group (21.0% (64/305)). There was statistically significant difference in compliance rates among the six groups (χ2=4.712, P=0.023), the compliance rates of standard triple therapy group and sequential therapy group were highest (100% (100/100) and 100% (90/90)), and second was individualized treatment group (97.7% (298/305)). Conclusions Both the levofloxacin and bimuth-containing quadruple therapy group and individualized treatment group can effectively eradicate H.pylori infection. The former may be safe and effective to patients unable to receive individualized therapy. Key words: Helicobacter pylori; Eradication rate; Compliance; Safety; Individualized