The efficacy and safety of in addition to antofloxacin-based bismuth quadruple therapy for eradication: a single-center, prospective randomized-control study.

BACKGROUND

We previously reported that antofloxacin-based bismuth quadruple therapy was safe and effective for () eradication. It is not clear whether the addition of () to antofloxacin-based quadruple therapy can improve the eradication rate of and reduce adverse events.

OBJECTIVE

To investigate the effect of adding to antofloxacin-based quadruple therapy on the eradication rate of and the adverse events.

DESIGN

Single-center, prospective randomized controlled study.

METHODS

A total of 172 patients with infection were randomly assigned to the test and control groups. Patients in the control group ( = 86) received antofloxacin-based bismuth quadruple therapy for 14 days. On this basis, cases in the test group ( = 86) received 500 mg b.i.d. The eradication rate of and adverse events were observed 4 weeks after the treatment.

RESULTS

There were no statistically significant differences in the eradication rates of and frequency of diarrhea between the test group and control group ( > 0.05). The duration of diarrhea in the test group was significantly shorter than in the control group ( < 0.001). In addition, the two groups exhibited similar adverse event rates for epigastric pain, abdominal distention, dizzy, vomiting, and rash ( > 0.05). The severity of adverse reactions was similar between the two groups ( > 0.05), and most of them had mild adverse events.

CONCLUSION

Although the addition of to antofloxacin-based quadruple therapy could not improve the eradication rate of , it could shorten the time of antibiotic-associated diarrhea and reduce the incidence of diarrhea.

TRIAL REGISTRATION NUMBER

ChiCTR2200056931.