A clinical trial to study the failure of treating initial Helicobacter pylori eradication with the doxycycline,amoxicillin and clavulanate potassium containing rescue quadruple regimen / 实用医学杂志

ABSTRACT

Objectives To investigate the efficacy and safety of quadruple regimen containing doxycy-cline,amoxicillin and clavulanate potassium in the treatment of Helicobacter pylori(Hp)after the failed initial eradication. Methods A total of 136 patients who had a failed course of initial eradication therapy were randomly divided into four groups. The 46 patients in group A were given rabeprazole,colloidal bismuth tartrate,doxycy-cline,amoxicillin and clavulanate potassium for 14 days). The 45 cases in group B were treated with rabeprazole, colloidal bismuth tartrate,doxycycline,amoxicillin and clavulanate potassium for 10 days. The 45 cases in control group received rabeprazole,colloidal bismuth tartrate,levofloxacin,amoxicillin for 14 days. After 4 weeks of treat-ment,the 13C-urea breath test was performed. The Hp eradication rates,adverse reactions,treatment compliance and cost-effectiveness ratio of the three groups were evaluated. Results A total of 130 patients completed the study. The intention to treat(ITT)and Per-protocol(PP)analyses revealed that the eradication rates of the three groups were 71.74% and 76.74%(group A),71.11% and 72.72%(group B),51.11% and 53.49%(control group),respectively. The ITT and PP of group were significantly higher than those of control group(P < 0.05). But there was no significant difference between group B and control group(P > 0.05). The rates of adverse reac-tions in each group were not statistically significant(P > 0.05),and the patient compliance of three groups was more than 80%. The cost and cost-effectiveness ratio showed that group B < control group < group A. Conclu-sions The quadruple therapy containing doxycycline,amoxicillin and clavulanate potassium as a rescue regimen given for 14 days is safe,effective and with high patient compliance,which is of high clinical significance.