Cost-effectiveness analysis of antimicrobial susceptibility testing-guided therapy and empirical quadruple therapy in the treatment of Helicobacter pylori infection / 中华消化杂志

ABSTRACT

Objective:To investigate the cost-effectiveness of Helicobacter pylori ( H. pylori) antimicrobial susceptibility testing-guided therapy versus an effective empiric modified bismuth quadruple therapy for first-line H. pylori treatment. Methods:This cost-effectiveness analysis was based on the data from a multicenter prospective randomized controlled clinical trial (NCT02935010), which included 382 patients with H. pylori infection. Among them, 286 cases were in the antimicrobial susceptibility testing group, which were diagnosed by biopsy under endoscopy. And according to the results of antimicrobial susceptibility testing of H. pylori, patients were treated with triple or quadruple therapy of eradicating H. pylori for 14 days. A total of 96 patients were in empirical therapy group, which were diagnosed by biopsy under endoscopy (96 cases, endoscopy empirical group), who were treated with 14-day empiric bismuth quadruple therapy. At the same time, based on the patients of empirical group, a simulated 13C-urea breath test (UBT) empirical group (UBT empirical group) was set up (96 cases, H. pylori infection was first diagnosed by 13C-UBT examination) and in the cost accounting the expenses related to endoscopy, biopsy and drug sensitivity test were removed and the expense of 13C-UBT was added. The information of patients of endoscopy empirical group was kept. Taking the eradication rate of H. pylori as an effectiveness indicator, the cost, cost-effective ratio (CER), incremental cost-effective ratio (ICER) among antimicrobial susceptibility testing group, endoscopy empirical group and UBT empirical group were compared by intention-to-treat (ITT) analysis and per-protocol (PP) analysis. Sensitivity analysis was conducted based on the results of ITT analysis to evaluate the reliability of the research results. Results:The results of ITT analysis indicated that the cost of antimicrobial susceptibility testing group, endoscopy empirical group and UBT empirical group were (1 747.41±149.30), 1 032.71 and 657.71 Yuan, respectively. The cost of antimicrobial susceptibility testing group was (714.70±149.30) and (1 089.70±149.30) Yuan higher than that of the endoscopy empirical therapy group and UBT empirical therapy group, respectively. The CER of antimicrobial susceptibility testing group, endoscopy empirical group and UBT empirical group were (19.08±1.49), 12.09 and 7.70 Yuan/%, respectively. ICER of antimicrobial susceptibility testing group was (115.27±1.49) and (175.76±1.49) Yuan /% in comparison with the endoscopy empirical group and the UBT empirical therapy group. Compared with that of empirical group, the ICER of antimicrobial susceptibility testing group was more likely to be affected by H. pylori eradication rate and the cost of antimicrobial susceptibility testing. When the H. pylori eradication rate decreased in the empirical group, the ICER of the antimicrobial susceptibility testing group also decreased; when the H. pylori eradication rate increased in antimicrobial susceptibility testing group, the ICER decreased, and vice versa. When the cost of antimicrobial susceptibility test was upregulated or downregulated by 20%, for every 1% increase in the eradication rate of H. pylori in comparison with that of the endoscopy empirical group, the cost of the antimicrobial susceptibility testing group increased by 99.15 and 131.40 Yuan; in comparison with that of the UBT empirical group, the cost of the antimicrobial susceptibility testing group increased by 159.63 and 191.89 Yuan. Conclusions:For patients diagnosed with H. pylori infection by 13C-UBT and without indications for endoscopy examination, the empirical quadruple therapy is the first choice. For patients intended to do endoscopy to confirm H. pylori infection, with additional affordability of 115.27 Yuan for every 1% increase in the eradication rate of H. pylori, antimicrobial susceptibility testing can be conducted and personalized. H. pylori eradication therapy can be carried out based on the results of antimicrobial susceptibility test. Reduced cost of the antimicrobial susceptibility test will be more conductive to the promotion of personalized treatment after antimicrobial susceptibility test.