Efficacy of tailored second-line therapy of Helicobacter pylori eradication in patients with clarithromycin-based treatment failure: a multicenter prospective study

Abstract

Background: After the failure of clarithromycin-and bismuth-based quadruple therapy (CBQT), levofloxacin-and bismuth-based quadruple therapy (LBQT) is recommended for Helicobacter pylori eradication. We compared the efficacies of second-line tailored bismuth-based quadruple therapy (TBQT) and empirical LBQT. Methods: Patients with CBQT failure were randomly assigned to receive TBQT or LBQT for 14 days. All patients underwent endoscopy for culture-based antibiotic susceptibility testing. Patients in the TBQT group exhibiting levofloxacin susceptibility were randomized to receive amoxicillin, levofloxacin, esomeprazole, and colloidal bismuth pectin (ALEB) or amoxicillin, furazolidone, esomeprazole, and colloidal bismuth pectin (AFEB) for 14 days; patients with levofloxacin resistance received AFEB. Results: From May 2016 to June 2019, 364 subjects were enrolled. Eradication rates were significantly higher in the TBQT group (n = 182) than in the LBQT group (n = 182) according to both intention-to-treat (ITT) analysis (89.6% vs. 64.8%, P < 0.001) and per protocol (PP) analysis (91.1% vs. 67.8%, P < 0.001). Among patients in the TBQT group with levofloxacin susceptibility, eradication rates were similar in the ALEB (n = 51) and AFEB (n = 50) subgroups according to both the ITT (86.3% vs. 90.0%, P = 0.56) and PP (88.0% vs. 90.0%, P = 0.75) analyses. Isolated clarithromycin and levofloxacin resistance rates were 57.7% and 44.5%, respectively. The total clarithromycin and levofloxacin resistance rate in strains with dual or triple resistance was 35.7%. Conclusions: TBQT was more effective than LBQT as a second-line strategy after CBQT failure. In the absence of antibiotic susceptibility testing, AFEB therapy might be used as a rescue therapy to eradicate H. pylori and avoid levofloxacin resistance. Trial registration: Chinese Clinical Trial Registry (www.chict r.org.cn): ChiCTR1900027743.

The effect of previous eradication failure on antibiotic resistance of Helicobacter pylori: A retrospective study over 8 years in Beijing

“…Although not included in our study, furazolidone has low antibiotic resistance rate against H. pylori in China according to published data. [37][38][39] The bismuth-quadruple therapy containing AMX plus furazolidone could achieve an eradication rate of more than 80% in both first-line and rescue therapy, which was better than other traditional therapies. 37,40 Bismuth quadruple therapy with TET plus furazolidone could also achieve an eradication rate of 91.7% in ITT analysis for patients who failed from previous treatment.…”

“…Although not included in our study, furazolidone has low antibiotic resistance rate against H . pylori in China according to published data 37–39 . The bismuth‐quadruple therapy containing AMX plus furazolidone could achieve an eradication rate of more than 80% in both first‐line and rescue therapy, which was better than other traditional therapies 37,40 .…”

Culture-based antibiotic susceptibility testing for Helicobacter pylori infection: a systematic review

“…A total of 31 studies reported data on therapeutic outcomes [ 31 - 61 ]. Of these, 19 studies compared the cure rates between culture-tailored and empiric therapies [ 31 - 42 , 52 - 58 ], whilst only the cure rates of tailored therapies were reported in the remaining 12 studies [ 43 - 51 , 59 - 61 ].…”

Susceptibility testing alone will not reliably achieve high Helicobacter pylori cure rates: A systematic review and meta‐analysis

“…Studies reporting duplicate data were excluded. After careful evaluation of the full texts, 48 studies reported detailed regimen and their eradication rates according to antibiotic resistances were finally included 4,5,12–57 …”