title: Efficacy of real-time PCR-based detection of Helicobacter pylori infection and genotypic resistance-guided quadruple therapy as the first-line treatment for functional dyspepsia with Helicobacter pylori infection.
abstract: BACKGROUND
  The eradication rate of Helicobacter pylori is steadily decreasing because of increasing resistance to clarithromycin. According to the new version of Maastricht IV guidelines, molecular tests can be performed as a substitute for bacterial culture and the standard clarithromycin susceptibility test for the detection of H. pylori and clarithromycin resistance directly on gastric biopsy samples.
  
  
  OBJECTIVE
  To evaluate the clinical efficacy of H. pylori detection using a molecular test and treatment outcomes of the clarithromycin-based genotypic resistance test.
  
  
  METHODS
  A total of 385 patients diagnosed with functional dyspepsia were recruited in this clinical trial. Total DNA was extracted from formalin-fixed paraffin-embedded samples and prepared for a molecular test and H. pylori detection was performed simultaneously by modified Giemsa staining. Genotypically sensitive patients with positive H. pylori were treated by quadruple therapy: bismuth potassium citrate, rabeprazole, amoxicillin, and clarithromycin (BRAC) and genotypically resistant individuals were treated by bismuth potassium citrate, rabeprazole, amoxicillin, and furazolidone (BRAF) twice daily for 7 consecutive days. The eradication rate of H. pylori was assessed using the C-urea breath test at 6 weeks after treatment.
  
  
  RESULTS
  The prevalence of H. pylori infection in functional dyspepsia patients was 35.3% (136/385), 29.1% for women (53/182) and 40.9% for men (83/203). The sensitivities of real-time PCR and histological examinations were 95.6% (130/136) and 69.9% (95/136). Forty-one samples were found to be positive by real-time PCR alone and six by histological examination alone, the majority of which (32/41, 5/6) were identified as grade 1 multiplicity of infection. The overall resistance rate to clarithromycin was 37.7% (49/130): 37.3% (19/51) for women and 38.0% for men (30/79). Eighty-nine patients with positive H. pylori detected by both real-time PCR and histological examinations received quadruple therapies. For the intention-to-treat analysis, the eradication rates of BRAC and BRAF were 98% (52/53) and 92% (33/36), or 100% (52/52) and 94% (33/35) for per-protocol analysis.
  
  
  CONCLUSIONS
  Real-time PCR is efficacious for H. pylori detection and genotypic resistance-guided quadruple therapy has a high efficacy in treating functional dyspepsia with H. pylori infection.
authors: Departments of aPathology bGastroenterology, the First Affiliated Hospital of General Hospital of PLA, Beijing cDepartment of Oncology, Affiliated Zhongshan Hospital of Dalian University, Dalian, China.
authors: Qian
authors: Q
authors: Liu
authors: Dongdong
authors: D
authors: Qi
authors: Jiarui
authors: J
authors: Kang
authors: Yiduo
authors: Y
authors: Jin
authors: Wenxiang
authors: W
authors: Liu
authors: Wenbin
authors: W
authors: Gao
authors: Peng
authors: P
authors: Hou
authors: Jiangyang
authors: J
authors: Lu
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D001944:Breath Tests / Q000379:methods; D017291:Clarithromycin / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D024881:Drug Resistance, Bacterial / Q000235:genetics; D004359:Drug Therapy, Combination / Q000009:adverse effects / Q000379:methods; D004415:Dyspepsia / Q000382:microbiology; D005260:Female; D005838:Genotype; D016481:Helicobacter Infections / Q000150:complications / Q000175:diagnosis* / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori / Q000187:drug effects* / Q000235:genetics / Q000302:isolation & purification; D006801:Humans; D008297:Male; D008826:Microbial Sensitivity Tests / Q000379:methods; D008875:Middle Aged; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D017291:Clarithromycin