|Title:||Efficacies of Genotypic Resistance-Guided vs Empirical Therapy for Refractory Helicobacter pylori Infection||Authors:||Liou J.-M.
Taiwan Gastrointestinal Disease and Helicobacter Consortium
|Issue Date:||2018||Journal Volume:||155||Journal Issue:||4||Start page/Pages:||1109-1119||Source:||Gastroenterology||Abstract:||
Background & Aims: We aimed to compare the efficacy of genotypic resistance–guided therapy vs empirical therapy for eradication of refractory Helicobacter pylori infection in randomized controlled trials. Methods: We performed 2 multicenter, open-label trials of patients with H pylori infection (20 years or older) failed by 2 or more previous treatment regimens, from October 2012 through September 2017 in Taiwan. The patients were randomly assigned to groups given genotypic resistance–guided therapy for 14 days (n = 21 in trial 1, n = 205 in trial 2) or empirical therapy according to medication history for 14 days (n = 20 in trial 1, n = 205 in trial 2). Patients received sequential therapy containing esomeprazole and amoxicillin for the first 7 days, followed by esomeprazole and metronidazole, with levofloxacin, clarithromycin, or tetracycline (doxycycline in trial 1, tetracycline in trial 2) for another 7 days (all given twice daily) based on genotype markers of resistance determined from gastric biopsy specimens (group A) or empirical therapy according to medication history. Resistance-associated mutations in 23S ribosomal RNA or gyrase A were identified by polymerase chain reaction with direct sequencing. Eradication status was determined by 13C-urea breath test. The primary outcome was eradication rate. Results: H pylori infection was eradicated in 17 of 21 (81%) patients receiving genotype resistance–guided therapy and 12 of 20 (60%) patients receiving empirical therapy (P =.181) in trial 1. This trial was terminated ahead of schedule due to the low rate of eradication in patients given doxycycline sequential therapy (15 of 26 [57.7%]). In trial 2, H pylori infection was eradicated in 160 of 205 (78%) patients receiving genotype resistance–guided therapy and 148 of 205 (72.2%) patients receiving empirical therapy (P =.170), according to intent to treat analysis. The frequencies of adverse effects and compliance did not differ significantly between groups. Conclusions: Properly designed empirical therapy, based on medication history, is an acceptable alternative to genotypic resistance–guided therapy for eradication of refractory H pylori infection after consideration of accessibility, cost, and patient preference. ClinicalTrials.gov ID: NCT01725906. ? 2018 AGA Institute
|URI:||https://scholars.lib.ntu.edu.tw/handle/123456789/551383||ISSN:||0016-5085||DOI:||10.1053/j.gastro.2018.06.047||SDG/Keyword:||amoxicillin; clarithromycin; DNA topoisomerase (ATP hydrolysing) A; doxycycline; esomeprazole; levofloxacin; metronidazole; RNA 23S; tetracycline; urea c 13; amoxicillin; antiinfective agent; clarithromycin; doxycycline; esomeprazole; levofloxacin; metronidazole; proton pump inhibitor; tetracycline; abdominal pain; adult; antibiotic resistance; Article; bloating; breath analysis; comparative effectiveness; constipation; controlled study; diarrhea; dizziness; empirical therapy; eradication therapy; female; gene mutation; genotype; headache; Helicobacter infection; human; human tissue; intention to treat analysis; intermethod comparison; major clinical study; male; marker gene; multicenter study; nausea; patient compliance; polymerase chain reaction; priority journal; randomized controlled trial; rash; resistance guided therapy; sequence analysis; single blind procedure; stomach biopsy; Taiwan; taste disorder; treatment failure; treatment outcome; vomiting; aged; clinical decision making; clinical trial; combination drug therapy; comparative study; drug administration; drug effect; genetics; Helicobacter infection; Helicobacter pylori; microbiological examination; microbiology; middle aged; pathogenicity; predictive value; time factor; Adult; Aged; Amoxicillin; Anti-Bacterial Agents; Bacteriological Techniques; Breath Tests; Clarithromycin; Clinical Decision-Making; Doxycycline; Drug Administration Schedule; Drug Resistance, Bacterial; Drug Therapy, Combination; Esomeprazole; Female; Genotype; Helicobacter Infections; Helicobacter pylori; Humans; Levofloxacin; Male; Metronidazole; Middle Aged; Predictive Value of Tests; Proton Pump Inhibitors; Taiwan; Tetracycline; Time Factors; Treatment Outcome
|Appears in Collections:||醫學院附設醫院 (臺大醫院)|
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