New regimens as first‐line eradication therapy for Helicobacter pylori infection in patients allergic to penicillin: A randomized controlled trial

Abstract

Background: Helicobacter pylori eradication in penicillin-allergic patients is challenging. The effective regimen is lacking in areas with high antibiotic resistance and tetracycline unavailable. Minocycline, cefuroxime, and full-dose metronidazole are promising drugs. Aims:To compare the eradication rate, safety, and compliance among three new bismuth quadruple therapies for first-line H. pylori eradication in penicillin-allergic patients.Methods: This randomized trial was conducted on 450 naive patients with H. pylori infection and penicillin allergy. The 14-day minocycline-metronidazole-containing (minocycline 100 mg twice daily and metronidazole 400 mg four times/day), minocycline-cefuroxime-containing (minocycline 100 mg twice daily and cefuroxime 500 mg twice daily), and cefuroxime-metronidazole-containing (cefuroxime 500 mg twice daily and metronidazole 400 mg four times/day) bismuth quadruple therapies were randomly assigned to the participants. Safety and compliance were assessed within 3 days after eradication. Urea breath test was performed 4-8 weeks after eradication to evaluate outcome. Results:The differences of eradication rates in either intention-to-treat (84.0%, 82.7%, and 23 82.0%, p = .896) or per-protocol (91.7%, 90.9%, and 88.2%, p = .599) analysis among minocycline-metronidazole, minocycline-cefuroxime, and cefuroximemetronidazole-containing bismuth quadruple therapies were statistically insignificant.The incidence of adverse events (35.1%, 22.6%, and 28.9%) and compliance (90.5%, 91.8%, and 91.9%) were similar. Taste distortion, nausea, and anorexia were more common in metronidazole-containing regimens, and dizziness was more common in minocycline-containing regimens. The allergy was rare (~3%). Conclusions:The efficacies of three bismuth quadruple therapies containing minocycline, cefuroxime, and full-dose metronidazole (pairwise) for first-line H. pylori eradication in penicillin-allergic patients were similarly satisfactory with relatively good safety and compliance. The study was registered in the Chinese Clinical Trials Registration (ChiCTR1900023702). How to cite this article: Zhang Y, Suo B, Tian X, et al. New regimens as first-line eradication therapy for Helicobacter pylori infection in patients allergic to penicillin: A randomized

Application of cefuroxime in the eradication therapy of Helicobacter pylori infection: A review article

“…36 Furthermore, two additional clinical studies conducted by the same center in 2019 and 2023 involving the use of quadruple therapy containing cefuroxime in patients with penicillin allergies showed resistance rates of 4.6% (3/65) and 4.5% (6/134) for cefuroxime (E test), respectively, which were similar to the resistance rates of amoxicillin during the same period. 17,18,30,37 In other resistance rate studies from China, the resistance rate of H. pylori strains to cefuroxime was also found to be very low, similar to the aforementioned studies. [38][39][40] There are also a few studies indicating higher resistance rates of H. pylori strains to cefuroxime, 41,42 Exclusion Criteria: (i) Treatment duration less than 7 days; (ii) duplicate studies identified and removed and (iii) loss to follow-up exceeding 20%.…”

“…The application of cefuroxime in penicillin‐allergic patients did not result in a significant increase in allergic reactions such as rash 17,18,46 . Regarding compliance, studies have consistently reported high compliance rates ranging from 91.8% to 98.0% for regimens containing cefuroxime 17,18,36,43,45,46 …”

Efficacy and safety of minocycline quadruple therapy for Helicobacter pylori eradication: A meta‐analysis of RCTs

“…In this study, we identified and retrieved a total of 72 potentially relevant articles. After removing duplicates and screening the titles and abstracts, nine studies were retrieved for detailed evaluation, and only five [18][19][20][21][22] studies being eligible for our final data analysis according to out inclusion criteria (Figure 1). Three 11,12,26 studies excluded without suitable control, and one 27 article excluded without quadruple therapy.…”

“…Three 11,12,26 studies excluded without suitable control, and one 27 article excluded without quadruple therapy. The control group in two studies 18,21 contained tetracycline, and the other three 19,20,22 did not contain minocycline. A total of 2004 patients were included, and the characteristics of the studies were shown in Table 1.…”

“…14,15 Furthermore, minocycline is characterized by higher absorption and an extended half-life relative to tetracycline, 16,17 necessitating only once or twice daily administration, thus potentially ameliorating patient compliance. Recent studies have demonstrated that minocycline regimens have accomplished satisfactory outcomes in H. pylori eradication, both as a first-line [18][19][20] and rescue treatment. 21,22 A systematic review and meta-analysis were conducted to evaluate the efficacy and safety of semisynthetic tetracycline regimens in H. pylori treatment.…”