Context:Goals: To compare the efficacy of standard triple therapy with clarithromycin versus triple therapy with levofloxacin for treatment of Helicobacter pylori-positive infection in a referral hospital in Damascus, Syria.Design:pilot prospective open-label randomized controlled trial.Subjects and Methods:Eighty treatment-naive patients who tested positive for H. pylori gastric infection were randomly assigned to one of two treatment groups with randomization ratio of 50/50. Group (A) was treated with clarithromycin (500 mg), amoxicillin (1000 mg), and esomeprazole (20 mg), each twice/day for 14 days, while Group (B) was treated with levofloxacin (500 mg), amoxicillin (1000 mg), and esomeprazole (20 mg), each twice/day for 14 days.[1] After 6 weeks of treatment, all patients underwent endoscopy and biopsy to evaluate H. pylori infection eradication.Results:Forty patients were allocated in each group; 37 patients completed the follow-up in each group. Thirteen patients in Group (A) were cured, with an eradication rate of 35.1% according to per-protocol analysis (PPA) and 32.5% according to intention-to-treat analysis (ITT), while in Group (B), 11 patients were cured, with an eradication rate of 29.7% according to PPA and 27.5% according to ITT with P = 0.80. No serious adverse events reported in both the groups.Conclusions:Clarithromycin is slightly better than levofloxacin in treatment of H. pylori gastric infection, but both regimens show low effectiveness with suboptimal eradication rates in our selected population.
Background Antibiotic-resistance reduces the efficacy of conventional triple therapy for Helicobacter Pylori infections worldwide, which necessitates using various treatment protocols. We used two protocols, doxycycline-based quadruple regimen and concomitant levofloxacin regimen. The aim was to assess the effectiveness of doxycycline-based quadruple regimen for treating Helicobacter Pylori infections compared with levofloxacin concomitant regimen as empirical first-line therapy based on intention-to-treat (ITT) and per-protocol analyses (PPA) in Syrian population. Settings and design An open-label, randomised, parallel, superiority clinical trial. Methods We randomly assigned 78 naïve patients who tested positive for Helicobacter Pylori gastric infection, with a 1:1 ratio to (D-group) which received (bismuth subsalicylate 524 mg four times daily, doxycycline 100 mg, tinidazole 500 mg, and esomeprazole 20 mg, each twice per day for 2 weeks), or (L-group) which received (levofloxacin 500 mg daily, tinidazole 500 mg, amoxicillin 1000 mg, and esomeprazole 20 mg each twice per day for two weeks). We confirmed Helicobacter Pylori eradication by stool antigen test 8 weeks after completing the treatment. Results Thirty-nine patients were allocated in each group. In the D-group, 38 patients completed the follow-up, 30 patients were cured. While in the L-group, 39 completed the follow-up, 32patients were cured. According to ITT, the eradication rates were 76.92%, and 82.05%, for the D-group and L-group respectively. Odds ratio with 95% confidence interval was 1.371 [0.454–4.146]. According to PPA, the eradication rates were 78.9%, and 82.05% for the D-group and L-group respectively. The odds ratio with 95% confidence interval was 1.219 [0.394–3.774]. We didn’t report serious adverse effects. Conclusions Levofloxacin concomitant therapy wasn’t superior to doxycycline based quadruple therapy. Further researches are required to identify the optimal first-line treatment for Helicobacter-Pylori Infection in the Syrian population. Trial registration We registered this study as a standard randomized clinical trial (Clinicaltrial.gov, identifier-NCT04348786, date:29-January-2020).
Rationale: The ongoing coronavirus pandemic has caused severe acute respiratory syndrome, posing a significant challenge for patients receiving immunotherapy for immune-mediated inflammatory diseases. As of January 2022, immunosuppressants such as tumor necrosis factor inhibitors (anti-TNFα) and azathioprine are inadvisable for an infectious disease caused by the SARS-CoV-2 virus (COVID-19). We continued infliximab as a second induction dose nine days after the onset of COVID-19 symptoms in a patient with acute severe ulcerative colitis. Patient concerns: We report the case of a 34-year-old male with 6 to 8 times bloody diarrhea, fever, and cramping abdominal pain. Ulcerative colitis was diagnosed 6 months earlier and treated with mesalamine 80 mg/kg/day and azathioprine 2.5 mg/kg/day. The patient had never undergone surgery before. Sigmoidoscopy revealed multiple ulcerations and spontaneous bleeding, and the colon samples tested negative for cytomegalovirus and Clostridium difficile. However, intravenous corticosteroids did not induce remission. A nasopharyngeal swab tested positive for SARS-CoV-2. Diagnosis: Acute severe ulcerative colitis and SARS-CoV-2 (COVID-19) pneumonia. Interventions: The second loading dose of infliximab was administered nine days after the diagnosis of COVID-19. Outcome: The patient completed infliximab induction at a dose of 5 mg/kg at weeks 0, 2, and 6, with no complications. Lessons: It is unclear whether anti-TNF-α treatment improves or deteriorates COVID-19 patient outcomes, and this case demonstrates that infliximab can be used safely. Current guidelines make a weak recommendation to avoid using anti-TNFα agents in the presence of acute COVID-19 infection. There is an urgent need for research on biologics therapy.
Introduction: Golimumab is a fully human antitumor necrosis monoclonal antibody that can be administered by either subcutaneous injection or intravenous infusion. Golimumab is approved for the treatment of the adults with rheumatic diseases, and ulcerative colitis, Whereas in children, golimumab is indicated only for the treatment of active polyarticular juvenile idiopathic arthritis. We have written on the off-label use of subcutaneous golimumab, which helped to induce and maintain remission on a low-weight biologically experienced child with steroid-refractory ulcerative colitis flare. Patient concerns: A 13-year-old pancolitis Syrian boy presented with abdominal pain and six to seven times bloody diarrhea. The child had treated with mesalamine 80 mg/kg/day, azathioprine 2.5 mg/kg/day, infliximab with an induction dose of 5 mg/kg at weeks 0, 2, and 6 followed by 5 mg/kg every 8 weeks. Infliximab did not maintain remission as the patient suffered from two flares that required hospital admission, intravenous corticosteroids, and infliximab escalation. Initial tests disclosed leukocytosis, anemia, hypoalbuminemia, an elevation in C-reactive protein and fecal calprotectin. All Stool studies were negative including routine stool cultures, Clostridium difficile toxin, Escherichia coli O157:H7, Cryptosporidium, and microscopy for ova and parasites. A sigmoidoscopy revealed multiple large ulcerations and spontaneous bleeding, colon biopsies were negative for Clostridium difficile and Cytomegalovirus. Cyclosporine, tacrolimus, and adalimumab were unavailable in Syria. Child's parents opposed colectomy as a treatment option. Diagnosis: Ulcerative colitis flare. Interventions: A subcutaneous golimumab with a loading dose of 200 mg at week 0, followed by 100 mg at week 2, then 50 mg every 4 weeks. Outcomes: The patient achieved clinical remission by week sixth and maintained the remission for the next 90 weeks. At the time of last evaluation, tests, including C-reactive protein and fecal calprotectin, were within normal limits, complete colonoscopy revealed erythema, edema, mucosal friability, loss of vascular patterns, and pseudo-polyps. The Pediatric Ulcerative Colitis Activity Index and Mayo scores were 5 and 2 points, respectively. No adverse events were documented. Conclusion: Golimumab has shown potential efficacy and safety in the treatment of ulcerative colitis in children which may indicate a significant future role for subcutaneous golimumab in pediatrics ulcerative colitis.
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