RESUMEN
Background: Sickle cell disease (SCD) is a chronic hemolytic disorder characterized by the presence of crescent-shaped red blood cells. Abdominal pain is the common presenting symptom in adults with SCD. Among the patients who are not in crisis, it is estimated that one third of patients with homozygous SCD with chronic recurrent epigastric pain has endoscopic evidence of peptic ulcer disease. Aims and Objectives: This study was undertaken with an aim to analyze the incidence and management of acid peptic disorders among SCD patients in Western Odisha. Materials and Methods: A prospective study was done considering 88 homozygous SCD patients. All the patients underwent upper gastrointestinal endoscopy (UGIE) with gastric antral biopsy and rapid urease test (RUT). Cases with Helicobacter pylori were administered a 14 days course of three drug regimen of anti H. pylori drugs and followed-up to 6 weeks of beginning the treatment with repeat UGIE and RUT. Results: Out of 88 cases, 19 cases had duodenal ulcer (21.6%) which was significantly high than patients with gastric ulcer (13.6%). Other findings were gastroesophageal reflux disease and gastritis. About 93.5% of patients became RUT negative after taking anti H. pylori medication. Conclusion: SCD patients with acid peptic disorder constitute a sizeable proportion of patients attending surgical outpatient department and indoor department of surgery. Conservative treatment with life style modification can effectively improve the symptoms of acid peptic disease.
RESUMEN
Aims: A post marketing study to assess the symptomatic efficacy and safety of Troxipide (TROXIPTM) 100mg in the management of acid peptic disorders (APDs) in Indian population. Study Design: An observational, prospective, uncontrolled, open-label, multicenter post marketing study. Place and Duration of Study: Patients were enrolled from 62 centers across 11 states of India, between October 2010 and March 2012. Methodology: Out of 1500 APD patients, 1486 (850 men, 636 women; age range 16-85 years) were prescribed Troxipide 100mg tablet orally thrice daily. The efficacy and safety assessments were performed on day 14 and day 28 after beginning the treatment and recorded in the case report forms. The efficacy of Troxipide was estimated based on the changes from the baseline in the symptom score on a 100 point visual analogue scale (VAS) for individual symptoms. Safety was assessed by adverse events reported with usage of Troxipide on day 14 and day 28 after start of the treatment. Results: Troxipide monotherapy (n=1427) significantly reduced the mean VAS score from baseline for all major symptoms, viz. nausea, vomiting, belching, heart burn, epigastric pain, acid regurgitation, abdominal bloating & loss of appetite at the end of the study. The global mean VAS score (a sum of individual symptom VAS score) of these patients decreased from 134.26 ± 75.31 to 21.88 ± 39.52 at the end of the study (P < .001). All the patients who were previously treated but uncontrolled, with acid inhibitors like proton pump inhibitors (PPIs), histamine 2 receptor antagonists (H2RAs) etc. had a significant reduction in the VAS score from 164.38 ± 64.54 to 35.56 ± 54.24 on day 28 (P<.001). Troxipide was well tolerated with overall incidence of adverse events being 1.05% (n=15) and all the events were resolved without any sequel. Conclusion: The present study demonstrates that Troxipide symptomatically controls APDs like gastritis, dyspepsia, gastro-esophageal reflux disease (GERD) and ulcers with good tolerability.