A Clinical Study And Evaluation Of 5-Aminosalicylic Acid Enteric-Coated Tablets,Mosapride And Rebeprazole

Objective To investigate the efficacy and safety of 5-aminosalicylic acid (5-ASA), enteric-coated tablets, mosapride and rebeprazole in treatment ulcerative colitis(UC),functional dyspepsia (FD) and active duodenal ulcer (DU) respectively.Methods (1) A 6-week-long study enrolled 120 patients with UC confirmed by endescopy. The patients were randomly allocated to 5-ASA group (n61) or salicylazosulfapyridine (SASP) group (n=5 9). The efficacy and the drugs adverse events were assessed by clinical symptoms, endoscopic change and items of laboratory. After the patients taking the drugs serum concentration of 5-ASA was measured by high-performance liquid chromatographic (HPLC) assay for the determination of 5-ASA. (2) 34 patients with FD were randomly assigned to mosapride group (n20) or domperidone group (n=14) for 4 weeks. The clinical symptoms and the emptying rate of radiolabels and side the effects were evaluatated. (3) 32 patients with active DU were enrolled and randomly allocated either rebeprazole(n=17) or omeprazole(n15) for 4 weeks. Clinical symptoms, endoscopic signs were observed to assess the effect of rebeprazole on active DU.Results (1) Total efficiency rate was 70.05% in 5-ASA group vs 67.79% in SASP group (P>0.05). Cure rate confirmed by endoscopy in 5-ASA group was superior to SASP group (29.51% vs 13.31%). There was significant difference between the two groups (P>0.05). The incidence of side effects was 11.48% in 5-ASA group vs 23.33% in SASP group (P>0.05). In steady state serum concentration of 5-ASA was 0.032?0.008 L?g/ml in S-ASP group vs 0.041 ?0.005 ii glml in SASP group (P>0.05). (2) It was observed that total efficiency rates of improved early satiety and bloating bymosapride at end of the 4th week were 100% and 95% which was superior to SASP (78.6%,85.7%) slightly. While the emptying rate radiolabels was no decreased significantly in either group. The incidence of the side effects was 5% in mosapide group vs 21.4% in SASP group. (3) The symptoms such as epgastric pain and acid regurgitation could be rapidly relieved by rebeprazole or omeprazole. The either drug could achieved 100% of DU healing rate and well-tolerate without side effects.Conlusion (1) It is observed that 5-ASA enteric-coated tablets is absorbed to systematic blood rarely after taking it and its total efficiency rate or the incidence of side effects is similar to SASP. But its cure rate is superior to SASP. (2) Mosapride can relieve symptoms of upper gastrointestinal tract in FD significantly and dose not produce more side effects. (3) Rebeprazole can rapidly relieve the symptoms and achieved satisfactory cure rate in DU, which is proved to be a novel safety and effective PPI in peptic ulcer.