| Objective: To assess and compare the efficacy and safety of tepnenone andsucrafate in patients with chronic non-atrophic gastritis with erosion by changes ofsymptoms and endoscopic scores before and after treatment.Methods: A double blind, double dummy, randomized, controlled trial ofsucralfate tablets for positive drug was designed.32patients satisfied the inclusioncriteria are randomly divided into two groups. There are sixteen patients in the studygroup, including nine male and seven female patients, the average age is44±11years.There are sixteen patients in the controlled group, including ten male and six femalepatients in the controlled group, the average age is43±11years. In the study group (16patients): teprenone1tablet (50mg)+sucrelfate placebo4tablets were taken after meal,3times a day. In the controlled group (16patients): teprenone placebo1tablet+sucrelfate4tablets (1.0g) were taken after meal,3times a day. After4weeks,endoscopy was done again in order to analyze and judge the improvement.Result:1. Before and after treatment, the score of the patients`symptoms was2.8±0.7and0.7±0.3in the study group. In the controlled group it was2.5±0.6and1.8±0.5scores. Before treatment the two groups of the clinical symptoms score was notstatistically different (P>0.05). While after treatment the clinical symptoms score wasstatistically different between the two groups (P <0.05).This study showed that theefficacy of Teprenons in the study group was significantly higher than that in thecontrolled group. After treatment, the effective rate of the symptom improvement in thestudy group was93.75%, while in the controlled group the effective rate was only75%.Compare with the effective rate of the symptom improvement in the two groups, thescore was statistically different (P<0.05).2. Before and after treatment, the score of the patients`endoscope was2.6±0.6and 0.8±0.4in the study group. In the controlled group it was2.4±0.5and1.9±0.3. Beforetreatment the two groups of the clinical endoscope score was not statistically different(P>0.05). While after treatment the two groups of the clinical endoscope score wasstatistically different between the two groups (P <0.05).This study showed that theefficacy of Teprenons in the study group was significantly higher than that in thecontrolled group. After treatment, the effective rate of the inflammation improvement inthe study group was87.5%, while in the controlled group the effective rate was only62.5%. Compare with the effective rate of the inflammation improvement in the twogroups, the score was statistically different (P<0.05).3. Drug safety comparison: in the two groups a few the side effects were observed,such as constipation and abdominal distension. But the treatment was not affected bythe side effects. After the drug was stopped, the above symptoms soon disappeared. Theside effects in the two groups was not statistically different (P>0.05). Before and aftertreatment the patients’ laboratory tests, such as routine analysis of blood, urine andfunction of liver and kidney, were all normal.Conclusion: Teprenone is an effective and safe drug in treatment of chronicnon-atrophic gastritis with erosion. |
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