A Study On The Safety And Efficacy Of Sofalcone Tablets In Gastric Ulcer Treatment

Background and Objective: Sofalcone, a gastroprotective drug, was invented firstly in Japan to treat gastric ulcer and gastritis. The purpose of the study was to assess the clinical efficacy and safety of sofalcone tablets in gastric ulcer treatment by using rebamipida as the control drug.Methods:The patients with gastric ulcer who met the inclusion criteria were randomly assigned to one of the following two groups and medicated for 8w. The patients in the treatment group were given sofalcone 300 mg/day (three times a day, 100mg/time), while the patients in the control group were given rebamipida 300 mg/day (three times a day, 100mg/time). Subjective symptoms (epigastralgia, bloating, acid regurgitation, nausea, belching, anorexia, heartburn) were evaluated using four grades before and after the treatment. The laboratory examinations (blood routine test, urine routine test, stool routine test, AST, ALT, TBIL, BUN, Cr) ECG and endoscopy were performed before and after the treatment. And H. pylori eradication was assessed after the treatment. Adverse events were monitored for the duration of the study. SPSS17.0 software was used for statistical analysis. A significance level of less than 5% was considered to indicate significant difference.Results:1.The total cases of 64 patients were enrolled, and one patient was rejected. So 63 patients were assessed for eligibility. 58 patients completed the protocol. There were 28 and 30 patients in the control group and the treatment group respectively. There was no deviation between the two groups in terms of age, sex, body weigh, heart rate, blood pressure, baseline diagnosis, the laboratory examinations and ECG.2.Using per protocol analysis, the ulcer healing rate of the control group and the treatment group was 64.29% and 70.00% respectively. On intention-to-treat basis, the ulcer healing rate of the control group and the treatment group was 58.06% and 65.62% respectively. Compared with the control group, there was no statistically significant in the ulcer healing rate in the treatment group by ITT and PP analysis. Before the treatment, the ulcer diameter was 10.29±5.08 mm and 9.28±4.71 mm in the control group and the treatment group. After the treatment, the ulcer diameter was 1.61±2.63 mm and 1.52±2.91 mm in the control group and the treatment group. Compared with that before treatment, an average diameter of ulcer in two groups was significantly reduced.3.There was no significant difference in abdominal pain relief between the treatment group and the control group.4.The average duration of pain relief in the treatment group (7±4 days) was significantly shorter than the control group (13±7 days).5.The subjective symptoms in the two groups had obvious improvement compared with those before treatment. However, the relief rate of nausea and abdominal distension was higher in the treatment group than the control group.6.No significant differences were seen between the two groups in terms of H. pylori eradication rate.7.There were no significant differences in the laboratory examinations in the two grous before and after the treatment. No serious adverse events were found during the study.Conclusion:1.Sofalcone can effectively and safely promote gastric ulcer healing.2.The ulcer healing rate of sofalcone was equivalent to that of rebamipide.