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目的:观察尿囊素铝颗粒对消化性溃疡和急慢性胃炎的疗效及安全性。方法:采用多中心、随机单盲、平行对照方法进行临床观察。共选取132例患者,其中胃溃疡32例,十二指肠球部溃疡32例,胃炎68例,按病种随机均分为治疗组和对照组各66例。治疗组给予尿囊素铝颗粒每次0.2g,tid;对照组给予替普瑞酮,每次50mg,tid。2组均辅助使用雷尼替丁用于抑酸,2组疗程均为4周。结果:治疗组和对照组用药4周后消化性溃疡患者的疼痛缓解率分别为100％和96.55％,胃炎患者疼痛缓解率分别为79.31％和78.46％,组问比较差异无显著性;返酸、烧心、恶心、腹胀、嗳气等缓解率组间比较差异无显著性。胃镜下消化性溃疡的愈合率治疗组为87.49％,对照组为48.28％;胃炎愈合率治疗组为85.29％,对照组为55.17％,治疗组均显著高于对照组(P<0.05)。治疗组胃黏膜组织中前列腺素水平用药后明显升高,差值为(1 794.23±3474.53)ng·g-1,显著高于对照组[-(925.61±7 099.59)ng·g-1]。结论:尿囊素铝颗粒治疗消化性溃疡和急、慢性胃炎安全有效。
Objective: To observe the efficacy and safety of allantoin aluminum granules in the treatment of peptic ulcer and acute and chronic gastritis. Methods: Multi-center, randomized single-blind, parallel control method for clinical observation. A total of 132 patients were selected, of which 32 cases of gastric ulcer, 32 cases of duodenal ulcer, gastritis 68 cases, were randomly divided into treatment group and control group, 66 cases. The treatment group were given allantoin aluminum particles 0.2g each tid; control group given teprenone, each 50mg, tid. Both groups assisted the use of ranitidine for acid suppression, and the two courses of treatment were 4 weeks. Results: The pain relief rates of peptic ulcer patients in treatment group and control group were 100% and 96.55% respectively after 4 weeks of treatment. The pain relief rates in patients with gastritis were 79.31% and 78.46%, respectively. There was no significant difference between the two groups , Heartburn, nausea, bloating, belching and other mitigation rates were no significant difference between the groups. The rate of healing of peptic ulcer under endoscopy was 87.49% in the treatment group and 48.28% in the control group. The healing rate of gastritis was 85.29% in the treatment group and 55.17% in the control group, which was significantly higher in the treatment group than in the control group (P <0.05). The level of prostaglandin in the gastric mucosa of the treated group was significantly higher after treatment (1794.23 ± 3474.53) ng · g-1, which was significantly higher than that in the control group [- (925.61 ± 7099.59) ng · g-1]. Conclusion: Allantoin aluminum granules are safe and effective for the treatment of peptic ulcer and acute and chronic gastritis.