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本临床验证目的是验证南宁制药企业集团公司研制的铝碳酸镁混悬液治疗消化性溃疡的效果及安全性。由北京和广西五家医院,用随机开放的对照研究方法,完成可评价病例177例,其中铝碳酸镁混悬液105例,西咪替丁对照组72例。研究方法:用铝碳酸镁混悬液10ml(1g)/次,一日四次,对照西咪替丁0.2g/次,一日四次,疗程为六周。铝碳酸镁混悬液治疗消化性溃疡的愈合率和总有效率为77.1%和91.4%(对照51.4%和73.6%)。二组的疼痛消失率分别为88.6%和81.2%,消化道症状消失率分别为90.0%和84.0%。铝碳酸镁混悬液治疗消化性溃疡的效果,疼痛症状的消失率和消化道症状消失率均高于西咪替丁对照组。治疗期间未发现明显不良反应。
The purpose of this clinical validation is to verify the effectiveness and safety of the suspension of aluminum magnesium carbonate developed by Nanning Pharmaceutical Enterprise Group in the treatment of peptic ulcer. A total of 177 evaluable cases were completed with a randomized open-ended controlled study in five hospitals in Beijing and Guangxi, including 105 cases of aluminum magnesium carbonate suspension and 72 cases of cimetidine control group. Research Methods: Aluminum-magnesium carbonate suspension 10ml (1g) / times, four times a day, control cimetidine 0.2g / time, four times a day, the course of treatment for six weeks. The healing rate and total effective rate of aluminum magnesium carbonate suspension in the treatment of peptic ulcer were 77.1% and 91.4% (control 51.4% and 73.6%). Two groups of pain disappearance rate was 88.6% and 81.2%, disappearance rate of gastrointestinal symptoms were 90.0% and 84.0%. The effect of hydrotalcite suspension on the treatment of peptic ulcer, the disappearance of pain symptoms and disappearance of gastrointestinal symptoms were higher than that of cimetidine control group. No significant adverse reactions were found during treatment.