铝镁混悬液治疗胃酸相关性症状的临床疗效和安全性研究

Clinical efficacy and safety of Aluminium and Magnesium suspension for the treatment of gastric acid-related symptoms

目的:评价铝镁混悬液治疗胃酸相关性症状的有效性和安全性。方法:用多中心、随机、单盲、阳性药物平行对照设计。共有151例受试者参加试验,其中铝镁混悬液组(试验组)75例和铝镁加混悬液组(对照组)76例,试验组和对照组均口服相应药物溶液,每日3次,连续服用2周。结果:用药2周,两组受试者胃酸相关性症状的改善情况基本一致,组间比较无统计学差异,铝镁混悬液和铝镁加混悬液两组间不良事件发生率比较无统计学差异。结论:铝镁混悬液可以有效治疗胃酸相关性症状,而且安全性良好。

Objective：To evaluate the clinical efficacy and safety of Aluminium and magnesium suspension for the treatment of patients with gastric acid-related symptom.Methods： The trial was designed as a multicenter randomized single-blind and parallel comparative study. The trial enrolled 151 subjects, including Aluminium and magnesium suspension group （treatment group,n=75） and Almagate suspension group （control group,n=76）. Both of groups took study drugs 3 times daily for 2 weeks.Results： After 2 weeks, clinical improvement of gastric acid-related symptoms was similar between Aluminium and magnesium suspension group and Almagate suspension group. There was no difference in the rate of drug related adverse event between two groups.Conclusion： Aluminium and magnesium suspension can effectively treat gastric acid-related symptoms, and has satisfactory safety.