镁加铝咀嚼片治疗酸相关性疾病症状的多中心随机双盲双模拟对照临床研究  

Compound magaldrate chewable tablets in treatment of symptoms of gastric acid-related diseases： a multicenter, randomized, double-blind, double-dummy, controlled trial

作　　者：何相宜[1] 季峰[2] 蔡建庭[3] 蒋义斌 钟良 袁耀宗[1] 无 

机构地区：[1]上海交通大学医学院附属瑞金医院消化科,200025 [2]浙江大学医学院附属第一医院消化科 [3]浙江大学医学院附属第二医院消化科 [4]复旦大学附属华山医院消化科 [5]镁加铝咀嚼片临床研究协作组

出　　处：《中华消化杂志》2017年第11期761-764,共4页Chinese Journal of Digestion

摘　　要：目的观察镁加铝咀嚼片治疗酸相关性疾病症状的临床疗效及安全性。方法纳入2004年5月至2005年5月就诊的132例酸相关性疾病患者，分成试验组64例和对照组68例。试验组患者嚼服镁加铝咀嚼片和铝碳酸镁咀嚼模拟片，对照组患者嚼服铝碳酸镁咀嚼片和镁加铝咀嚼模拟片，疗程均为2周。比较两组治疗后的临床总有效率、各症状的完全缓解率。统计学方法采用卡方检验。结果试验组患者治疗后1周的总有效率为73．4％（47／64），高于对照组的55．9％（38／68），差异有统计学意义（χ^2=5．165，P=0．023）；试验组患者治疗后2周的总有效率为85．9％（55／64），对照组为79．4％（54／68），差异无统计学意义（χ^2=1.256，P=0．263）。治疗后1周，试验组反酸的完全缓解率为50．8％（32／63），高于对照组的27．7％（18／65），差异有统计学意义（χ^2=7．173，P=0．011）；试验组上腹痛的完全缓解率为70．8％（34／48），高于对照组的48．i％（26／54），差异有统计学意义（χ^2=5．399，P=0．027）。试验组和对照组的不良反应发生率分别为4．7％（3／64）和2．9％（2／68），差异无统计学意义（P〉0.05）。结论镁加铝咀嚼片较铝碳酸镁咀嚼片能更迅速地缓解酸相关性疾病的症状，尤其是反酸和上腹痛，并且安全。Objective To evaluate the efficacy and safety of magaldrate chewable tablets in the treatment of symptoms of gastric acid-related diseases. Methods From May 2004 to May 2005, a total of 132 patients with gastric acid-related disease were enrolled and divided into trial group （64 cases） and control group （68 cases）. The patients of trial group took magaldrate chewable tablets and talcid chewable tablets placebo while the patients of control group took talcid chewable tablets and magaldrate chewable tablets placebo, and the course of treatment was two weeks. After the treatment, the total clinical effective rate and complete relieving rate of symptoms of two groups were compared. Chi-square test was performed for statistical analysis. Results One week after treatment, the total effective rate of trial group was 73.4%（47/64）, which was higher than that of control group （55.9%, 38/68）, and the difference was statistically significant （χ^2= 5. 165, P= 0. 023）. Two weeks after treatment, the total effective rates of trial group and control group were 85.9 % （ 55 / 64） and 79.4 %（ 54 / 68）, respectively, and the difference was not significant （χ^2= 1. 256, P= 0. 268）. One week after treatment, the complete relieving rate of acid regurgitation of trial group was 50.8% （32/63）, which was higher than that of control group （27.7%, 18/65）, and the difference was statistically significant （χ^2= 7. 173, P= 0. 011）. The complete relieving rate of up abdominal pain of trial group was 70.8% （34/48）, which was higher than that of control group （48.1%, 26/54）, and the difference was statistically significant （Z2 = 5. 399, P= 0. 027）. The rates of adverse effects of trial group and control group were 4.70% （3/64）and 2.9% （2/68）, respectively, and the difference was not significant （P 〈 0. 05）. Conclusion Magaldrate chewable tablets can relieve symptom of acid-related diseases fast and safely as compared with talcid chewable tablets, especially the acid regurgit

关 键 词：镁加铝咀嚼片 酸相关性疾病 多中心研究 随机对照试验 双盲法 双模拟法 

分 类 号：R57[医药卫生—消化系统]