复方法莫替丁咀嚼片缓解胃酸相关性症状随机双盲双模拟多中心研究

Compound famotidine chewing tablets relieve gastric acid associated symptoms:a randomized,double-blind,double-dummy,multicenter controlled study

目的:评价复方法莫替丁咀嚼片缓解烧心、反酸等胃酸相关性症状的有效性和安全性。方法:采用多中心、随机、双盲、双模拟、法莫替丁阳性药平行对照研究。共入组215例,复方法莫替丁咀嚼片组(试验组)106例,法莫替丁组(对照组)109例。结果:治疗2 wk后,试验组烧心、反酸等症状发作频率、症状积分、症状总积分下降值与治疗前比较差异均有统计学意义(P＜0．05)。试验组和对照组首次服药后烧心症状缓解时间分别为(87±s 125)min和(120±131)min(P＜0．05)。2组不良反应发生率为8．6％和6．6％(P＞0．05)。结论:复方法莫替丁咀嚼片能迅速改善烧心、反酸等胃酸相关性症状,且使用方便、安全、有效。

AIM： To evaluate the efficacy and safety of compound famotidine chewing tablets in relieving gastric acid associated symptoms, including heartburn, gastric acid regurgitation etc. METHODS： A multi-center, randomized, double-blind, double-dummy, parallel controlled study was conducted taking famotidine as the positive control medicine. Two hundred and fifteen patients were enrolled and divided into two groups including compound famotidine chewing tablets group （experimental group） with one hundred and six patients and famotidine group （control group） with one hundred and nine patients. RESULTS： After two weeks of treatment, the symptoms of seizure frequency, symptom scores, declining value of symptom total scores in experimental group were in significant difference statistically in comparing with those before the treatment （P 〈 0,05）, The first heartburn relief times in experimental group and control group were （87 ± s 125） min and （120 ± 131 ） min respectively （P 〈 0.05） . The incidences of adverse reactions in experimental group and control group were 8.6 % and 6.6 % respectively, showing no significant differences between the two groups （P 〉 0.05）. CONCLUSION： Compound famotidine chewing tablets, possess the capabilities of convenient use, safety and effectiveness, together with rapid improvements for gastric acid associated symptoms, including heartburn, gastric acid regurgitation etc.