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目的:评估复方法莫替丁咀嚼片治疗胃酸相关性疾病症状的疗效及安全性。方法:2005年9月至2006年3月期间胃酸相关性疾病患者60例,随机分为2组:复方法莫替丁组和法莫替丁组(每组30例)。复方法莫替丁组中,男12例,女18例,平均年龄(45.50±10.09)岁;法莫替丁组中男14例,女16例,平均年龄(49.72±9.54)岁。复方法莫替丁组第1天出现胃酸相关症状时给予复方法莫替丁咀嚼片1片(每片含法莫替丁10 mg、碳酸钙800 mg、氢氧化镁165 mg),1次/d,第2天有症状时,继续给予复方法莫替丁咀嚼片1片,1～2次/d,如无症状,于睡前服1片,每天最多服2片;法莫替丁组第1天出现胃酸相关症状时给予法莫替丁胶囊(20 mg)1粒,第2天用法同复方法莫替丁组,每天不超过2粒,2组疗程均为7 d。观察2组首次服药后10、30、60、120 min时症状即刻缓解率和症状完全缓解时间,治疗前和治疗结束后症状评分情况和治疗结束后症状缓解率,以及不良反应、血常规、血钙、肝肾功能、心电图变化。结果:复方法莫替丁组和法莫替丁组首次服药后,症状完全缓解时间分别为(64.31±39.64)min与(72.75±51.41)min,差异无统计学意义(P>0.05)。2组首次服药后10、30 min症状即刻缓解率分别为53.57%和82.14%与22.22%和55.56%,差异均有统计学意义(均P<0.05);60、120 min症状即刻缓解率分别为89.29%和92.86%与81.48%和92.59%,差异均无统计学意义(均P>0.05)。治疗结束后2组症状即刻缓解率分别为92.86%和96.30%,差异无统计学意义(P>0.05)。复方法莫替丁组和法莫替丁组症状积分值治疗前分别为(3.70±1.18)分与(4.39±1.27)分,治疗结束后分别为(2.93±1.12)分与(2.72±1.26)分,治疗前后比较差异均有统计学意义(均P<0.001),但2组间比较差异无统计学意义(P>0.05)。复方法莫替丁组不良反应发生率为3.57%(1例出现口干),法莫替丁组不良反应发生率为7.41%(头晕、恶心各1例),2组比较差异无统计学意义(P>0.05)。治疗后2组血常规、肝肾功能及血钙均无异常改变(均P>0.05)。结论:复方法莫替丁咀嚼片可快速缓解烧心、反酸等症状,是治疗胃酸相关性疾病安全有效的药物。
Objective: To evaluate the efficacy and safety of compound famotidine chewable tablets in the treatment of symptoms of gastric acid-related diseases. Methods: From September 2005 to March 2006, 60 cases of gastric acid-related diseases were randomly divided into 2 groups: compound famotidine group and famotidine group (30 cases in each group). The composite famotidine group, 12 males and 18 females, mean age (45.50 ± 10.09) years; famotidine group, 14 males and 16 females, mean age (49.72 ± 9.54) years old. The compound famotidine group was given compound famotidine chewable tablets 1 tablet (each tablet containing famotidine 10 mg, calcium carbonate 800 mg, magnesium hydroxide 165 mg) on the first day after the compound famotidine group appeared gastric acid-related symptoms, once / d, the first two days of symptoms, continue to give compound famotidine chewable tablets 1, 1 or 2 times / d, such as asymptomatic, taking 1 at bedtime, serving up to 2 tablets per day; famotidine group Famotidine capsule (20 mg) was given on the first day when stomach acid-related symptoms were given. On the second day, the group was treated with the same combination of famotidine and no more than two capsules daily for 7 days. Immediate relief of symptoms and complete remission of symptoms at 10, 30, 60 and 120 minutes after the first administration were observed in 2 groups. Symptom scores before and after treatment and symptom relief after the treatment were observed, as well as adverse reactions, blood tests, blood Calcium, liver and kidney function, ECG changes. Results: After the first dose of compound famotidine group and famotidine group, the complete remission time was (64.31 ± 39.64) min and (72.75 ± 51.41) min, respectively, with no significant difference (P> 0.05). The rates of immediate relief at 10 and 30 min after the first administration in both groups were 53.57% and 82.14% and 22.22% and 55.56%, respectively (all P <0.05). The rates of immediate relief at 60 and 120 min were 89.29% and 92.86% and 81.48% and 92.59%, respectively, with no significant difference (all P> 0.05). Immediate relief rate of the two groups after treatment was 92.86% and 96.30% respectively, with no significant difference (P> 0.05). The symptom scores of the compound famotidine group and the famotidine group before treatment were (3.70 ± 1.18) points and (4.39 ± 1.27) points respectively, and were 2.93 ± 1.12 and 2.72 ± 1.26 respectively after the treatment, There was significant difference between before and after treatment (all P <0.001), but there was no significant difference between the two groups (P> 0.05). The rate of adverse reactions in the compound famotidine group was 3.57% (1 case of dry mouth), and the rate of adverse reactions in the famotidine group was 7.41% (1 case of dizziness and nausea respectively). There was no significant difference between the two groups (P> 0.05). After treatment, there were no abnormal changes in blood routine, liver and kidney function and serum calcium (all P> 0.05). Conclusion: The compound famotidine chewable tablets can relieve heartburn, acid reflux and other symptoms and is a safe and effective drug for the treatment of gastric acid-related diseases.