复方法莫替丁咀嚼片治疗胃酸相关性疾病症状的临床疗效及安全性评估

Treatment of symptoms in gastric acid-related diseases with compound famotidine chewable tablets:evaluation of clinical efficacy and safety

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 treatment of symptoms in gastric acid-related diseases. Methods： Sixty patients with gastric acid-related diseases from September 2005 to March 2006 were randomly divided into two groups： the compound famotidine group and the famotidine group （30 cases in each group）. The compound famotidine group comprised 12 men and 18 women with average age （45.50 ± 10.09） years. The famoditine group comprised 14 men and 16 women with average age of （49.72 ± 9.54 ） years. The patients in compound famotidine group received 1 compound famotidine chewable tablet （each tablet contains famotidine 10 mg, calcium carbonate 800 mg, magnesium hydroxide 165 mg） once daily when gastric acid-related symptoms occurred on day 1 ; and on day 2, 1 tablet once or twice daily when symptoms occurred or 1 tablet at bed time if no symptoms occurred; the maximum daily dosage was 2 tablets. The patients in the famotidine group received 1 famotidine 20 mg capsule when gastric acid-related symptoms occurred on day 1, and the administration were the same as those in the compound famotidine group on day 2; the maximum daily dosage was 2 capsules. The duration of treatment was 7 days in both groups. Observations included immediate symptom relief rate and complete symptom relief time 10, 30, 60, and 120 minutes after the first administration, symptom scores before treatment and after treatment completion, svmotom relief rate after treatment comnletion, adverse reactions, routine blood tests, blood calcium level, liver and renal function, and changes in electrocardiogram. Results ： The complete symptom relief time after the first administration in the compound famotidine and famotidine groups was （ 64.31 ± 39.64 ） min and （72.75 ± 51.41 ） min, respectively; there was no significant difference （ P 〉 0.05 ）. The immediate symptom relief rate 10 and 30 minutes after the first administration in the compound famotidine and famotidine groups was 53.57% vs 82.14% and 22.22% vs 55.56%, respectively; the differences were statistically significant （all P 〈 0. 05 ）. The immediate symptom relief rate 60 and 120 minutes after the first administration was 89.29% vs 92.86% and 81.48% vs 92.59%, respectively; there was no significant difference （ all P 〉0.05 ）. The immediate symptom relief rate after treatment completion in both groups were 92.86% and 96.30% ; there was no significant difference （ P 〉 0.05）. The symptom scores in the compound famotidine and famotidine groups were （3.70 ± 1.18） and （4.39 ± 1.27） before treatment, and （2.93 ± 1.12） and （2.72 ± 1.26） after treatment completion, respectively; the difference between before treatment and after treatment was statistically significant （ all P 〈 0. 01 ）, but there was no significant difference between the two groups （P 〉 0. 05 ）. The incidence of adverse reactions was 3.57% （one case of dry mouth） in the compound famotidine group and 7.41% （ one case of dizziness and one case of nausea） in the famotidine group, there was no significant difference between the two groups （ P 〉 0.05 ）. No abnormal changes were found in routine blood tests, liver and renal function, and blood calcium level （all P 〉 0.05 ）. Conclusion： Compound famotidine chewable tablets can rapidly relieve heartburn and acid regurgitation, it is a safe and effective medical preparation in treatment of symptoms in gastric acid-related diseases.