复方法莫替丁咀嚼片治疗酸相关性疾病引起的烧心、反酸等症状的多中心、随机、双盲、阳性药物平行对照临床试验

目的观察复方法莫替丁咀嚼片治疗酸相关性疾病引起的烧心、反酸等症状的疗效和安全性。方法采用多中心、随机、双盲、阳性药物平行对照的试验设计，240例患者按1：l比例随机进入试验组（A组）和对照组（B组）。A组：有症状时，先口服法莫替丁模拟胶囊1粒，后咀嚼复方法莫替丁咀嚼片1片。B组：有症状时，先口服法莫替丁胶囊1粒，后咀嚼复方法莫替丁模拟咀嚼片1片。无症状时，两组均于睡前先服用胶囊，后咀嚼片剂。试验药和对照药一日不超过2片或2粒。疗程7d。治疗前及治疗每天分别对烧心、反酸、上腹痛等症状进行评分，每剂服药后5、10、15、20、30、40、50、60、120min时进行观察。结果227例患者按方案完成研究，A组114例，B组113例。第l天：A组服药10min和15min后烧心症状的即刻缓解率分别为31．63％和4-4．90％，显著高于B组（P分别为0．0067和0．0370）；A组服药后10-60min内各时间点反酸、上腹痛症状的即刻缓解率均显著高于B组（P均〈0．05）；A组服药5min后总体症状的即刻缓解率为17．70％，至60min内各时间点总体症状的即刻缓解率均显著高于B组（P分别〈0．05）。第2—7天各症状的即刻缓解率与第1天类似。A组所有症状完全缓解时间在50min之内，治疗第1天和第2天，完全缓解时间分别为（46．57±27．39）min和（40．95±22．02）min，显著快于B组（P分别为0．0106和0．0062）。本研究发生不良事件7起，均在B组，A组无不良事件发生。结论复方法莫替丁咀嚼片较法莫替丁胶囊更快速缓解酸相关性疾病引起的烧心、反酸、上腹痛等症状。

Compound famotidine chewable tablets in treatment of symptoms of heartburn,sour regurgitation due to acid-related disorders:a randomized,double-blind,active controlled,multi-center study

A/M To evaluate the efficacy and safety of compound famotidine chewable tablets in treatment of symptoms of heartburn, sour regurgitation due to acid-related disorders. METHODS It was a randomized, doubleblind, active controlled and multi-center study. A total of 240 proper patients were randomized to enter either compound famotidine chewable tablet group （group A） or active drug famotidine group （group B） in 1 ： 1 ratio. Patients in group A took one famotldine placebo capsule first, then took one compound famotidine chewable tablet when having symptoms. Patients in group B took one famotidine capsule first, then took one compound famotidine placebo chewable tablet when having symptoms. Patients in both groups took study drugs before sleeping if the patients had no symptoms. Daily test drug and active oontrolled drug were not allowed to more than two. The course was 7 d. Symptoms of heartburn, sour re- gurgitation and upper abdominal pain should be evaluated before treatment and everyday after treatment. Symptoms were evaluated in 5,10,15,20,30,40,50,60 and 120 rain after every drug administration. RESULTS A total of 227 patients completed the study according to the protoool,including 114 in group A and 113 in group B. In the first day,instant re- mission rate of heartburn in group A 10 and 15 min after drug administration was 31.63% and 44.90% respectively, which was significantly higher than group B（ P values were 0.006 7 and 0.037 0, respectively）. Instant remission rate of sour regurgitation and upper abdominal pain in group A in every time spot within 10 - 60 min after drug administration was significantly higher than group B, respectively（ P values were all less than 0.05）. Instant remission rate of overall symptoms in group A 5 min after drug administration was 17.70%. Instant remission rate in every time spot till 60 min after drug administration was significantly higher than group B（ P values were all less than 0.05）. Instant remission rate of every symptom in 2nd day to 7th day similar to 1 st day. Complete remission time in group A for all symptoms was with- in 50 min. Complete remission time was （46.57 ± 27.39） and （40.95 ± 22.02） rain in 1st day and 2nd day, respectively, which was significantly faster than group B（ P values were 0.010 6 and 0.006 2, respectively）.There were 7 adverse events found in this study, all in group B. No adverse events were found in group A. CONCLUSION Compound famotidine chewable tablet can result in faster remission of symptoms of heartburn, sour regurgitation and upper abdominal pain due to acid-related disordersas compared with famotidine.