复方法莫替丁治疗酸过多型消化不良的临床试验

目的观察复方法莫替丁咀嚼片治疗烧心、酸过多型消化不良的疗效和安全性。方法采用多中心、随机、双盲、双模拟、阳性药物平行对照的临床试验,共入选229例受试者,其中复方法莫替丁咀嚼片组（A组）114例,法莫替丁片组（B组）115例。结果进入符合方案数据分析（PP）的有218例（A组106例,B组112例）,进入意向性分析（ITT）的有229例（A组114例,B组115例）,进入安全性分析数据集（SA）的有229例（A组114例,B组115例）。复方法莫替丁咀嚼片治疗烧心、反酸、腹部不适、上腹痛、嗳气及腹胀等症状的临床疗效与法莫替丁片相似,而烧心、反酸的临床缓解时间明显短于法莫替丁片,烧心、反酸症状总记分下降值和下降率亦大于法莫替丁片,不良事件发生率和程度与法莫替丁片相似。结论复方法莫替丁咀嚼片是治疗烧心和胃酸分泌过多型消化不良的安全有效药物,并且具有起效快、有效时间长等特点,值得在临床推广使用。

Clinic Research of Compound Famotidine of Disorders Digestion

AIM To investigate efficacy and safety of Pepcid Complete(compound famotidine) on heartburn,acid related functional disorders.METHODS 229 patients with heartburn,acid related FD in different trial centers were enrolled and double-blindly,randomly prescribed either Pepcid Complete or Famotidine.Intention-to-treat(ITT),Per-Protocol and Safety Population(PP) are employed for analysis of efficacy and safety respectively.RESULTS 218,229,229 patients were enrolled PP,ITT and Safety Population respectively.No significant difference in efficacy and safety were found between Pepcid Complete and Famotidine on heartburn, acid reflux, abdominal discomfort or pain. The mean time of control heartburn and acid reflux of Pepcid Complete is shorter than that of Famotidine. There was more significant improvement in heartburn and acid reflux scores during the first treatment period in Pepcid Complete group. CONCLUSIONS Both Pepcid Complete and Famotidine are effective and safe in treatment of heartburn and acid related FD.Patients in Pepcid Complete group got sooner and longer remission than those in Famotidine group.