复方阿嗪米特治疗消化不良的自身对照多中心临床研究

目的 观察复方阿嗪米特肠溶片治疗消化不良的疗效和安全性.方法 观察北京8家医院消化科门诊的180例多潘立酮(10 mg/次,3次/d)治疗2周症状积分下降<30%的消化不良患者,根据引起消化不良症状的基础疾病分成胃肠疾病相关的消化不良(A组)和胆系疾病相关的消化不良(B组),使用复方阿嗪米特肠溶片治疗(2片/次,3次/d)2周,观察治疗前、后上腹胀、上腹痛或不适、食欲不振积分变化,计算有效率,同时观察记录不良事件.结果 A、B两组患者治疗后上腹胀、上腹痛或不适、食欲不振积分及总症状积分明显下降(P<0.01),各单项症状及总症状有效率均在84.9%和92.5%以上.1例患者于复方阿嗪米特治疗14 d时出现皮疹伴有瘙痒,3 d后皮疹消退,未遗留其他不适及检验异常.结论 复方阿嗪米特肠溶片可以有效缓解多潘立酮治疗无效的消化不良患者的上腹胀、上腹痛或不适、食欲不振症状,且安全性较好.

Efficacy and safety of compound azintamide on dyspepsia symptoms in a multicentre self-controlled trial

Objective To investigate the efficacy and safety of compound azintamide on dyspepsia symptoms. Methods One hundred and eighty dyspepsia patients were divided into two groups according to dyspepsia symptom related with gastrointestinal disease ( group A) or biliary system disease (group B),whose dyspepsia symptom were not improved by the Domperidone 10 mg tid for 2 weeks. Two tablets of compound azintamide were administered orally following a meal, tid for 2 weeks. The changes of symptoms score of upper abdominal distention, upper abdominal pain or discomfort anorexia and effective rate as well as adverse events were recorded. Results Compound azintamide greatly improved the symptoms of upper abdominal distention, upper abdominal pain or discomfort and anorexia. All symptoms scores were significantly decreased after 2 weeks of compound azintamide (P < 0.01). The effective rate of each symptom and total symptoms score were more than 84.9% and 92.5%. One patient reported mild rash at the fourteenth days, which disappeared 3 days later. Conclusion Compound azintamide showed effective and safety in treatment of patient with dyspepsia symptoms when Domperidone therapy is not satisfactory.