复方阿嗪米特肠溶片治疗消化不良的多中心、随机、双盲、安慰剂平行对照临床研究

背景:复方阿嗪米特肠溶片(商品名:泌特)含阿嗪米特和多种消化酶,国外用于治疗慢性消化不良已有多年,但迄今为止在国内尚无多中心、随机、安慰剂平行对照研究.目的:评价应用复方阿嗪米特肠溶片治疗慢性消化不良的临床疗效、安全性和依从性.方法:采用多中心、随机、双盲、安慰剂平行对照临床研究.上海市11个临床中心共纳入消化不良患者203例,随机分为两组,资料完整并纳入统计分析者191例,治疗组86例,对照组105例.餐后分别立即服用复方阿嗪米特肠溶片或安慰剂2片,每日3次,疗程2周.治疗前后和治疗期间每天分别评估各消化不良症状的积分、药物副作用和患者的依从情况.结果:两组消化不良患者的年龄、性别、疾病类别和消化不良症状积分均有较好的匹配性,且均完成了研究规定的疗程.与对照组相比,治疗组治疗1周后各消化不良症状积分均小于对照组,腹胀、嘈杂和总症状积分显著下降(P<0.05);治疗2周后,除便秘症状(P=0.214)外,治疗组食欲不振、腹胀、腹痛、嗳气、恶心、嘈杂、腹泻症状和症状总积分均显著低于对照组(P均＜0.05).治疗1周和2周后,治疗组各消化不良症状积分和症状总积分改善率均显著高于对照组(P<0.0001).结论:复方阿嗪米特肠溶片治疗各种病因相关性消化不良安全有效,依从性好,无严重不良反应.

A Multicenter, Randomized, Double-blind, Placebo-controlled, and Parallel Clinical Study of Complex Azintamide Enteric Tablet in the Treatment of Dyspepsia

Background: Complex azintamide enteric tablet (brand name Mite) that contains azintamide and several digestive enzymes, has been used in the treatment of patients with dyspepsia for several years. Aims: To evaluate the clinical efficacy, safety and compliance in dyspeptic patients with complex azintamide enteric tablets. Methods: A multicenter, randomized, placebo-controlled, and parallel clinical trial was carried out at 11 hospitals in Shanghai. A total of 203 patients with dyspepsia were enrolled, and 191 patients had completed the study. All patients were divided into two groups randomly, complex azintamide enteric tablet treatment group (86 patients) and control group (105 patients). Patients took 2 complex azintamide enteric tablets or placebo enteric tablets immediately after meal 3 times daily for 2 weeks. The index scores of dyspeptic symptoms, side effects, and compliance were evaluated before and after treatment. Results: The patients in the two groups were matched well with age, sex, diseases, and index scores of dyspeptic symptoms. The average index scores of dyspeptic symptoms were lower in the treatment group than those in the control group after 1-week treatment, the index scores of abdominal distension, gastric upset and all symptoms were all lowered significantly (P<0.05). In the treatment group, the index scores of all dyspeptic symptoms such as poor appetite, abdominal distension, stomachache, belching, nauseation, gastric upset, and diarrhea decreased significantly (all P values were less than 0.05) than those in the control group after 2-week treatment, except constipation (P=0.214). After 1-week and 2-week treatment, the decrease of index scores of each symptom and total symptoms was more significant in the treatment group than in the control group (P<0.000 1). Conclusions: Complex azintamide enteric tablet is effective in the treatment of dyspepsia caused by various diseases, and it is safe with good compliance.