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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。
BACKGROUND: Compound Atrazide enteric-coated tablets (trade name: Secret) contain azlite and various digestive enzymes, and have been used abroad for chronic indigestion for many years. However, so far there are no more centers in China that are random , Placebo-controlled parallel study. Objective: To evaluate the clinical efficacy, safety and compliance of compound azimit enteric-coated tablets in the treatment of chronic dyspepsia. METHODS: A multicenter, randomized, double-blind, placebo-controlled clinical study was performed. A total of 203 patients with dyspepsia were enrolled in 11 clinical centers in Shanghai. They were randomly divided into two groups. The data were complete and included in the statistical analysis of 191 cases, 86 cases in the treatment group and 105 cases in the control group. Immediately after meals, taking compound Azimilate enteric-coated tablets or placebo 2 tablets 3 times daily for 2 weeks. The scores of indigestion symptoms, drug side effects and patient compliance were evaluated daily before and after treatment and during treatment. Results: The scores of age, sex, disease type and indigestion symptom scores of two groups of patients with dyspepsia were well matched, and all the treatments prescribed in the study were completed. Compared with the control group, the score of dyspepsia symptom in the treatment group after 1 week of treatment was lower than that of the control group, the bloating, noisy and the total symptom score decreased significantly (P <0.05); After 2 weeks of treatment, except for constipation symptoms (P = 0.214) The appetite, bloating, abdominal pain, belching, nausea, noisy, diarrhea symptoms and symptom scores of the treatment group were significantly lower than those of the control group (all P <0.05). After treatment for 1 week and 2 weeks, the improvement rates of indigestion points and symptom scores in the treatment group were significantly higher than those in the control group (P <0.0001). Conclusion: The compound azinamid enteric-coated tablets is safe and effective in treating various causes of dyspepsia, with good compliance and no serious adverse reactions.