三九胃泰颗粒与奥美拉唑联用治疗功能性消化不良疗效和安全性的多中心、随机、双盲、双模拟、平行对照临床试验

摘要

Objective To evaluate the efficacy and safety of sanjiuweitai particles combined with omeprazole in the treatment of functional dyspepsia (FD).Methods A multicenter,randomized,double-blind,double-dummy,parallel-controlled clinical trial was carried out.A total of 405 FD patients were divided into sanjiuweitai group,omeprazole group and combination group.There were 135 cases in each group and were treated with sanjiuweitai particle and omeprazole simulant,omeprazole and sanjiuweitai particle stimulant and sanjiuweitai particle and omeprazole respectively.The medicine was continuously taken for 14 days.The improvement of clinical symptoms of each group was evaluated before and after treatment.Kruskal-Wallis H test was performed for measurement data.Chi-square test or Fisher exact probability method was used for counting material.Pairwise comparisons among three groups,the inspection level was α'=0.0125.Results Two weeks after treatment,clinical symptoms of all the three groups improved significantly.The total efficiency of sanjiuweitai group was 69.2 ％ (90/130),omeprazole group was 65.6 ％ (86/131) and combination group was 83.7％ (103/123).The total efficiency of combination group was higher than those of sanjiuweitai and omeprazole group (x2 =7.3543 and10.9033,P=0.0067 and 0.0010).The total efficiency of sanjiuweitai group was equal with that of omeprazole group (P＞0.05).The main adverse reaction included dizziness,sleepiness,heartburn,abdominal pain and ALT increase.There were no significant differences in the incidence of adverse events among three groups (P＞0.05).Conclusion The efficacy of sanjiuweitai particles with omeprazole combination in the treatment of FD was significant and with few adverse reactions.%目的 评价三九胃泰颗粒与奥美拉唑联合应用治疗功能性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、平行对照设计.将405例功能性消化不良患者分为三九胃泰组、奥美拉唑组和联合用药组,每组135例,分别给予三九胃泰颗粒+奥美拉唑模拟剂、奥美拉唑十三九胃泰颗粒模拟剂和三九胃泰颗粒+奥美拉唑.各组均连续服药14d.观察各组治疗后临床症状的改善情况和不良反应.计量资料行Kruskal-Wallis H秩和检验.计数资料行卡方检验或Fisher确切概率法检验.三组间的两两比较,其检验水准α'=0.0125.结果治疗14 d后,三组患者临床症状均得到显著改善,三九胃泰组、奥美拉唑组、联合用药组的总有效率分别为69.2％(90/130)、65.6％(86/131)、83.7％(103/123).联合用药组的总有效率高于三九胃泰组和奥美拉唑组(x2=7.3543和10.9033,P=0.0067和0.0010),三九胃泰组与奥美拉唑组比较差异无统计学意义(P＞0.05).不良反应主要为头晕、嗜睡、烧心、腹痛、ALT升高等,三组的不良反应发生率差异无统计学意义(P＞0.05).结论 三九胃泰颗粒与奥美拉唑联用治疗功能性消化不良的综合疗效显著,且不良反应少.