Cost-effective clinical trial on compound digestive enzymes tablet in the treatment of dyspepsia

目的 评价复方消化酶片治疗中国消化不良人群的有效性及经济学特性. 方法 8个中心采用随机、双盲双模拟、阳性药物平行对照的方法,将203例消化不良患者随机分为两组,试验组( A组,106例)为复方消化酶片1片,1日3次;对照组( B组,91例)为复方消化酶胶囊2粒,1日3次. 治疗2周. 观察两组主要疗效指标和次要疗效指标;以日治疗费用和每例患者直接医疗成本评价其经济性. 结果 试验组与对照组的主要疗效指标和次要疗效指标相似,总有效率分别为80. 2℅和19. 4℅(P>0. 05). 试验组平均日治疗费用和每例患者直接医疗成本分别比对照组低1. 59元和22. 26元. 结论 复方消化酶片治疗消化不良有良好的临床疗效及安全性,与对照组比较具有一定的成本优势.Objective The study was undertaken to demonstrate the clinical efficacy and cost-effectiveness of com-pound digestive enzymes tablet in the treatment of dyspepsia under various physiological gastrointestinal conditions. Method This was a multicenter(8 hospitals),randomized,double blind,parallel group,and double dummy study. The trial comprised a total of 203 outpatients who were randomized to treatment with dyspepsia syndrome. The A Group( experimental group) was comprised of 106 patients who were given 1 tablet of compound digestive enzymes tablet( Bearse) 3 times per day. The B Group( control group) of 91 patients was given 2 capsules of compound di-gestive enzyme capsule( Dages) 3 times per day. The total duration of drug treatment was 2 weeks. The primary end-point was the total effective rate of all dyspepsia symptoms. The second endpoint was cost-effectiveness of the com-pound digestive enzymes tablet in the treatment of dyspepsia. Result The total efficacy rate of group A and group B were 80.2℅ and 19. 4℅(P>0. 05). The adverse effects in group A and group B were 1. 9℅ and 4. 1℅(P>0. 05). The adverse effects were mild in all the two groups. The daily drug costs and total direct medical costs with Bearse were lower than Dages RMB 1. 59/day and RMB 22. 26/day respectively. Conclusion Compound digestive enzymes tablet and compound digestive enzyme capsule are both effective and safety in patients with dyspepsia. Com-pound digestive enzymes tablet has a better benefit-cost ratio than compound digestive enzyme capsule.中国科技核心期刊(ISTIC)1158-615