复方消化酶片治疗消化不良的有效性及药品经济学研究

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,97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79.4%(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.