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

作　　者：吴咏冬[1] 胡善联 何江江 张澍田[1] 于中麟[1] 谢鹏雁[3] 郝建宇[4] 王邦茂[5] 董雷[6] 王吉凌[7] 冯子坛[8] 

机构地区：[1]首都医科大学附属北京友谊医院,北京100050 [2]上海市卫生发展研究中心,上海200000 [3]北京大学第一医院,北京100034 [4]首都医科大学附属北京朝阳医院,北京100020 [5]天津医科大学总医院,天津300052 [6]西安交通大学医学院第二附属医院,陕西西安710004 [7]内蒙古自治区包头市中心医院,内蒙古包头014000 [8]中国人民解放军白求恩国际和平医院,河北石家庄050000

出　　处：《中国医刊》2015年第11期58-61,共4页Chinese Journal of Medicine

摘　　要：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.

关 键 词：复方消化酶 消化不良 多中心 随机对照研究 药物经济学评价 

分 类 号：R975[医药卫生—药品]