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目的评价复方消化酶片(商品名:贝尔渭)治疗消化不良症状的有效性和安全性。方法用多中心、随机、双盲双模拟、阳性药物平行对照设计。共有141例消化不良症状受试者完成试验,其中试验组71例和对照组70例。试验组予复方消化酶片1片,对照组予复方消化酶胶囊(商品名:达吉)2粒,tid,连续口服2周。结果用药2周后,2组受试者消化不良反应症状的改善情况基本一致,组间比较差异无统计学意义。且2组不良反应发生率之间差别也未见统计学意义。结论复方消化酶片可以有效治疗消化不良症状,且安全性良好。
Abstract：AIM To evaluate the clinical efficacy and safety of compound digestive enzyme tablet Bearse in treatment of patients with dyspepsia.METHODS The trial was designed as a multicenter,randomized,double-blind and double-dummy,positive and parallel comparative study.The trial enrolled 141 subjects with dyspepsia,including Bearse group(treatment group,n =71) and Dages group(control group,n = 70).Both of groups took study drugs 1 tablet/2capsules 3 times daily for 2 weeks.RESULTS After 2 weeks,clinical improvement of dyspepsia symptoms was similar between Bearse group and Dages group.There were no differences in the rate of adverse drug reactions between 2 groups.CONCLUSION Bearse can effectively treat dyspepsia symptoms,and has satisfactory safety.
[1]Bykov VA,Demina NB,Kataeva NN,el al.Enzyme preparations used for the treatment of digestion insufficiency[J].Pharm Chem J,2000,34(3):105.
[2]上海市达吉临床研究协作组.多种消化酶抑制剂治疗消化不良的多中心、随机、安慰剂、双盲、平行对照研究[J].胃肠病学,2003,8(2):79.
[3]范文伟,黄容旺,梁汉昌.复方消化酶治疗功能性消化不良消化功能减退53例[J].中国中西医结合消化杂志,2004,12(3):180.
[4]张万岱.消化酶制剂的临床应用[J].中国处方药,2005,36(3):24.
[5]上海市泌特临床协作组.复方阿嗪肠溶片治疗消化不良的多中心、随机、双盲、安慰剂平行对照临床研究[J].胃肠病学,2005,10(2):83.
[6]Lee CD,Jeon JW.A Clinical trial on bearse in chronic maldigestive status in korea[J].The Journal of Recent Medical,1988,29(11):65.
基本信息:
DOI：10.19577/j.cnki.issn10074406.2016.06.006
中图分类号:R57
引用信息:
[1]颜耀东,温泉,董宏鸿,等.复方消化酶片治疗消化不良症状的临床疗效和安全性[J].中国临床药学杂志,2016,25(06):357-360.DOI:10.19577/j.cnki.issn10074406.2016.06.006.
2016-11-25
2016-11-25