肠乐康治疗肠易激综合征347例  

The efficacy of changlekang in treatment of 347 cases of irritable bowel syndrome

作　　者：傅丽娜[1] 张泰昌[2] 张尚忠[3] 甘立平[4] 董蕾[5] 杨昭徐[6] 吴志强[7] 熊德鑫[7] 程留芳[8] 汤旦林[9] 孙瑞华[9] 崔云龙 万阜昌 

机构地区：[1]山东省立医院,济南250021 [2]北京宣武医院,北京100053 [3]山东医科大学附属医院,济南250012 [4]北京军区总医院,北京100070 [5]西安医科大学第二附属医院,西安710004 [6]北京天坛医院,北京100050 [7]解放军第304医院,北京100037 [8]解放军总医院,北京100853 [9]中日友好医院,北京100029 [10]北京东方百信生物技术有限公司,北京100037

出　　处：《中国新药杂志》2001年第6期463-465,共3页Chinese Journal of New Drugs

基　　金：国家新药基金重点科技(攻关)项目!十个新药的研究与产业化开发 (96-90 1-0 5 -14 5 )

摘　　要：目的 :观察和评价肠乐康胶囊、散剂对肠易激综合征 (IBS)的临床疗效和安全性。方法 :Ⅱ期临床试验采用多中心随机双盲三模拟对照试验共 16 0例。肠乐康胶囊 po,1.2 6 g ,bid ;肠乐康散剂 po ,1.5 g ,bid ;对照药米雅片 po ,1.0 5 g ,bid。疗程均为 14～ 2 1d。测定治疗前后患者的生命质量。Ⅲ期临床试验采用多中心随机开放对照试验共 187例。肠乐康胶囊、散剂用法、剂量同Ⅱ期临床试验 ;对照药米雅片 po ,0 .7g ,tid ,疗程同前。 结果 :Ⅱ期临床试验肠乐康胶囊治疗IBS有效率为 78.3% (36 / 46 ) ;肠乐康散剂有效率为 72 .9% (4 3/ 5 9) ;对照药米雅片为74.5 % (4 1/ 5 5 )。 3种药物均能显著 (P均 <0 .0 0 1)改善患者的生命质量。Ⅲ期临床试验肠乐康胶囊治疗IBS有效率为 81.5 % (6 6 / 81) ;肠乐康散剂有效率为 80 .8% (5 9/ 73) ;米雅片为 78.8% (2 6 / 33) ;Ⅱ及Ⅲ期临床试验组间疗效均无显著性差异 (P >0 .0 5 ) ,各药均未发现与药物有关的不良反应。结论 :肠乐康胶囊、散剂是治疗IBS的有效安全的生物类药物 ,其疗效相当于米雅片。Objectives:To evaluate the efficacy and safety of changlekang(CLK) capsule and powder in treatment of irritable bowel syndrome(IBS).Methods:In the phase Ⅱ clinical trial,multi-center,randomized,double blind,triple dummy and controlled method was adopted.160 patients were divided to receive twice daily oral dose of 1.26g CLK capsule,or twice daily oral dose of 1.5g CLK powder,or twice daily oral dose of Miya tablet of 1.05g for 14～21d.The quality of life was observed before and after treatment.In the phase Ⅲ trials 187 patients were enrolled.The method adopted,the active and control drugs used,the dose of these drug,and duration of treatment were the same as in phase Ⅱ trials except that the regimen of control drug was in a triple daily oral dose of 0.7g Miya tablet.Results:The effective rate in phase Ⅱ trial was 78.3%(36/46) for CLK capsule,72.9%(43/59) for CLK powder,and 74.5%(41/55) for Miya tablet.The corresponding effective rate in phase Ⅲ trial was 81.5%(66/81),80.8%(59/73) and 78.8%(26/33) for Miya tablet respectively.The quality of life in all 3 arms was significantly improved at phases Ⅱ and Ⅲ trials (P<0.001).No significant difference in effective rate among arms were observed (P>0.05) and no adverse reactions were observed in all arms.Conclusion:CLK capsule and powder were effective and safe in treatment of IBS and their efficacy is as effective as Miya.

关 键 词：肠乐康 肠易激综合征 临床试验 安全性 临床疗效 

分 类 号：R975.3[医药卫生—药品] R969.4[医药卫生—药学]