【摘要】 目的 :观察肠乐康胶囊、散剂对急性肠炎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 15 1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 3～ 7d。Ⅲ期临床试验采用多中心随机开放对照试验 5 43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急性肠炎有效率为 87.3% (4 8/ 5 5 ) ;肠乐康散剂有效率为 93.6 % (4 4/ 47) ;对照药米雅片为 81.6 % (4 0 / 49)。Ⅲ期临床试验肠乐康胶囊治疗急性肠炎有效率为 93.2 % (2 0 5 / 2 2 0 ) ;肠乐康散剂有效率为 94.3% (2 14/ 2 2 7) ;米雅片为 93.8% (90 / 96 ) ;Ⅱ及Ⅲ期临床试验组间疗效均无显著性差异 (P >0 .0 5 )。 3种药物也均未出现明显的不良反应。结论 :肠乐康胶囊、散剂是安全有效的治疗急性肠炎的生物类药物 ,其疗效与安全性均相当于米雅片。更多还原

【Abstract】 Objectives:To evaluate the safety and efficacy of changlekang(CLK) capsule and powder in treatment of acute enteritis.Methods:A multi-center,randomized,triple dummy and controlled methods were adopted in the phase Ⅱ trials of CLK.151 patients were divided to receive twice daily CLK capsule of 1.26g,or twice daily CLK powder of 1.5g,or twice daily Miya tablet of 1.05g for 3～7d.In the phase Ⅲ trials,a multi-center,randomized open and controlled methods were adopted.543 patients were divided and treated in accordance with phase Ⅱ trials ecxept that the regimen of control drug (Miya tablet)was given in triple daily dose of 0.7g.Results:For treatment of acute enteritis,the effective rate of CLK capsule,CLK powder,and Miya tablet were 87.3%(48/55),93.6%(44/47) and 81.6%(40/49) respectively in phase Ⅱ study.The corresponding effective rate in phase Ⅲ trials were 93.2%(205/220),94.3%(214/227) and 93.8%(90/96) respectively.No significant differences were observed among CLK capsule,CLK powder and the control drug (Miya tablet) in phase Ⅱ and phase Ⅲ studies.Conclusion:CLK capsule,CLK powder are effective in treatment of acute enteritis,the efficacy and adverse reaction of CLK capsule and CLK powder are similar to that of Miya tablet.更多还原