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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。
Objective: To observe and evaluate the clinical efficacy and safety of Changlekang capsule and powder on irritable bowel syndrome (IBS). Methods: Phase Ⅱ clinical trials using a multi-center randomized double-blind three-controlled trial of 160 cases. Intestinal Lek Capsule po, 1.2 6 g, bid; ilealconazole po, 1.5 g, bid; control drug Miya Pope, 1.05 g, bid. Treatment are 14 ~ 21d. Determination of the quality of life of patients before and after treatment. A total of 187 randomized open-label multi-center controlled trials were included in the phase III trial. Intestinal Lok Hong capsules, powder usage, dose with the phase Ⅱ clinical trials; control drug Miya film po, 0. 7g, tid, treatment with the previous. Results: The effective rate of IBE Capsule in treating IBS was 78.3% (36/46) in the phase Ⅱ clinical trial, 72.9% (43/59) in the control group, 74.5% (4 1/5 5). All three drugs were significantly (P <0.01) to improve the quality of life of patients. The effective rate of IBE capsule for treating IBS was 81.5% (66/81); the effective rate of XINGERANG powder was 80.8% (59/73); that of MICA tablet was 78.8% (26/81) 33). There was no significant difference between the two groups (P> 0.05). There were no drug-related adverse reactions in each group. Conclusion: Changlekang capsules and powders are effective and safe biological agents for the treatment of IBS. The efficacy is equivalent to Miya Pills.