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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。
Objective: To observe the clinical efficacy and safety of Changlekang capsule and powder on acute enteritis. Methods: Phase Ⅱ clinical trials using a multicenter randomized double-blind tri-modeled controlled trial of 15 1 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 3 ~ 7d. Phase III clinical trials using multicenter randomized open-label controlled trial of 433 cases. 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 Phase Ⅱ clinical trial of Changlekang Capsule in treatment of acute enteritis was 87.3% (48/55), that of Xialikang Dispensing was 93.6% (44/47), that of control Miya Pill was 81.6% (40/49). The effective rate of clinical trial of Changlekang Capsule in treating acute enteritis was 93.2% (205/220), that of Xialikang Dishes was 94.3% (2 14/2 227), that of Miya Pills was 93.8% (90/96). There was no significant difference between the two groups (P> 0.05). Three kinds of drugs also did not appear obvious adverse reactions. Conclusion: Changlekang capsules and powders are safe and effective biological medicines for the treatment of acute enteritis. The efficacy and safety of these capsules are equivalent to Miya Pills.