DOSE RESPONSE OF ASACOL (MEZALAZINE) IN TREATMENT OF ULCERATIVE COLITIS

5-氨基水杨酸酯类药物在管理中的作用已经确立。 患有溃疡性结肠炎的成年人。这些药物在儿科的应用研究 人口一直非常有限。Asacol，一种对ph值敏感的聚合物涂层 5-氨基水杨酸酯口服制剂的研究将测定其含量 治疗儿童溃疡性结肠炎的最佳剂量 执迷不悟。大约25名体重至少27公斤的儿科患者将 在这项研究中登记进入维护阶段。病人将会是 盲目随机接受相当于50毫克/公斤/天的或 15 mg/kg/d，连服1年。患者将被跟踪一年或直到 疾病活动的临床复发。这项研究的假设是 基于30%的患者接受较大剂量的 Asacol将复发，而患者的复发率为55% 接受较低剂量的阿萨科尔。

The 5-aminosalicylate drugs have a well established role in the management of adults with ulcerative colitis. Study of these drugs in the pediatric population has been very limited. Asacol, a ph-sensitive, polymer-coated oral preparation of 5-aminosalicylate, will be studied to determine the optimal dose to treat ulcerative colitis in children without associated deversity. Approximately 25 pediatric patients weighing at least 27KG will enrolled into the maintenance phase on this study. The patient will be blindly randomized to receive either the equivalent of 50 mg/kg/day or 15mg/kg/day for one year. Patients will be followed for one year or until clinical relapse of disease activity. The hypothesis of this study is based on the probability that 30% of patients receiving the higher dose of Asacol will relapse compared with 55% rate of relapse in patients receiving the lower dose of Asacol.