Tremaine W J, Schroeder K W, Harrison J M, Zinsmeister A R
Inflammatory Bowel Disease Clinic, Mayo Clinic and Foundation, Rochester, Minnesota 55905.
J Clin Gastroenterol. 1994 Dec;19(4):278-82. doi: 10.1097/00004836-199412000-00003.
Oral mesalamine (Asacol) in a dose of 3.2 g/day was administered in a 16-week placebo-controlled trial in 38 patients for the treatment of mildly to moderately active Crohn's colitis or ileocolitis. Eighteen patients continued a stable dose of prednisone of no more than 20 mg/day and 20 patients did not take prednisone. Changes in the Crohn's Disease Activity Index (CDAI) were used as the primary measure of efficacy. Oral mesalamine was effective in achieving partial or complete remission in 60% of patients as compared with 22% of placebo-treated patients. However, only 20 of 38 patients completed the 17-week study. The others withdrew early because of worsening of symptoms or were dropouts counted as failures. The high percentage of early withdrawals prevented comparison of mean 17-week CDAI scores. Although the number of patients in this study was relatively small, Asacol 3.2 g/day appears to be safe and effective treatment for mildly to moderately active Crohn's colitis and ileocolitis as compared with placebo, and this regimen is an option for treatment of patients who fail or are intolerant of sulfasalazine.
在一项为期16周的安慰剂对照试验中，对38例轻度至中度活动性克罗恩结肠炎或回结肠型克罗恩病患者给予3.2克/天剂量的口服美沙拉嗪（艾迪莎）进行治疗。18例患者继续服用稳定剂量不超过20毫克/天的泼尼松，20例患者未服用泼尼松。克罗恩病活动指数（CDAI）的变化被用作疗效的主要衡量指标。与22%接受安慰剂治疗的患者相比，口服美沙拉嗪使60%的患者实现了部分或完全缓解。然而，38例患者中只有20例完成了为期17周的研究。其他患者因症状恶化而提前退出，或被计为失败的退出者。高比例的提前退出妨碍了对17周平均CDAI评分的比较。尽管本研究中的患者数量相对较少，但与安慰剂相比，3.2克/天的艾迪莎似乎是治疗轻度至中度活动性克罗恩结肠炎和回结肠型克罗恩病的安全有效的疗法，并且该治疗方案是对柳氮磺胺吡啶治疗失败或不耐受的患者的一种治疗选择。
