COATED ORAL 5-AMINOSALICYLIC ACID THERAPY FOR MILDLY TO MODERATELY ACTIVE ULCERATIVE-COLITIS - A RANDOMIZED STUDY
COATED ORAL 5-AMINOSALICYLIC ACID THERAPY FOR MILDLY TO MODERATELY ACTIVE ULCERATIVE-COLITIS - A RANDOMIZED STUDY
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DOI：
10.1056/nejm198712243172603
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发表时间：
1987-12-24
影响因子：
158.5
通讯作者：
ILSTRUP, DM
中科院分区：
文献类型：
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作者：
SCHROEDER, KW;TREMAINE, WJ;ILSTRUP, DM
在一项双盲、安慰剂对照试验中，我们评估了87例轻度至中度活动性溃疡性结肠炎患者口服5-氨基水杨酸（5-阿萨）的疗效。患者被随机分配接受每天4.8或1.6 g剂量的5-阿萨或安慰剂治疗6周。结果通过灵活的直肠乙状结肠镜检查和医生的评估，以三周的时间间隔和患者的日常症状记录进行监测。 结果显示，每天服用4.8 g 5-阿萨的患者有24%完全缓解和50%部分缓解，而服用安慰剂的患者有5%完全缓解和13%部分缓解（P < 0.0001，秩和检验）。在每天1.6的剂量下，反应是安慰剂的两倍，但差异没有达到统计学显著性（P = 0.51）。年龄、性别、病程、活动性症状持续时间或疾病程度不影响临床结局。 我们的结论是，口服5-阿萨的剂量为4.8克，每天是有效的治疗，至少在短期内，轻度至中度活动性溃疡性结肠炎。
We assessed oral 5-aminosalicylic acid (5-ASA) prepared with a pH-sensitive polymer coating in 87 patients with mildly to moderately active ulcerative colitis in a double-blind, placebo-controlled trial. Patients were randomly assigned to receive 5-ASA at a dosage of either 4.8 or 1.6 g per day or placebo for six weeks. The outcome was monitored by flexible proctosigmoidoscopic examinations and physicians'' assessments at three-week intervals and by patients'' recordings of daily symptoms. Results showed 24 percent complete and 50 percent partial responses in those receiving 4.8 g of 5-ASA per day as compared with 5 percent complete and 13 percent partial responses in those receiving placebo (P < 0.0001, rank-sum test). At a dosage of 1.6 per day, the response was twice as good as with placebo, but the difference did not reach statistical significance (P = 0.51). Age, sex, duration of disease, duration of active symptoms, or extent of disease did not affect the clinical outcome. We conclude that oral 5-ASA administered in a dosage of 4.8 g per day is effective therapy, at least in the short term, for mildly to moderately active ulcerative colitis.