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低剂量颇得斯安与氢化可的松局部治疗活动期溃疡性结肠炎的随机双盲研究

Low Pentasa dosage versus hydrocortisone in the topical treatment of active ulcerative colitis: a randomized, double-blind study.

作者信息

Bianchi Porro G, Ardizzone S, Petrillo M, Fasoli A, Molteni P, Imbesi V

机构信息

Gastrointestinal Unit, L. Sacco Hospital, Milan, Italy.

出版信息

Am J Gastroenterol. 1995 May;90(5):736-9.

PMID:7733079
Abstract

OBJECTIVES

To compare a low dosage (1 g/day) rectal preparation of 5-aminosalicylic acid in slightly acidic, buffered suspension (Pentasa) with a hydrocortisone 100 mg/day enema (Cortenema).

METHODS

Fifty-two patients with mild to moderate distal ulcerative colitis were randomized under double-blind conditions to receive a rectal preparation of either Pentasa (1 g/day) or Cortenema (100 mg/day) for 3 wk.

RESULTS

After 3 wk, both types of treatment resulted in statistically significant improvements in clinical and endoscopic activity. No significant difference was observed between the two drugs in any of the parameters considered, although a statistical trend in favor of Pentasa was evident when analysis was limited to clinical activity (p = 0.07). No side effects were reported in either group.

CONCLUSIONS

Our experience confirms that short term topical treatment with a low dosage 5-aminosalicylic acid is at least as effective as 100-mg hydrocortisone enemas in treating mild to moderate distal ulcerative colitis and is generally well tolerated.

摘要

目的

比较低剂量(1克/天)的5-氨基水杨酸微酸性缓冲混悬液直肠制剂(颇得斯安)与100毫克/天氢化可的松灌肠剂(可的索纳)。

方法

52例轻至中度远端溃疡性结肠炎患者在双盲条件下随机分组,接受颇得斯安(1克/天)或可的索纳(100毫克/天)直肠制剂治疗3周。

结果

3周后,两种治疗方式在临床和内镜活动度方面均有统计学意义上的显著改善。在所考虑的任何参数中,两种药物之间均未观察到显著差异,尽管仅分析临床活动度时,有明显的统计学趋势显示颇得斯安更具优势(p = 0.07)。两组均未报告有副作用。

结论

我们的经验证实,低剂量5-氨基水杨酸短期局部治疗在治疗轻至中度远端溃疡性结肠炎方面至少与100毫克氢化可的松灌肠剂一样有效,且一般耐受性良好。

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