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中国临床药理学与治疗学 ›› 1999, Vol. 4 ›› Issue (1): 12-16.

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国产奥沙拉秦钠胶囊治疗溃疡性结肠炎149例

范竹萍, 曾民德   

  1. 上海市消化疾病研究所,上海 200001
  • 收稿日期:1998-10-23 修回日期:1998-12-08 出版日期:1999-03-26 发布日期:2020-12-03
  • 作者简介:范竹萍,女,33岁,硕士,主治医生。

Double-blind comparison of olsalazine sodium and sulphasalazine in active ulcerative colitis

FAN Zhu-Ping, ZENG Min-De   

  1. Shanghai Institute of Digestive Disease 200001
  • Received:1998-10-23 Revised:1998-12-08 Online:1999-03-26 Published:2020-12-03

摘要: 目的 验证国产奥沙拉秦钠胶囊治疗轻、中度溃疡性结肠炎(活动期)的治疗效果,比较国产奥沙拉桊钠胶囊与水杨酸柳氨磺胺吡啶(SASP)对轻、中度溃疡性结肠炎(活动期)的疗故和不良反应。方法 采用多中心随机双窗对照验证107例轻、中度溃疡性结肠炎(活动期)的疗效和不良反应,同时,治疗42例作为开放组,疗程为8周。结果 国产奥沙拉秦钠胶囊的总有效率达84.6%,双盲组中,其临床完全缓解率、内镜完全缓解率和组织学完全缓解率在治疗8周后均比治疗前明显改善,分別各自达75.00%, 34.62%, 55.77%,其疗故与开放组和对照组SASP均类同。BI产奥沙拉秦纳胶囊不良反应主要为腹泻。结论 国产奥沙拉秦钠胶囊治疗活动期轻、中度溃疡性结肠炎有效,其结果与SASP相当,主要不良反应为腹泻,宣与控制腹泻药物合用。

关键词: 真沙拉秦钠, 水杨酸柳氨磺胺吡啶(SASP), 溃疡性结肠炎

Abstract: Aim The effect and adverse events of olsalazine sodium were evaluated and compared with those of sulphasalazine in 149 patients with mild to moderate ulcerative colitis (active). Methods 107 patients with ulcerative colitis were randomized to receive 4 g of sulphasalazine or 2 g of olsalazine daily and were followed up for 8 weeks. Another 42 Patients were given known olsalazine. The enteroscopy were done before and after treat-ment. Results The total effective rate of olsalazine was 84.61%. The complete remission of synptoms, in clinical observation enteroscopy and histological was 75.00%, 34.62% and 55.77%, respectively, and comparable to that in SASP and opened study. The main adverse event was diarrhea. Conclusion Olsalazine sodium is effective in the treatmeat of active ulcerative colitis. The effect is comparable to SASP. The main ad-verse event was diarrhea.

Key words: olsalazine, ulcerative colitis, double-blind

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