摘要
目的：观察巴柳氮胶囊治疗轻、中度溃疡性结肠炎(UC)的临床疗效和安全性。方法：采用随机、双盲、双模拟及阳性药物平行对照方案,将46例UC病人随机分为巴柳氮胶囊试验组(24例,6.75 g·d^(-1))和柳氮磺吡啶(SASP)对照组(22例,3 g·d^(-1)),疗程均为8 wk。对2组病人治疗前后的临床症状、肠镜检查及不良反应情况进行比较。结果：试验组总有效率为96%,明显高于对照组45%(P＜0.01)。试验组不良反应发生率低于对照组(4%比36%,P＜0.05)。结论：巴柳氮胶囊治疗轻、中度急性发作性溃疡性结肠炎是安全、有效的,适用于SASP耐受性差的UC病人。
AIM： To evaluate the effect and safety of balsalazide sodium capsule in the treatment of mildmoderate active ulcerative colitis （UC）. METHODS： Forty-six patients with UC were randomly allocated into balsalazide group（n=24） or salfasalazine（SASP） group（n=22） in double-blind and double mimic trial, with a course of treatment for eight weeks. The efficacy and adverse reactions of this drug were evaluated on the basis of the clinical improvements shown by symptoms and colonoscopic changes. RESULTS： The rate of total efficiency in balsalazide group was higher than that in SASP group（96 % vs 45 % ,P 〈 0.01 ）. The rate of drug adverse reactions in balsalazide group was lower than that in SASP group（4 % vs 36 %,P 〈 0.05）. CONCLUSION： Balsalazide is obviously effective and safe in the treatment of mild-moderate active ulcerative colitis, especially for the intolerant patients.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2006年第4期273-276,共4页
Chinese Journal of New Drugs and Clinical Remedies
关键词
巴柳氮
柳氮磺吡啶
结肠炎
溃疡性
随机对照试验
双盲法
balsalazide
salfasalazine
colitis,ulcerative
randomized controlled trials
double blind method
