奥沙拉嗪钠胶囊治疗溃疡性结肠炎的临床疗效

目的　以柳氮磺胺吡啶 (SASP)片对照 ,观察奥沙拉嗪钠胶囊治疗溃疡性结肠炎 (活动期 )的疗效及不良反应。方法　采用随机、双盲对照的设计进行临床试验。试验组 31例病人口服奥沙拉嗪钠胶囊每次 4粒 ,一日 2次 ,模拟SASP片每次 4片 ,一日 4次 ;对照组 2 7例病人口服SASP片每次 4片 ,一日 4次 ,模拟奥沙拉嗪钠胶囊每次 4粒 ,一日 2次。疗程 8周。结果　试验组 31例病人 8周后近期治愈 13例、显效 9例、有效 3例、无效6例 ,总有效率 70 .97% ( 2 2 / 31) ;对照组 2 5例病人 (包括 2 4例完成病例和 1例因无效脱落的病例 ) 8周后近期治愈 5例、显效 10例、有效 3例、无效 7例 ,总有效率 6 0 % ( 15 / 2 5 )。试验组 31例溃疡性结肠炎病人有 3例发生不良反应 ,不良反应发生率为 9.6 8% ;对照组 2 6例溃疡性结肠类病人 (包括 2 4例完成病例和 2例有不良反应的脱落病例 ) ,有 7例发生不良反应 ,不良反应发生率为 2 6 .92 %。两组不良反应发生率无统计学意义。结论　奥沙拉嗪钠胶囊治疗溃疡性结肠炎疗效与SASP相似

Clinical Effect of Olsalazine Sodium Capsule in the Treatment of Ulcerative Colitis

Purpose To compare the effect and reliability of olsalazine sodium capsule in the treatment of ulcerative colitis (active phase) with those of salicylazosulphapyridine (SASP). Methods We designed a randomized,double blind and control study.The patients of trial group received olsalazine sodium capsule two capsules twice daily and modelling SASP four sheets four times daily for 8 weeks.The patients of control group took SASP four sheets four times daily and modelling olsalazine sodium capsule two capsules twice daily for 8 weeks. Results After 8 weeks,among patients of trial groups,13 cases were clinical healing,9 cases were distinct utility,3 case was efficiency,6 cases were inefficiency.The total effective rate was 70.97% .Among patients of control group,5 cases were clinical healing,10 cases were distinct utility,3 ca ses were effeciency,7 cases were inefficiency (including twenty four cases of complete treatment and one abscission patient because of inefficency).The total effective rate was 60.00%.In control group,3 cases had adverse reaction and 7 cases had adverse reaction among 26 control patients (including twenty four cases of complete treatment and two abscission patients because of adverse reaction).The incidence of adverse reaction was 9.68% and 26.92%,separately,which had no statistics signifcance. Conclusions The effecacy and safty of Olsalazine sodium capsule in the treatment of ulcerative colitis were similar to those of salicylazosulphapyridine.