奥沙拉嗪钠胶囊治疗溃疡性结肠炎的临床疗效

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

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。

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 cases 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.