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目的以柳氮磺吡啶为对照药观察巴柳氮治疗溃疡性结肠炎活动期的疗效及安全性。方法62例溃疡性结肠炎(活动期)病人分为治疗组31例、对照组31例。治疗组给予巴柳氮1.5g,每日4次,对照组给予柳氮磺吡啶(SASP)片剂1.0g,每日4次,均为餐后服用,总疗程为8wk,对2组治疗前后病人的临床症状、肠镜检查结果及不良反应情况进行比较。结果治疗组的总有效率为94%,不良反应发生率为6%,对照组的总有效率为90%,不良反应发生率为45%,2组总有效率差异不明显(P>0.05),但巴柳氮改善病人腹泻、脓血便及内镜下黏膜组织外观改善等临床症状比SASP迅速(P<0.05),且不良反应发生率明显低于SASP(P<0.01)。结论巴柳氮治疗溃疡性结肠炎效果好、迅速,且安全性高。
Objective To observe the efficacy and safety of balsalazide in the active stage of ulcerative colitis with sulfasalazine as control. Methods Sixty-two patients with ulcerative colitis (active stage) were divided into treatment group (31 cases) and control group (31 cases). The treatment group was given balsalazide 1.5g, 4 times a day, the control group was given sulfasalazine (SASP) tablets 1.0g, 4 times daily, were taken after meal, the total course of treatment was 8wk, before and after treatment of two groups The patient’s clinical symptoms, colonoscopy results and adverse reactions were compared. Results The total effective rate was 94%, the adverse reaction rate was 6%, the total effective rate was 90%, the adverse reaction rate was 45% in the treatment group, but there was no significant difference between the two groups (P> 0.05) (P <0.05), and the adverse reactions were significantly lower than those of SASP (P <0.01). However, the clinical symptoms of balsalazine, such as diarrhea, pus and blood stool, and endoscopic mucosal appearance were improved. Conclusion Balsalazine is effective and rapid in the treatment of ulcerative colitis, and is safe.