巴柳氮钠治疗溃疡性结肠炎的疗效评价

评价巴柳氮钠疗效及安全性。方法：符合2000年全国炎症性肠病会议标准确诊的轻、中度溃疡性结肠炎患者为入组对象,进行双盲双模拟,随机多中心,平行对照研究：A组：巴柳氮钠（100例）每日6 g;B组：柳氮磺胺吡啶（100例）每日4 g。疗程均为8周。结果：（1）ITT分析：总有效率：A组-71.43%;B组-64.08%（P=0.248 7）。（2）PP分析：总有效率：A组-73.58%;B组-69.15%（P=0.487 9）。不良反应率：A组：4.39%;B组：13.08%（P=0.021 2）;B组发生1例严重不良反应。结论：ITT分析和PP分析均表明：巴柳氮钠治疗溃疡性结肠炎疗效高于柳氮磺胺吡啶;试验组不良反应率明显低于对照组。

Clinical Efficacy of Balsalazide Sodium for Active Ulcerative Colonitis

OBJECTIVE： To evaluate the efficacy and safety of balsalazide sodium in treating active ulcerative colitis （UC）. METHODS： 200 patients who were confirmed as having mild or moderate UC based on the Chinese consensus of inflammatory bowel disease in 2000 symposium were enrolled in this randomized, multicenter, doubleblind, doubledummy, parallel controlled study. Of whom, 100 patients were assigned to receive balsalazide sodium 6 g daily for 8 weeks （Group A）, another 100 to receive Sulfasalazine 4 g daily for 8 weeks （Group B）. RESULTS： （1） ITT analysis： The total effective rate was 71.43% in Group A versus 64.08% in Group B （ P = 0.248 7）. （2） PP analysis： The total effective rate were 73.58% in Group A versus 69.15% in Group B （P = 0.487 9）. The incidence of adverse drug recations in Group A was 4.39% versus 13.08% in Group B （P = 0.021 2）;one serious adverse event occurred in Group B. CONCLUSION： ITT and PP analysis showed Balsalazide sodium is more effective and better tolerated than Sulfasalazine for acute UC.