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目的探讨巴柳氮钠(商品名:贝乐司)治疗活动性溃疡性结肠炎(UC)的临床疗效。方法收集2005年10月—2006年6月在河南省16家医院治疗的活动性UC患者139例,随机分为治疗组(n=78)和对照组(n=61)。治疗组患者服用巴柳氮钠片剂每天6 g,连续4周,缓解后改为每天2 g,继续4周;对照组服用柳氮磺胺吡啶(SASP)片剂每天4 g,连续4周,缓解后改为每天2 g,继续4周。比较治疗前后两组患者的临床症状(腹痛、腹泻、脓血便)、生化和免疫学指标(肝功能、肾功能、红细胞沉降率、C反应蛋白),以及结肠镜下黏膜和组织学表现。结果治疗后8周,发现巴柳氮钠与SASP均可有效控制UC患者的病情发作(总有效率为84.2%比76.7%,P>0.05)。在治疗2周后,巴柳氮钠比SASP能更迅速地缓解患者的临床症状,如腹痛(42.1%比69.8%)、腹泻(23.1%比55.6%)和脓血便(58.3%比76.5%),并可改善内镜下黏膜炎症表现及降低黏膜组织炎症分级(P<0.05)。患者服用巴柳氮钠的依从性好。该药对患者的肝、肾功能无影响,治疗后血细胞沉降率和C反应蛋白的水平均显著降低(P<0.05),且不良反应发生率亦明显低于SASP(P<0.01)。结论巴柳氮钠是一种良好的控制UC活动性的药物,能维持病情缓解,不良反应少。
Objective To investigate the clinical efficacy of balsalazide sodium (product name: Belato) in the treatment of active ulcerative colitis (UC). Methods A total of 139 active UC patients were treated in 16 hospitals in Henan Province from October 2005 to June 2006 and were randomly divided into treatment group (n = 78) and control group (n = 61). The patients in the treatment group took balsamon sodium 6 g daily for 4 weeks and then changed to 2 g daily for 4 weeks. The control group took 4 g SASP daily for 4 weeks, Allegedly changed to 2 g daily for 4 weeks. The clinical symptoms (abdominal pain, diarrhea, pus and blood stool), biochemical and immunological parameters (liver function, renal function, erythrocyte sedimentation rate, C-reactive protein), and colonoscopic mucosal and histological findings were compared between the two groups before and after treatment. Results Eight weeks after treatment, bazide sodium and SASP were found to be effective in controlling the onset of UC (84.2% vs 76.7%, P> 0.05). After 2 weeks of treatment, balsalazide relieved the clinical symptoms of patients more rapidly than SASP, such as abdominal pain (42.1% vs 69.8%), diarrhea (23.1% vs 55.6%) and pus and blood (58.3% vs 76.5%), , And can improve the endoscopic mucosal inflammation and reduce the grade of mucosal inflammation (P <0.05). Patient compliance with balsalazide sodium is good. The drug had no effect on the liver and kidney function of patients. After treatment, the blood sedimentation rate and the level of C-reactive protein were significantly decreased (P <0.05), and the incidence of adverse reactions was also significantly lower than that of SASP (P <0.01). Conclusion Balsalazide sodium is a good drug to control the activity of UC, can maintain the disease remission with few adverse reactions.