奥替溴铵联合柳氮磺吡啶治疗溃疡性结肠炎的临床研究

Clinical study on otibromide combined with sulfasalazine in treatment of ulcerative colitis

目的探讨采用奥替溴铵联合柳氮磺吡啶治疗溃疡性结肠炎的有效性与安全性。方法选取2016年3月—2017年3月赤峰学院附属医院收治的溃疡性结肠炎患者121例,随机分成对照组(60例)和治疗组(61例)。对照组患者口服柳氮磺吡啶肠溶片,6片/次,3次/d。治疗组在对照组的基础上口服奥替溴铵片,2片/次,3次/d。两组患者均连续治疗8周。观察两组患者临床疗效,比较治疗前后两组患者临床症状恢复时间、临床活动指数、炎症因子和肠黏膜TLR-4水平。结果治疗后,对照组和治疗组的临床有效率分别为81.67%和95.08%,两组比较差异具有统计学意义(P<0.05)。治疗后,两组患者临床活动指数评分均显著降低(P<0.05),且治疗后治疗组患者临床活动指数评分显著低于对照组(P<0.05),治疗组患者血便消失时间、腹泻症状恢复时间均显著短于对照组患者(P<0.05)。治疗后,两组患者的IL-6、TNF-α血清水平和肠黏膜TLR-4组织水平均显著降低,同组比较差异具有统计学意义(P<0.05);且治疗组IL-6、TNF-α和TLR-4水平明显低于对照组,两组比较差异具有统计学意义(P<0.05)。结论奥替溴铵联合柳氮磺吡啶治疗溃疡性结肠炎疗效好、不良反应少,具有一定的临床推广应用价值。

Objective To investigate the efficacy and safety of otibromide combined with sulfasalazine in treatment of ulcerative colitis. Methods Patients（121 cases） with ulcerative colitis in Affiliated Hospital of Chifeng University from March 2016 to March 2017 were randomly divided into control（60 cases） and treatment（61 cases） groups. Patients in the control group were po administered with Sulfasalazine Enteric-coated Tablets, 6 tablets/time, three times daily. Patients in the treatment group were po administered with Otilonium Bromide Tablets on the basis of the control group, 2 tablets/time, three times daily. Patients in two groups were treated for 8 weeks. After treatment, the clinical efficacy was evaluated, and the clinical symptoms recovery time, clinical activity index, the inflammatory factors and TLR-4 levels in two groups before and after treatment were compared. Results After treatment, the clinical efficacy in the control and treatment groups was 81.67% and 95.08%, respectively, and there were differences between two groups（P〈0.05）. After treatment, the clinical activity index score in two groups was significantly decreased（P〈0.05）, and the score in the treatment group after treatment was significantly lower than that in the control group（P〈0.05）. After treatment, the disappearance time bloody stool and diarrhea in the treatment group after treatment was earlier than that in the control group（P〈0.05）. After treatment, the IL-6, TNF-α and TLR-4 levels in two groups were significantly decreased, and the difference was statistically significant in the same group（P〈0.05）. And the IL-6, TNF-α and TLR-4 levels in the treatment group after treatment were significantly lower than those in the control group, with significant difference between two groups（P〈0.05）. Conclusion otibromide combined with sulfasalazine in treatment of ulcerative colitis has good curative effect and high safety, which has a certain clinical application value.