摘要
目的:评价白头翁加味汤治疗溃疡性结肠炎(UC)的临床有效性及安全性。方法:采用该汤剂与阳性药物对照的试验设计。符合入选标准的患者,随机分为试验组和对照组。试验组予白头翁加味汤150 m L,每日一剂,睡前保留灌肠。对照组予柳氮磺胺吡啶片(SASP),每次1.0 g,每日4次,口服。两组均一个月为一疗程,连续观察两个疗程。观察治疗前后两组的临床症状缓解、肠镜评分及病理改变,监测肝肾功能及血常规等变化。结果:共入组病例76例,可进行疗效评价分析的共68例,对照组、试验组各34例,试验组总有效率97.1%,对照组总有效率76.5%,两组间比较有统计学意义(P<0.05)。试验组未观察到不良反应,对照组不良反应发生率14.7%,两组间比较无统计学意义(P>0.05)。结论:白头翁加味汤治疗UC效果优于SASP,具有减轻炎症、促进溃疡愈合的作用,且安全性高,不良反应少。
Objective: To assess the clinical efficacy and safety of Compound Pulsatilla chinensis Decoction in the treatment of ulcerative colitis. Methods: Sixty-eight patients with ulcerative colitis were randomly divided into experimental and control groups. The experimental group were treated with the Compound Pulsatilla chinensis Decoction, the control group were treated with 1.0 g salicyl azosulfapyridine, four times a day. Both groups were treated for 2 months. Changes of clinical symptoms, endoscopic score,pathology, blood routine, liver and kidney functions before and after the treatments were observed. Results:The total effective rate was 97.1% in the experimental group and 76.5% in the control group(P<0.05). Incidences of adverse effect showed no statistical differences between the treatment and the control groups(0vs 14.7%, P >0.05). Conclusion: Compound Pulsatilla chinensis Decoction can reduce inflammation and promote ulcer healing. It provides a safe and effective control of ulcerative colitis.
出处
《药学与临床研究》
2016年第3期234-237,共4页
Pharmaceutical and Clinical Research
基金
江苏省中医药局科技项目(LZ13196)
江苏省药学会--百特生物药学基金科研项目
