健脾清热活血方与美沙拉嗪治疗溃疡性结肠炎的对比研究

Comparative study of Jianpi Qingre Huoxue formula versus Mesalazime in treating patients with ulcerative colitis

[目的]评价健脾清热活血方辨治溃疡性结肠炎的疗效。[方法]采用非劣效试验设计,应用随机对照设计,将120例符合诊断标准、纳入标准的溃疡性结肠炎患者随机分为2组,治疗组60例,对照组60例。治疗组予中药复方健脾清热活血方干预12周,对照组予美沙拉嗪干预12周。详细记录治疗前、后患者肠镜及症状变化。[结果]治疗前、后肠镜病变疗效判定,治疗组总有效率为66.66%,对照组总有效率为63.33%,在促进溃疡愈合方面,2组疗效无差异(P>0.05);治疗前、后症状积分判定疗效,治疗组总有效率为78.33%,对照组总有效率为61.66%,在改善临床症状方面,治疗组疗效优于对照组(P<0.05)。[结论]健脾清热活血方具有提高溃疡性结肠炎愈合质量、缓解其临床症状的功效,值得临床推广应用。

[Objective]To evaluate the clinical effect of Jianpi Qingre Huoxue formula（JQHF） in treating ulcerative eolitis（UC）. [Methods] It was a non-inferiority design, randomized, controlled trial. One hundred and twenty patients who conformed to diagnosis criteria and inclusion criteria were divided into two groups. The treatment group and the control group was administrated with JQHF and Mesalazine respectively for 12 weeks. The changes of colon endoscopy and clinical manifestations were observed before and after the treatment. [Results]There was no sig nificant difference in the effective rate of improving the ulcer healing between the treatment group （66. 66%）and the control group（63.33%）. The effective rate of improving clinical symptoms showed significant difference, 78. 33 % in the treatment group was higher than 61.66 % in the control group（P〈0.05）. [Conclusion]The JQHF has effects in improving quality of ulcer healing and alleviating clinical symptoms.