基于NF-κBp65变化及溃疡愈合质量探讨健脾清热活血类方药干预溃疡性结肠炎随机对照研究

A Randomized Controlled Trial of Spleen-strengthening,Heat-clearing,Blood-activating Recipes for Treatment of Ulcerative Colitis:An Evaluation Based on NF-κBp65 Expression and Ulcer Healing Quality

【目的】基于观察结肠黏膜NF-κBp65 mRNA表达,结合肠镜下溃疡愈合质量及中医证候评分,主客观指标合参评价健脾清热活血类方药干预溃疡性结肠炎疗效。【方法】采用非劣效试验设计,应用随机对照方法,将60例溃疡性结肠炎患者随机分为2组,治疗组30例,对照组30例。治疗组予健脾清热活血类方药干预9个月,对照组予美沙拉嗪(艾迪莎)干预9个月。详细记录治疗前后患者肠镜及症状变化,应用实时荧光定量PCR技术检测治疗前后结肠黏膜NF-κBp65变化。【结果】基于治疗前后肠镜病变疗效判定,治疗组总有效率为63.33%,对照组总有效率为60.00%,在促进溃疡愈合方面,两组疗效相近(P>0.05);基于治疗前后症状积分判定疗效,治疗组总有效率为76.66%,对照组总有效率53.33%,在改善临床症状方面,健脾清热活血方疗效优于美沙拉嗪(P<0.05)。治疗前,2组溃疡性结肠炎患者NF-κBp65 mRNA均呈高表达变化;治疗后,2组NF-κBp65 mRNA表达呈下降改变,与治疗前比较差异有统计学意义(P<0.05);但治疗后组间比较,差异无统计学意义(P>0.05)。【结论】健脾清热活血类方药可能通过介导NF-κBp65信号通路,降低炎症反应,减少靶器官损伤,提高溃疡愈合质量,发挥缓解溃疡性结肠炎的作用,值得临床推广应用。

Objective The clinical effect of spleen-strengthening,heat-clearing,blood-activating recipes（SHBR） for the treatment of ulcerative colitis was evaluated through observing the expression of NF-κBp65 mRNA,syndrome scores and the quality of ulcer healing.Methods Non-inferiority design was adopted.A randomized,controlled trial was carried out in 60 patients who were subject to the diagnosis criteria and inclusion criteria of ulcerative colitis.The patients were equally divided into two groups.The intervention group was administrated by SHBR orally for 9 months,and the control group was administrated orally by Mesalazine for 9 months.The changes of colonoscopy and clinical manifestations were documented before and after treatment,and the expression of NF-κBp65 mRNA was assayed by real-time fluorescent quantitation polymerase chain reaction（PCR）.Results The colonoscopy evaluation results showed that the total effective rate was 63.33% in the intervention group and 60.00% in the control group,indicating that the effect of SHBR was similar to that of Mesalazine（P〈0.05）.The results of symptom scoring showed that the total effective rate was 76.66% in the intervention group and 53.33% in the control group,indicating that the effect of SHBR wassuperior to that of Mesalazine（P〈0.05）.Before treatment,high NF-κBp65 mRNA expression was shown in both groups,and then the expression was decreased in both groups after treatment（P〈0.05）.The difference of NF-κBp65 mRNA expression level was insignificant between the two groups after treatment（P〈0.05）.Conclusion Spleen-strengthening,heat-clearing,blood-activating recipes are effective for relieving ulcerative colitis and increasing ulcer healing quality,and the therapeutic mechanism may be related with the reduction of inflammatory reaction and with the relief of target organ injury through down-regulating the expression of NF-κBp65.