Clinical Efficacy of Kuijietong Against Mild to Moderate Active Ulcerative Colitis / 中国实验方剂学杂志

ABSTRACT

Objective:To re-evaluate the intervention effect of Kuijietong（KJT） on ulcerative colitis（UC）. Method:Sixty patients with mild-to-moderate UC in the active stage were enrolled and randomized into a KJT group （<italic>n</italic>=30） and a sulfasalazine （SASP） group （<italic>n</italic>=30）. Patients in the KJT group were treated with KJT granules， one bag divided in two daily doses， once in the morning and once in the evening， while those in the SASP group received SASP， 1 g per time， four times per day. Then the clinical efficacy was evaluated. Result:According to the modified Mayo score，the clinical remission rates of the KJT group and SASP group were determined to be 46.7% （14/30）and 40% （12/30），exhibiting no significant difference between the two groups （<italic>P</italic>>0.05）. The clinical effective rate of the KJT group was 83.3% （25/30），which was better than 60% （18/30） of the SASP group （<italic>P</italic><0.05）. The mucosal healing rate in the KJT group was 36.7% （11/30）， not significantly different from 30% （9/30） in the SASP group. In the alleviation of UC symptoms，the score of large intestine dampness heat syndrome in the KJT group was remarkably better than that in the SASP group （<italic>P</italic><0.05），but there was no significant difference in inflammatory bowel disease questionnaire （IBDQ） score between the two groups. In terms of physical and chemical indexes，serum erythrocyte sedimentation rate （ESR） in the KJT group after intervention was lower than that in the SASP group （<italic>P</italic><0.05），whereas the interleukin-10 （IL-10） level was higher（<italic>P</italic><0.05）. The comparison between the two groups revealed no significant difference in C-reactive protein （CRP）， tumor necrosis factor-<italic>α</italic> （TNF-<italic>α</italic>）， CD4⁺ T cells and regulatory T （Treg） cells after intervention. During the intervention，no obvious adverse reactions were found in the two groups，indicating good safety. Conclusion:KJT is not inferior to SASP in relieving mild-to-moderate UC in the active stage.