Clinical Observation on Jiechang Qingre Pills Combined with Conventional Western Medicine Therapy in Improving Dampness-heat Syndrome of Large Intestine at Active Stage of Ulcerative Colitis / 中国实验方剂学杂志

ABSTRACT

Objective:To observe the clinical efficacy of Jiechang Qingre pills for dampness-heat syndrome of large intestine at active stage of ulcerative colitis （UC） and investigate its effect on inflammatory factors. Method:One hundred and eight patients with active UC were divided into observation group and control group. Both groups were treated with Mesalazine enteric-coated tablets， 2 g/times， 2 times/day， for 2 weeks. If symptoms were poorly controlled， prednisone acetate tablets would be used instead， 0.75 mg·kg^-1·d^-1in 3 times by oral administration. Patients in the observation group took Jiechang Qingre pills， 10 g/time， 3 times/day before meals. Patients in the control group took Jiechang Qingre pills simulated drug， 10 g/time， 3 times/day before meals. The course of treatment was 12 weeks in both groups and the patients were followed up for 3 months. The modified Mayo score was used to evaluate disease activity. Before and after treatment， large intestine dampness-heat syndrome score， inflammatory bowel disease questionnaire （IBDQ）， mucosal histology assessment and scores of major symptoms and intestinal mucosal lesion severity were graded. The incidence of non-reactivity， hormone failure， hormone dependence， and early recurrence were recorded 2 weeks after treatment. Tumor necrosis factor-<italic>α </italic>（TNF-<italic>α</italic>）， interleukin-6（IL-6） and IL-17 levels were measured before and after treatment. Result:The clinical effective rate in the observation group was 94.00% （47/50）， higher than 77.55% （38/49） in the control group （<italic>χ</italic>²=5.514，<italic>P</italic><0.05）. The clinical remission rate was 82.00%（41/50） in the observation group， higher than 61.22% （30/49） in the control group （<italic>χ</italic>²=5.266，<italic>P</italic><0.05）. The endoscopic response rate was 96.00% （48/50） in the observation group， higher than 79.59% （39/49） in the control group （<italic>χ</italic>²=6.251，<italic>P</italic><0.05）. The rate of mucosal healing in the observation group was 90.00% （45/50）， higher than 79.59% （35/49） in the control group （<italic>χ</italic>²=5.503，<italic>P</italic><0.05）. The scores of diarrhea， purulent stool， abdominal pain， tenesmus， hyperemia， edema， erosion and ulcer in the observation group were lower than those in the control group （<italic>P</italic><0.01）. The rate of non-reactivity in the observation group was 16.00% （8/50）， lower than 34.69% （17/49） in the control group（<italic>χ</italic>²=4.581，<italic>P</italic><0.05）. The hormone failure rate in the observation group was 37.50%（3/8）， lower than 64.71%（11/17）in the control group，but the difference was not statistically significant（tested by the exact probaility method）. The hormone dependence rate in the observation group was 12.50%（1/8）， lower than 23.53% （4/17） in the control group，but the difference was not statistically significant（tested by the exact probaility method）. The early recurrence rate in the observation group was 14.00% （7/50）， lower than 32.65%（16/49） in the control group（<italic>χ</italic>²=4.827，<italic>P</italic><0.05）. The scores of Mayo， dampness and heat syndrome and Geboes index in the observation group were lower than those in the control group （<italic>P</italic><0.01）， and the IBDQ scores were significantly higher than those in the control group （<italic>P</italic><0.01）. The TNF-<italic>α， </italic>IL-6 and IL-17 levels of the patients in the observation group were lower than those in the control group （<italic>P</italic><0.01）. Conclusion:Based on the routine treatment of western medicine， Jiechang Qingre pills treatment for the patients with active UC can effectively induce clinical remission， alleviate inflammatory reaction， promote intestinal mucosal healing， improve clinical symptoms， quality of life and the response of treatment. Its clinical efficacy and enteroscopy efficacy are better than western medicine treatment alone， so it is worthy of clinical use.