Long Term Observation On The Clinical Effects Of Kuikeling For The Treatment In Patients With Ulcerative Colitis

Objective:The aims of study was to evaluate long term observation on the clinical effects and safety of kuikeling (KKL), a traditional Chinese medicine (TCM), for the treatment in patients with ulcerative colitis (UC) on the basis of experiments, and try to offer the basis for guiding therapy of UC and basic research.Methods:The clinical data and endoscopic findings of 56 outpatients and inpatients with UC were collected. The patients were randomized into KKL group and SASP (or 5-ASA) group. The KKL group with 22 cases was given KKL 100ml/d by oral or enema and the SASP (or 5-ASA) group given SASP 1.0 qid (or 5-ASA 1.0 tid) by oral. The indicators were observed to assess the severity of patients with UC at 4 weeks,24 weeks and 48 weeks, respectively. The primary recording items were clinical symptoms (diarrhea, bloody stool, etc.), the body condition assessment, the mucosal feature in colonoscopy, the DAI score, and laboratory tests (WBC, liver and kidney function, ESR, CRP, etc.). The primary evaluation indicators on effect included each symptom score, DAI and its value difference. Liver and kidney function tests, and other side effects were taken as the safety indicators.Results:1. In the study, the main type of patients with UC were of proctosigmoiditis (34.1%), total colitis (32.6%) and left colon colitis (25%).2. The indicator score and DAI value were significantly decreased after KKL or ASA treatment for 4W,24 W and 48 W. The DAI value in KKL group was lower than that of in ASA group after treatment.3. The therapeutic effect of diarrhea and mucosal feature in KKL group were better than that in ASA group. Bloody stool were not significantly improved between KKL and ASA group.4. There was significant difference between KKL group (27.3%) and ASA group (12%) in the clinical complete remission rate at 4 weeks, which indicated the effect of KKL was better than that of ASA group in short term effect. At 24 weeks and 48 weeks, the clinical remission rates in KKL group (68.4%and 81%) were significantly higher than that in ASA group (52.3% and 63.5%) (p<0.05).5. The laboratory items such as HB, PLT, ESR and CRP were significantly improved after treatment with KKL or ASA, but there was no significant difference between the two groups. There was also no significant difference in liver and kidney function before and after treatment in each group or between the two groups.Conclusions:(1) A good short and long term clinical efficacy was observed in patients with mild to moderate UC after treatment of KKL.(2) KKL was better than ASA in patients with mild to moderate UC in the overall effect.(3) There were no side effects observed after treatment with KKL for a long time.