| ObjectiveThe study is tend to observe the clinical efficacy of the combination of Guben Xiaoyang decoction with mesalamine in the treatment of mild to moderate ulcerative colitis which traditional chinese medicine syndrome is deficiency of yang of spleen and kidney,in order to evaluate the efficacy and safety of this treatment protocol,so as to provide clinical data support and new treatment ideas for a study on traditional Chinese medicine in the treatment of mild to moderate ulcerative colitis(spleen and kidney yang deficiency type).MethodsWith the approval of the Medical Ethics Committee,a group sequential design was adopted to select 28 patients who met the inclusion criteria from December 2020 to December 2022 in the outpatient department of the spleen and stomach disease department of Shanxi Hospital of Traditional Chinese medicine each time,1:1 patients were divided into test group and control group,every group has 14 patients,the maximum of the test was5 times,the test was stopped after the positive results or the maximum number of times.The experimental group was given Guben Xiaoyang decoction combined with mesalazine enteric-coated tablets(1.5 g,twice a day).The control group was treated with mesalazine enteric-coated tablets(1.5 g,twice a day)for 12 weeks.After 12-week treatment,They were observed including the clinical effective rate,remission rate,TCM syndrome effect,TCM syndrome total score,TCM single symptom(diarrhea,abdominal pain,pus blood,abdominal distension,poor appetite,cold limbs,waist and knee soreness)score,colonoscopy,mucosal pathological grading,liver and kidney function and other safety indexes.Results1.Before treatment,the two groups of baseline information were comparable.2.After treatment,the clinical effective rate of the experimental group was 90.00 %,and the clinical effective rate of the control group was 61.75 %.The experimental group was better than the control group(P < 0.008);the remission rate was 40.00 % in the experimental group and 12.20 % in the control group.The experimental group was better than the control group(P<0.008).3.The total effective rate of TCM syndrome was 95.00% in the experimental group and 56.10% in the control group,which was significantly higher in the experimental group than in the control group(P<0.008).After treatment,the total scores of TCM syndromes were decreased in both groups,and the test group was superior to the control group(P<0.008).4.In terms of clinical symptoms,both groups could improve diarrhea,purulent bloody stool and abdominal pain,and the test group was superior to the control group(P<0.008),and both groups could improve abdominal distention,there was no significant difference between the two groups(P > 0.008).There was significant difference between the two groups(P<0.008),the symptoms of low appetite and cold limbs were relieved in the test group,but not in the control group(P<0.008),the symptoms of lumbar and knee soreness were improved in the test group,but not in the control group,there was no significant difference between the two groups(P>0.008).5.Colonoscopy performance: Compared with before and after treatment,the experimental group could improve the colonoscopy performance(P < 0.008),and the improvement of colonoscopy mucosa in the experimental group was better than that in the control group(P<0.008).6.In terms of mucosal pathological grading,compared with before and after treatment,the experimental group could reduce the mucosal pathological grading(P<0.008),and the mucosal pathological grading of the experimental group was significantly lower than that of the control group after treatment(P<0.008).7.During the clinical observation period,there were no adverse reactions in the experimental group and the control group,and no adverse reactions occurred.There were no abnormalities in blood,urine and stool routine,liver and kidney function,electrocardiogram and other safety tests before and after treatment.ConclusionGuben Xiaoyang Decoction combined with mesalazine in the treatment of mild and moderate ulcerative colitis(spleen and kidney yang deficiency type)can significantly improve clinical symptoms,reduce intestinal inflammation,improve pathological grading of intestinal mucosa,and greatly improve the quality of life of patients.It is superior to oral administration of western medicine alone.The curative effect is definite and worthy of promotion. |