| ObjectiveTo observe the curative effect and safety of Tiaochang Xiaoyan Tablet in the treatment of mild-to-moderate ulcerative colitis through prospective,non-blind and randomized controlled clinical study.MethodsPatients selected from the Department of spleen and stomach diseases in Guangdong Provincial Hospital of Traditional Chinese Medicine from November 2017 to November 2018.There were 45 quali fied pati ents wi th mild to moderate Ulcerative colitis were enrolled.They were randomly divided into mesalazine group,Tiaochang Xiaoyan tablet group and integrated Chinese and Western medicine group(mesalazine+Tiaochang Xiaoyan tablet),with 15 cases in each group.Each group was given corresponding medicine treatment for 8 weeks.All patients underwent colonoscopy and their clinical symptoms were recorded before and after treatment.The curative effect was evaluated by modified Mayo score,endoscopy score and TCM syndrome score.All patients were received safety evaluation and their adverse reactions were recorded before and after treatment.Results1.Disease curative effect:(1)After treatment,the modified Mayo score and endoscopy score of the three groups decreased significantly(P<0.05),but there was no significant difference among the three groups(P>0.05).(2)In terms of clinical curative effect,the total effective rates of integrated Chinese and Western medicine group was 100%,which was better than that of mesalazine group(78.57%)and Tiaochang Xiaoyan tablet group(66.67%),but there was no significant difference between the three groups(P>0.05);(3)In terms of colonoscopy curative effect,the total effective rates of integrated Chinese and Western medicine group was 69.23%,which was better than that of mesalazine group(57.14%)and Tiaochang Xiaoyan tablet group(50.00%),but there was no significant difference between the three groups(P>0.05).The curative effects of the three treatment schemes are comparable.2.Therapeutic effect of TCM:(1)In terms of TCM syndromes,the scores of main symptoms and secondary symptoms of the three groups decreased significantly after treatment(P<0.05).However,there was no significant difference between the three groups(P>0.05).(2)According to the evaluation criteria of TCM syndromes,the total effective rates of integrated Chinese and Western medicine group and Tiaochang Xiaoyan Tablet group were 100%,which were better than of Mesalazine group(86.67%),but there was no significant difference between the three groups(P>0.05).Therapeutic effect of TCM in the three groups are comparable.3.There were no abnormal safety examinations of patients in the three groups before before and after treatment.Only one patient in the integrated Chinese and Western medicine group appeared uncomfortable feel in stomach,then could not tolerate the drugs.The symptoms disappeared after drugs withdrawal.ConclusionTiaochang Xiaoyan Tablet is effective and safe in the treatment of UC patients with mild to moderate active stage.It can effectively reduce the improved Mayo score,endoscopy score and TCM syndrome score of patients.It has the similar effect as mesalazine.Tiaochang Xiaoyan Tablet combined with mesalazine has no obvious synergistic effect. |