Objective:To evaluate the clinical efficacy and safety of modified Zhuche Pills in maintaining the remission of ulcerative colitis with deficiency of yin with damp-heat symptom,and to provide clinical application basis for the maintenance treatment of ulcerative colitis in remission stage with Chinese medicine.Methods:60 patients with ulcerative colitis with deficiency of yin with damp-heat symptom in remission were divided into experimental group and control group,with 30 cases in each group.The experimental group was treated with modified Zhuche Pills combined with mesalazine orally,and the control group was treated with mesalazine orally for 12 weeks.The recurrence,clinical symptoms,TCM syndrome efficacy,mucosal and serum markers of the two groups before and after treatment were observed and compared,and evaluate the safety of medication.Results:(1)Recurrence rate:the recurrence rate of the experimental group was 3.33%,while that of the control group was 26.67%,with statistical significance(P<0.05).(2)Single symptom score comparison:within the group comparison,the experimental group has obvious improvement effect on 4 main symptoms and 7 secondary symptoms(P<0.01),while the control group can improve the symptoms of loose stool,abdominal dull pain,dry mouth,five upset hot,night sweat,insomnia virtual tired,abdominal distension and short red urine(P<0.05),especially for loose stool,dry mouth and five upset hot(P<0.01);There was no obvious improvement in symptoms such as sticky defecation,tenesmus and anal burning(P>0.05).Compared between the two groups,the two groups have the same curative effect in relieving abdominal dull pain,insomnia virtual tired,abdominal distension,short red urine(P>0.05),while the experimental group has better curative effect than the control group in improving the symptoms of loose stool,sticky defecation,sticky defecation,anal burning,dry mouth,five upset hot and night sweat(P<0.05),especially in improving sticky defecation and anal burning(P<0.01).(3)comparison of total symptom scores:within the group,the scores of the two groups were changed compared with those before treatment,and the difference was statistically significant(P<0.05),and the curative effect of the experimental group was more significant(P<0.01).(4)comparison of the curative effect of TCM syndrome:the total effective rate of TCM syndrome in the test group was 96.67%,while that in the control group was 63.33%.There was significant difference between the two groups(P<0.01).(5)Mayo score:within the group,the change of Mayo score in the test group was statistically significant,while that in the control group was not statistically significant(P>0.05),and there was no significant difference between the two groups(P<0.05).(6)UCEIS score:within the group,there was no significant change in UCEIS score in the test group,but there was significant increase in the control group(P<0.05),and there was significant difference between the two groups(P<0.05).(7)Comparison of serum markers:As for serum markers ESR,CRP and Fc,there was no significant difference between the two groups after treatment(P>0.05).Compared with the two groups,the difference was statistically significant(P<0.05),especially for keeping ESR and Fc low,the curative effect of the experimental group was more significant(P<0.01).For D dimer,there was no obvious change in the two groups after treatment(P>0.05).Compared between the two groups,the curative effect of the two groups was equivalent(P>0.05).(8)Comparison of quality of life:after the last treatment,the quality of life of patients in the experimental group was significantly improved(P<0.01),while the quality of life in the control group had no statistical difference(P>0.05).Compared with the two groups,the control group is worse than the experimental group in improving the quality of life,which is statistically significant(P<0.01).(9)Comparison of safety indicators:there was no significant change in safety indicators between the two groups before and after treatment(P>0.05).Research conclusion:Through clinical observation,modified Zhuche pills combined with mesalazine sustained-release tablets can maintain the remission of UC with deficiency of yin with damp-heat symptom,reduce the recurrence rate,effectively maintain mucosal healing,and alleviate inflammatory reaction,which has certain advantages in improving symptoms of traditional Chinese medicine and improving the quality of life.What’s more,compared with the single therapy,this combination therapy does not increase the adverse reactions,and has better safety and can be used in clinical practice. |