| Objective:To verify the efficacy and safety of Modified Wumei Pill with Mesalazine in the treatment of active ulcerative colitis with complex syndrome of cold and heat.During the treatment,in order to test and verify the clinical efficacy of Modified Wumei Pill and Mesalazine,we observe the change in the levels of TCM syndrome,inflammation factors,quality and security,and so on.Methods:Follow the principle of randomness and control,dividing patients with UC with complex syndrome of cold and heat into two groups.Give Wumei pill and Mesalazine to the treatment group,and only Mesalazine to the tcontrol group.Thoughout the study period,we observe the clinical efficacy,TCM syndromes,inflammation factors,quality and security,and so on.Results:(1)Clinically effective ratio:The efficacy of the treatment group was 84.4%,and the control group was 58.6%.The treatment group was more statiscally different than control group(P<0.05).(2)Clinical remission:The remission rate was 50.0%of the treatment group.It was better than the control group,which relieved 24.1%(P<0.05).(3)TCM sysptoms efficacy:a.Total scores:Two groups at the first option no difference in the total scores(P>0.05).Both groups at the end could significantly reduced the symptoms(P<0.001),and Slightly better treatment group(P<0.05).b.Symptom intergral single:At the first visit,two groups of diarrhea,abdominal pain,pus and blood in the stools,anal burning,chills and cold limbs,thirsty and hunger no difference(P>0.05).The treatment gtoup could relieve diarrhea,abdominal pain,pus and blood in the stools significantly(P<0.001)since the 4th week,and anal burning,chills and cold limbs,thirsty and hunger also could be eased(P<0.05).In the control group,pain,pus and blood could be relieved significantly(P<0.001)and diarrhea,chills,thirsty were relieved normally(P<0.05)from the 4th week,and ease hunger at the 12th week(P<0.05).Comparing with the control,the treatment group was better in diarrhea from the 4th week,,and in abdominal and hungry from the 8th week,and in anal burning from the 11th week(P<0.05).No distinction in pus and blood in the stools for the two groups.(4)Effectiveness of syndrome:93.8%was acheived by the treatment group.It was more higher than 72.4%of the control group with statistically sigificant(P<0.05)(5)Endoscopic response:Colonoscopy response rate was 56.2%in the treatment group.Colonoscopy response rate in the control was 27.6%.The treatment group was better,in terms of endoscopic response,than another group(P<0.05).(6)Mucosal healing:The treatment group healed the mucous membranes approximately one-third(31.3%),and the control group had healing rate of 24.1%.It could be said that the two were not different(P>0.05).(7)Inflammatory indexes(ESR,CRP,FC):Both could reduce ESR(P<0.05)with not different efficacy(P>0.05).FC could be improved by the two groups and the treatment group was better(P<0.05).Both groups had no effect on CRP(P>0.05).(8)Quality of life:Both groups could significantly make a better life for patients with UC(P<0.001),and the integrated TCM and Western Medicine was better(P<0.05).(9)Safety index:It didn’t change obviously in safety factors during the treatment(P>0.05),and no adverse events.Conclusion:Modified Wumei Pills combined with mesalazine in the treatment of ulcerative colitis with complex syndromes of cold and heat during active period is superior to western medicine treatment in terms of improving clinical efficacy,inducing symptom relief,promoting endoscopic response,improving TCM syndrome score and quality of life score.It has good safety and can be used as a treatment option for patients with cold and heat mixed with UC. |
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