| Objectives:To evaluate the clinical efficacy and safety of Professor Xu Jingfan’s prescription for treating ulcerative colitis.To clarify the prescription rule and predict the potetial therapeutic targets of Professor Xu Jingfan’s prescription for treating ulcerative colitis.Methods:Study 1:All subjects were recruited in Affiliated Hospital of Chinese Medicine of Nanjing University of Chinese Medicine from September 2015 to December 2017,who met the inclusion criterias.A total of 60 subjects were randomly divided into treatment group and control group respectively.There are 30 subjects in each group.One case lost to follow-up in control group.The patients were gived Chinese medice in the rectum and oral mesalazine in treatment group and were just administered with mesalazine in control group.After 84 days follow-up,clinical remission rate,Clinial efficiency rate,Mayo score,TCM syndrome score,biochemical parameter were evaluated.Study 2:A retrospective analysis was performed from 77 patients with ulcerative colitis treated by professor Xu Jingfan in Affiliated Hospital Nanjing University of Chinese Medicine from March 2009 to March 2011.The clinial data were collected,including name,age,diagnosis,traditional Chinese medicine prescription,etc.To clarify the prescription rule,we calculated the using frequency of all the herbs and analysis the prescription rules by system clustering method.In order to analyze potential molecular targets of the frequently-used herbs,GO enrichment analysis and KEGG signal pathway enrichment analysis were performed by a bioinformatics analysis tool for molecular mechanism of Traditional Chinese Medicine(BATMAN-TCM).Results:Study1:1.Clinical remission rate is 83.33%in the treatment group and 56.66%in the control group respectively.The clinical remission rate of the treatment group was better than that of the control group(P=0.024).2.The clinical efficiency rate of the treatment group was better than that of the control group(96.66%vs 79.31%,P=0.039).3.The total effective rate in improving the symptoms of TCM of the treatment group was better than that of the control group(96.66%vs 75.86%,p=0.036)4.Clinical symptoms:diarrhea symptom scores in treatment group were significantly superior to the control group(P<0.001)on the 56th day.Pus and blood in stool could be significantly improved in both groups on the 14th day(P<0.001).Abdominal pain was relieved in both groupson the 14th day(P<0.001)ITenesmus was significantly relieved in both groups on the 14th day(P<0.001).Furthermore,there was statistically significant difference(P=0.002)between the two groups On the 84th day(P =0.002).The symptom of anal burning could be improved on the 14th day in both groups.The scores of anal buring in treatment group were better than that of the control group on 56th day(P=0.002).The treatment group was better than the control group in improving the mouth dry and bitterness on the 14th day(P = 0.002);the treatment group was better than the control group in improving oliguria with reddish urine on the 28th day(P<0.01),4.The treatment group was superior to the control group in improving the mayo score and intestinal mucosal tissue integral(P<0.01).5.There was no statistically significant difference between the two groups of safety indicators(P<0.05).No serious adverse reactions and complications occurred in any group.Study 2:1.Frequency of use:a total of 131 drugs were used by professor Xu jingfan for the 77 prescriptions of UC,among which the highest frequency was paeoniae(71.43%)and white(68.83%).2.The traditional Chinese medicine category showed the highest use frequency of the heat-clearing drug(41.4%),followed by the hemostatic drug(38.31%)and the water-hygroscopic drug(37.66%).3.Cluster analysis of traditional Chinese medicine system,and a total of 10 kinds of combination of 2 and multi-flavor drugs.4.After the GO and KEGG molecular signaling pathway enrichment analysis,we founded that the traditional Chinese medicine herbs might regulate intestinal inflammation by activating PPAR-,y signaling pathways.Conclusions:1.The clinial efficacy of Pofessor Xu Jiangfan’s formula plus mesalazine is better than-mesalazine monotherapy group.Pofessor Xu Jiangfan’s formula has great safety in treating ulcerative colitis.2.The most frequently used drugs are clearing-heat herbs,followed by hemostatic herbs,excreting-dampness herbs,improving-digestion herbs,tonifying-Qi herbs.In addition,a total of 10 new drug pairs and new drug combinations were discovered.the Chinese herbs may possibly regulate intestinal inflammation by the activation of the PPAR-y pathway so as to play the role in the treatment of ulcerative colitis.The exact mechanisms need to be verified by molecular biological experiments. |
PDF Full Text Request