Clinical Effect of Changyanqing Mixture Combined with Mesalazine Enteric-coated Tablets for Maintenance Treatment of Ulcerative Colitis in Remission Period / 中国实验方剂学杂志

Objective:This study aims to evaluate the clinical effect of Changyanqing mixture combined with mesalazine enteric-coated tablets in the maintenance treatment of ulcerative colitis（UC） in remission period. Method:The 140 patients with UC in remission period were randomly divided into control group （70 cases） and observation group （70 cases）. The 61 patients in control group completed the therapy （6 cases lost or lost to follow-up and 3 were eliminated）， 63 patients in observation group completed the therapy （5 cases lost or lost to follow-up and 2 were eliminated）. Both groups′ patients got treatment of lifestyle adjustment， and they also took mesalazine enteric-coated tablets orally， 0.5 g/time， 3 times/day. Patients in observation group took Changyanqing mixture orally for a month in the morning and evening every day， 150 mL/time， and then changed to 150 mL/time， 1 time/day， for 3 consecutive months， finally changed to once every other day for 8 months. Patients in control group took simulated medicine of Changyanqing mixture orally in the same way as observation group. The treatment was continued for 12 months. When UC recurred during the treatment， patients took mesalazine enteric-coated tablets orally at 1 g/time， 3 times/day until remission， when the above intervention plan was continued to be adopted. The recurrence rate， first recurrence time within 12 months （duration from remission to Mayo≥3） and the degree of disease activity at recurrence were recorded. Scores of traditional Chinese medicine（TCM）syndrome and inflammatory bowel disease questionnaire （IBDQ） were evaluated once every 2 months. Before treatment， and at the 6^th and 12^th month after treatment， colonoscopy and mucosal histology were performed once， enteroscopic mucosal scores， Geboes index of mucosal histology were evaluated， and fecal calprotectin（FC） levels were detected. Also， safety evaluation was conducted. Result:During 12 months， the recurrence rate in observation group was 20.63% （13/63）， lower than 39.34% （24/61） in control group（<italic>P</italic><0.05）， the frequency of recurrence and the first recurrence duration in observation group were all less than those in control group（<italic>P</italic><0.01）. All these meant the disease activity of patients in observation group was lighter than that in control group （<inline-formula><alternatives><mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M3"><mml:msup><mml:mrow><mml:mi>χ</mml:mi></mml:mrow><mml:mrow><mml:mn mathvariant="normal">2</mml:mn></mml:mrow></mml:msup></mml:math><graphic specific-use="big" xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="alternativeImage/444CE72A-DE9D-4013-BB0B-F487F60C8DC8-M003.jpg"><?fx-imagestate width="3.30200005" height="3.64066648"?></graphic><graphic specific-use="small" xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="alternativeImage/444CE72A-DE9D-4013-BB0B-F487F60C8DC8-M003c.jpg"><?fx-imagestate width="3.30200005" height="3.64066648"?></graphic></alternatives></inline-formula>=5.947， <italic>P</italic><0.05）. After repeated measurements of variance analysis， scores of TCM syndrome， enteroscopic mucosal scores， Geboes index and FC levels in two groups gradually increased（<italic>P</italic><0.05）， and scores of IBDQ gradually decreased （<italic>P</italic><0.05） during the 12-month period. At the second， fourth， sixth， eighth， tenth and twelfth month， scores of TCM syndromes in observation group were lower than those in control group （<italic>P</italic><0.01）， and scores of IBDQ were higher than those in control group （<italic>P</italic><0.01）. At the sixth and twelfth month after treatment， intestinal endoscopic mucosal scores， Geboes index and FC levels in observation group were all lower than those in control group （<italic>P</italic><0.01）. And there were no adverse reactions related to Changyanqing mixture. Conclusion:Changyanqing mixture combined with mesalazine enteric-coated tablets in the maintenance treatment of patients with UC in remission can control the FC level， further reduce the recurrence rate， delay the recrudescence-time， reduce the frequency of UC and the disease activity， maintain the good remission state of UC， stabilize the quality of life of patients， and ensure the safety of clinical use.

Clinical Efficacy of Changyanqing Mixture on Chronic Recurrent Ulcerative Colitis with Damp-heat Ayndrome of Large Intestine / 中国实验方剂学杂志

Objective::To observe the clinical efficacy of Changyanqing mixture on chronic recurrent ulcerative colitis (UC) with damp-heat syndrome of large intestine and the effect on the recurrence of disease, in order to discuss the mechanism of action in terms of the neuro-endocrine-immune inflammation network. Method::One hundred and twelve patients were randomly divided into control group (55 cases) and observation group (57 cases) by random number table. Patients in control group got mesalazine slow release tablets, 0.1 g/time, 4 times/days, and those the score of Mayo≥7 were added with prednisone acetate tablets, 0.75 mg·kg-1·d-1, and bifidobacterium viable powder with warm water after dinner, 1 pack/day, 2 times/days. In addition to the therapy of control group, patients in observation group were also given Changyanqing mixture in the morning and evening, 1 pack/day. A course of treatment was 6 weeks, and patients got further consultation once a week. During the remission stage, patients in both groups got mesalazine slow release tablets, 0.5 g/time, 3 times/days, and patients in observation group were added with Changyanqing mixture until the score of damp-heat syndrome of large intestine reduced by more than 90%. The number of patients entering the remission stage of 6 weeks and the time of remission stage were recorded. Before and after treatment, colonoscopy was detected, and Geboes index, Baron, damp-heat syndrome of large intestine and Mayo were scored. And levels of peripheral blood interleukin-6 (IL-6), IL-8, IL-10, IL-17, vasoactive intestinal peptide (VIP), motilin (MTL) and neuropeptide (NPY) were detected, and relapse at the 24-week follow-up was recorded. Result::After the 6-week treatment, the clinical efficacy in observation group was 100%, which was higher than 89.09%in control group (P<0.05). And the healing rate of mucosa was 96.4%, which was higher than 81.82%in control group (P<0.05). And the response rate in two groups was 100%. At the 6th month after the treatment, the clinical remission rate in observation group was 91.23%, which was higher than 76.36%in control group (χ2=4.581, P<0.05). And the average remission time was shorter than that in control group (P<0.01). After treatment, scores of colonic mucosa, Geboes index, colonic mucosa and Mayo were all lower than those in control group (P<0.01). And levels of IL-6, IL-8, IL-17, VIP and MTL were lower than those in control group (P<0.01), while levels of IL-10 and NPY were higher than those in control group (P<0.01). The relapse rate in observation group was 17.54%, which was lower than 38.18%in control group (χ2=5.955, P<0.05). And the mean recurrence time was longer than that in control group (P<0.01). Conclusion::In addition to the routine western medicine therapy, Changyanqing mixture can alleviate the condition of patients by shortening the course of the disease, reducing the recurrence rate, delaying the recurrence time, and regulating the nerve-endocrine-immune inflammation network.

Study on the Chinese medical syndrome distribution of ulcerative colitis / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To study on the Chinese medicine (CM) syndrome distribution of ulcerative colitis (UC) and the distribution of CM syndrome types at different staging periods.</p><p><b>METHODS</b>From March 2007 to April 2010, 110 UC out- or inpatients at the Department of Digestive Diseases of Guangzhou Municipal Hospital of Traditional Chinese Medicine were recruited. The patients' symptoms were calculated. The systematic clustering was used. The symptom was taken as the variable in the clustering. The syndrome types were confirmed according to the clustering results. The syndrome typing was performed and its results were analyzed.</p><p><b>RESULTS</b>There were 64 main symptoms in UC patients, including diarrhea, mushy stool, watery stool, abdominal pain, and bloody stool. Seventy cases belonged to the active period and 40 to the remission period. The UC syndrome types were sequenced from high to low as the dampness-heat of Dachang syndrome, Pi-Wei qi deficiency syndrome, Gan depression and Pi deficiency syndrome, Pi-Shen yang deficiency syndrome, blood stasis in the intestinal collaterals syndrome, yin and blood deficiency syndrome. There was statistical difference in the case number among different syndrome types (P < 0.05). In the active period, dominated were the dampness-heat of Dachang syndrome (28 cases, 25.5%), Gan depression and Pi deficiency syndrome (14 cases, 12.7%), and blood stasis in the intestinal collaterals syndrome (10 cases, 9.0%). In the remission period, dominated were Pi-Wei qi deficiency syndrome (18 cases, 16.4%) and Pi-Shen yang deficiency syndrome (10 cases, 9.0%), showing statistical difference (P<0.05). The typical symptoms of patients of the dampness-heat of Dachang syndrome were sequenced from high to low as yellow tongue fur (31 cases, 28.1%), tenesmus (26 cases, 23.6%), mucopurulent bloody stool (25 cases, 227%), diarrhea (24 cases, 21.8%), anal burning (24 cases, 21.8%), watery stool (21 cases, 19.0%), abdominal pain (19 cases, 17.2%), red tongue (19 cases, 17.2%), and greasy tongue fur (19 cases, 17.2%). The typical symptoms of patients of Pi-Wei qi deficiency syndrome were sequenced from high to low as tastelessness (25 cases, 22.7%), fine pulse (25 cases, 22.7%), pink tongue (22 cases, 20.0%), eructation (21 cases, 19.1%), hypodynamia (21 cases, 19.1%), loss of appetite (20 cases, 18.2%), and white tongue fur (20 cases, 18.2%). The typical symptoms of patients of Pi-Shen yang deficiency syndrome were sequenced from high to low as abdominal pain (17 cases, 15. 5%), preference for warmth (17 cases, 15. 5%), diarrhea (16 cases, 14.5%), aggravation while encountering cold (15 cases, 13.6%), white tongue fur (15 cases, 13.6%), pale white tongue (14 cases, 12.7%). The typical symptoms of patients of Gan depression and Pi deficiency syndrome were sequenced from high to low as emotions inducing (18 cases, 16.4%), eructation (16 cases, 14.5%), white tongue coating (16 cases, 14.5%), dry stool before loose stool (15 cases, 13.6%), frequent break wind (15 cases, 13.6%), and frequent sigh (15 cases, 13.6%). The typical symptoms of patients of blood stasis in the intestinal collaterals syndrome were sequenced from high to low as abdominal pain (12 cases, 10.9%), sting (12 cases, 10.9%), soreness of the waist (12 cases, 10.9%), dark red tongue with petechiae (12 cases, 10.9%), thick fur (12 cases, 10.9%). There was statistical difference in the symptom ratio among each syndrome types (P<0.05). There was no statistical difference in other symptoms except yin and blood deficiency syndrome (P>0.05).</p><p><b>CONCLUSIONS</b>The dampness-heat of Dachang syndrome, Gan depression and Pi deficiency syndrome, and blood stasis in the intestinal collaterals syndrome were dominated in the UC active period. Pi-Wei qi deficiency syndrome and Pi-Shen yang deficiency syndrome were dominated in the remission period.</p>