Inflammatory bowel disease,particularly ulcerative colitis(UC),poses significant treatment challenges due to its chronic nature and potential for severe complications.This editorial reviews a recent network meta-analy...Inflammatory bowel disease,particularly ulcerative colitis(UC),poses significant treatment challenges due to its chronic nature and potential for severe complications.This editorial reviews a recent network meta-analysis that evaluated the efficacy of and highlighted the superior outcomes achieved by combining each of five traditional Chinese medicine(TCM)formulations with mesalazine for the adjuvant treatment of UC.Clinical outcomes included enhanced mucosal healing,improved quality of life,and reduced recurrence rates.Additionally,the combination therapy resulted in a lower incidence of adverse reactions compared with mesalazine monotherapy.Despite these promising results,limitations such as variability in study quality and TCM dosage highlight the need for further highquality,large-sample,multicenter randomized controlled trials.This editorial underscores the potential of TCM in enhancing UC management and calls for more rigorous research to substantiate these findings and refine clinical guidelines.展开更多
118 cases of ulcerative colitis were treated by integration of traditional Chinese and Western medicine. Another 86 cases of ulcerative colitis were treated by simple western drugs as controls. The therapeutic effects...118 cases of ulcerative colitis were treated by integration of traditional Chinese and Western medicine. Another 86 cases of ulcerative colitis were treated by simple western drugs as controls. The therapeutic effects for both groups were observed and compared after two therapeutic courses of 40 consecutive days. As a result, 39 cases were cured, 60 cases improved and 19 cases failed, with a total effective rate of 84% in the treatment group; in the control group, 15 cases were cured, 37 cases improved and 34 cases failed, with a total effective rate of 60.5%. Statistically, the difference was very significant (P展开更多
BACKGROUND Ulcerative colitis(UC),also known as chronic nonspecific UC,is an inflammatory bowel disease characterized by diffuse colonic mucosal inflammation.The incidence and prevalence of UC have risen markedly,and ...BACKGROUND Ulcerative colitis(UC),also known as chronic nonspecific UC,is an inflammatory bowel disease characterized by diffuse colonic mucosal inflammation.The incidence and prevalence of UC have risen markedly,and the disease seriously affects the quality of life of patients and imposes a great burden on the world health care infrastructure and economy.CASE SUMMARY Case I describes a 34-year-old female who came to see a doctor because of repeated abdominal pain,diarrhoea and purulent blood for 2 mo.This patient had UC with an initial onset,an active stage and a wide range of lesions.After the poor effect of sulfasalazine and mesalazine,the patient’s condition gradually deteriorated,her abdominal pain and bloody stools continued,and anemia occurred.She began treatment with the Chinese medicine Guizhi Dahuang decoction,which was taken orally twice a day,200 mL each time.After 6 mo of treatment,abdominal pain,diarrhoea,bloody stool and other symptoms disappeared.No abnormality was found by repeat electronic enteroscopye,and the anemia was corrected.The patient’s condition did not recur after nearly 4 years of follow-up.CONCLUSION A series of symptoms in this UC patient significantly improved with the administration of traditional Chinese medicine.展开更多
Objective:To analyze the therapeutic effects of Integrated Traditional Chinese and Western Medicine on ulcerative colitis (UC) and its effects on coagulation function and inflammatory factors.Methods: 220 cases of pat...Objective:To analyze the therapeutic effects of Integrated Traditional Chinese and Western Medicine on ulcerative colitis (UC) and its effects on coagulation function and inflammatory factors.Methods: 220 cases of patients with UC were selected as the research subjects and randomly divided into the observation group and the control group, 110 cases were included into each group. The patients in the control group were treated with single western medicine, while the patients in the observation group were treated with enema treatment of traditional Chinese Medicine. The clinical therapeutic effects of the two groups were evaluated and compared. The blood coagulation indexes of the activated partial thromboplastin time (APTT), prothrombin time (PT), the plasma fibrinogen (Fib), the D dimer (D-D) of two groups patients who in the treatment were detected and compared. The serum tumor necrosis factor (TNF-α), interleukin-6 (IL-6), interleukin-8 (IL-8) levels of the patients in the two groups were measured and compared.Results: The clinical efficiencies of the observation group and the control group were 97% and 75%, the clinical efficiencies and the therapeutic effects of the observation group were better than those in the control group, there were statistically significant differences between the two groups. The plasma Fib levels and the plasma D-D levels after the treatment of the patients in the two groups were significantly lower than those before the treatment, the difference was statistically significant. The plasma Fib levels and the plasma D-D levels after the treatment of the patients in the observation group were lower than those in the control group, the difference was statistically significant. The serum inflammatory factors levels after the treatment of the patients in the two groups were significantly lower than those before the treatment, the difference was statistically significant. The serum inflammatory factors levels after the treatment of the patients in the observation group were lower than those in the control group, the difference is powerful and have statistically significant.Conclusion: The application of Integrated Traditional Chinese and Western Medicine in the treatment of UC can improve the therapeutic effect significantly, correct imbalance of the patients' coagulation dissolution function, reduce the degree of inflammatory reaction, which benefits to promote of the patients' rehabilitation, reduce the incidence of complications and improve the prognosis of patients.展开更多
AIM To investigate the current state of research output from Chinese studies into severe ulcerative colitis(SUC) using a bibliometric analysis of publications. METHODS The contents of the Chinese periodical databases ...AIM To investigate the current state of research output from Chinese studies into severe ulcerative colitis(SUC) using a bibliometric analysis of publications. METHODS The contents of the Chinese periodical databases WANFANG, VIP, and China National Knowledge Infrastructure were searched for all papers regarding UC or SUC published in last the 15 years (from 2001 to 2015). The number of publications in each year was recorded to assess the temporal trends of research output. All SUC related publications were downloaded and the complexity of this research was evaluated with methods described previously. The number of patients with SUC reported each year was recorded and their clinical characteristics were analyzed using information available in the relevant papers. RESULTS There were 13499 publications regarding UC published in Chinese medical journals between 2001 and 2015, of which 201 focused on SUC. The number of publications increased rapidly with more than half of all papers being published in the most recent 5-year period. There was a significant increase in analyticalstudies and clinical trials over the study period (P < 0.01), with research into the management of SUC, included pharmacotherapy, nutrition support as well as surgery, predominating. Almost half (46.2%) of the observational analytical studies and clinical trials focused on Traditional Chinese Medicine, with little research on the efficacy of cyclosporin and infliximab in disease management. About 6222 patients with SUC were reported in the 201 SUC relevant papers, with a ratio of male/female of 1.38. The number of patients reported in each 5-year period significantly increased. The colectomy rate and short-term mortality rate were 7.7% and 0.8% respectively. The most commonly employed operation was total proctocolectomy with ileal pouch-anal anastomosis.CONCLUSION The output and complexity of research related to SUC in China increased significantly over the previous 15 years, however few of these studies focused on salvage therapy.展开更多
Diabetes mellitus is one of the most frequent co-morbidities of ulcerative colitis patients.The epidemiological association of these diseases suggested a genetic sharing and has challenged gene identification.Diabetes...Diabetes mellitus is one of the most frequent co-morbidities of ulcerative colitis patients.The epidemiological association of these diseases suggested a genetic sharing and has challenged gene identification.Diabetes co-morbidity in ulcerative colitis has also relevant clinical and therapeutic implications,with potential clinical impact on the follow up and outcome of patients.These diseases share specific complications,such as neuropathy,hepatic steatosis,osteoporosis and venous thrombosis.It is still unknown whether the coexistence of these diseases may increase their occurrence.Diabetes and hyperglycaemia represent relevant risk factors for postoperative complications and pouch failure in ulcerative colitis.Medical treatment of ulcerative colitis in patients with diabetes mellitus may be particularly challenging.Corticosteroids are the treatment of choice of active ulcerative colitis.Their use may be associated with the onset of glucose intolerance and diabetes,with difficult control of glucose levels andwith complications in diabetic patients.Epidemiologic and genetic evidences about diabetes co-morbidity in ulcerative colitis patients and shared complications and treatment of patients with these diseases have been discussed in the present review.展开更多
Objective: To study the therapeutic effects and mechanism of Jiechangning (结肠宁, JCN) decoction on carrageenan induced experimental ulcerative colitis (UC). Methods: After sensitizing guinea pigs with carrageenan, w...Objective: To study the therapeutic effects and mechanism of Jiechangning (结肠宁, JCN) decoction on carrageenan induced experimental ulcerative colitis (UC). Methods: After sensitizing guinea pigs with carrageenan, we established UC animal models by free drinking water containing 2% acid degraded carrageenan (ADC). JCN decoction was orally administered once a day for 2 weeks after carrageenan treatment. Salicylazosulfapyridine (SASP) and normal saline were given to the other two groups as control. The levels of colon lipid peroxide (LPO), acid phosphatase (ACP)activity and tumor necrosis factor-α (TNF-α) were measured; colitis activity score (CAS) was carried out for assessment of the degree of tissue inflammation and injury; the colonic pathological changes were examined simultaneously with hematoxylin and eosin (HE) and toluidine blue staining used to evaluate the therapeutic effects of JCN decoction and SASP. Results: Experimental colitis models resembling human UC were successfully induced. The levels of tissue LPO, ACP activity and the content of tissue TNF-α were markedly increased in the model group as compared with the normal control group ( P <0.01) and were positively correlated with CAS. JCN decoction could reverse these changes like SASP. HE staining showed that JCN decoction and SASP could reduce CAS and the degree of tissue injury, toluidine blue staining revealed that mucosa and submucosa red metachromasia pellets in JCN group and SASP group were markedly fewer than those in the model group. Conclusion: JCN decoction is effective in treating experimental UC, which provides theoretical basis for its clinical application.展开更多
Crohn’s disease (CD) and ulcerative colitis (UC) are chronic inflammatory diseases of the gastrointestinal tract. While a cure remains elusive, both can be treated with medications that induce and maintain remission....Crohn’s disease (CD) and ulcerative colitis (UC) are chronic inflammatory diseases of the gastrointestinal tract. While a cure remains elusive, both can be treated with medications that induce and maintain remission. With the recent advent of therapies that inhibit tumor necrosis factor (TNF) alpha the overlap in medical therapies for UC and CD has become greater. Although 5-ASA agents have been a mainstay in the treatment of both CD and UC, the data for their efficacy in patients with CD, particularly as maintenance therapy, are equivocal. Antibiotics may have a limited role in the treatment of colonic CD. Steroids continue to be the first choice to treat active disease not responsive to other more conservative therapy; non- systemic steroids such as oral and rectal budesonide for ileal and right-sided CD and distal UC respectively are also effective in mild-moderate disease. 6-mercaptopurine (6-MP) and its prodrug azathioprine are steroid-sparing immunomodulators effective in the maintenance of remission of both CD and UC, while methotrexate may be used in both induction and maintenance of CD. Infliximab and adalimumab are anti-TNF agents approved in the US and Europe for the treatment of Crohn's disease, and infliximab is also approved for the treatment of UC.展开更多
Objective: To evaluate the safety and efficacy of composite sophora colon-soluble capsule (CSCC) in treating ulcerative colitis (UC) of the damp-heat accumulation syndrome pattern (DHAS) and to prepare a basis ...Objective: To evaluate the safety and efficacy of composite sophora colon-soluble capsule (CSCC) in treating ulcerative colitis (UC) of the damp-heat accumulation syndrome pattern (DHAS) and to prepare a basis for a phase Ⅲ clinical trial.Methods: A multi-center,randomized,single-blind,and positive drug parallel-controlled design was adopted.There were 126 patients of UC-DHAS stratified and assigned equally to three groups.Patients in two CSCC treated groups,Groups T1 and T2,were treated orally with high (six capsules,thrice a day) and low (four capsules,thrice a day) doses CSCC,and patients in the control group were treated orally with Mesalazine Enteric-coated Tablets (four tablets,thrice a day),respectively,all for eight weeks.The clinical efficacy and safety of treatments were evaluated through clinical symptom observations and colonoscopic examinations.Results: (1) Full analysis set (FAS) and per-protocol set (PPS) analyses showed the comprehensive curative effect in Groups T1,T2,and the control group,obtaining the values of 85.7%,92.9%,and 71.4% (P=0.330),and 89.5%,92.7%,and 73.2% (P=0.552),respectively,demonstrating no statistical significance among the three groups.(2) FAS and PPS analysis showed the efficacy on membranous lesions in Groups T1,T2,and the control group,obtaining the values of 83.3%,92.9%,and 73.8% (P=0.063),and 86.8%,92.7%,and 75.6% (P=0.070),respectively,showing statistical insignificance among the three groups.(3) FAS analysis showed an efficacy tendency on improving tenesmus (P=0.056).No changes were found in improving the other symptoms,and statistical significance was not shown among the three groups (P〉0.05).PPS analysis showed the efficacy on single item symptom in Groups T1,T2,and the control group was not statistically significant among the three groups (P=0.082).Conclusions: The comprehensive effect of CSCC in treating UC is basically equivalent to that of Mesalazine enteric-coated tablet;however,the tendency was shown to improve symptoms.Its efficacy could not be raised by increasing the dosage used.Therefore,the recommended dosage of CSCC is four capsules,three times a day.展开更多
Objective:To investigate the effects of Modified Sanhuang Decoction(加味三黄汤,MSD)enema on the serum tumor necrosis factor alpha(TNF-α)and colonic mucosa interleukin-1β(IL-1β),interleukin-6(IL-6)levels in...Objective:To investigate the effects of Modified Sanhuang Decoction(加味三黄汤,MSD)enema on the serum tumor necrosis factor alpha(TNF-α)and colonic mucosa interleukin-1β(IL-1β),interleukin-6(IL-6)levels in experimental ulcerative colitis(UC)rats.Methods:Forty-five male Wistar rats were randomly divided into 4 groups:normal group(n=12),model group(n=11),salazosulfapyridine(SASP)group(n=11)and MSD group(n=11).The UC model was induced by 2,4,6-trinitrobenzene sulfonic acid(TNBS)/ethanol solution.Rats in the normal group and model group were clystered with 0.9%normal saline,while in the SASP group and MSD group were clystered with SASP and MSD enema,respectively.After drug administration(10 mL/kg body weight,for 7 days),colonic gross changes and colonic mucosa histology were observed,serum TNF-αand colonic mucosa IL-1β,IL-6 levels were tested by enzyme linked immunosorbent assay and radioimmunoassay,respectively.Results:As compared with the normal group,the experimental UC rats,the colonic mucosal damage index scores(CMDIs),histopathological scores(HS)and the serum TNF-a and colonic mucosa IL-1β,IL-6 levels significantly increased(P〈0.05 or P〈0.01).In the MSD and SASP groups,the ulcer area significantly reduced,and edema disappeared.The CMDIs,HS,the serum TNF-a and colonic mucosa IL-1β,IL-6 levels in the MSD and SASP groups significantly decreased(P〈0.05 or P〈0.01)compared with the model group.The CMDIs in the MSD group were lower than that in the SASP group(P〈0.05),but there were no significant differences in HS,serum TNF-αor colonic mucosa IL-1β,IL-6 levels between the MSD and SASP groups.Conclusion:MSD enema can improve colonic mucosa impairment and decrease serum TNF-αand colonic mucosa IL-1β,IL-6 levels in experimental UC.展开更多
文摘Inflammatory bowel disease,particularly ulcerative colitis(UC),poses significant treatment challenges due to its chronic nature and potential for severe complications.This editorial reviews a recent network meta-analysis that evaluated the efficacy of and highlighted the superior outcomes achieved by combining each of five traditional Chinese medicine(TCM)formulations with mesalazine for the adjuvant treatment of UC.Clinical outcomes included enhanced mucosal healing,improved quality of life,and reduced recurrence rates.Additionally,the combination therapy resulted in a lower incidence of adverse reactions compared with mesalazine monotherapy.Despite these promising results,limitations such as variability in study quality and TCM dosage highlight the need for further highquality,large-sample,multicenter randomized controlled trials.This editorial underscores the potential of TCM in enhancing UC management and calls for more rigorous research to substantiate these findings and refine clinical guidelines.
文摘118 cases of ulcerative colitis were treated by integration of traditional Chinese and Western medicine. Another 86 cases of ulcerative colitis were treated by simple western drugs as controls. The therapeutic effects for both groups were observed and compared after two therapeutic courses of 40 consecutive days. As a result, 39 cases were cured, 60 cases improved and 19 cases failed, with a total effective rate of 84% in the treatment group; in the control group, 15 cases were cured, 37 cases improved and 34 cases failed, with a total effective rate of 60.5%. Statistically, the difference was very significant (P
基金Supported by Zhejiang Provincial Natural Science Foundation of China,No.LQ20H270010。
文摘BACKGROUND Ulcerative colitis(UC),also known as chronic nonspecific UC,is an inflammatory bowel disease characterized by diffuse colonic mucosal inflammation.The incidence and prevalence of UC have risen markedly,and the disease seriously affects the quality of life of patients and imposes a great burden on the world health care infrastructure and economy.CASE SUMMARY Case I describes a 34-year-old female who came to see a doctor because of repeated abdominal pain,diarrhoea and purulent blood for 2 mo.This patient had UC with an initial onset,an active stage and a wide range of lesions.After the poor effect of sulfasalazine and mesalazine,the patient’s condition gradually deteriorated,her abdominal pain and bloody stools continued,and anemia occurred.She began treatment with the Chinese medicine Guizhi Dahuang decoction,which was taken orally twice a day,200 mL each time.After 6 mo of treatment,abdominal pain,diarrhoea,bloody stool and other symptoms disappeared.No abnormality was found by repeat electronic enteroscopye,and the anemia was corrected.The patient’s condition did not recur after nearly 4 years of follow-up.CONCLUSION A series of symptoms in this UC patient significantly improved with the administration of traditional Chinese medicine.
基金Projects funded by the National Natural Science Foundation of China.Project,No:81472305.
文摘Objective:To analyze the therapeutic effects of Integrated Traditional Chinese and Western Medicine on ulcerative colitis (UC) and its effects on coagulation function and inflammatory factors.Methods: 220 cases of patients with UC were selected as the research subjects and randomly divided into the observation group and the control group, 110 cases were included into each group. The patients in the control group were treated with single western medicine, while the patients in the observation group were treated with enema treatment of traditional Chinese Medicine. The clinical therapeutic effects of the two groups were evaluated and compared. The blood coagulation indexes of the activated partial thromboplastin time (APTT), prothrombin time (PT), the plasma fibrinogen (Fib), the D dimer (D-D) of two groups patients who in the treatment were detected and compared. The serum tumor necrosis factor (TNF-α), interleukin-6 (IL-6), interleukin-8 (IL-8) levels of the patients in the two groups were measured and compared.Results: The clinical efficiencies of the observation group and the control group were 97% and 75%, the clinical efficiencies and the therapeutic effects of the observation group were better than those in the control group, there were statistically significant differences between the two groups. The plasma Fib levels and the plasma D-D levels after the treatment of the patients in the two groups were significantly lower than those before the treatment, the difference was statistically significant. The plasma Fib levels and the plasma D-D levels after the treatment of the patients in the observation group were lower than those in the control group, the difference was statistically significant. The serum inflammatory factors levels after the treatment of the patients in the two groups were significantly lower than those before the treatment, the difference was statistically significant. The serum inflammatory factors levels after the treatment of the patients in the observation group were lower than those in the control group, the difference is powerful and have statistically significant.Conclusion: The application of Integrated Traditional Chinese and Western Medicine in the treatment of UC can improve the therapeutic effect significantly, correct imbalance of the patients' coagulation dissolution function, reduce the degree of inflammatory reaction, which benefits to promote of the patients' rehabilitation, reduce the incidence of complications and improve the prognosis of patients.
基金Supported by Doctoral Fund of Ministry of Education of China,No.20130181120041
文摘AIM To investigate the current state of research output from Chinese studies into severe ulcerative colitis(SUC) using a bibliometric analysis of publications. METHODS The contents of the Chinese periodical databases WANFANG, VIP, and China National Knowledge Infrastructure were searched for all papers regarding UC or SUC published in last the 15 years (from 2001 to 2015). The number of publications in each year was recorded to assess the temporal trends of research output. All SUC related publications were downloaded and the complexity of this research was evaluated with methods described previously. The number of patients with SUC reported each year was recorded and their clinical characteristics were analyzed using information available in the relevant papers. RESULTS There were 13499 publications regarding UC published in Chinese medical journals between 2001 and 2015, of which 201 focused on SUC. The number of publications increased rapidly with more than half of all papers being published in the most recent 5-year period. There was a significant increase in analyticalstudies and clinical trials over the study period (P < 0.01), with research into the management of SUC, included pharmacotherapy, nutrition support as well as surgery, predominating. Almost half (46.2%) of the observational analytical studies and clinical trials focused on Traditional Chinese Medicine, with little research on the efficacy of cyclosporin and infliximab in disease management. About 6222 patients with SUC were reported in the 201 SUC relevant papers, with a ratio of male/female of 1.38. The number of patients reported in each 5-year period significantly increased. The colectomy rate and short-term mortality rate were 7.7% and 0.8% respectively. The most commonly employed operation was total proctocolectomy with ileal pouch-anal anastomosis.CONCLUSION The output and complexity of research related to SUC in China increased significantly over the previous 15 years, however few of these studies focused on salvage therapy.
文摘Diabetes mellitus is one of the most frequent co-morbidities of ulcerative colitis patients.The epidemiological association of these diseases suggested a genetic sharing and has challenged gene identification.Diabetes co-morbidity in ulcerative colitis has also relevant clinical and therapeutic implications,with potential clinical impact on the follow up and outcome of patients.These diseases share specific complications,such as neuropathy,hepatic steatosis,osteoporosis and venous thrombosis.It is still unknown whether the coexistence of these diseases may increase their occurrence.Diabetes and hyperglycaemia represent relevant risk factors for postoperative complications and pouch failure in ulcerative colitis.Medical treatment of ulcerative colitis in patients with diabetes mellitus may be particularly challenging.Corticosteroids are the treatment of choice of active ulcerative colitis.Their use may be associated with the onset of glucose intolerance and diabetes,with difficult control of glucose levels andwith complications in diabetic patients.Epidemiologic and genetic evidences about diabetes co-morbidity in ulcerative colitis patients and shared complications and treatment of patients with these diseases have been discussed in the present review.
文摘Objective: To study the therapeutic effects and mechanism of Jiechangning (结肠宁, JCN) decoction on carrageenan induced experimental ulcerative colitis (UC). Methods: After sensitizing guinea pigs with carrageenan, we established UC animal models by free drinking water containing 2% acid degraded carrageenan (ADC). JCN decoction was orally administered once a day for 2 weeks after carrageenan treatment. Salicylazosulfapyridine (SASP) and normal saline were given to the other two groups as control. The levels of colon lipid peroxide (LPO), acid phosphatase (ACP)activity and tumor necrosis factor-α (TNF-α) were measured; colitis activity score (CAS) was carried out for assessment of the degree of tissue inflammation and injury; the colonic pathological changes were examined simultaneously with hematoxylin and eosin (HE) and toluidine blue staining used to evaluate the therapeutic effects of JCN decoction and SASP. Results: Experimental colitis models resembling human UC were successfully induced. The levels of tissue LPO, ACP activity and the content of tissue TNF-α were markedly increased in the model group as compared with the normal control group ( P <0.01) and were positively correlated with CAS. JCN decoction could reverse these changes like SASP. HE staining showed that JCN decoction and SASP could reduce CAS and the degree of tissue injury, toluidine blue staining revealed that mucosa and submucosa red metachromasia pellets in JCN group and SASP group were markedly fewer than those in the model group. Conclusion: JCN decoction is effective in treating experimental UC, which provides theoretical basis for its clinical application.
文摘Crohn’s disease (CD) and ulcerative colitis (UC) are chronic inflammatory diseases of the gastrointestinal tract. While a cure remains elusive, both can be treated with medications that induce and maintain remission. With the recent advent of therapies that inhibit tumor necrosis factor (TNF) alpha the overlap in medical therapies for UC and CD has become greater. Although 5-ASA agents have been a mainstay in the treatment of both CD and UC, the data for their efficacy in patients with CD, particularly as maintenance therapy, are equivocal. Antibiotics may have a limited role in the treatment of colonic CD. Steroids continue to be the first choice to treat active disease not responsive to other more conservative therapy; non- systemic steroids such as oral and rectal budesonide for ileal and right-sided CD and distal UC respectively are also effective in mild-moderate disease. 6-mercaptopurine (6-MP) and its prodrug azathioprine are steroid-sparing immunomodulators effective in the maintenance of remission of both CD and UC, while methotrexate may be used in both induction and maintenance of CD. Infliximab and adalimumab are anti-TNF agents approved in the US and Europe for the treatment of Crohn's disease, and infliximab is also approved for the treatment of UC.
基金Supported by Items of Creative Research and Development of Drugs,Beijing Municipal Committee of Sciences (No.D08080200290805)
文摘Objective: To evaluate the safety and efficacy of composite sophora colon-soluble capsule (CSCC) in treating ulcerative colitis (UC) of the damp-heat accumulation syndrome pattern (DHAS) and to prepare a basis for a phase Ⅲ clinical trial.Methods: A multi-center,randomized,single-blind,and positive drug parallel-controlled design was adopted.There were 126 patients of UC-DHAS stratified and assigned equally to three groups.Patients in two CSCC treated groups,Groups T1 and T2,were treated orally with high (six capsules,thrice a day) and low (four capsules,thrice a day) doses CSCC,and patients in the control group were treated orally with Mesalazine Enteric-coated Tablets (four tablets,thrice a day),respectively,all for eight weeks.The clinical efficacy and safety of treatments were evaluated through clinical symptom observations and colonoscopic examinations.Results: (1) Full analysis set (FAS) and per-protocol set (PPS) analyses showed the comprehensive curative effect in Groups T1,T2,and the control group,obtaining the values of 85.7%,92.9%,and 71.4% (P=0.330),and 89.5%,92.7%,and 73.2% (P=0.552),respectively,demonstrating no statistical significance among the three groups.(2) FAS and PPS analysis showed the efficacy on membranous lesions in Groups T1,T2,and the control group,obtaining the values of 83.3%,92.9%,and 73.8% (P=0.063),and 86.8%,92.7%,and 75.6% (P=0.070),respectively,showing statistical insignificance among the three groups.(3) FAS analysis showed an efficacy tendency on improving tenesmus (P=0.056).No changes were found in improving the other symptoms,and statistical significance was not shown among the three groups (P〉0.05).PPS analysis showed the efficacy on single item symptom in Groups T1,T2,and the control group was not statistically significant among the three groups (P=0.082).Conclusions: The comprehensive effect of CSCC in treating UC is basically equivalent to that of Mesalazine enteric-coated tablet;however,the tendency was shown to improve symptoms.Its efficacy could not be raised by increasing the dosage used.Therefore,the recommended dosage of CSCC is four capsules,three times a day.
基金Supported by Beijing Excellent Talents Cultivation Project(No.2010D003034000044)
文摘Objective:To investigate the effects of Modified Sanhuang Decoction(加味三黄汤,MSD)enema on the serum tumor necrosis factor alpha(TNF-α)and colonic mucosa interleukin-1β(IL-1β),interleukin-6(IL-6)levels in experimental ulcerative colitis(UC)rats.Methods:Forty-five male Wistar rats were randomly divided into 4 groups:normal group(n=12),model group(n=11),salazosulfapyridine(SASP)group(n=11)and MSD group(n=11).The UC model was induced by 2,4,6-trinitrobenzene sulfonic acid(TNBS)/ethanol solution.Rats in the normal group and model group were clystered with 0.9%normal saline,while in the SASP group and MSD group were clystered with SASP and MSD enema,respectively.After drug administration(10 mL/kg body weight,for 7 days),colonic gross changes and colonic mucosa histology were observed,serum TNF-αand colonic mucosa IL-1β,IL-6 levels were tested by enzyme linked immunosorbent assay and radioimmunoassay,respectively.Results:As compared with the normal group,the experimental UC rats,the colonic mucosal damage index scores(CMDIs),histopathological scores(HS)and the serum TNF-a and colonic mucosa IL-1β,IL-6 levels significantly increased(P〈0.05 or P〈0.01).In the MSD and SASP groups,the ulcer area significantly reduced,and edema disappeared.The CMDIs,HS,the serum TNF-a and colonic mucosa IL-1β,IL-6 levels in the MSD and SASP groups significantly decreased(P〈0.05 or P〈0.01)compared with the model group.The CMDIs in the MSD group were lower than that in the SASP group(P〈0.05),but there were no significant differences in HS,serum TNF-αor colonic mucosa IL-1β,IL-6 levels between the MSD and SASP groups.Conclusion:MSD enema can improve colonic mucosa impairment and decrease serum TNF-αand colonic mucosa IL-1β,IL-6 levels in experimental UC.