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.

Study on pharmacokinetic and gastrointestinal distribution study of mesalazine enteric-coated sustained-release granules in rats / 药学实践杂志

Objective To evaluate the pharmacokinetics of the new mesalazine enteric-coated sustained-release granules in SD rats and their distribution in the gastrointestinal tract, and to understand the preclinical pharmacokinetics and gastrointestinal distribution characteristics of the preparation. Methods Rats were administered orally to determine the drug concentrations in plasma samples and in the gastrointestinal tract. The commercially available mesalazine sustained-release granule was used as a reference to self-developed one to evaluate the process of absorption and elimination in vivo, relative bioavailability, and distribution in the gastrointestinal tract. Results The relative bioavailability of mesalazine enteric-coated sustained-release granule and non-enteric-coated one characterized by mesalazine was 89.62% ± 9.36%. After oral administration of mesalazine enteric-coated sustained-release granules, the drug has a high concentration distribution in the stomach within 2-8 hours, and gradually enters and remains in the jejunum, ileum and colon over time for 6-12 hours and then reaching a high concentration distribution in the colon. This help for the absorption of mesalazine, as well as the fixed-point release of the drug to produce a therapeutic effect. Conclusion The absorption and elimination process of mesalazine enteric sustained-release granule showed linear kinetic characteristics. There was no significant difference in pharmacokinetic parameters from the commercially available formulations, and it had a certain fluidity in the gastrointestinal tract. Good gastrointestinal distribution characteristics help the absorption of drugs in the body and the targeted release of the site of action

Evaluation of polyelectrolyte and emulsion covalent crosslink of chitosan for producing mesalasine loaded submicron particles

This study evaluates various techniques for producing mesalamine (5ASA)-loaded particles employing chitosan as a biopolymer: (1) the polyelectrolyte complexation of chitosan with phthalate hypromelose (HP), (2) the chemical crosslinking of chitosan with genipin and (3) the water-in-oil emulsion method associated with chemical crosslinking with genipin. Systems were characterized by dynamic light scattering, zeta potential (ζ), powder X-ray diffraction (PXRD), Fourier transform infrared spectroscopy (FTIR) and a drug release profile. Method (1) was efficiently produced unloaded nanoparticles (491 nm, PdI=0.26 and ζ = 23.2), but the conditions for chitosan and HP cross-linking enhanced the precipitation of 5ASA. Method (2) caused the degradation of the drug. Method 3 produced sub-micron and microparticles, thereby varying the agitation method; 3 h magnetic agitation resulted in 2692 nm, Pdi = 0.6 and ζ = 46, while Ultra-Turrax, 5 min produced submicron particles (537 nm, PdI = 0.6). The percentage yield was approximately 50%, which is very satisfactory considering the impossibility of encapsulating 5ASA using other methods. FTIR showed the covalent interaction of chitosan and genipin. The drug release was rapid in acidic fluid, but in neutral pH a slower release was obtained in the initial stage, followed by rapid release, which may ensure the controlled release of 5ASA in the colon.

Effect of mesalazine combined with compound glutamine in the treatment of acute radiation enteritis / 中国医师进修杂志

Objective To evaluate the efficacy of mesalazine combined with compound glutamine in the treatment of radiation related enteritis. Methods Ninety-four patients were randomly divided into the observation group and the treatment group, with 47 cases in each group. Patients in control group were given compound glutamine orally. On the basis of compound glutamine, patients in the observation group was added mesalazine orally. Before and after treatment, all patients were assessed according to acute radiation injury grading (RTOG), and the quality of life (QOL) scale for cancer patients was used to evaluate the improvement of quality of life. Results The total effective rate of the observation group was 95.7％(45/47) , and that of the control group was 78.7％(37/47).The difference was statistically significant (P<0.05). At the end of radiation therapy, patients in the observation group showed significant superiority in quality of life (P<0.05). Conclusions Mesalazine combined with compound glutamine in the treatment of radiation-associated enteritis has advantages and can improve the quality of life.

Recurrent Eosinophilic Pneumonia Associated with Mesalazine Suppository in a Patient with Ulcerative Colitis / 대한소화기학회지

Mesalazine suppositories are widely used to treat ulcerative colitis and have a guaranteed safety profile, but although rare, they can cause pulmonary toxicity. A 35-year-old woman with ulcerative colitis was diagnosed to have acute eosinophilic pneumonia after 29 days of oral mesalazine use and improved after mesalazine and corticosteroid were withdrawn. Reintroduction of mesalazine suppositories resulted in acute eosinophilic pneumonia recurrence after 28 days. Mesalazine re-administration (even via a different route) in patients with a history of mesalazine-induced eosinophilic pneumonia should be undertaken cautiously, because eosinophilic pneumonia may recurrence.

Acupuncture combined with acupoint catgut embedding sequential therapy for mild and moderate ulcerative colitis / 中国针灸

<p><b>OBJECTIVE</b>To observe the efficacy of acupuncture combined with acupoint catgut embedding sequential therapy and medication for mild and moderate ulcerative colitis.</p><p><b>METHODS</b>One hundred and twenty patients were randomized into an acupuncture and acupoint catgut embedding sequential therapy group (a combination group) and a mesalazine group, 60 cases in each one. Fifty-seven cases in the combination group and 55 cases in the mesalazine group were included into analysis. In the combination group, acupuncture was applied at Tianshu (ST 25), Shangjuxu (ST 37), Quchi (LI 11) during the activity period, and acupoint catgut embedding was applied at Pishu (BL 20), Zusanli (ST 36), Guanyuan (CV 4) during the alleviate period. The patients in the mesalazine group were treated with mesalazine orally. The treatment was given for 12 weeks. The scores of TCM symptoms, colonoscopy, mucosa healing rate were compared before and after treatment in the two groups. The effects, adverse reactions and the recurrent rates during 1-year follow-up were observed.</p><p><b>RESULTS</b>After treatment, the scores of TCM symptoms decreased in the two groups (both <0.05), and the result in the combination group was better than that in the mesalazine group (<0.05). The total effective rate in the combination group was 87.7% (50/57), which was better than 70.9% (39/55) in the mesalazine group (<0.05). The colonoscopy scores decreased after treatment in the two groups (both <0.05). There was no significant difference between the two groups on colonoscopy score and mucosal healing rate [50.9% (29/57) vs 34.5% (19/55), both >0.05]. The recurrent rate in the combination group was 8.5% (4/47)，which was lower than 32.4% (11/34) in the mesalazine group (<0.05). No severe adverse reaction was found during the treatment in the two groups.</p><p><b>CONCLUSION</b>Acupuncture combined with acupoint catgut embedding sequential therapy can improve mild and moderate ulcerative colitis and reduce the recurrent rate.</p>

Consensus recommendations for patient-centered therapy in mild-to-moderate ulcerative colitis: the i Support Therapy–Access to Rapid Treatment (iSTART) approach

Symptomatic ulcerative colitis (UC) can be a chronic, disabling condition. Flares in disease activity are associated with many of the negative impacts of mild-to-moderate UC. Rapid resolution of flares can provide benefits to patients and healthcare systems. i Support Therapy–Access to Rapid Treatment (iSTART) introduces patient-centered care for mild-to-moderate UC. iSTART provides patients with the ability to self-assess symptomology and self-start a short course of second-line treatment when necessary. An international panel of experts produced consensus statements and recommendations. These were informed by evidence from systematic reviews on the epidemiology, mesalazine (5-ASA) treatment, and patient use criteria for second-line therapy in UC. Optimized 5-ASA is the first-line treatment in all clinical guidelines, but may not be sufficient to induce remission in all patients. Corticosteroids should be prescribed as second-line therapy when needed, with budesonide MMX® being a preferred steroid option. Active involvement of suitable patients in management of UC flares has the potential to improve therapy, with patients able to show good accuracy for flare self-assessment using validated tools. There is a place in the UC treatment pathway for an approach such as iSTART, which has the potential to provide patient, clinical and economic benefits.

Clinical efficacy of mesalazine combined with Clostridium butyricum tablets in the treatment of colitis gravis / 中国基层医药

Objective To investigate the clinical efficacy and safety of mesalazine combined with Clostridium butyricum tablets in the treatment of colitis gravis.Methods From January 2016 to December 2016, a total of 120 patients with colitis gravis in the Second Hospital of Qinhuangdao were selected in the research .According to different treatment methods,the patients were divided into observation group and control group ,with 60 cases in each group.The control group was given mesalazine , and the observation group was given mesalazine combined with Clostridium butyricum tablets.All the patients were treated for 2 months.The changes of cytokine levels and C -reactive protein were observed.The therapeutic effects and adverse drug reactions were compared between the two groups . Results The total effective rate of the observation group was significantly higher than that in the control group (91.66%vs.78.33%),and there was statistically significant difference between the two groups ( χ2＝4.183,P＝0.041).The level of IL-10 in the observation group was significantly higher than that in the control group [(110.05 ± 2.61)pg/L vs.(98.35 ±2.42)pg/L,t＝25.462,P＜0.05].The IL-18 level in the observation group was significantly lower than that in the control group [(97.74 ±2.82) pg/L vs.(120.86 ±3.21) pg/L,t＝41.914,P＜0.05].The level of C-reactive protein in the observation group was lower than that in the control group [(8.02 ±1.97) mg/L vs.(6.33 ±3.82)mg/L,t＝14.976,P＜0.05].The incidence rate of adverse reactions of the observation group was significantly lower than that of the control group ( 5.00% vs.25.00%, χ2＝9.412, P ＝0.002 ).Conclusion Mesalazine combined with Clostridium butyricum tablets in the treatment of colitis gravis has obvious curative effect , and can effectively improve the levels of cytokines and C -reactive protein and with high safety.

Comparison of the effects of mesalazine oral plus enema and only oral administration in the treatment of ulcerative colitis / 中国基层医药

Objective To compare the efficacy and safety of mesalazine oral plus enema or only oral admin-istration in the treatment of ulcerative colitis .Methods 114 patients with ulcerative colitis were selected , and they were randomly divided into the observation group and treatment group according to random number table , with 57 cases in each group .The observation group was given mesalazine oral treatment ,and the treatment group was given mesalazine oral plus enema .The changes of CRP ,Fid,MPV after treatment were compared between the two groups .The situation of mucosa under colonoscopy , effective rate and the incidence of adverse reactions were compared between the two groups.Results After treatment,the CRP,Fid levels in the treatment group were lower than those in the observation group [(3.17 ±1.48)mg/L vs.(6.14 ±2.53)mg/L,(2.14 ±0.17)g/L vs.(2.91 ±0.27)g/L],the MPV in the treatment group was higher than that in the observation group [(10.93 ±0.59) fL vs.(10.21 ± 1.21)fL],the differences were statistically significant (t=7.650,18.220,4.038,all P<0.05).The total remission rate of the treatment group was higher than that of the observation group (100.00%vs.78.95%) (χ2 =13.412,P<0.001).The total effective rate of treatment group was higher than that of the observation group (89.47% vs .75.44%) (χ2 =3.881,P=0.049).The incidence rate of adverse reactions in the treatment group was lower than that in the observation group (3.51%vs.26.32%) (χ2 =11.683,P=0.001).Conclusion Mesalazine oral plus enema in the treatment of ulcerative colitis has good effect ,minor adverse reactions,high safety,which is worthy of clinical application .

Comparison of efficacy of once daily multimatrix mesalazine 2.4 g/day and 4.8 g/day with other 5-aminosalicylic acid preparation in active ulcerative colitis: a randomized, double-blind study

BACKGROUND/AIMS: This study compared the efficacy of multimatrix mesalazine 2.4 g/day and 4.8 g/day with controlled-release mesalazine 2.25 g/day. METHODS: In this multicenter, randomized, double-blind study, 251 patients with mildly to moderately active ulcerative colitis received multimatrix mesalazine 2.4 g/day once daily (Multimatrix-2.4), 4.8 g/day once daily (Multimatrix-4.8), or controlled-release (time-dependent) mesalazine 2.25 g/day 3 times daily (Time-2.25) for 8 weeks. The primary efficacy endpoint was the change in the ulcerative colitis-disease activity index (UC-DAI) score. RESULTS: The mean change in the UC-DAI score and standard deviation in the per protocol set was −1.9±2.5 for Multimatrix-2.4 and −2.4±2.8 for Time-2.25. The difference between Multimatrix-2.4 and Time-2.25 was 0.3 (two-sided 95% confidence interval [CI], −0.5 to 1.1), thus non-inferiority was not demonstrated based on the pre-defined non-inferiority margin (1.0). In the full analysis set, the difference between Multimatrix-4.8 and Time-2.25 was −1.2 (two-sided 95% CI, −2.0 to −0.5), and the mean change in UC-DAI score in the FAS was −3.3 (two-sided 95% CI, −3.9 to −2.8) for Multimatrix-4.8 and −1.9 (two-sided 95% CI, −2.5 to −1.3) for Multimatrix-2.4, indicating that Multimatrix-4.8 was more effective than Time-2.25 and Multimatrix-2.4. There was no difference among the treatment groups in terms of safety. CONCLUSIONS: This study showed that the efficacy of multimatrix mesalazine 2.4 g/day was comparable to controlled release mesalazine 2.25 g/day, although non-inferiority was not demonstrated. Importantly, this was the first study to indicate that multimatrix mesalazine 4.8 g/day was more effective than 2.4g/day with no associated safety concerns.

Comparison of efficacy of multimatrix mesalazine 4.8 g/day once-daily with other high-dose mesalazine in active ulcerative colitis: a randomized, double-blind study

BACKGROUND/AIMS: This study assessed the efficacy and safety of high-dose multimatrix mesalazine once-daily (QD) compared to another form of high-dose mesalazine. METHODS: In this multicenter, randomized, double-blind study, 280 patients with mildly to moderately active ulcerative colitis (UC) received multimatrix mesalazine 4.8 g/day QD or pH-dependent-release mesalazine 3.6 g/day three times daily for 8 weeks. The primary endpoint was the change in the UC-Disease Activity Index (UC-DAI) at the end of the treatment period. RESULTS: The change in the UC-DAI (mean±standard deviation) in the per-protocol set was −2.6±2.47 in the multimatrix mesalazine 4.8 g/day group (n=134) and −1.8±2.64 in the pH-dependent-release mesalazine 3.6 g/day group (n=129). The difference in the mean change between the 2 groups was −0.7 (two-sided 95% confidence interval, −1.3 to −0.1). The noninferiority of multimatrix mesalazine 4.8 g/day to pH-dependent-release mesalazine 3.6 g/day was verified within the noninferiority margin (1.1). The superiority of multimatrix mesalazine 4.8 g/day to pH-dependent-release mesalazine 3.6 g/day was also investigated and confirmed in the full analysis set, according to the study protocol. In subgroup analyses, the effectiveness of multimatrix mesalazine 4.8 g/day was consistent in all subgroups. There was no difference in safety between the 2 treatment groups. CONCLUSIONS: Multimatrix mesalazine 4.8 g/day has higher efficacy and shows no difference in safety in mildly to moderately active UC, in comparison with pH-dependent-release mesalazine 3.6 g/day.

Clinical Observation of Mesalazine Combined with Kangfuxin Solution Retention Enema in the Treatment of Active Ulcerative Colitis / 中国药房

OBJECTIVE:To observe clinical efficacy and safety of mesalazine combined with Kangfuxin solution retention en-ema in the treatment of active ulcerative colitis(UC). METHODS:A total of 120 patients diagnosed as active UC selected from gastroenterology department of our hospital during Mar. 2012 to Aug. 2014 were divided into observation group and control group according to random number table,with 60 cases in each group. Both groups received conventional treatment of active UC. Control group was additionally given Mesalazine enteric coated tablets 1 g,tid,on the basis of routine treatment.Observation group was ad-ditionally given Kangfuxin solution 30 mL diluted with normal saline 150 mL for enema,qd,on the basis of control group. Both groups were treated for 30 d. The serum levels of TNF-α,IL-1,IL-8,IL-10,SOD,NO and LPO were observed in 2 groups be-fore and after treatment;clinical efficacies,recurrence rates,colonoscopy efficacies and the occurrence of ADR were compared be-tween 2 groups. RESULTS:Before treatment,there was no statistical significance in the serum levels of TNF-α,IL-1,IL-8, IL-10,SOD,NO or LPO between 2 groups(P>0.05).After treatment,the serum levels of TNF-α,IL-1,IL-8,NO and LPO in 2 groups were decreased significantly,while the serum levels of IL-10 and SOD were increased significantly;the serum levels of TNF-α,IL-1,IL-8,NO and LPO in observation group were significantly lower than control group,while the serum levels of IL-10 and SOD were significantly higher than control group,with statistical significance(P<0.05). Clinical response rate,recur-rence rate and colonoscopy response rate of observation group were 83.3%,11.7% and 88.3%,which were significantly better than 66.7%,30.0%,70.0%of control group,with statistical significance(P<0.05).There was no statistical significance in the in-cidence of ADR between 2 groups(P>0.05). CONCLUSIONS:Mesalazine combined with Kangfuxin solution can effectively alle-viate inflammatory reaction in patients with active UC,and reduce oxygen free radical damage with good safety.

Preparation and Properties of Mesalazine β-Cyclodextrin Inclusion Compound / 中国药师

Objective:To prepare mesalazineβ-cyclodextrin inclusion compound and observe its properties. Methods:The struc-ture was characterized by UV, IR and DSC. The inclusion process of mesalazine andβ-cyclodextrin was simulated using molecular doc-king technique. The solubility and dissolution of inclusion compound were determined. Results:UV, IR and DSC were used to deter-mine the formation of inclusion complex. The inclusion ratio was 1: 1 and the phase solubility diagram was AL type. The solubility of inclusion compound in deionized water (25 ℃, pH 7. 0) was 7. 8 mg·ml-1 . The preparation of mesalazine β-cyclodextrin inclusion compound could significantly increase the dissolution rate and solubility of mesalazine. Conclusion:The prepared mesalazineβ-cyclo-dextrin inclusion compound can obviously improve the poor water solubility and dissolution of mesalazine.

Clinical Observation of Mesalazine Combined with Kangfuxin Solution Retention Enema in the Treatment of Active Ulcerative Colitis / 中国药房

OBJECTIVE:To observe clinical efficacy and safety of mesalazine combined with Kangfuxin solution retention en-ema in the treatment of active ulcerative colitis(UC). METHODS:A total of 120 patients diagnosed as active UC selected from gastroenterology department of our hospital during Mar. 2012 to Aug. 2014 were divided into observation group and control group according to random number table,with 60 cases in each group. Both groups received conventional treatment of active UC. Control group was additionally given Mesalazine enteric coated tablets 1 g,tid,on the basis of routine treatment.Observation group was ad-ditionally given Kangfuxin solution 30 mL diluted with normal saline 150 mL for enema,qd,on the basis of control group. Both groups were treated for 30 d. The serum levels of TNF-α,IL-1,IL-8,IL-10,SOD,NO and LPO were observed in 2 groups be-fore and after treatment;clinical efficacies,recurrence rates,colonoscopy efficacies and the occurrence of ADR were compared be-tween 2 groups. RESULTS:Before treatment,there was no statistical significance in the serum levels of TNF-α,IL-1,IL-8, IL-10,SOD,NO or LPO between 2 groups(P>0.05).After treatment,the serum levels of TNF-α,IL-1,IL-8,NO and LPO in 2 groups were decreased significantly,while the serum levels of IL-10 and SOD were increased significantly;the serum levels of TNF-α,IL-1,IL-8,NO and LPO in observation group were significantly lower than control group,while the serum levels of IL-10 and SOD were significantly higher than control group,with statistical significance(P<0.05). Clinical response rate,recur-rence rate and colonoscopy response rate of observation group were 83.3%,11.7% and 88.3%,which were significantly better than 66.7%,30.0%,70.0%of control group,with statistical significance(P<0.05).There was no statistical significance in the in-cidence of ADR between 2 groups(P>0.05). CONCLUSIONS:Mesalazine combined with Kangfuxin solution can effectively alle-viate inflammatory reaction in patients with active UC,and reduce oxygen free radical damage with good safety.

Clinical study on the clinical effect of Sophora powder combined with Xianfang-Huoming decoction for ulcerative colitis / 国际中医中药杂志

Objective To explore the clinical effect of Sophora powder combined with Xianfang-Huoming decoction for ulcerative colitis.Methods A total of 80 UC patients with TCM syndrome of excessive noxious heat were randomly divided into 2 groups (40 patients each group). The Western medicine group(control group) were treated with Mesalazin Enteric-coated tablets, and the Traditional Chinese medicine(observation group) group were treated with Sophora powder combined with Xianfang-Huoming decoction. The tumor necrosis factor-α(TNF-α)and Interleukin-8(IL-8) were detected. The Mayo index scores were conducted, and the curative effect and the recurrence rate were observed.ResultsAfter treatment, the level of TNF-α (66.11 ± 3.72 ng/Lvs. 92.61 ± 4.32 ng/L,t=29.398,P﹤0.01), IL-8 (53.11 ± 2.72 ng/L vs. 69.31 ± 1.32 ng/L,t=33.888,P﹤0.01)in the observation groupwere significantly lower than those in the control group. The Mayo index score (2.07 ± 0.57 vs. 3.30 ± 0.93, t=7.132,P﹤0.01) in the observation group was significantly lower than that in the control group. The total effective rate (92.5% vs. 85.0%,χ2=1.127, P=0.288) in the observation group was not significantly different from that in the control group. The recurrence rate (5.4% vs. 26.5%,χ2=6.005,P=0.013) in the observation group was significantly lower than that in the control group.Conclusions The Sophora powder combined withXianfang-Huoming decoction can treat the UC patients with TCM syndrome of excessive noxious hest, and the its recurrence rate is low.

An observation on clinical efficacy of paeoniae decoction add and subtract combined with mesalazine for treatment of ulcerative colitis / 中国中西医结合急救杂志

Objective To investigate the clinical efficacy of paeoniae decoction (PD) add and subtract or modified PD combined with mesalazine for treatment of patients with ulcerative colitis (UC).Methods A prospective study was conducted, 98 patients with UC admitted to the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine from August 2015 to August 2016 were enrolled, and they were divided into an observation group and a control group by random number table, 49 cases in each group. The control group was treated with mesalazine 1 g, 3 times daily; the observation group was treated with paeoniae decoction (ingredients: paeonia 30 g, coptis chinensis 15 g, Chinese angelica 15 g, betel nut 6 g, Chinese rhubarb 6 g, baikal skullcap 6 g, cinnamon 6 g, licorice 6 g) add and subtract, on the basis of treatment of the control group ,1 dose daily, each dose was decocted 2 times and warm decoction was taken once in the morning and once in the evening; the therapeutic course in both group was consecutive 6 weeks. The contents of different inflammatory factors, interleukin (IL-1, IL-8), tumor necrosis factor-α (TNF-α), C-reactive protein (CRP)in serum were compared before and after treatment between the two groups, and the clinical curative effects and adverse reactions were observed in two groups.Results After treatment, the levels of serum IL-1, IL-8, TNF-α, CRP in two groups were significantly lower than those before treatment, and the degrees of decrease were more significant in the observation group than those in the control group [IL-1 (ng/L): 8.48±3.05 vs. 9.38±3.37, IL-8 (ng/L): 10.15±2.23 vs. 11.94±2.30, TNF-α (μg/L): 122.13±6.40 vs. 137.02±7.35, CRP (mg/L): 7.16±1.93 vs. 8.02±2.63, allP 0.05].Conclusion The clinical efficacy of add and subtract of paeoniae decoction combined with mesalazine for treatment of ulcerative colitis is prominent, and no increase of adverse reaction occurrence was seen.

Effect of Mesalazine Combined with Trimebutine on Mast Cell and Related Inflammatory Mediators in Colonic Mucosa in Patients with Irritable Bowel Syndrome / 胃肠病学

Background: Mast cell activation is a characteristic of irritable bowel syndrome (IBS).Study on mast cell and the related inflammatory mediators in colonic mucosa is helpful for the evaluation and treatment of IBS.Aims: To assess the effect of mesalazine combined with trimebutine on colonic mucosal mast cell and related inflammatory mediators in patients with IBS.Methods: Forty patients with diarrhea-predominant IBS (IBS-D) and 40 patients with constipation-predominant IBS (IBS-C) from Oct.2014 to June 2016 at Shanghai Jiading District Central Hospital were enrolled, 20 healthy volunteers were served as controls.Forty patients with IBS-D and 40 patients with IBS-C were randomly divided into mesalazine+trimebutine group and trimebutine group, the treatment courses were all 4 weeks.Number of mast cell was counted by modified toluidine blue staining.Score of related inflammatory mediators were evaluated by immunohistochemistry.Clinical efficacy was assessed.Results: Compared with healthy controls, number of mast cell at baseline was significantly increased both in IBS-D and IBS-C patients (P<0.05).After treatment with mesalazine+trimebutine, number of mast cell was significantly decreased (P<0.05).At baseline, immunohistochemical staining score of 5-HT, IL-1, TNF-α, histamine, tryptase were significantly increased in IBS patients than in healthy controls (P<0.000 1).After treatment with mesalazine+trimebutine, above-mentioned inflammatory mediators were significantly decreased (P<0.05).In IBS-D patients, the total efficacy rate in mesalazine+trimebutine group was significantly increased than that in trimebutine group (85.0% vs.45.0%, P=0.008).In IBS-C patients, no significant difference in total efficacy rate was found between mesalazine+trimebutine group and trimebutine group (55.0% vs.25.0%, P=0.053).Conclusions: Mesalazine combined with trimebutine is an effective and safe approach to reduce mast cell infiltration and release of related inflammatory mediators, and is more efficient for patients with IBS-D.

Effect of mesalazine combined Bifidobacterium triple viable in the treatment of ulcerative colitis / 中国生化药物杂志

Objective To explore the beauty of mesalazine combined with Bifid Triple viable bacilli clinical efficacy in the treatment of ulcerative colitis.Methods 72 patients with ulcerative colitis ( UC) in zhoushan maternal and child health hospital were selected and divided into experimental group and control group,36 cases in each group.The control group was treated with oral administration of melamine and the experimental group was treated with Bifidobacterium triple live bacteria on the basis of oral control group.The levels of superoxide dismutase (SOD), malondialdehyde (MDA) and reactive protein ( CRP) concentration in serum of patients were detected.Follow up observation and record of the experimental group and the control group to improve the symptoms, clinical efficacy and adverse reactions after treatment.Results After treatment,serum MDA, CRP concentrations of the two groups were significantly lower than those before treatment concentration, SOD concentration was significantly increased, the differences were statistically significant (P<0.05) , serum MDA, CRP levels in the experimental group were lower than the control group, the concentration of SOD was significantly higher than control group,the differences were statistically significant (P<0.05) .After treatment, abdominal pain, diarrhea, mucus and blood stool symptoms of two groups were significantly improved compared with before treatment, abdominal pain, diarrhea and bloody mucus symptoms in the experimental group were lower than the control group(P<0.05).Incidence of adverse reactions in the experimental group was significantly lower than the control group, the differences were statistically significant (P<0.05).Conclusion The efficacy of oral administration of methadiazole in combination with Bifidobacterium triple live bacteriain the treatment of ulcerative colitis is significant, Can reduce MDA, CRP concentration, increased SOD activity.

Effect of trimebutine maleate tablets on serum TNF-α, IL-23, ESR, D-D ulcerative colitis in patients with ulcerative colitis / 中国生化药物杂志

Objective To study the effect of Trimebutine maleate tablets on serum tumor necrosis factor(TNF)-α,interleukin(IL)-23,erythrocyte sedimentation rate(ESR),D-dimer(D-D)ulcerative colitis in patients with ulcerative colitis.Methods 92 patients of ulcerative colitis who received therapy from October 2014 to October 2016 in our hospital were selected.According to random number table,those patients were divided into the observation group(n=46)and the control group(n=46).The control group was treated with mesalazine slow release tablets,while the observation group was treated with trimebutine maleate tablets on this basis.After 8 weeks of treatment,the changes of the disease activity index(Sutherland DAI score),TNF-α,IL-23,ESR,D-D and clinical effect were compared.Results After treatment,the Sutherland DAI score in the observation group was significantly lower than that of the control group DAI(P<0.05); the TNF-αand IL-23 in the observation group were significantly lower than that of the control group(all P<0.05); the ESR and D-D in the observation group were significantly lower than that of the control group(all P<0.05); the total effective rate in the observation group was significantly higher than that of the control group[93.48％(43/46)vs.69.57％(32/46)](P<0.05).Conclusion Trimebutine maleate tablets is well for ulcerative colitis,which can effectively reduce inflammation,improve hypercoagulable state,promote the recovery of the disease,it is worthy of application and promotion.

Comparison of efficacies of once-daily dose multimatrix mesalazine and multiple-dose mesalazine for the maintenance of remission in ulcerative colitis: a randomized, double-blind study

BACKGROUND/AIMS: This study compared the efficacy of once-daily administration of multimatrix mesalazine 2.4 g/day with multiple-dose mesalazine for the maintenance of remission. METHODS: In this multicenter, randomized, double-blind study, 203 patients with ulcerative colitis in remission received multimatrix mesalazine 2.4 g/day once-daily or time-dependent (controlled-release) mesalazine 2.25 g/day 3 times-daily for 48 weeks. The primary efficacy endpoint was the proportion of patients without rectal bleeding. RESULTS: The proportion of patients without rectal bleeding during the 48-week treatment period in the per protocol set was 84.8% (84/99) in the multimatrix mesalazine 2.4 g/day group and 78.0% (78/100) in the controlled-release mesalazine 2.25 g/day group. The difference between the 2 treatment groups was 6.8% (two-sided 95% confidence interval, −3.9% to 17.6%). The noninferiority margin of −10% was met in the comparison of multimatrix mesalazine 2.4 g/day once-daily with controlled-release mesalazine 2.25 g/day. Multimatrix mesalazine 2.4 g/day once-daily demonstrated consistent efficacy in all subgroups. There was no difference between the 2 treatment groups with regard to safety. CONCLUSIONS: A once-daily dose of 2 multimatrix mesalazine tablets (2.4 g) was not inferior to controlled-release mesalazine 2.25 g/day 3 times-daily in maintaining absence of rectal bleeding in ulcerative colitis.