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The long-term natural history of collagenous (CC) and lymphocytic colitis (LC) is not well known. The aims of this study were to evaluate the clinical course of microscopic colitis (MC) and to describe the morbidity evolution of the disease.
Butyrate enemas have been shown to be effective in treatment of ulcerative colitis, but the mechanism of the effects of butyrate is not totally known. This study evaluates effects of topical treatment of sodium butyrate (NaB) and 5-aminosalicylic acid (5-ASA) on the expression of trefoil factor 3 (TFF3), interleukin 1beta (IL1beta), and nuclear factor kappaB (NFkappaB) in trinitrobenzene sulphonic acid (TNBS) induced colitis in rats.
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Three hundred forty-three patients with active, mild-to-moderate ulcerative colitis received MMX mesalamine 2.4 g/day or 4.8 g/day given once daily, ASACOL 2.4 g/day given in 3 divided doses, or placebo for 8 weeks. The primary end point was the proportion of patients in clinical and endoscopic remission (modified ulcerative colitis disease activity index of < or =1 with rectal bleeding and stool frequency scores of 0, no mucosal friability, and a > or =1-point reduction in sigmoidoscopy score from baseline).
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Sodium butyrate and factor XIII improve colitis, sodium butyrate plus mesalamine reduce early thromboxane B2 synthesis, and transglutaminase(s) plays a role in ulcer healing.
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The aim of this work is to design, prepare and characterize L-lysine based prodrugs capable of targeting 6-mercaptopurine to the colon, an anti-tumor and immunosuppressant drug, and 5-aminosalicylic acid (5-ASA), drug of choice for inflammatory bowel disease (IBD). More specifically, Nɛ-feruloyl-S-(6-purinyl)-L-lysine and Nɛ-acryloyl-S-(6-purinyl)-L-lysine were synthesized and then characterized by FT-IR, (1)H-NMR and GC/MS spectroscopies. The ability of feruloyl derivative in inhibiting lipid peroxidation in rat liver microsomal membranes, induced in vitro by tert-butyl hydroperoxide as source of free radicals, was evaluated. Moreover, Nɛ-acryloyl-S-(6-purinyl)-L-lysine, polymerizable prodrug, was used to microspheres realization for 5-ASA release. These lasts, obtained by emulsion inverse technique, were characterized by light scattering and scanning electron microscopy (SEM) analysis. The microspheres equilibrium swelling degree was evaluated and showed good swelling behaviour in simulating colonic fluids. Results confirm the possibility that the application range of L-lysine prodrug can be extended to the treatment of intestinal diseases whose conventional therapy envisages medications with serious side effects that, thanks to this new strategy, can be minimized in an optimal way.
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The purpose was to propose two-stage single-compartment models for evaluating dissolution characteristics in distal ileum and ascending colon, under conditions simulating the bioavailability and bioequivalence studies in fasted and fed state by using the mini-paddle and the compendial flow-through apparatus (closed-loop mode). Immediate release products of two highly dosed active pharmaceutical ingredients (APIs), sulfasalazine and L-870,810, and one mesalamine colon targeting product were used for evaluating their usefulness. Change of medium composition simulating the conditions in distal ileum (SIFileum ) to a medium simulating the conditions in ascending colon in fasted state and in fed state was achieved by adding an appropriate solution in SIFileum . Data with immediate release products suggest that dissolution in lower intestine is substantially different than in upper intestine and is affected by regional pH differences > type/intensity of fluid convection > differences in concentration of other luminal components. Asacol® (400 mg/tab) was more sensitive to type/intensity of fluid convection. In all the cases, data were in line with available human data. Two-stage single-compartment models may be useful for the evaluation of dissolution in lower intestine. The impact of type/intensity of fluid convection and viscosity of media on luminal performance of other APIs and drug products requires further exploration.
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Concurrent use of 5-aminosalicylate drugs did not reduce the relapse rates of inflammatory bowel disease patients who were established on azathioprine therapy. The use of 5-aminosalicylate drugs did not lead to any increase in discontinuation of azathioprine due to adverse events.
These data suggest budesonide is not effective for maintenance of remission in CD, particularly when used beyond three months following induction of remission. Budesonide does have minor benefits in terms of lower CDAI scores and longer time to relapse of disease. However, these benefits are offset by higher treatment-related adverse event rates and more frequent adrenocorticoid suppression in patients receiving budesonide.
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Colorectal cancer (CRC) is a feared complication of chronic ulcerative colitis (UC). Annual endoscopic surveillance is recommended for the detection of early neoplasia. 5-Aminosalicylates (5-ASAs) may prevent some UC-associated CRC. Therefore, in patients prescribed 5-ASAs for maintenance of remission, annual surveillance might be overly burdensome and inefficient. We aimed to determine the ideal frequency of surveillance in patients with UC maintained on 5-ASAs.
While PSC-IBD patients received more 5-aminosalicylates (8.7 years/patient vs 2.9 years/patient, P < 0.001), they required less immuno-suppressors (24% vs 46% at 10 years; P < 0.001) and less intestinal resection (10% vs 44% at 10 years, P < 0.001). The 25-year cumulative rate of colectomy was 25.1% in PSC-IBD and 37.3% in controls (P = 0.004). The 25-year cumulative rate of colorectal cancer was 23.4% in PSC-IBD vs 0% in controls (P = 0.002). PSC was the only independent risk factor for the development of colorectal cancer (OR = 10.8; 95% CI, 3.7-31.3). Overall survival rate without liver transplantation was reduced in PSC-IBD patients (67% vs 91% in controls at 25 years, P = 0.001).
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Data of all newly diagnosed active Crohn's disease pediatric cases seen from June 2009 to December 2013 in Children's Hospital, Zhejiang University School of Medicine were retrospectively recorded and reviewed.
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Rheumatoid arthritis (RA) is characterized by leukocyte recruitment and angiogenesis. We investigated the effects of sulfasalazine (SSZ) and its metabolites, sulfapyridine (SP) and 5-aminosalicylic acid (5-ASA), on components of angiogenesis, namely, endothelial cell (EC) chemotaxis and proliferation, as well as on EC chemokine and soluble adhesion molecule expression.
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MMX mesalamine given once or twice daily is well-tolerated and, compared with placebo, demonstrated efficacy for the induction of clinical and endoscopic remission in mild to moderately active ulcerative colitis.
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Angiogenesis is fundamental to support the continued synovial proliferation observed in rheumatoid arthritis. We investigated the effects of sulfasalazine and its metabolites on endothelial cell proliferation, a prerequisite to angiogenesis. At concentrations achieved in vivo sulfapyridine inhibited basal and endothelial cell growth factor stimulated endothelial cell proliferation. Sulfasalazine and 5 amino salicylic acid had no effect.
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The histologic slides of 8 cases indexed in our pathology files as "lymphoid follicular proctitis of the rectal mucosa" from January 2001 to November 2003 were reviewed retrospectively.
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A computer-assisted literature search for relevant studies (1981-2005) was performed using MEDLINE, BIOS, the Cochrane Controlled Trials Register, the Cochrane IBD/FBD Group Specialized Trials Register, and the Science Citation Index, followed by a manual search of reference lists from previously retrieved articles, review articles, symposia proceedings, and abstracts from major gastrointestinal conferences.
The therapeutic effects and metabolism of mesalazine (5-aminosalicylic acid) in patients with inflammatory bowel disease require intracellular accumulation of the drug in intestinal epithelial cells and hepatocytes. The molecular mechanisms of mesalazine uptake into cells have not been characterized so far. Using human embryonic kidney cells stably expressing uptake transporters of the organic anion-transporting polypeptide (OATP) family, which are expressed in human intestine and/or liver, we found that mesalazine uptake is mediated by OATP1B1, OATP1B3, and OATP2B1 but not by OATP1A2 and OATP4A1. Moreover, genetic variations (*1b, *5, *15) in the SLCO1B1 gene encoding OATP1B1 reduced the K(m) value for mesalazine uptake from 55.1 to 16.3, 24.3, and 32.4 μM, respectively, and the respective V(max) values. Finally, budesonide, cyclosporine, and rifampin were identified as inhibitors of OATP1B1-, OATP1B3-, and OATP2B1-meditated mesalazine uptake. These in vitro data indicate that OATP-mediated uptake and its modification by genetic factors and comedications may play a role for mesalazine effects.
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The in vitro susceptibility of diarrhoea producing Gram negative enteric bacteria to sulfasalazine, 5-aminosalicylic acid, sulfapyridine and four quinolones was investigated using an agar dilution method. All strains were resistant to 1600 micrograms/ml of sulfasalazine and 5-aminosalicylic acid. MIC range of sulfapyridine for Y. enterocolitica was 3.1-25 micrograms/ml (median:6.2) and for Salmonella 25-100 micrograms/ml (median: 100) Campylobacter jejuni/coli were less susceptible to sulfapyridine with MIC values ranging from 200 to 800 micrograms/ml. Shigella and three of five E. coli strains were resistant to 1600 micrograms/ml of sulfapyridine. Two strains of E. coli were inhibited by 25 micrograms/ml. All strains were fairly susceptible to enoxacin, ciprofloxacin, pefloxacin and ofloxacin. Cirpofloxacin was the most active drug on weight basis.
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To evaluate the potential effectiveness of hydroxynaphthoquinone mixture (HM) in rats with 2,4,6-trinitrobenzene sulfonic acid (TNBS)-induced colitis.
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Four novel cyclic phosphates of the anti-inflammatory agent 5-aminosalicylic acid (5-ASA) were designed and synthesized as cytochrome P450 (CYP)-activated prodrugs. These prodrugs can be used for targeting into gut wall, since these types of cyclic phosphates are known to be activated mainly by CYP3A forms, which are expressed not only in the liver but also in the small intestine and to a lesser extent in the colon. The present study shows that aromatic ring activating substituents, like chlorine, are definitely needed to obtain the desired enzymatic cleavage of the cyclic phosphate prodrugs of 5-ASA. However, the position of the activating substituent has also a strong impact on the chemical stability, and therefore, an appropriate balance between the rates of prodrug bioactivation and chemical stability needs to be taken into consideration in future studies on cyclic phosphate prodrugs of 5-ASA.
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Our results suggest that UC does not worsen MT, inflammation, or immune activation in HIV-infected subjects. The anti-inflammatory activity of chronic mesalazine administration on intestinal mucosa may contribute to this finding.
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In two large studies referred to as CORE (Colonic Release Budesonide trial), budesonide-MMX 9 mg daily was significantly more effective in achieving a combined end point of clinical and endoscopic remission than placebo in patients with mild-moderately active UC. Safety data are reassuring, with no clinically relevant differences between budesonide-MMX and placebo, including steroid-related side effects.
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The increasing demand for on-line measurement of milk composition directs science and industry to search for practical solutions, and biosensors may be a possibility. The specific objective of this work was to develop an electrochemical biosensor to determine lactose concentration in fresh raw milk. The sensor is based on serial reactions of three enzymes--beta-galactosidase, glucose oxidase, and horseradish peroxidase--immobilized on a glassy carbon electrode. The sequential enzymatic reactions increase the selectivity and sensitivity of the sensor. The sensor requires dilution of the raw milk and the addition of 5-aminosalicylic acid. Lactose concentrations in raw milk measured by the sensor were in good agreement with those measured by a reference laboratory using infrared technology. The results were obtained in milk samples that varied in fat and protein composition. From the results, we conclude that an electrochemical biosensor for determination of lactose concentration in fresh raw milk can be developed, and that the biosensor presented in this study maintained the qualities required for further development into an online sensor in the milking parlor.
A systematic review to evaluate the efficacy of 5-aminosalicylates for induction of remission or clinical response in patients with mild to moderately active Crohn's disease is described. The effect of either high (3 to 4.5 g/day) or low dose (1 to 2 g/day) 5-aminosalicylic acid was similar to that of placebo. Overall, sulfasalazine was not superior to placebo and was inferior to glucocorticoids for the treatment of mild to moderately active Crohn's disease. Neither published nor unpublished data support any use of 5-aminosalicylates for the treatment of Crohn's disease.
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Thirty-eight studies fulfilled the inclusion criteria. Rectal 5-ASA was superior to placebo for inducing symptomatic, endoscopic and histological improvement and remission, with POR for symptomatic improvement 8.87 (8 trials, 95% CI: 5.30 to 14.83; P < 0.00001), endoscopic improvement 11.18 (5 trials, 95% CI 5.99 to 20.88; P < 0.00001), histologic improvement 7.69 (6 trials, 95% CI 3.26 to 18.12; P < 0.00001), symptomatic remission 8.30 (8 trials, 95% CI 4.28 to 16.12; P < 0.00001), endoscopic remission 5.31 (7 trials, 95% CI 3.15 to 8.92; P < 0.00001), and histologic remission 6.28 (5 trials, 95% CI 2.74 to 14.40; P < 0.0001). Rectal 5-ASA was superior to rectal corticosteroids for inducing symptomatic improvement and remission with POR 1.56 (6 trials, 95% CI 1.15 to 2.11; P = 0.004) and 1.65 (6 trials, 95% CI 1.11 to 2.45; P = 0.01), respectively. Rectal 5-ASA was not superior to oral 5-ASA for symptomatic improvement (POR 2.25; 95% CI 0.53 to 19.54; P = 0.27). Neither total daily dose nor 5-ASA formulation affected treatment response.
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This developed HPLC-ESI-MS/MS method is suitable for massive biomedical analysis. Trial and reference preparations are bioequivalent under fasting and fed state. High-fat-food administration delays the absorption of mesalazine while total exposure is not affected. Dietary habits should always be taken into consideration when enteric-coated mesalazine tablets were prescribed to patients.
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Aminosalicylate and folic acid use may decrease the risk of CRC among IBD patients.
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The relationship between the ingested dose of delayed-release mesalazine and rectal tissue drug concentrations is complex. Factors other than dose are likely to be important determinants of rectal tissue drug concentrations.
Balsalazide is a mesalamine prodrug that is generally well tolerated and useful in the treatment of inflammatory bowel disease (IBD). This review will focus on newer safety information regarding the use of balsalazide in the treatment of patients with IBD. In general, mesalamine compounds such as balsalazide are better tolerated than sulfasalazine. Balsalazide therapy should be avoided in patients with known hypersensitivity reaction to salicylates, mesalamine, other balsalazide metabolites, or the components of the Colazal (Salix Pharmaceuticals; Morrisville, NC) capsule (silicon dioxide, magnesium stearate) but may be tolerated in patients who were unable to tolerate other mesalamine compounds for non-hypersensitivity reasons. Overall, balsalazide is well tolerated and effective in the treatment of IBD.
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Oral BDP was well tolerated and acts significantly faster and more effectively than 5-ASA in inducing clinical remission and endoscopic improvement in pediatric mild-to-moderate UC.
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Patients with ulcerative colitis given prolonged-release oral mesalamine 2 g once daily had better remission rates, acceptability, and self-reported adherence to therapy compared with patients given oral mesalamine 1 g twice daily.
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Of the five different clinical course patterns that we observed, persistent remission or mild clinical activity was the most frequent course (56.2 %). The majority of patients (74.6 %) had remission or mild clinical activity at 5 years, and only the minority (16.2 %) had multiple relapses or chronic symptoms. The clinical course of the first year after diagnosis of intestinal BD influenced the clinical course of the following years. Patients in the severe clinical course group were younger, and had a higher ESR, CRP level, and disease activity index for intestinal Behcet's disease (DAIBD), and lower albumin level at diagnosis than patients in the mild clinical course group. Initial presentation with a high DAIBD was independently associated with a severe clinical course.
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Sulfasalazine's role as the first-line of therapy in patients with inflammatory bowel disease has led to the development of other "designer" aminosalicylates, which eliminate the sulfa-moiety, and attempt to target the topically active mesalamine to the inflamed bowel. Olsalazine sodium and balsalazide disodium utilize the same azo-bond structure as sulfasalazine, requiring release of active mesalamine by colonic bacteria, and thus targeting these agents to the colon. Other mesalamine delivery systems use pH-dependant- or moisture-release to liberate the active mesalamine in both the large and small bowel. Direct application of mesalamine via enema or suppository is also effective in patients with distal colitis. The pharmacology and thus the undesirable drug absorption rates differ between drugs, although the clinical importance of these characteristics is debatable. Differences in release-systems, the impact of the fed and fasting state, and unique patient intolerances to individual agents demand an understanding of each of these products, and their application to patient therapy.
A review of clinical notes. The prevalence of adenomas in patients with IBD attending for either sigmoidoscopy or colonoscopy was compared with local age matched controls that participated in the national screening trial for colorectal cancer with flexible sigmoidoscopy.
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Azo-bonded prodrugs of 5-aminosalicylic acid (mesalazine)-sulfasalazine, balsalazide, and olsalazine, which are used in the treatment of ulcerative colitis, rely on colonic bacteria to cleave the azo bond and liberate the active drug in the large intestine. The aim of this study was to use an in vitro colonic simulator to determine the rates of metabolism of these three prodrugs in the presence of colonic bacteria, and to link the data to results obtained previously in humans. In individual fecal slurries prepared from five different donors, sulfasalazine degradation was rapid and virtually complete within 4 h, confirming the ubiquitous nature of azo-reduction between individuals. In pooled fecal slurry, the rate of degradation of sulfasalazine was faster (t1/2 , 32.8 min) than balsalazide (t1/2 , 80.9 min) and olsalazine (t1/2 , 145.1 min). These results are in agreement with data in humans, where it was found that sulfasalazine was more extensively metabolized on passage through the human colon than the other two drugs. These findings indicate that other than the azo bond itself, the broader chemical structure of the molecules play a role in the degradation of this class of compound, and highlight the utility of this in vitro model to evaluate the metabolism of drugs in the presence of colonic microbiota.
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The average cost of treatment to transition an active UC patient into remission using oral plus topical mesalazine or oral mesalazine monotherapy was v2207 (95% CI: v1402 to v3332) and v2945 (95% CI: v1717 to v4592), respectively. The annual average cost-saving of adding topical mesalazine delivered for four weeks during active UC was v738. The average annual costs of maintenance of remission with OD and BID therapy were v1293 (95% CI: v1062 to v1496) and v1502 (95% CI: v1262 to 1708), respectively with an annual average per person savings of v209.
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In Caco-2 cells a P-gp-mediated efflux of 5-ASA (5-500 muM) could be excluded. Likewise, in L-MDR1 and MRP2 cells no transport differences in either the basal-to-apical or apical-to-basal direction were measurable. 5-ASA (50 muM to 5 mM) had no effect on the transport of digoxin.