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A high-performance liquid chromatographic method was developed, validated and applied to the simultaneous determination of 5-aminosalicylic acid (5-ASA) and its acetylated metabolite (acetyl-5-ASA) in human plasma. The method involves liquid-liquid extraction with methanol followed by isocratic reversed-phase chromatography on a Kromasil KR100 C(18) column with electrochemical detection. The recovery, selectivity, linearity, precision and accuracy of the method were evaluated from spiked human plasma samples. The effects of mobile phase composition, buffer concentration, mobile phase pH and concentration of organic modifiers on retention of 5-ASA, acetyl 5-ASA and internal standard were investigated. Limits' of detection were 5 ng/mL for 5-ASA and 10 ng/mL for acetyl-5-ASA, respectively. The method can be used for supporting therapeutical drug monitoring and pharmacokinetic studies.
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To determine differences in phenotype and treatment among hospitalized elderly and young patients with inflammatory bowel disease (IBD), and the utility of International Classification of Diseases, 10th Revision (ICD)-10 codes in hospital discharge abstracts in diagnosing IBD in elderly patients.
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A 40-year-old white man with ulcerative colitis, treated with chronic mesalamine and occasional steroids, was admitted to the hospital with a 3-day history of fever, nausea, vomiting, and a rash. Fourteen days prior to admission, the patient had been started on azathioprine for ulcerative colitis. Upon admission, azathioprine therapy was temporarily withheld, resulting in resolution of his signs and symptoms. Symptoms returned when azathioprine was restarted. It was decided that these signs and symptoms were most likely caused by azathioprine hypersensitivity, and the agent was discontinued.
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5-Aminosalicylic acid (5-ASA) is an active ingredient of therapeutic agents used for Crohn's disease and ulcerative colitis. Because it is absorbed rapidly and extensively in the upper intestine, delivery of the agent specifically to the colon is necessary. We selected taurine as a colon-specific promoiety and designed 5-aminosalicyltaurine (5-ASA-Tau) as a new colon-specific prodrug of 5-aminosalicylic acid (5-ASA). It was expected that introduction of taurine would restrict the absorption of the prodrug and show additive effect to the anti-inflammatory action of 5-ASA after hydrolysis. 5-ASA-Tau was prepared in good yield by a simple synthetic route. The apparent partition coefficient of 5-ASA-Tau in 1-octanol/pH 6.8 phosphate buffer or CHCl3/pH 6.8 phosphate buffer was 0.10 or 0.18, respectively, at 37 degrees C. To determine the chemical and biochemical stability in the upper intestinal environment, 5-ASA-Tau was incubated in pH 1.2 and 6.8 buffer solutions, and with the homogenates of tissue and contents of stomach or small intestine of rats at 37 degrees C. 5-ASA was not detected from any of the incubation medium with no change in the concentration of 5-ASA-Tau. On incubation of 5-ASA-Tau with the cecal and colonic contents of rats, the fraction of the dose released as 5-ASA was 45% and 20%, respectively, in 8 h. Considering low partition coefficient and stability in the upper intestine, 5-ASA-Tau might be nonabsorbable and stable in the upper intestine. After oral administration, it would be delivered to the colon in intact form and release 5-ASA and taurine. These results suggested 5-ASA-Tau as a promising colon-specific prodrug of 5-ASA.
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In a double-blind, single-center, 1-year prospective trial, we compared a pH-dependent Eudragit L-coated formulation of oral 5-aminosalicylic acid (5-ASA) (Claversal), 0.5 g b.i.d., and sulfasalazine (SASP), 1 g b.i.d., in the prophylactic treatment of quiescent ulcerative colitis. Forty-four patients received 5-ASA and 44 received SASP. Clinical, sigmoidoscopic, and histologic findings were assessed at 6 and 12 months. The two groups were comparable in all pretrial characteristics. No significant difference was observed in the relapse rate in the two groups either after 6 months [5-ASA 20.5%, SASP 27.5%, p = 0.32, 95% confidence interval (CI) 0.28 +/- 0.13] or after 12 months (5-ASA 38.4%, SASP 51%, p = 0.18, 95% CI 0.38 +/- 0.1). We conclude that (a) 5-ASA was as effective as SASP in maintaining remission of ulcerative colitis; (b) the relapse rate was, however, higher than expected in both groups; (c) the incidence of side effects was similar with both treatments.
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Intestinal Behcet's disease in a 19-year-old girl was diagnosed because of the history of recurrent oral aphthous ulcers and typical endoscopic findings of esophageal and ileal ulcers. Her symptoms (e.g., dysphagia and retrosternal pain) were gradually relieved by treatment with prednisolone and total parenteral nutrition. However, about one month later, oral and esophageal ulcers appeared again. Mesalazine was added. Oral and esophageal ulcers healed promptly, and have not relapsed for about one year. Although mesalazine appears to act locally in the small intestine and colon, the therapeutic effect of mesalazine in this case may be explained by the systemic antiinflammatory effect. This case suggests that mesalazine is an effective drug and is a good candidate in the treatment of intestinal Behcet's disease, especially accompanied with esophageal involvement.
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The transition from pediatric to adult care for inflammatory bowel disease (IBD) is poorly understood.
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In ulcerative colitis patients (n = 82), mean relapse rates for the azathioprine + 5-aminosalicylate group were 0.21/year compared with 0.19/year for the azathioprine alone group (P = not significant). In Crohn's disease patients (n = 104), mean relapse rates for the azathioprine + 5-aminosalicylate group were 0.27/year compared with 0.3/year for the azathioprine alone group (P = not significant). The cumulative remission percentage (determined from time to first relapse) was used in Kaplan-Meier survival analysis and showed no difference between the azathioprine + 5-aminosalicylate group and the azathioprine alone group by log-rank analysis, for ulcerative colitis and Crohn's disease as well as for all inflammatory bowel disease patients. Concurrent use of 5-aminosalicylates was no more frequent in patients who discontinued azathioprine due to adverse events. The only malignancy recorded was Waldenström's macroglobulinaemia after 7 years of azathioprine therapy.
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The MEDLINE database (1966-December 2002) was searched using the key words budesonide and inflammatory bowel diseases and restricted to the English language. The references from relevant articles were also reviewed for additional citations.
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The recurrence rate of Crohn's disease after surgery is very high. Approx. 30-50% of patients require surgery after the last operation within 1-3 years. While ileal disease in women appears to have the highest rate of relapse, colonic disease seems to have the lowest rate of recurrence. The procedure of surgery had no significant influence, i.e. strictureplasty with or without resection. So far, there are no serological parameters to estimate the risk of relapse for Crohn's disease. Several trials of medical treatment for prevention of recurrence showed a positive effect for mesalazine (2-4 g/d), at least for the maintainance of remission. The medical treatment of fistulas in patients with Crohn's disease consists initially in the combination of cyclosporine, azathioprine and low-dose prednisolone. In the follow-up the remission can be maintained with azathioprine in a majority of patients.
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The aim of the present study was to investigate the effects of 5-aminosalicyclic acid (5-ASA) on the cell injury mediated by activated neutrophils. We used a system constituted of neutrophils, triggered with phorbol myristate acetate, and 51Cr-labelled Daudi cells as targets. The results show that 5-ASA is capable of efficiently preventing neutrophil-mediated lysis. 5-ASA was up to 10-fold more effective than taurine, which acts as an hypochlorous acid scavenger. Moreover, 5-ASA was found to compete with taurine for the neutrophil derived hypochlorous acid. The results are consistent with the conclusion that 5-ASA is capable of limiting the neutrophil mediated cell damage by scavenging the generated hypochlorous acid. This may represent a potential mechanism for the therapeutic action of 5-ASA in ulcerative colitis.
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Crohn's disease (CD) is characterized by a reduction in mucosal integrity that permits antigen penetration into the intestinal tissue. The administration of probiotics has been suggested to improve the barrier function of the mucosa. The objective of this study was to evaluate the influence of Saccharomyces boulardii on the intestinal permeability in CD.
In two studies in healthy young Caucasians, NAT2 phenotyping was carried out using a caffeine metabolic ratio in urine 4-6 h postdose. In study A, 1,000 mg mesalazine doses were given thrice daily for 5 days, and urine and blood samples were drawn during the last dosing interval. In study B, a 1,000 mg single dose was given, and samples were taken for 48 h postdose. Pharmacokinetics of mesalazine and N-acetylmesalazine (LC-MS/MS) were calculated by noncompartmental methods.
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Once-daily 5-ASA-MMX is similarly effective with a comparable safety profile to Asacol administered twice daily, for the maintenance treatment of ulcerative colitis.
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To follow-up clinical and biochemical features in patients with Crohn's disease (CD) of the upper gastrointestinal (GI) tract and to evaluate the impact of different therapeutics on the outcome of these patients.
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A number of agents, including aspirin, nonsteroidal antiinflammatory drugs, cyclooxygenase-2 inhibitors, folic acid, calcium, and vitamins, have been evaluated for their potential in chemoprevention of sporadic colorectal adenomas or cancer. Preclinical data suggest that 5-aminosalicylates also may have a chemopreventive effect.
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Male mice imprinting control regions (ICR) were randomly divided into five groups: normal, TNBS-induced colitis, colitis treated with liquiritigenin at low dose (10 mg/kg) and high dose (20 mg/kg), or mesalazine (10 mg/kg). TNBS colitis induction was performed except for in the normal group, and they were treated with liquiritigenin or mesalazine except control group. The treatment effect was measured after three days treatment, by body weight, colon length, macroscopic score, histological score, levels of cytokines (tumor necrosis factor-α, interleukin [IL]-1β, IL-6, and IL-10) in colon tissue as well as the nuclear factor kappa-light-chain-enhancer pathway of activated B cells (NF-κB) activation.
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The use of the highly effective thiopurines as early therapeutic option in Crohn's Disease (CD) may be discouraged by the long time interval required to obtain clinical efficacy as also by their potential side effects. The development of non-invasive markers of responsiveness to thiopurines represents a major attempt in the clinical management of CD patients. Azathioprine is able to induce apoptosis of T cells. We studied the effect of thiopurines on "in vitro" T cell apoptosis, IFN-γ and IL-10 production in a group of CD patients with known response to a previous treatment with AZA.
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An 11-year-old girl with Crohn's disease was given 40 mg/kd/day of sulphasalazine after achieving remission with prednisone. She developed urticaria and eosionophilia 8 days later, then extended skin edema during a second course of sulphasalazine requiring methyl prednisolone therapy. Mesalazine administration (25 mg/kg/day), one month later, resulted to watery stools, vomiting, and fever, a side effect observed again after two further mesalazine challenges of one-month interval. Eosionophilia was present and the lymphocyte stimulation test with mesalazine was positive. Successful desensitization to sulphasalazine could be obtained 9 months later permitting further safe administration of this drug up to 18 months.
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Crohn's disease is characterised by recurrent flare-ups alternating with periods of remission. A number of interventions are currently used in clinical practice to try and maintain remission in Crohn's disease but the evidence base for some of them may be questionable.
Patients with ulcerative colitis tend to be young, potentially at peak lifetime productivity levels, and the disease can be devastating in its effects on the quality of life in these individuals. No treatment for ulcerative colitis can be comprehensively evaluated without careful attention to its impact on such psychosocial issues. The quality of life was evaluated in 374 ulcerative colitis patients using mesalamine capsules at 1 g, 2 g, and 4 g daily versus placebo in an 8-week, randomized, dose-response, placebo-controlled, double-blind, multicentre trial. Function-related quality of life parameters were assessed in this study, including five pertinent clinical symptoms and seven general life capabilities. These parameters have been previously shown to be valid, reliable, and responsive to the disease activity of ulcerative colitis. All of the parameters were recorded using a 10-cm visual analogue scale, except trips to the toilet which were recorded in patients' diaries. The mean change was calculated from baseline and endpoint data. Mesalamine at 2 g and 4 g daily was significantly superior to placebo in improving each of the 12 quality of life parameters (P < 0.05). These results indicate that controlled-release mesalamine significantly enhances the quality of life for patients with either left-sided ulcerative colitis or pancolitis.
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Between November 2013 and March 2014, 570 ambulatory patients (471 patients with IBD and 99 non-IBD controls) visiting a tertiary IBD-referral centre were requested to complete the Morisky 8-Item Medication Adherence Scale (MMAS-8) questionnaire as well as a survey of sociodemographic data (smoking, educational level, marital status and occupation). On the basis of the self-reported MMAS questionnaire, adherence was categorized as low (MMAS-8 score: >2), medium (MMAS-8 score: 1-2) or high (MMAS-8 score: 0).
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Seventeen studies containing 1,508 cases of colorectal neoplasia and a total of 20,193 subjects published from 1994 to 2012 were analyzed. 5-aminosalicylates use was associated with a reduced risk of colorectal neoplasia in patients with ulcerative colitis (OR 0.63; 95%CI 0.48-0.84). Pooled OR of a higher average daily dose of 5-aminosalicylates (sulfasalazine ≥ 2.0 g/d, mesalamine ≥ 1.2 g/d) was 0.51 [0.35-0.75]. Pooled OR of 5-aminosalicylates use in patients with extensive ulcerative colitis was 1.00 [0.53-1.89].