No abstract available.
Colitis, Ulcerative* ; Mesalamine* ; Ulcer*

No abstract available.
Colitis, Ulcerative* ; Humans ; Mesalamine* ; Ulcer*

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.
Colitis, Ulcerative* ; Double-Blind Method* ; Humans ; Mesalamine* ; Ulcer*

Pulmonary complications of ulcerative colitis are relatively uncommon and may present as a variety of disorders. Ulcerative colitis-related interstitial lung disease is extremely rare. There are a few case reports of nonspecific interstitial pneumonia in ulcerative colitis worldwide but none in Korea. We report a patient with ulcerative colitis related biopsy-proven nonspecific interstitial pneumonia, who responded to prednisolone (1 mg/kg) and mesalazine therapy
Colitis, Ulcerative* ; Humans ; Korea ; Lung Diseases, Interstitial* ; Mesalamine ; Prednisolone ; Ulcer*

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.
Colitis, Ulcerative* ; Double-Blind Method* ; Hemorrhage ; Humans ; Mesalamine* ; Tablets ; Ulcer*

Behcet's disease (BD) affects gastrointestinal tract is defined as intestinal BD. The diagnosis and therapeutic efficacy of intestinal BD are still lack of specific diagnostic method and effective treatment. Intestinal BD is diagnosed according to established criteria based on colonoscopic features and biopsy. To date, 5-aminosalicylic acid and systemic corticosteroids are established as the first-line therapy, while immunosuppressants and infliximab are used as second-line therapy for patients with glucocorticoid resistant. In the process of therapy, we need to carefully evaluate the patient's condition and be cautious about surgical treatment. Surgical intervention should only be considered in patients with serious complications. In this review, we summarize the recent advances in diagnosis, disease activity index and treatment of intestinal BD, and provide the theoretic proofs to clinical application.
Behcet Syndrome ; Colonoscopy ; Humans ; Immunosuppressive Agents ; Intestinal Diseases ; Mesalamine

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.
Colitis, Ulcerative* ; Double-Blind Method* ; Humans ; Mesalamine* ; Ulcer*

Behcet's disease (BD) is a systemic immunological disorder characterized by recurrent mucosal ulcerative lesions including oral and genital ulcerations in association with skin and ocular involvements. BD also can involve the gastrointestinal tract. Gastrointestinal involvement of BD is one of the major causes of morbidity and mortality for this disease. However, clinical data are quite limited because of the rarity of intestinal BD. Therefore, the management of intestinal BD is heavily dependent on expert opinions and standardized medical treatments of intestinal BD are yet to be established. In this brief review, the authors summarized the currently available medical treatments such as 5-aminosalicylic acids, corticosteroids, immuno-modulators, and anti-TNF agents. Moreover, we sought to suggest a treatment algorithm for intestinal BD based on the recently published and updated data.
Adrenal Cortex Hormones ; Expert Testimony ; Gastrointestinal Tract ; Immunologic Factors ; Inflammatory Bowel Diseases ; Mesalamine ; Skin ; Ulcer

Crohn's disease of the perineum is notably resistant to treatment. We describe our experiences of tacrolimus ointment application in three patients with intractable perianal Crohn's disease. At the time of diagnosis patients showed anal fissure with ulcer, anal fistula, or perianal abscess, respectively. These lesions did not respond to steroid, metronidazole, mesalazine, or azathioprine, though the pediatric Crohn's disease activity index was markedly improved during the treatment period (4 to 12 months). Topical tacrolimus was applied and resulted in marked healing and a rapid granulation of cavity edges within 6 weeks to 3 months. Topical tacrolimus at a low dose shows a promise for the management of childhood perianal Crohn's disease. Further controlled studies are required to assess the efficacy and safety of this treatment.
Abscess ; Azathioprine ; Child ; Crohn Disease* ; Diagnosis ; Fissure in Ano ; Fistula ; Humans ; Mesalamine ; Metronidazole ; Perineum ; Tacrolimus*

BACKGROUND/AIMS: The therapeutic effect of mesalamine is considered to be dose-dependent; however, no consensus has been reached regarding the optimal doses for individual patients. This study aimed to provide new insight for dose optimization using two doses of pH-dependent release mesalamine for induction of remission of moderately active ulcerative colitis (UC). METHODS: In a multicenter, double-blind, randomized study, 110 patients with moderately active UC were assigned to two groups after treatment with a constant dose of mesalamine. Fifty-five patients were treated with a pH-dependent release formulation of 3.6 or 4.8 g/day for 8 weeks. The primary endpoint was a decrease in the UC disease activity index (UCDAI) adjusted by covariates. RESULTS: In the full analysis set (n=110), the mean decrease in UCDAI was 3.1 in the 3.6 g/day group and 3.4 in the 4.8 g/day group (P>0.05). In a subgroup analysis, the effectiveness of the 4.8 g/day dose was greater in particular populations, such as those who had been previously treated with a lower dose of mesalamine and those with more severe disease. The safety was comparable between the two groups. CONCLUSIONS: The results suggest that treatment with pH-dependent release mesalamine at either 3.6 or 4.8 g/day was effective and safe for the induction of remission in patients with moderately active UC. However, the patients receiving mesalamine at 2.4 g/day but in whom the therapeutic effect is not sufficient and having more severe symptoms (UCDAI 9-10), benefit from higher doses of mesalamine compared to others.
Colitis, Ulcerative* ; Consensus ; Double-Blind Method ; Humans ; Mesalamine* ; Remission Induction ; Ulcer*