دورية أكاديمية
Placebo-controlled clinical trial of mesalazine in the prevention of early endoscopic recurrences after resection for Crohn's disease. Groupe d'Etudes Thérapeutiques des Affections Inflammatoires Digestives (GETAID).
العنوان: | Placebo-controlled clinical trial of mesalazine in the prevention of early endoscopic recurrences after resection for Crohn's disease. Groupe d'Etudes Thérapeutiques des Affections Inflammatoires Digestives (GETAID). |
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المؤلفون: | Florent C; Division of Gastroenterology and Surgery, University of Paris, Saint-Antoine Hospital, France., Cortot A, Quandale P, Sahmound T, Modigliani R, Sarfaty E, Valleur P, Dupas JL, Daurat M, Faucheron JL, Lerebours E, Michot F, Belaiche J, Jacquet N, Soulé JC, Rothman N, Gendre JP, Malafosse M |
المصدر: | European journal of gastroenterology & hepatology [Eur J Gastroenterol Hepatol] 1996 Mar; Vol. 8 (3), pp. 229-33. |
نوع المنشور: | Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
اللغة: | English |
بيانات الدورية: | Publisher: Lippincott Williams And Wilkins Country of Publication: England NLM ID: 9000874 Publication Model: Print Cited Medium: Print ISSN: 0954-691X (Print) Linking ISSN: 0954691X NLM ISO Abbreviation: Eur J Gastroenterol Hepatol Subsets: MEDLINE |
أسماء مطبوعة: | Publication: London : Lippincott Williams And Wilkins Original Publication: [London, UK ; Philadelphia, PA, USA] : Current Science, c1989- |
مواضيع طبية MeSH: | Aminosalicylic Acids/*therapeutic use , Anti-Inflammatory Agents, Non-Steroidal/*therapeutic use , Crohn Disease/*prevention & control, Administration, Oral ; Adolescent ; Adult ; Aged ; Aminosalicylic Acids/administration & dosage ; Aminosalicylic Acids/adverse effects ; Anastomosis, Surgical ; Anti-Inflammatory Agents, Non-Steroidal/administration & dosage ; Anti-Inflammatory Agents, Non-Steroidal/adverse effects ; Chemoprevention ; Colonic Diseases/pathology ; Colonic Diseases/prevention & control ; Colonic Diseases/surgery ; Colonoscopy ; Constriction, Pathologic/pathology ; Crohn Disease/pathology ; Crohn Disease/surgery ; Double-Blind Method ; Drug Tolerance ; Female ; Humans ; Ileal Diseases/pathology ; Ileal Diseases/prevention & control ; Ileal Diseases/surgery ; Male ; Mesalamine ; Middle Aged ; Placebos ; Recurrence ; Ulcer/pathology |
مستخلص: | Objective: Endoscopic postoperative recurrences occur early after 'curative' surgery for Crohn's disease. Pentasa has been shown to be effective in the maintenance treatment of quiescent Crohn's disease. The aim of this study was to test the efficacy of a 12-week oral intake of Claversal in the prevention of endoscopic recurrences after 'curative' resection for ileal, colonic or ileocolonic Crohn's disease. We conducted a multicentre double-blind controlled trial comparing Claversal (1g tid) with placebo, starting within 15 days after surgery. The macroscopic normality of the two anastomotic segments was assessed at surgery. Patients were clinically and biologically evaluated twice (6-week interval), and colonoscopy was performed at 12 weeks. Endoscopic relapse was defined by any anastomotic ulcerations or stenosis and staged according to a four-grade score. Results: Between May 1989 and May 1991 12 centres included 126 patients, 70 women and 56 men, aged 33 +/- 12 years (range 16-70) in the study. Disease locations were ileal, colonic and ileocolonic in 45, 6 and 49%, respectively. Claversal and placebo groups were similar at inclusion, except for ESR (37 +/- 26 vs. 27 +/- 23 mm/h in the Claversal and placebo groups, respectively; P < 0.05). Nine patients were withdrawn from the study. Adverse reactions occurred only in six patients. Five patients were excluded for protocol violation. Finally, 106 patients could be evaluated at 12 weeks (55 Claversal and 51 placebo). An endoscopic relapse was observed in 50% and 63% of the Claversal and placebo groups, respectively (P = 0.16), with a similar grade distribution. Claversal was well tolerated. Conclusions: Our study confirms that a large proportion of endoscopic recurrences occur within 3 months of resection in Crohn's disease. There was a slight trend towards greater efficacy of Claversal; it could be worthwhile trying higher dosages and/or 5-ASA compounds with different intestinal release profiles. |
المشرفين على المادة: | 0 (Aminosalicylic Acids) 0 (Anti-Inflammatory Agents, Non-Steroidal) 0 (Placebos) 4Q81I59GXC (Mesalamine) |
تواريخ الأحداث: | Date Created: 19960301 Date Completed: 19961010 Latest Revision: 20190905 |
رمز التحديث: | 20231215 |
DOI: | 10.1097/00042737-199603000-00008 |
PMID: | 8724022 |
قاعدة البيانات: | MEDLINE |
تدمد: | 0954-691X |
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DOI: | 10.1097/00042737-199603000-00008 |