Tesis doctoral de Míriam Mañosa Ciria
Background: endoscopic recurrence occurs in up to 80% of cd patients 1 year after intestinal resection. Imidazolic antibiotics, thiopurines, and particularly their combination, have proven efficacy in preventing endoscopic recurrence. Aim: to evaluate the efficacy of the association of metronidazole (for 3 months after surgery) to azathioprine (aza) for the prevention of postsurgical endoscopic recurrence in cd as compared to aza plus placebo. Patients and methods: cd patients undergoing intestinal resection with ileocolic anastomosis were randomized to receive metronidazole 15-20mg/kg/day or placebo for 3 months, in addition to aza 2-2.5mg/kg/day. Patients were followed clinically every 3 months. Ileocolonosocopy was performed at 6 and 12 month after surgery. Treatment failure was defined as the ocurrence of endoscopic recurrence (rutgeerts index >1) at 6 or 12 months. Results: fifty patients were included (25 in each treatment arm), 57% were active smokers and 48% were operated on because of penetrating cd complicactions. Endoscopic recurrence occurred in 21.7% and 36.4 at 6 months (p=0,226) and in 30.4% and 50% (p=0,150) at 12 months, in the metronidazole and placebo groups, respectively. No differences were also found between treatment groups when severe endoscopic recurrence (rugeerts index >2) at 6 months was evaluated (17.4% and 27.3%, respectively -p=0.33-). The rate of adverse events was also similar in both study groups (40% in placebo group vs 60% in metronidazole group, p= 0.20). Conclusions: the addition of metronidazole for the first three months after intestinal resection does not increase the efficacy of azathioprine alone in preventing postoperative endoscopic recurrence in cd.
Datos académicos de la tesis doctoral «Assaig clínic, doble cec, aleatoritzat, multicéntric i controlat amb placebo, sobre l¿eficÁ cia d¿associar metronidazol a azatioprina en la prevenció de recurréncia post-quirúrgica a la malaltia de crohn«
- Título de la tesis: Assaig clínic, doble cec, aleatoritzat, multicéntric i controlat amb placebo, sobre l¿eficÁ cia d¿associar metronidazol a azatioprina en la prevenció de recurréncia post-quirúrgica a la malaltia de crohn
- Autor: Míriam Mañosa Ciria
- Universidad: Autónoma de barcelona
- Fecha de lectura de la tesis: 15/07/2011
Dirección y tribunal
- Director de la tesis
- Eduard Cabré Gelada
- Tribunal
- Presidente del tribunal: jordi Tor aguilera
- Elena Ricart gomez (vocal)
- (vocal)
- (vocal)