Resumen de Assaig clínic, doble cec, aleatoritzat, multicèntric i controlat amb placebo, sobre l¿eficàcia d¿associar metronidazol a azatioprina en la prevenció de recurrència post-quirúrgica a la malaltia de crohn
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.
