Medical treatment of patients with chronic refractory pouchitis is particularly difficult and disappointing. The usual therapeutic strategy for these patients, who fail to respond to antibiotics or relapse once antibiotic therapy is stopped, includes: (1) a prolonged course of an antimicrobial agent, (2) a maintenance therapy with the most effective antibiotic at the lowest clinically effective dose, (3) cycles of multiple antibiotics at 1-week intervals. A possible therapeutic alternative for chronic refractory pouchitis is the use of a combined antibiotic treatment. We carried out a pilot trial to evaluate the efficacy of the association of two antibiotics in chronic active treatment-resistant pouchitis. Eighteen patients who were not responders to the standard therapy (metronida-zole or ciprofloxacin or amoxycillin/clavulanic acid) for 4 weeks, were treated orally with rifaximin 2 g/day (non-absorbable, wide spectrum antibiotic) plus ciprofloxacin 1 g/day for 15 days; symptoms assessment, endoscopic and histologic evaluations were performed at screening and after 15 days using the PDAI. Sixteen out of 18 patients (88.8%) either improved (n=10) or went into remission (n=6); the median PDAI scores before and after therapy were 11 and 4 respectively (p<0.002) . Unfortunately all patients relapsed within 2 months.
More recently, 44 patients with refractory pouchi-tis received metronidazole 800 mg - 1 g/day and ciprofloxacin 1 g/day for 28 days. Symptomatic, endoscopic and histological evaluations were undertaken before and after the antibiotic therapy, according to the PDAI score, and the related quality of life was assessed with the inflammatory bowel disease questionnaire (IBDQ). Thirty-six patients (82%) went into remission; the median PDAI scores before and after therapy were 12 and 3 respectively (p<0.0001). Patients' quality of life significantly improved with the treatment and median IBDQ strongly correlated with the disease activity and general satisfaction (from 96.5 to 175). Even in the eight patients who did not go into remission, the median PDAI score significantly improved from 14.5 to 9.5 as well as the median IBDQ score from 96 to 127 .
Oral-controlled release budesonide can be useful for certain patients. In a small open trial, 16 patients with chronic pouchitis refractory to a 1-month antibiotic therapy (ciprofloxacin 1 g/day and metronidazole 1 g/day) were treated with budesonide CIR 9 mg/day for 8 weeks; the dose was gradually tapered (3 mg every month) and remission was defined as a clinical PDAI score ^2 and an endoscopic PDAI ^1. Twelve patients (72%) went into remission and the total PDAI score significantly decreased from 13 (range 8-16) to 3 (range 2-9) (p<0.001). Budesonide treatment increased the IBDQ score from 102 (range 77-176) to 182 (range 84-225) (p<0.001) .
In a subsequent study, 12 patients with active pou-chitis refractory to ciprofloxacin and metronidazole for 1 month and oral budesonide for 8 weeks, were treated with three infusions of infliximab at a dosage of 5 mg/kg at week 0, 2 and 6. Ten patients (83.3%) achieved remission; the total PDAI score decreased from 13 (range 8-18) to 2 (range 0-9) (p<0.001). The IBDQ score strongly increased from 96 (range 74-184) to 196 (range 92-230; p<0.001) .
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