Despite the general acceptance of these drugs in UC, there are few randomised controlled trials (RCT) evaluating the efficacy of AZA and 6-MP. This is mainly due to the fact that researchers must adjust the dosage of the drugs to their haematological effects, which makes the maintenance of blindness difficult. The first trials in the seventies showed a steroid-sparing effect, but not an improvement in disease activity [33-34].
In a large and long-term retrospective clinical survey, AZA was significantly more effective in inducing remissions in patients with UC compared with CD (87% vs. 64%) . This was also true in a recent prospective, randomised, controlled study on the efficacy and safety of AZA and 5-ASA in inducing remission in steroid dependent UC . Seventy-two patients were randomised to receive AZA 2 mg/kg/day or oral 5-ASA 3.2 g/day, for a 6-month period. At the beginning, all patients were taking 40 mg of prednisolone, which was gradually tapered according to the clinical improvement. Endoscopic and clinical remission was achieved in 19 of 36 AZA patients compared to 7 of 36 in the 5-ASA group. Four AZA and 3 5-ASA patients underwent colecto-my. Significantly more AZA than 5-ASA patients complained of mild to moderate adverse events.
Patients with UC in whom remission was induced by AZA benefited from maintenance treatment, since withdrawal of therapy doubled the relapse rate ; moreover, AZA is effective in avoiding colectomy in steroid-dependent or steroid-resistant UC .
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