Randomized double blind trial of prednisolone and azathioprine, vs. prednisolone and placebo, in the treatment of pemphigus vulgaris.

摘要: Background  The classic treatment for pemphigus vulgaris is prednisolone. Immunosuppressive drugs can be used in association. Objective  To compare the efficacy of Azathioprine reducing Disease Activity Index (DAI). Patients and methods  A double blind randomized controlled study was conducted on 56 new patients, assigned to two therapeutic groups: (i) prednisolone plus placebo; (ii) Azathioprine. Patients were checked regularly 1 year. ‘Complete remission’ defined as healing all lesions after 12 months, <7.5 mg daily, (DAI ≤ 1). Analysis done by ‘Intention Treat’ (ITT) ‘Treatment Completed Analysis’ (TCA). Results  Both groups similar age, gender, disease duration, DAI. Primary endpoint: By ITT TCA, mean DAI improved both with no significant difference between them. became last trimester (3 months; ITT: P = 0.033, TCA: P = 0.045). Secondary total steroid dose decreased significantly groups, them, except (ITT: P = 0.011, P = 0.035). daily gradually becoming statistically favour azathioprine, trimester, especially at 12th months P = 0.002, P = 0.005). Complete remission 12 months only TCA (AZA/Control: 53.6%/39.9%, P = 0.043). Limitations  Sample size rather small demonstrate differences. Other limitations include choice primary secondary endpoints unavailability measure thiopurine methyltransferase activity. Conclusion  helps reduce long-run.