Randomized open comparative trial of dexamethasone-cyclophosphamide pulse and daily oral cyclophosphamide versus cyclophosphamide pulse and daily oral prednisolone in pemphigus vulgaris.

摘要

BACKGROUND: In various case series, pulse therapy has shown good results in pemphigus vulgaris (PV), with long-term remissions. AIMS: To compare the efficacy and side-effects of dexamethasone-cyclophosphamide pulse and daily oral cyclophosphamide (DCP+C) versus cyclophosphamide pulse and daily oral prednisolone (CP+P) in PV. METHODS: Twenty-eight active PV patients were randomized to receive either DCP with daily oral cyclophosphamide (Group A, n = 15) or CP with tapering doses of daily oral prednisolone (Group B, n = 13) for 12 months and followed-up for at least 3 months after stopping therapy. They were compared for time taken to achieve mucocutaneous disease control, achieve remission, relapse during treatment period, relapse after stopping therapy and side-effects. Results: Of 28 cases, 25 (Group A - 15, Group B - 10) completed the study period and were analyzed. The time for initiation of cutaneous response and time to achieve complete disease remission were significantly lesser in group B. However, other efficacy parameters were comparable. In Group A, significant adverse events were dysgusea, hiccups, palpitation, nail discoloration, bone pain and urinary tract infection while in Group B, they included nausea, moon facies, flushing, secondary amenorrhea, steroid withdrawal symptoms and dyspnea due to weight gain. CONCLUSIONS: Early remission was achieved in group B but the relapse rates during the treatment phase or after stopping therapy were comparable. Both therapies had comparable side-effect profiles, although Group B showed greater steroid-induced adverse events.