title: Assessment of the therapeutic benefit of dexamethasone cyclophosphamide pulse versus only oral cyclophosphamide in phase II of the dexamethasone cyclophosphamide pulse therapy: a preliminary prospective randomized controlled study.
abstract: BACKGROUND
  Dexamethasone cyclophosphamide pulse (DCP) therapy is an established mode of treatment for pemphigus in India.
  
  
  OBJECTIVE
  To assess the therapeutic benefit of additional DCPs (phase II, consolidation phase) versus immediate oral cyclophosphamide, usually used in phase III (maintenance phase), after initial DCP therapy (phase I) and to assess which laboratory test (DIF or ELISA) will reflect the clinical relapse best.
  
  
  METHODS
  Nineteen newly recruited patients of pemphigus vulgaris (PV) received monthly DCPs in phase I and were then randomized into two groups. Group A (10 patients) received monthly DCPs for nine months and Group B (nine patients) received only oral cyclophosphamide for nine months. Direct immunofluorescence (DIF) and enzyme-linked immunosorbent assay (ELISA) were tested before starting DCP regimen, and at 0,3,6,9 months after randomization.
  
  
  RESULTS
  Clinical relapse by the end of follow-up period occurred in only one patient in each group. In these cases, DIF became (again) positive before the relapse. No statistically significant difference between the two groups was found at three, six and nine months by ELISA indices and DIF grading.
  
  
  CONCLUSIONS
  Although the DCP regimen is the standard therapy for pemphigus in India, we found no difference in the clinical outcome between patients receiving nine DCPs in phase II and patients shifted directly from phase I to III. Periodic testing using DIF and Dsg ELISA were found to be useful to monitor disease activity and predict a relapse. Further large scale studies are required to assess if patients can be shifted directly from phase I to III and maintained only on oral cyclophosphamide.
authors.affiliation: Department of Dermatology, Venereology and Leprology, Post-Graduate Institute of Medical Education and Research, Chandigarh, India.
authors.forename: Nisha V
authors.initials: NV
authors.lastname: Parmar
authors.forename: Amrinder J
authors.initials: AJ
authors.lastname: Kanwar
authors.forename: Ranjana W
authors.initials: RW
authors.lastname: Minz
authors.forename: Davinder
authors.initials: D
authors.lastname: Parsad
authors.forename: Keshavamurthy
authors.initials: K
authors.lastname: Vinay
authors.forename: Daisuke
authors.initials: D
authors.lastname: Tsuruta
authors.forename: Norito
authors.initials: N
authors.lastname: Ishii
authors.forename: Takashi
authors.initials: T
authors.lastname: Hashimoto
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D003520:Cyclophosphamide / Q000008:administration & dosage*; D003907:Dexamethasone / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D005455:Fluorescent Antibody Technique; D006801:Humans; D007194:India; D008297:Male; D008875:Middle Aged; D010392:Pemphigus / Q000188:drug therapy*; D020551:Pulse Therapy, Drug / Q000379:methods; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D003907:Dexamethasone; D003520:Cyclophosphamide