Randomized controlled open-label trial of four treatment regimens for pemphigus vulgaris - 19/08/11
, Nafiseh Esmaili, MD, Maryam Daneshpazhooh, MD, Mahin Valikhani, MD, Kamran Balighi, MD, Zahra Hallaji, MD, Masoumeh Barzegari, MD, Maryam Akhyani, MD, S. Zahra Ghodsi, MD, Hassan Seirafi, MD, Mohammad-Javad Tabrizi Nazemi, MD, Hossein Mortazavi, MD, Mostafa Mirshams-Shahshahani, MD
Reprint requests: Cheyda Chams-Davatchi, MD, Dermatology Department, Tehran University of Medical Sciences, Razi Hospital, Vahdat Eslami Square, Tehran 11996, Iran.Abstract |
Background |
Pemphigus is a severe autoimmune blistering disease affecting the skin and mucosa. Mortality is high in the absence of treatment. Nowadays, treatment is based mainly on corticosteroids and cytotoxic drugs; however, because of the rarity of the disease worldwide, there is not yet a standard treatment based on randomized controlled trials, and the treatment used is based mainly on the experience of experts.
Objective |
The aim of this study was to compare the efficacy and safety of 4 treatment regimens for pemphigus vulgaris: prednisolone alone, prednisolone plus azathioprine, prednisolone plus mycophenolate mofetil, and prednisolone plus intravenous cyclophosphamide pulse therapy.
Methods |
One hundred twenty new cases of pemphigus vulgaris were enrolled. These patients were randomly allocated into 1 of 4 treatment groups (each comprising 30 patients) and received prednisolone (P), prednisolone and azathioprine (P/A), prednisolone and mycophenolate mofetil (P/MM), and prednisolone and intravenous cyclophosphamide pulse therapy (P/PC). They were followed up for 1 year at the Pemphigus Research Unit.
Results |
In groups P, P/A, P/MM, and P/PC, 23 (76.5%), 24 (80%), 21 (70%), and 22 (73.3%) of the patients, respectively, followed the regimen for the full 1-year period. The mean total dose of prednisolone administered in groups P, P/A, P/MM, and P/PC was 11631 mg (standard deviation [SD] = 7742), 7712 mg (SD = 955), 9798 mg (SD = 3995), and 8276 mg (SD = 810), respectively. The mean total dose of prednisolone in group P (prednisolone alone) was 11,631 mg, The mean total dose of prednisolone in the 3 cytotoxic groups was 8652 mg. By using analysis of variance, the difference was statistically significant (P = .047). In the cytotoxic groups, there was a significant difference between the P/A and P/MM groups (P = .007), but not between P/A and P/PC (P = .971), and P/MM and P/PC (P = .670). Side effects were not significantly different among the 4 groups.
Limitations |
Larger sample sizes and blind design are suggested for future studies.
Conclusion |
The efficacy of prednisolone is enhanced when it is combined with a cytotoxic drug. The most efficacious cytotoxic drug to reduce steroid was found to be azathioprine, followed by cyclophosphamide (pulse therapy), and mycophenolate mofetil.
Le texte complet de cet article est disponible en PDF.Abbreviations used : P, P/A, P/MM, P/PC, PV
Plan
| Supported by a grant from the vice chancellor of research at Tehran University of Medical Sciences. |
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| Conflicts of interest: None declared. |
Vol 57 - N° 4
P. 622-628 - octobre 2007 Retour au numéro
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