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What's the study about?
This study focused on comparing two different treatments for pemphigus vulgaris, a skin condition caused when body's immune system works against itself. The treatments were dexamethasone cyclophosphamide pulse (DCP) therapy and dexamethasone azathioprine pulse (DAP) therapy.
Why was this study done?
The goal of the study was to determine which treatment, DCP or DAP, was more effective in treating pemphigus vulgaris. Both treatments involve high-dose steroids combined with other medications, but they differ in the specific medications used.
How did they do the study?
Researchers conducted a randomized controlled trial, where patients were randomly assigned to receive either DCP or DAP therapy. They then followed these patients to see how well each treatment worked.
Consenting patients presenting with pemphigus vulgaris visiting Outpatient Department of Dermatology, Jinnah Postgraduate Medical Centre, Karachi, were enrolled in this study who fulfilled the inclusion criteria. Permission from the institutional ethical review committee were taken prior to conduction of study. Brief history was taken about the duration of pemphigus vulgaris, demographic data (age, gender and residence status) and written informed consent in local language (Urdu) was taken from each patient. Patients were randomly allocated using sealed opaque envelop bearing A= Dexamethasone cyclophosphamide pulse (DCP) therapy and B= and dexamethasone azathioprine pulse (DAP) therapy. Patients in group A received monthly doses of 100 mg of dexamethasone dissolved in 500 ml of 5% dextrose by slow intravenous infusion over 2 h on 3 consecutive days along with 500 mg of cyclophosphamide in the infusion on day 2. In between the pulses, patients received 50 mg of oral cyclophosphamide daily. Patients in group B, cyclophosphamide bolus dose on day 2 omitted, and a daily dose of 50 mg of azathioprine will be given throughout the pulses. Patient's blood pressure, pulse rate, heart rate was monitored every 15 min during the period of infusion. Serum electrolytes and electrocardiography was repeated after completion of each pulse. The cycles was repeated at 28-day interval starting from day 1 of the previous cycle. Response to both treatment regimens was evaluated after 3 cycle and successful treatment outcome was labeled as per operational definition. The findings of quantitative variable (age, mean PDAI score in group A and B, and duration of pemphigus vulgaris) and qualitative variables (gender, residence status, smoking status, family monthly income, occupational status and successful treatment outcome) was entered in a form.
Data was analyzed on Statistical Package for the Social Sciences software Version 22.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone Cyclophosphamide Pulse therapy group (DCP group) | Active Comparator | Patients were randomly assigned to two groups. The DCP group received therapy consisting of monthly doses of 100 mg dexamethasone dissolved in 500 ml of 5% dextrose, administered intravenously over 2 hours on 3 consecutive days. On the second day, 500 mg of cyclophosphamide was added in infusion. Between treatment cycles, patients took 50 mg of cyclophosphamide orally each day. This treatment regimen continued for 6 months, and outcomes were assessed after 3 treatment cycles. |
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| Dexamethasone Azathioprine Pulse therapy group (DAP group) | Active Comparator | Patients were randomly assigned to two groups. The DAP group received therapy consisting of monthly doses of 100 mg dexamethasone dissolved in 500 ml of 5% dextrose, administered intravenously over 2 hours on 3 consecutive days. Cyclophosphamide is replaced by daily oral azathioprine. No bolus dose of azathioprine is given. This treatment regimen continued for 6 months, and outcomes were assessed after 3 treatment cycles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone Cyclophosphamide Pulse therapy | Drug | 33 patients were enrolled in DCP group. They were given Dexamethasone Cyclophosphamide pulse therapy for 6 months and successful treatment outcome was assessed using Pemphigus Disease Area Index (PDAI) scores. |
| Measure | Description | Time Frame |
|---|---|---|
| Pemphigus Disease Area Index (PDAI) | Successful treatment outcome is assessed with Pemphigus Disease Area Index (PDAI) score. Lower score means better outcome | Baseline, 3 months & 6 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Dermatology Life Quality Index | Life quality of patients enrolled was assessed during study using Dermatology Life Quality Index (DLQI). Higher score means negative impact on patient's quality of life | baseline, 3 months, 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zainab Javed, MBBS | Jinnah Postgraduate Medical Centre | Principal Investigator |
| Rabia Ghafoor, MBBS, FCPS | Jinnah Postgraduate Medical Centre | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinnah Postgraduate Medical Center | Karachi | Sindh | 75510 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7657447 | Background | Chryssomallis F, Dimitriades A, Chaidemenos GC, Panagiotides D, Karakatsanis G. Steroid-pulse therapy in pemphigus vulgaris long term follow-up. Int J Dermatol. 1995 Jun;34(6):438-42. doi: 10.1111/j.1365-4362.1995.tb04450.x. | |
| 24068153 | Background | Fernandes NC, Menezes M. Pulse therapy in pemphigus: report of 11 cases. An Bras Dermatol. 2013 Jul-Aug;88(4):672-5. doi: 10.1590/abd1806-4841.20131840. |
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| ID | Term |
|---|---|
| D010392 | Pemphigus |
| ID | Term |
|---|---|
| D012872 | Skin Diseases, Vesiculobullous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
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Randomized controlled trial
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| Dexamethasone Azathioprine Pulse therapy | Drug | 33 patients were enrolled in DAP group. They were given Dexamethasone Azathioprine pulse therapy for 6 months and successful treatment outcome was assessed using Pemphigus Disease Area Index (PDAI) scores. |
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| 24470657 | Background | Hassan I, Sameem F, Masood QM, Majid I, Abdullah Z, Ahmad QM. Non Comparative Study on Various Pulse Regimens (DCP, DAP and DMP) in Pemphigus: Our Experience. Indian J Dermatol. 2014 Jan;59(1):30-4. doi: 10.4103/0019-5154.123487. |
| 31041203 | Background | Mustafi S, Sinha R, Hore S, Sen S, Maity S, Ghosh P. Pulse therapy: Opening new vistas in treatment of pemphigus. J Family Med Prim Care. 2019 Mar;8(3):793-798. doi: 10.4103/jfmpc.jfmpc_114_19. |
| D007154 | Immune System Diseases |