| Pimecrolimus versus placebo in genital aphthous ulcers of Behcet's disease: a randomized double-blind controlled trial. | |
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MedLine Citation:
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PMID: 20704623 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: Genital aphthous ulcers of Behcet's disease (BD) are painful and usually resistant to local treatments. Pimecrolimus is an ascomycin macrolactam, used in inflammatory skin diseases. OBJECTIVE: To discover if pimecrolimus can accelerate the healing of BD genital aphthous ulcers. METHODS: Ninety patients with genital aphthous ulcers were enrolled. Only patients treated with colchicine alone were selected. All patients signed a written consent form. Patients were randomly assigned to pimecrolimus or placebo cream, applied twice daily for 1 week. The primary outcome was the healing period. Up to 7 days, it was considered as a positive result. Results were compared by chi-square test. The mean healing time was compared by analysis of variance. Analyses were done both by the 'intention-to-treat' and 'treatment-completed' methods. RESULTS: Both groups were similar at the entry (gender, age, ulcer size, pain intensity and treatment delay). By intention-to-treat analysis, in the pimecrolimus group, 18 patients had positive and 27 negative results. In the control group, four had positive and 41 negative results. The difference was significant (chi(2) = 10.167, P = 0.001). By treatment-completed analysis, with pimecrolimus, 18 patients had positive and 22 negative results. With placebo, four had positive, and 41 negative results. The difference was significant (chi(2) = 12.574, P = 0.0004). Comparison of mean healing time in the pimecrolimus versus placebo group, demonstrated a significant acceleration both in intention-to-treat analysis (10.7 vs. 20.7 days, F = 17.466, P < 0.0001) and treatment-completed analysis (8.3 vs. 20.7 days, F = 29.289, P < 0.0001). CONCLUSION: Pimecrolimus is safe and efficient in the treatment of BD genital ulcers, by accelerating the healing process. |
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Authors:
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Cheyda Chams-Davatchi; Behrooz Barikbin; Farhad Shahram; Abdolhadi Nadji; Maryam Moghaddassi; Maryam Yousefi; Fereydoun Davatchi |
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Publication Detail:
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Type: Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: International journal of rheumatic diseases Volume: 13 ISSN: 1756-185X ISO Abbreviation: Int J Rheum Dis Publication Date: 2010 Aug |
Date Detail:
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Created Date: 2010-08-13 Completed Date: 2010-12-07 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101474930 Medline TA: Int J Rheum Dis Country: England |
Other Details:
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Languages: eng Pagination: 253-8 Citation Subset: IM |
Affiliation:
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Behçet's Disease Unit, Rheumatology Research Center, Kargar Avenue, Tehran 14114, Iran. fddh@davatchi.net |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Administration, Cutaneous Adolescent Adult Behcet Syndrome / complications* Chi-Square Distribution Dermatologic Agents / administration & dosage, therapeutic use* Double-Blind Method Female Genital Diseases, Female / drug therapy*, etiology, pathology Genital Diseases, Male / drug therapy*, etiology, pathology Humans Iran Male Middle Aged Placebo Effect Stomatitis, Aphthous / drug therapy*, etiology, pathology Tacrolimus / administration & dosage, analogs & derivatives*, therapeutic use Time Factors Treatment Outcome Wound Healing / drug effects Young Adult |
| Chemical | |
Reg. No./Substance:
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0/Dermatologic Agents; 0/pimecrolimus; 109581-93-3/Tacrolimus |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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