Pimecrolimus versus placebo in genital aphthous ulcers of Behcet's disease: a randomized double-blind controlled trial

被引:23
作者
Chams-Davatchi, Cheyda [2 ]
Barikbin, Behrooz [2 ]
Shahram, Farhad
Nadji, Abdolhadi
Moghaddassi, Maryam
Yousefi, Maryam [2 ]
Davatchi, Fereydoun [1 ]
机构
[1] Univ Tehran Med Sci, Shariati Hosp, Rheumatol Res Ctr, Behcets Dis Unit,Razi Hosp, Tehran 14114, Iran
[2] Univ Tehran Med Sci, Shariati Hosp, Razi Hosp, Dept Dermatol, Tehran 14114, Iran
关键词
Behcet's disease; genital aphthosis; local treatment; pimecrolimus; TOPICAL CALCINEURIN INHIBITORS; EFFICACY; DERMATITIS; COLCHICINE;
D O I
10.1111/j.1756-185X.2010.01531.x
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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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页码:253 / 258
页数:6
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