tacrolimus and Stomatitis--Aphthous

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.. To discover if pimecrolimus can accelerate the healing of BD genital aphthous ulcers.. 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.. 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).. Pimecrolimus is safe and efficient in the treatment of BD genital ulcers, by accelerating the healing process.

Topics: Administration, Cutaneous; Adolescent; Adult; Behcet Syndrome; Chi-Square Distribution; Dermatologic Agents; Double-Blind Method; Female; Genital Diseases, Female; Genital Diseases, Male; Humans; Iran; Male; Middle Aged; Placebo Effect; Stomatitis, Aphthous; Tacrolimus; Time Factors; Treatment Outcome; Wound Healing; Young Adult

Topics: Behcet Syndrome; Humans; Stomatitis, Aphthous; Tacrolimus

Topics: Child, Preschool; Graft Rejection; Heart Transplantation; Humans; Immunosuppressive Agents; Male; Oral Ulcer; Stomatitis, Aphthous; Tacrolimus; Treatment Outcome

Topics: Humans; Lichen Planus, Oral; Pentoxifylline; Recurrence; Stomatitis, Aphthous; Tacrolimus

The buccal side effects of immunodepressors are well defined with cyclosporine and certain antimitotic agents. We report a case of buccal ulcerations in a patient treated with a new immunosuppressive macrolide: tacrolimus (Prograf).. A 53 year-old woman presenting a severe cardio-myopathy, underwent heart transplantation in May 1997. Tacrolimus was introduced in October 1997 after 3 episodes of acute reject. Eight months after tacrolimus, painful apthoid buccal ulcerations appeared. Biopsy of the buccal mucosa and other biological examinations revealed no particular etiology. Since tacrolimus could not be stopped, treatment with thalidomide was initiated. It was suspended on two occasions due to adverse events. The buccal ulcerations relapsed rapidly. The intrinsic imputability of tacrolimus in the occurrence of these lesions was noted "l2" ("plausible").. Several arguments suggest that these buccal ulcerations may result from the toxicity of tacrolimus: 1) absence of past history of apthae; 2) anatomo-clinical aspect of the lesion differing from that of common apthae, but similar to the ulcerations observed with nicorandil; 3) delay in occurrence of analogous ulcerations compared with that observed with methotrexate or nicorandil; 4) absence of another etiology; 5) relapse of ulcerations on two occasions after suspension of thalidomide, whilst tacrolimus was continued.

Topics: Biopsy; Female; Graft Rejection; Heart Transplantation; Humans; Immunosuppressive Agents; Middle Aged; Mouth Mucosa; Oral Ulcer; Stomatitis, Aphthous; Tacrolimus