The clinical usefulness of cilostazol, a platelet aggregation inhibitor, in the treatment of skin ulcer was evaluated in 31 patients with collagen diseases, including 16 patients with systemic sclerosis, 7 with SLE, 2 with MCTD and 6 with other subtypes of the disease. This evaluation followed administration of the drug at a daily dose of 100mg (50mg×2) for 8 successive weeks.
Twenty-four patients, excluding 7 patients with protocol violations, were included in the efficacy evaluation. The size of skin ulcer significantly decreased from 6.6±6.7mm (mean ± SD) to 3.8 ± 3.2mm at 2 weeks of treatment and to 2.2 ± 2.9mm at 8 weeks of treatment. The appearance of granuloma, and redness, swelling, spontaneous pain and haphalgesia were significantly improved at 2 weeks of treatment and thereafter. The final global improvement rating revealed an assessment of“moderately improved”or better in 87.5% (21/24) of the 24 patients. Adverse reactions were experienced by 48.4% (15/31 patients) : headache in 29%, palpitation or tachycardia in 9.7%, dull headache in 6.5% and tinnitus in 3.2%. Treatment was discontinued due to adverse reactions in 19.4% (6 patients) of the 31 patients.
Overall usefluness, which was assessed based on the final global improvement rating and overall safety, revealed an assessment of“useful”or better in 83.3% (20/24 patients), indicating that cilostazol is useful in the treatment of skin ulcer accompanying collagen diseases.
