부산대학교 도서관

Summary Background As psoriasis patients often require continuous treatment optimal therapy has to provide efficacy and a good safety profile over the long term. Objectives The aim of this multicentre study was to assess the efficacy, safety and tolerability of tacalcitol (4 µg g-1 ) ointment (Curatoderm® , Hermal, Reinbek, Germany) applied once daily over a treatment period of 18 months. Patients and methods Efficacy parameters were Psoriasis Area Severity Index (PASI), based on summed scores of erythema, infiltration and scaling and total body surface involvement (TBI). Safety assessment included serum levels of calcium, parathyroid hormone, calcitonin, 1,25-dihydroxy vitamin D3 (calcitriol); urinary calcium, creatinine, calcium/creatinine ratio in spot and 24-h urine and urinary α1 -microglobulin. A group of 304 patients with chronic plaque psoriasis, covering between 7% and 20% of the body surface area was included for the initial treatment phase of 3 months. Of the 257 patients who completed the initial 3 months, 197 patients continued in a second treatment phase of 15 months. Results Tacalcitol treatment proved to be effective in reducing the severity of psoriasis and maintained therapeutic response over the study period. The median PASI fell from 9·5 to 4·6 at month 3 and to 3·25 at month 18 (P < 0·0001). The median improvement in TBI was 30% at month 3 and 50% at month 18. In no patient was there any relevant disturbance of calcium homeostasis. There were no significant changes in mean values of serum calcium, parathyroid hormone and calcitriol. Additionally no significant changes in 24-h urinary excretion evaluation were observed. There was no correlation between levels of serum calcium or urinary calcium and amount of tacalcitol ointment used, even in the patients requiring the largest amounts of ointment (up to 13 g day-1 and up to 20% of body area affected).... [ABSTRACT FROM AUTHOR]