Long-Term Safety Of Topical Calcitriol 3 Mu G G(-1) Ointment

M. J. P. Gerritsen,P.C.M. van de Kerkhof, A. Langner

British Journal of Dermatology(2001)

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摘要
To assess the topical and systemic safety and tolerance of twice-daily application of 3 mug g(-1) 1 alpha 25-dihydroxyvitamin D-3 (calcitriol) ointment (Silkis ointment(R), Galderma Laboratories) in the longterm treatment of patients suffering from chronic plaque psoriasis. we performed an open-design. multicentre study. Two hundred and fifty-three patients (155 males, 98 females) treated all their psoriatic lesions, except for those on the head and scalp, for up to 78 weeks. No serious adverse events were reported: 37 patients (14.6%) had a transient skin irritation reaction on one or more occasions during the study that resulted in study withdrawal for seven of them. The baseline/endpoint analyses showed no clinically relevant changes in measures of calcium and phosphorus homeostasis and renal function. Slight hypercalcaemia was observed in five (2%) patients; in four of these patients, serum albumin-adjusted total calcium levels normalized during treatment. In conclusion, twice-daily calcitriol 3 mug g(-1) ointment is safe and well tolerated in the long-term treatment of chronic plaque psoriasis.
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关键词
calcitriol, long-term, plaque psoriasis, safety, tolerance
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