近日，美国食品药品监督管理局（FDA）最近批准了骨化三醇软膏3μg/g（Vectical，Galderma Laboratories，LP），这是第一种局部软膏，使用天然的维生素D3活性形式治疗银屑病。对于18岁及以上成人轻度至中度银屑病斑块的治疗，骨化三醇软膏已被证明是安全的，即使在敏感皮肤区域也能使用，并且可以耐受连续使用1年。骨化三醇软膏是美国唯一一种维生素D3软膏，它被认为通过与角质形成细胞（皮肤细胞）上的维生素D受体结合来帮助调节过度的皮肤细胞生成。
批准日期：2009年2月5日  公司：GALDERMA LABSINC
vectical（骨化三醇[calcitriol]）软膏3mcg/g，仅局部使用
美国初步批准：1978年
作用机理
骨化三醇在银屑病治疗中的作用机制尚不明确。
适应症和使用
Vectical软膏是一种维生素D类似物，适用于18岁及以上成人轻度至中度斑块型银屑病的局部治疗。
剂量和给药
每日两次，每次两次，每周最大剂量不超过200克。
Vectical软膏不适用于口服、眼科或阴道内使用。
剂型及强度
每克软膏含有3微克骨化三醇。
禁忌症
没有
警告和注意事项
如果发现钙代谢参数有异常，停止使用维卡软膏，直到这些正常化。
避免将Vectical软膏治疗区域过度暴露于自然或人工阳光下。
不良反应
最常见的不良反应（发生率≥3%）为实验室检查异常、尿异常、银屑病、高钙血症和瘙痒。
包装供应/储存和搬运
供应
Vectical软膏3mcg/g可用于以下包装尺寸的可折叠铝管：
100g管（NDC 0299-2012-10）
保管部
在受控室温下储存，温度68°-77°F（20°-25°C），允许在59°-86°F（15°-30°C）之间偏移。[见USP控制的室温]不要冷冻或冷藏。
完整资料附件：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a1567da9-af74-4afd-9ac5-8b53ec5d7cbf
Vectical(calcitriol topical)
February 5, 2009 — The US Food and Drug Administration (FDA) recently approved calcitriol ointment 3 μg/g (Vectical, Galderma Laboratories, LP), a first-of-its-kind, topical ointment, using a naturally occurring active form of vitamin D3 to treat psoriasis.
For treatment of mild-to-moderate psoriasis plaque in adults aged 18 years and older, calcitriol ointment has been proven safe, even for use in sensitive skin areas, and well-tolerated for continuous use up to 1 year. Calcitriol ointment, which is believed to help regulate excessive skin cell production by binding to the vitamin D receptors on keratinocytes (skin cells), is the only vitamin D3 ointment of its kind available in the United States.
"Because psoriasis is a chronic disease, topical products that are safe for extended use must fit within overall, long-term treatment regimens," Mark Lebwohl, MD, from Mount Sinai School of Medicine in New York City, said in a news release. "The [ointment]...has been proven safe and well-tolerated throughout 52 weeks of continuous use in treating mild-to-moderate disease. A safe, effective long-term therapy is critical to improve overall outcomes for these patients."
FDA approval was based on findings from two 8-week studies of more than 800 patients comparing twice-daily doses of calcitriol ointment with vehicle. Improvements in mild-to-moderate plaque psoriasis severity in the first study were first apparent at week 2, and these benefits were sustained during the 8-week treatment period.
Treatment success, defined as a global severity score of clear/minimal, was achieved by study end in 34% of patients treated with calcitriol ointment vs 22% of those treated with vehicle. At 8 weeks, 23% of patients achieved treatment success and also had a 2-grade improvement in disease severity. Efficacy results were similar in the second study.
The calcitriol ointment and vehicle groups had similar treatment-related adverse events. The most common adverse events (reported in more than 3%) were laboratory test abnormality, urine abnormality, psoriasis, hypercalciuria, pruritus, and skin discomfort.
A long-term, 52-week safety study showed that adverse events were similar to those reported in the 8-week studies. Although the 8-week studies showed some transient increases in plasma calcium levels, calcitriol ointment was not associated with any significant clinical effects on calcium homeostasis when used continuously during the 52-week study.
Psoriasis, a chronic skin disorder affecting 2% to 3% of the US population (about 7.5 million people) is characterized by thick, red, dry, scaly patches of skin and is caused by an abnormally high growth rate of skin cells that form plaques. Physical symptoms include inflammation, infection, soreness, and burning.
Patients with psoriasis may also have diabetes, heart disease, and obesity. Other available prescription options for psoriasis include corticosteroids, which are not typically used long term.
"The approval of Vectical Ointment is a welcome addition to the arsenal of topical treatments for mild-to-moderate plaque psoriasis that will help patients manage their condition both safely and effectively over the long-term," said Randy Beranek, president and chief executive officer of the National Psoriasis Foundation.
The maximum recommended dose is not more than 200g per week. Calcitriol ointment should be used with caution in patients who have known or suspected disturbances in calcium homeostasis, who take calcium or vitamin D supplements, or who use thiazide diuretics or other medications known to increase serum calcium levels. If abnormalities of calcium metabolism occur during treatment, calcitriol ointment should be withheld until these normalize.
Patients should avoid excessive exposure to natural or artificial sunlight after applying calcitriol ointment, discontinue use if severe irritation occurs, and avoid contact with eyes, lips, and face. Calcitriol ointment has not been studied in pregnant or nursing women.
VECTICAL ONT 100 GM  CALCITRIOL GALDERMA LABSINC  NDC：299201210