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Stiefel公司宣布FDA已批准其0.005%卡泊三烯(calcipotriene,Sorilux)泡沫剂用于治疗18岁以上轻中度斑块状银屑病。卡泊三烯是维生素D3类似物,具有抑制角质形成、促进细胞分化成熟及抑制炎症反应等药理作用。
制造商：
公司Stiefel实验室
药理分类：
维生素D3模拟。
“活性成分”（词）：
卡泊三醇（作为一水合物）0.005％;泡沫。
指示（S）：
外用治疗斑块型银屑病患者在年龄≥18岁的。
药理作用：
卡泊三醇是一种人工合成的维生素D3类似物，有一个类似的作为天然维生素D3受体的结合亲和力。然而，在治疗牛皮癣的临床疗效作出贡献的确切作用机制是未知的。
临床试验：
在两个多中心，随机，双盲，车辆控制的临床研究中，共659名牛皮癣患者随机2:1对SORILUX泡沫或车辆的应用分配药物，每天两次，共8周。基线时的疾病严重程度的分级使用了5点调查的静态全球评估的规模（ISGA），定义为（清除= 0级：没有证据显示缩放，红斑或斑块厚度，几乎明确= 1级：偶尔的判罚尺度，淡淡的红斑，并且几乎难以察觉，斑块厚度，轻度= 2级：光的色彩和温和的牌匾海拔的判罚尺度，中度= 3级：中度红色的色彩和斑块厚度适中的粗具规模，重度4级：厚厚的顽强的规模与深着色，重度斑块厚度）在其主题是“温和的”或“温和”的得分。
治疗成功被定义为“清除”（0级）或“几乎透明”（1级）和至少2级的改善从基线得分的得分在第8周进行疗效评价。大约30％的参加科目被评为“温和”的的ISGA规模。研究人群年龄从10名受试者基线时的年龄<18岁与12-89年。受试者为54％的男性和88％的白人。在研究1中，14％的治疗Sorilux泡沫被列为成功的在第8周相比，7％的车辆只治疗。在这项研究中受试者在基线评定为“温和的”，表现出较大的车辆，而不是Sorilux泡沫。在研究2 Sorilux的泡沫经验丰富的治疗成功率在8周的治疗，27％至16％，单独使用车辆。
法律分类：
接收
成人：
≥18yrs：受影响的地区，每天两次，轻轻揉搓完全涂上薄薄的一层。
儿童：
<18yrs：不成立。
禁忌（S）：
高钙血症。
警告/注意事项：
不适用于口腔，眼，或阴道内使用。停止，如果高钙血症的发生（直到normocalcemia收益）。避免眼睛，过度的阳光照射，光疗。易燃的。怀孕（Cat.C）。哺乳期的母亲。
不良反应（S）：
红斑。
如何提供：
泡沫-60G，120G
最后更新：
2012年8月13日
Manufacturer:
Stiefel Laboratories, Inc.
Pharmacological Class:
Vitamin D3 analog.
Active Ingredient(s):
Calcipotriene (as monohydrate) 0.005%; foam.
Indication(s):
Topical treatment of plaque psoriasis in patients ≥18 years of age.
Pharmacology:
Calcipotriene is a synthetic vitamin D3 analog that has a similar receptor binding affinity as natural vitamin D3. However, the exact mechanism of action contributing to the clinical efficacy in the treatment of psoriasis is unknown.
Clinical Trials:
In two multi-center, randomized, double-blind, vehicle-controlled clinical studies a total of 659 subjects with psoriasis were randomized 2:1 to SORILUX Foam or vehicle; subjects applied the assigned medication twice daily for 8 weeks. Baseline disease severity was graded using a 5-point Investigator Static Global Assessment scale (ISGA), defined as (Clear = grade 0: no evidence of scaling, erythema, or plaque thickness; Almost clear = grade 1: occasional fine scale, faint erythema, and barely perceptible plaque thickness; Mild = grade 2: fine scale with light coloration and mild plaque elevation; Moderate = grade 3: coarse scale with moderate red coloration and moderate plaque thickness; Severe = grade 4: thick tenacious scale with deep coloration and severe plaque thickness) on which subjects scored either “mild” or “moderate”.
Efficacy evaluation was carried out at Week 8 with treatment success being defined as a score of “clear” (grade 0) or “almost clear” (grade 1) and at least 2 grade improvement from the baseline score. Approximately 30% of enrolled subjects were graded as “mild” on the ISGA scale. The study population ranged in age from 12–89 years with 10 subjects <18 years of age at baseline. The subjects were 54% male and 88% Caucasian. In Study 1, 14% of subjects treated with Sorilux foam were classified as successful at Week 8 compared to 7% of subjects treated with vehicle only. In this study subjects graded as “mild” at baseline showed a greater response to vehicle than to Sorilux foam. In Study 2, 27% of subjects treated with Sorilux foam experienced treatment success at Week 8 compared to 16% using vehicle alone.
Legal Classification:
Rx
Adults:
≥18yrs: Apply a thin layer twice daily to affected areas and gently rub in completely.
Children:
<18yrs: not established.
Contraindication(s):
Hypercalcemia.
Warnings/Precautions:
Not for oral, ophthalmic, or intravaginal use. Discontinue if hypercalcemia occurs (until normocalcemia returns). Avoid eyes, excessive sunlight, phototherapy. Flammable. Pregnancy (Cat.C). Nursing mothers.
Adverse Reaction(s):
Erythema.
How Supplied:
Foam—60g, 120g
Last Updated:
8/13/2012
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