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当前位置:药品说明书与价格首页 >> 皮肤性病 >> 新药动态 >> VUSION OINTMENT药膏-用于治疗尿布皮炎

VUSION OINTMENT药膏-用于治疗尿布皮炎

2010-12-24 14:12:55  作者:新特药房  来源:中国新特药网天津分站  浏览次数:231  文字大小:【】【】【
简介: Vusion药膏(含0.25%的硝酸咪康唑,15%的氧化锌和81.35%的白凡士林)。 该药用于四周大以上的患儿,治疗由念珠菌引起的尿布皮炎(DDCC)。Vusion在美国是唯一通过批准治疗该病的处方药。 在美国2岁以 ...

Vusion药膏(含0.25%的硝酸咪康唑,15%的氧化锌和81.35%的白凡士林)。

该药用于四周大以上的患儿,治疗由念珠菌引起的尿布皮炎(DDCC)。Vusion在美国是唯一通过批准治疗该病的处方药。

在美国2岁以下的儿童大约有800万,每年有100万门诊患者有尿布皮炎,其中40%以上是DDCC。到目前为止,一般治疗DDCC的方法有使用抗真菌药物、类固醇药物以及其他不是用于DDCC或婴儿使用的药物。
 
Vusion不含类固醇,其活性成分为硝酸咪康唑,抗真菌效果显著。临床试验结果显示,DDCC患儿使用该药进行为期三天的治疗之后,获得的疗效达到了统计显著性水平。

Vusion Ointment
Generic Name: miconazole nitrate, zinc oxide and white petrolatum ointment
Date of Approval: February 16, 2006
Treatment for: Diaper Dermatitis Complicated by Candidiasis
The U.S. Food and Drug Administration (FDA) has approved Vusion (0.25% miconazole nitrate, 15% zinc oxide and 81.35% white petrolatum) Ointment for the treatment of diaper dermatitis complicated by candidiasis (DDCC) in infants 4 weeks and older.
This inflammatory condition occurs when diaper dermatitis, also known as diaper rash, is complicated with a fungal infection caused by yeast known as Candida. The existence of Candida is readily determined by microscopic evaluation for presence of pseudohyphae or budding yeast. Vusion is the only prescription product approved for the treatment of this condition in the United States.
There are approximately 8 million infants under the age of two in the U.S. It is estimated that diaper dermatitis is observed in approximately one million pediatric outpatient visits each year. Additionally, it is estimated that of all diaper dermatitis cases treated by physicians, more than 40% are complicated by the yeast Candida. Until now, common treatment options have included the use of antifungal products, steroids, and combination products not specifically approved for the treatment of DDCC or for use on infants.
Vusion is a steroid-free formulation that contains the active ingredient miconazole nitrate at a concentration of 0.25%, which directly treats the infection with proven antifungal efficacy. The ointment base for Vusion is comprised of zinc oxide and white petrolatum, which are the main components in most common diaper rash products. In clinical trials, statistically significant improvement was observed in infants with DDCC within three days of treatment with Vusion.
In the pivotal Phase 3 clinical study, more than twice the percentage of patients treated with Vusion achieved the primary endpoint of elimination of the yeast and complete clearing of all signs and symptoms of the disease at day 14, one week after stopping treatment, as compared with patients treated with the vehicle (zinc oxide and petrolatum). At the end of treatment (day 7), the average reduction in the signs and symptoms score, as determined by the Diaper Dermatitis Severity Score, was 72% with Vusion versus 25% with the vehicle ointment. The double-blind, vehicle-controlled study, which was conducted at 20 sites in the United States and Latin America, included 236 children under the age of three years who were diagnosed with DDCC.

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