与每日两次使用5% 5-氟尿嘧啶乳膏相比，每日一次使用含花生油的新型专利水性乳膏中4% 5-氟尿嘧啶乳膏治疗光化性角化病的疗效、安全性和耐受性：应对治疗挑战
Efficacy, Safety, and Tolerability of 4% 5-Fluorouracil Cream in a Novel Patented Aqueous Cream Containing Peanut Oil Once Daily Compared With 5% 5-Fluorouracil Cream Twice Daily: Meeting the Challenge in the Treatment of Actinic Keratosis.
作者信息
Dohil Magdalene A
出版信息
J Drugs Dermatol. 2016 Oct 1;15(10):1218-1224.
BACKGROUND
Actinic keratosis (AK) is a neoplastic keratosis and a precursor of squamous cell carcinoma (SCC).
OBJECTIVE
We are presenting data on a novel formulation of 4% 5-Fluorouracil (5-FU) in an aqueous vehicle cream containing peanut oil (Tolak) with once daily application versus treatment with 5% 5-FU twice daily for 4 weeks.
METHODS
- A dose ranging study of 4% 5-FU cream once or twice daily for 2 or 4 weeks and its vehicle, compared to 5% 5-FU cream twice daily for 4 weeks in 121 subjects. 2) A double-blinded multicenter study involving 841 subjects for non-inferiority and safety of 4% 5-FU cream once daily vs 5% 5-FU cream twice daily over 4 weeks with 100% and 75% clinical clearance of AK's.
RESULTS
4% 5-FU qd q4wks achieved 100% clearance in 80% and 75% clearance in 100% of subjects vs 75% and 95% respectively with 5% 5-FU bid q4wks. 4% 5-FU qd2wks achieved 100% clearance in 60% and 75% clearance in 85% of subjects. 4% 5-FU qd q4wks recorded 65 adverse events and 30% application site skin irritation versus 71 events and 60% with 5% 5-FU bid q4wks. 4% 5-FU exceeded non-inferiority by 1.32% with sub-analysis for higher percentage of severely affected patients. 4% 5-FU showed 75% clearance of AK's in 80.5% vs 80.2% for 5% 5-FU with superior tolerability.
CONCLUSIONS
4% 5-FU cream is a novel, efficacious, superior tolerated once daily topical treatment for better compliance and treatment outcome. The peanut oil component is safe even in peanut-allergic patients.
J Drugs Dermatol. 2016;15(10):1218-1224.
背景
光化性角化病（AK）是一种肿瘤性角化病，也是鳞状细胞癌（SCC）的前驱病变。
目的
我们正在展示一种新型制剂的数据，该制剂为含花生油（Tolak）的水性基质乳膏中的4% 5-氟尿嘧啶（5-FU），每日应用一次，与5% 5-FU每日两次治疗4周进行对比。
方法
1）在121名受试者中进行剂量范围研究，将4% 5-FU乳膏每日一次或两次应用2周或4周及其基质，与5% 5-FU乳膏每日两次应用4周进行比较。2）一项双盲多中心研究，涉及841名受试者，比较4% 5-FU乳膏每日一次与5% 5-FU乳膏每日两次在4周内对AK的非劣效性和安全性，AK临床清除率分别为100%和75%。
结果
4% 5-FU每日一次应用4周，80%的受试者达到100%清除率，100%的受试者达到75%清除率，而5% 5-FU每日两次应用4周的相应比例分别为75%和95%。4% 5-FU每日一次应用2周，60%的受试者达到100%清除率，85%的受试者达到75%清除率。4% 5-FU每日一次应用4周记录了65例不良事件，30%的患者出现应用部位皮肤刺激，而5% 5-FU每日两次应用4周记录了71例事件，60%的患者出现皮肤刺激。4% 5-FU在对受影响更严重患者的亚分析中超出非劣效性1.32%。4% 5-FU在80.5%的患者中显示AK清除率为75%，而5% 5-FU为80.2%，前者耐受性更好。
结论
4% 5-FU乳膏是一种新型、有效、耐受性良好的每日一次局部治疗药物，具有更好的依从性和治疗效果。花生油成分即使在花生过敏患者中也是安全的。《皮肤药物学杂志》2016年；15（10）：1218 - 1224。
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