1%吡美莫司乳膏对婴幼儿特应性皮炎的长期控制：一项为期两年的研究。
Long-term control of atopic dermatitis with pimecrolimus cream 1% in infants and young children: a two-year study.
作者信息
Papp Kim A, Werfel Thomas, Fölster-Holst Regina, Ortonne Jean-Paul, Potter Paul C, de Prost Yves, Davidson Miles J, Barbier Nathalie, Goertz Hans-Peter, Paul Carle
机构信息
Probity Medical Research, Hannover Medical University, Waterloo, Ontario, Canada.
出版信息
J Am Acad Dermatol. 2005 Feb;52(2):240-6. doi: 10.1016/j.jaad.2004.09.016.
OBJECTIVE AND METHODS
The safety and efficacy of treatment with pimecrolimus cream 1% was evaluated for up to 2 years in infants and young children with atopic dermatitis. Ninety-one patients participated in a 1-year, open-label extension to a 1-year double-blind study. Of these, 76 received pimecrolimus for 2 years. Pimecrolimus was applied twice daily at the first signs or symptoms of the disease until clearance. Outcome measures included the incidence of adverse events and the Eczema Area and Severity Index (EASI).
RESULTS
No patient discontinued because of adverse events. The incidence of systemic and skin infections did not increase over time. Over the 2-year period, 2 patients experienced an episode of clinically diagnosed eczema herpeticum. In patients receiving pimecrolimus for 2 years, the mean decrease in EASI score from baseline was 68.7% at 3 months and 70.8% at 24 months.
CONCLUSION
Treatment with pimecrolimus cream 1% for up to 2 years was well tolerated and resulted in a marked and sustained improvement of atopic dermatitis.
目的与方法
对1%吡美莫司乳膏治疗婴幼儿特应性皮炎长达2年的安全性和有效性进行评估。91名患者参与了一项为期1年的开放标签研究，该研究是在一项为期1年的双盲研究基础上进行的。其中，76名患者接受了2年的吡美莫司治疗。在疾病出现最初体征或症状时，每天两次外用吡美莫司，直至皮疹消退。观察指标包括不良事件的发生率和湿疹面积及严重程度指数（EASI）。
结果
无患者因不良事件停药。全身及皮肤感染的发生率未随时间增加。在2年期间，2名患者发生了临床诊断的疱疹样湿疹。接受2年吡美莫司治疗的患者，EASI评分较基线的平均降幅在3个月时为68.7%，在24个月时为70.8%。
结论
1%吡美莫司乳膏治疗长达2年耐受性良好，可显著并持续改善特应性皮炎。
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