Department of Dermatology and Venereology, J.-W. Goethe University School of Medicine, Frankfurt, Germany.
Dermatology. 2010;221(4):342-51. doi: 10.1159/000320125. Epub 2010 Nov 22.
To evaluate the systemic exposure of pimecrolimus cream 1% applied under occlusion in atopic dermatitis (AD) patients.
A noncomparative, open-label study conducted in 3 groups of moderate to severe AD patients: A (adults, n = 9), B (adolescents, n = 4) and C (children, n = 6). Pimecrolimus cream 1% was applied twice daily for 8.5 days with overnight occlusion in patients with investigator's global assessment scores of ≥3 and AD involving at least 30% of their body surface area. Pimecrolimus blood concentrations were analyzed.
The highest pimecrolimus blood concentrations observed in adults, adolescents and children were 1.84, 0.55 and 1.29 ng/ml, respectively. Pimecrolimus blood concentrations and affected body surface area showed no apparent correlation.
No measurable differences were found in pimecrolimus blood concentrations, efficacy and safety profile when pimecrolimus cream 1% was applied under occlusion versus application without occlusion. These findings reflect the high lipophilic properties of pimecrolimus.
评估在特应性皮炎(AD)患者中使用封包治疗时 1%吡美莫司乳膏的全身暴露情况。
在 3 组中重度 AD 患者中进行了一项非对照、开放性研究:A 组(成人,n=9)、B 组(青少年,n=4)和 C 组(儿童,n=6)。对于研究者整体评估评分≥3 分且 AD 累及至少 30%体表面积的患者,每天应用吡美莫司乳膏 1%两次,连续 8.5 天并进行过夜封包。分析吡美莫司的血药浓度。
成人、青少年和儿童观察到的吡美莫司血药浓度最高值分别为 1.84、0.55 和 1.29ng/ml。吡美莫司血药浓度与受累体表面积之间无明显相关性。
当 1%吡美莫司乳膏进行封包治疗与非封包治疗时,吡美莫司的血药浓度、疗效和安全性特征无明显差异。这些发现反映了吡美莫司的高亲脂性。