Fleischer Alan B, Abramovits William, Breneman Debra, Jaracz Eileen
Wake Forest University, Winston-Salem, NC, USA.
J Dermatolog Treat. 2007;18(3):151-7. doi: 10.1080/09546630701287332.
To compare the efficacy and safety of tacrolimus ointment 0.1% and pimecrolimus cream 1% in adult patients with moderate to very severe atopic dermatitis (AD).
A total of 281 patients (141 treated with tacrolimus and 140 treated with pimecrolimus) were randomized to a multicenter, investigator-blinded, 6-week study.
Tacrolimus-treated patients had significantly greater improvements in the Eczema Area Severity Index score compared with pimecrolimus-treated patients (mean percent reduction from baseline to study end: 57% vs 39%, respectively; p=0.0002). Treatment success was also significantly greater among the tacrolimus-treated patients compared with pimecrolimus-treated patients (40% vs 22% at study end; p=0.001), as was the improvement in percentage of total body surface area affected (a reduction of 49% vs 34% at study end; p=0.01). Both treatment groups had similar improvements in patient assessment of itch. There were no significant differences in the incidences of adverse events, including application-site burning and application-site pruritus, the two most commonly reported adverse events. Significantly more pimecrolimus-treated patients than tacrolimus-treated patients withdrew from the study due to lack of efficacy (10 vs 1, p=0.005).
Tacrolimus ointment is more effective than pimecrolimus cream in adults with moderate to very severe AD. Both agents have a similar safety profile.
比较0.1%他克莫司软膏和1%吡美莫司乳膏治疗中度至重度特应性皮炎（AD）成人患者的疗效和安全性。
共281例患者（141例接受他克莫司治疗，140例接受吡美莫司治疗）被随机分配至一项多中心、研究者设盲的6周研究。
与吡美莫司治疗的患者相比，他克莫司治疗的患者湿疹面积和严重程度指数评分改善更显著（从基线至研究结束时的平均降低百分比分别为57%和39%；p=0.0002）。与吡美莫司治疗的患者相比，他克莫司治疗的患者治疗成功率也显著更高（研究结束时为40%对22%；p=0.001），全身受累表面积百分比的改善情况也是如此（研究结束时降低49%对34%；p=0.01）。两个治疗组在患者瘙痒评估方面的改善相似。不良事件发生率，包括最常报告的两种不良事件即用药部位烧灼感和用药部位瘙痒，没有显著差异。因疗效不佳退出研究的吡美莫司治疗患者明显多于他克莫司治疗患者（10例对1例，p=0.005）。
在中度至重度AD成人患者中，他克莫司软膏比吡美莫司乳膏更有效。两种药物的安全性相似。
