Long-term management of atopic dermatitis in infants with topical pimecrolimus, a nonsteroid anti-inflammatory drug
Long-term management of atopic dermatitis in infants with topical pimecrolimus, a nonsteroid anti-inflammatory drug
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DOI：
10.1067/mai.2002.126500
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发表时间：
2002-08-01
影响因子：
14.2
通讯作者：
de Prost, Y
中科院分区：
文献类型：
--
作者：
Kapp, A;Papp, K;de Prost, Y
背景：1%吡美莫司乳膏(Elidel，SDZ ASM 981)是一种炎性细胞因子的非类固醇选择性抑制剂，治疗特应性皮炎(AD)有效。在这项为期1年的双盲对照研究中，251名3~23个月的AD婴儿被随机分为4：1组，分别采用基于吡美莫司的治疗方案(n=204)和常规治疗方案(n=47)。这两组人都对干燥的皮肤使用了润肤剂。早期阿尔茨海默病的症状和体征可以用吡美莫司乳膏预防，对照组则用赋形剂治疗。车辆被用来维持失明条件。在出现红斑的情况下，两组都允许使用中等强度的皮质类固醇。结果：与对照组相比，吡美莫司治疗后6个月内红斑发生率显著降低(P<；.001)，6个月内无红斑发生率为67.6%，12个月内无红斑发生率为56.9%，12个月内无红斑发生率为28.3%。吡美莫司组的总体皮质类固醇使用率显著较低：63.7%与34.8%的患者在研究期间根本不使用皮质类固醇。在长期控制瘙痒和AD体征方面，吡美莫司也比对照组更有效。两组不良事件发生率差异无统计学意义。结论：吡美莫司对早期体征和症状的治疗明显改善了婴儿的病程，减少了红斑的发生，提高了AD的总体控制率。吡美莫司是安全的，耐受性良好。
Background: Pimecrolimus cream 1% (Elidel, SDZ ASM 981), a nonsteroid selective inhibitor of inflammatory cytokines, is effective in the treatment of atopic dermatitis (AD). In this study we compared early intervention with pimecrolimus cream with treatment with a vehicle control.Objective: The purpose of this investigation was to assess whether early treatment in infants of AD signs/symptoms with pimecrolimus could influence long-term outcome by preventing disease flares.Methods: In this 1-year, double-blind controlled study, 251 infants aged 3 to 23 months with AD were randomized 4:1 to a pimecrolimus-based regimen (n = 204) or a conventional treatment regimen (n = 47). Both groups used emollients for dry skin. Early AD signs and symptoms were treated either with pimecrolimus cream to prevent flares or, in the control group, with vehicle. Vehicle was used to maintain blinding conditions. In the event of flares, moderately potent corticosteroid was permitted in both groups. The primary efficacy end point was the incidence of flares at 6 months.Results: Pimecrolimus significantly reduced the incidence of flares compared with control treatment (P < .001), with 67.6% versus 30.4% of patients completing 6 months with no flare and 56.9% versus 28.3% completing 12 months with no flare. Overall corticosteroid use was substantially lower in the pimecrolimus group: 63.7% versus 34.8% of patients did not use corticosteroids at all during the study. Pimecrolimus was also more effective than control treatment in the long-term control of pruritus and the signs of AD. There were no clinically significant differences in incidence of adverse events between the 2 treatment groups.Conclusions: Treatment with pimecrolimus of early signs and symptoms significantly modified the disease course in infants by reducing the incidence of flares and improving overall control of AD. Pimecrolimus was safe and well tolerated.