Two topical calcineurin inhibitors for the treatment of atopic dermatitis in pediatric patients: A meta-analysis of randomized clinical trials
Two topical calcineurin inhibitors for the treatment of atopic dermatitis in pediatric patients: A meta-analysis of randomized clinical trials
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DOI：
10.3109/09546630903401470
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发表时间：
2010-05-01
影响因子：
2.9
通讯作者：
Wang, Feng-Shan
中科院分区：
文献类型：
--
作者：
Chen, Sheng-Li;Yan, Jun;Wang, Feng-Shan
背景资料：两种新的外用免疫调节剂，吡美莫司乳膏和他克莫司软膏治疗儿童特应性皮炎（AD），提供了替代外用糖皮质激素而无相关不良事件的方法。目的：评价他克莫司软膏和吡美莫司乳膏治疗儿童AD的疗效和安全性。方法：检索了MEDLINE、Embase、CNKI和科克伦图书馆数据库，截止日期为2008年12月。其他数据来源包括对摘要程序的手动检索以及与研究者和制药公司的个人联系。两名研究者独立使用统一的表格对试验质量进行评价。通过与第三作者讨论或协商解决了关于有效性评估的分歧。方法学质量分析采用Jadad评分标准，包括随机化、设盲和患者退出等。结果：共纳入20个试验，涉及6288例婴幼儿AD患者。他克莫司组疗效好的患者多于溶媒组、1%醋酸氢化可的松组和1%吡美莫司组，其OR分别为（4.56; 95%CI：2.80 ~ 7.44）、（3.92; 95%CI：2.96 ~ 5.20）和（1.58; 95%CI：1.18 ~ 2.12）。0.03%他克莫司软膏与0.1%他克莫司软膏的疗效差异无统计学意义（OR = 0.90; 95%CI：0.55 ~ 1.48）。他克莫司软膏或吡美莫司乳膏的不良事件发生率与溶媒相似。主要不良事件为灼热和瘙痒。结论：他克莫司软膏和吡美莫司乳膏治疗儿童AD均安全有效。他克莫司软膏上级优于吡美莫司乳膏。
Background: Two new topical immunomodulators, pimecrolimus cream and tacrolimus ointment for atopic dermatitis (AD) in pediatric patients, have provided alternatives to topical corticosteroids without the associated adverse events.Objective: To evaluate the efficacy and safety of tacrolimus ointment and pimecrolimus cream for the treatment of AD in pediatric patients.Methods: MEDLINE, Embase, the CNKI and Cochrane Library databases were searched up to December 2008. Additional data sources were manual searches of abstract proceedings and personal contact with investigators and pharmaceutical companies. Two investigators assessed the quality of trials with unified tables independently. Disagreements on validity assessment were resolved through discussion or consultation with the third author. Quality analysis of methodology was evaluated according to the Jadad scale, including randomization, blinding and patients' discontinuation.Results: Twenty trials involving 6288 infants and children with AD met the inclusion criteria. More patients using tacrolimus had a good response than those in control groups including vehicle, 1% hydrocortisone acetate and 1% pimecrolimus, the corresponding OR were (4.56; 95%CI: 2.80 to 7.44), (3.92; 95% CI: 2.96 to 5.20) and (1.58; 95% CI: 1.18 to 2.12). The effect difference between 0.03% tacrolimus and 0.1% tacrolimus ointments was not statistically significant (OR = 0.90; 95% CI: 0.55 to 1.48). The incidence of adverse events of tacrolimus ointment or pimecrolimus cream was similar to the vehicle. The major adverse events were burning and pruritus.Conclusions: Both tacrolimus ointment and pimecrolimus cream are safe and effective in the treatment of AD in pediatric patients. Tacrolimus ointments were superior to pimecrolimus cream.