Department of Dermatology, Institute of Clinical Research in Malmö, Skåne University Hospital, Lund University, SE 205 02 Malmö.
Curr Med Res Opin. 2011 Jul;27(7):1395-406. doi: 10.1185/03007995.2011.582483. Epub 2011 May 12.
A systematic review and meta-analysis was conducted to determine the efficacy and tolerability of tacrolimus ointment for the treatment of atopic dermatitis (AD) compared with topical corticosteroids.
Electronic searches were performed in Medline, Embase and the Cochrane Library, as well as relevant conference proceedings. Two researchers independently selected trials investigating the efficacy and/or safety of tacrolimus ointment in the treatment of AD. No language restrictions were applied. Relevant outcome data from included trials were extracted by two independent reviewers. Direct meta-analysis to calculate relative risks (RR) (95% confidence intervals (CIs)) was conducted on dichotomous efficacy/safety outcomes of interest.
Seventeen trials comparing tacrolimus ointment with topical corticosteroids in both paediatric (n = 2328) and adult (n = 2849) patients were identified. No studies comparing tacrolimus ointment with class IV topical corticosteroids were identified. Tacrolimus 0.1% ointment was found to be of similar efficacy to class I/II and class III topical corticosteroids. In three individual trials (comparing tacrolimus 0.1% ointment to a topical corticosteroid), evaluation of the Physician's Global Evaluation of Clinical Response (PGECR) resulted in RRs of 0.95 (95% CI 0.78-1.16), 3.09 (95% CI 2.14-4.45) and 1.35 (95% CI 0.86-2.12), where values above one favour tacrolimus ointment. With the exception that tacrolimus ointment caused more skin burning than comparator treatments (tacrolimus 0.03% versus a class III topical corticosteroid, the RR was 3.00 (95% CI 1.21-7.43) in favour of the corticosteroid), no significant differences with regards to side-effects and withdrawals due to AEs were found. Quality of life data were reported in two studies. While one study reported greater improvements in tacrolimus-treated adult patients compared with topical steroids, the second reported greater improvements in paediatric patients treated with steroids compared with tacrolimus ointment.
The current review and meta-analysis showed tacrolimus ointment to be of similar efficacy to corticosteroids. The interpretation of available data is limited by heterogeneity in outcome measures between trials. Further trials are needed to assess the impact of treatments on patient reported outcomes.
系统评价和荟萃分析旨在确定他克莫司软膏治疗特应性皮炎（AD）的疗效和耐受性与局部皮质类固醇相比。
在 Medline、Embase 和 Cochrane 图书馆以及相关会议记录中进行了电子检索。两名研究人员独立选择了研究他克莫司软膏治疗 AD 的疗效和/或安全性的试验。未应用语言限制。由两名独立评审员提取纳入试验的相关结局数据。对感兴趣的二分类疗效/安全性结局进行直接荟萃分析以计算相对风险（RR）（95%置信区间（CI））。
共确定了 17 项比较他克莫司软膏与局部皮质类固醇在儿科（n = 2328）和成人（n = 2849）患者中的疗效和/或安全性的试验。未发现比较他克莫司软膏与 IV 类局部皮质类固醇的研究。他克莫司 0.1%软膏与 I/II 类和 III 类局部皮质类固醇的疗效相当。在三项单独的试验中（比较他克莫司 0.1%软膏与一种局部皮质类固醇），对医生整体临床疗效评估（PGECR）的评估得出 RR 分别为 0.95（95%CI 0.78-1.16）、3.09（95%CI 2.14-4.45）和 1.35（95%CI 0.86-2.12），高于 1 的值有利于他克莫司软膏。除了他克莫司软膏引起的皮肤烧灼感比对照治疗更严重（他克莫司 0.03%与 III 类局部皮质类固醇相比，RR 为 3.00（95%CI 1.21-7.43）有利于皮质类固醇）外，未发现关于不良反应和因 AE 停药的有意义差异。两项研究报告了生活质量数据。虽然一项研究报告称成年患者接受他克莫司治疗的改善程度大于皮质类固醇，而第二项研究报告称接受皮质类固醇治疗的儿科患者的改善程度大于他克莫司软膏。
本综述和荟萃分析显示，他克莫司软膏与皮质类固醇的疗效相当。由于试验之间的结局测量存在异质性，对现有数据的解释受到限制。需要进一步的试验来评估治疗对患者报告结局的影响。
