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外用皮质类固醇和钙调磷酸酶抑制剂治疗特应性皮炎的疗效和耐受性:系统评价和随机对照试验的荟萃分析。

Efficacy and tolerability of proactive treatment with topical corticosteroids and calcineurin inhibitors for atopic eczema: systematic review and meta-analysis of randomized controlled trials.

机构信息

Department of Dermatology, University Hospital Carl Gustav Carus, Technical University Dresden, D-01307 Dresden, Germany.

出版信息

Br J Dermatol. 2011 Feb;164(2):415-28. doi: 10.1111/j.1365-2133.2010.10030.x. Epub 2010 Nov 23.

DOI:10.1111/j.1365-2133.2010.10030.x
PMID:20819086
Abstract

BACKGROUND

Long-term low-level topical anti-inflammatory therapy has been suggested as a new paradigm in the treatment of atopic eczema (AE).

OBJECTIVES

To determine the efficacy and tolerability of topical corticosteroids and calcineurin inhibitors for flare prevention in AE.

METHODS

Systematic review of randomized controlled trials reporting efficacy of topical corticosteroids and/or topical calcineurin inhibitors for flare prevention in AE. Identification of relevant articles by systematic electronic searches (Cochrane Library, Medline) supplemented by hand search. Primary efficacy endpoint: proportion of participants experiencing at least one flare during proactive anti-inflammatory treatment. Relative risks (RRs) and corresponding 95% confidence intervals (CIs) were calculated and pooled by pharmaceutical agent using random-effects meta-analysis. Sensitivity analysis included meta-regression to explore the influence of study-specific covariates.

RESULTS

Nine articles reporting on eight vehicle-controlled trials were included. Three, four and one trial(s) evaluated proactive therapy with topical tacrolimus, fluticasone propionate and methylprednisolone aceponate, respectively. Each agent under study was more efficacious to prevent flares than vehicle. Meta-analysis suggested that topical fluticasone propionate (RR 0·46, 95% CI 0·38-0·55) may be more efficacious to prevent disease flares than topical tacrolimus (RR 0·78, 95% CI 0·60-1·00). Meta-regression indicated robustness of these findings. Proactive anti-inflammatory therapy was generally well tolerated. The trials identified, however, do not allow firm conclusions about long-term safety.

CONCLUSIONS

Vehicle-controlled trials indicate efficacy of proactive treatment with tacrolimus, fluticasone propionate and methylprednisolone aceponate to prevent AE flares. Indirect evidence from vehicle-controlled trials suggests that twice weekly application of the potent topical corticosteroid fluticasone propionate may be more efficacious to prevent AE flares than tacrolimus ointment. Head to head trials should be conducted to confirm these results. Future studies are also needed to evaluate the long-term safety of proactive treatment of AE.

摘要

背景

长期低水平局部抗炎治疗被认为是特应性皮炎(AE)治疗的新范例。

目的

确定局部皮质类固醇和钙调神经磷酸酶抑制剂预防 AE 发作的疗效和耐受性。

方法

系统评价报告预防 AE 发作的局部皮质类固醇和/或局部钙调神经磷酸酶抑制剂疗效的随机对照试验。通过系统电子搜索(Cochrane 图书馆,Medline)确定相关文章,并辅以手工搜索。主要疗效终点:在主动抗炎治疗中至少有一名参与者经历过一次发作的比例。使用随机效应荟萃分析计算和汇总药物制剂的相对风险(RR)和相应的 95%置信区间(CI)。敏感性分析包括元回归,以探索研究特定协变量的影响。

结果

纳入了 9 篇报告 8 项对照试验的文章。三项、四项和一项试验分别评估了外用他克莫司、丙酸氟替卡松和醋酸甲泼尼龙的主动治疗。每种研究药物在预防发作方面均优于载体。荟萃分析表明,外用丙酸氟替卡松(RR 0.46,95%CI 0.38-0.55)预防疾病发作可能优于外用他克莫司(RR 0.78,95%CI 0.60-1.00)。元回归表明这些发现是稳健的。主动抗炎治疗通常耐受性良好。然而,这些试验并不能确定长期安全性的可靠结论。

结论

对照试验表明,他克莫司、丙酸氟替卡松和醋酸甲泼尼龙的主动治疗可有效预防 AE 发作。来自对照试验的间接证据表明,每周两次应用强效局部皮质类固醇丙酸氟替卡松预防 AE 发作可能比他克莫司软膏更有效。应进行头对头试验以确认这些结果。还需要进行未来的研究来评估 AE 主动治疗的长期安全性。

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