外用钙调神经磷酸酶抑制剂治疗特应性皮炎的疗效与安全性：随机临床试验的荟萃分析
Efficacy and safety of topical calcineurin inhibitors for the treatment of atopic dermatitis: meta-analysis of randomized clinical trials.
作者信息
Abędź Natalia, Pawliczak Rafał
机构信息
Hirszfeld Institute of Immunology and Experimental Therapy, Polish Academy of Sciences, Wroclaw, Poland.
Department of Immunopathology, Chair of Allergology, Immunology and Dermatology, Medical University of Lodz, Lodz, Poland.
出版信息
Postepy Dermatol Alergol. 2019 Dec;36(6):752-759. doi: 10.5114/ada.2019.91425. Epub 2019 Dec 30.
INTRODUCTION
Calcineurin inhibitors, novel topical immunomodulators, may constitute a superior alternative for glucocorticosteroids in atopic dermatitis (AD) topical treatment.
AIM
Determination of efficacy and safety of each topical calcineurin inhibitor (TCI) formulation, 0.3% or 0.1% tacrolimus and 1% pimecrolimus, for the treatment of moderate to severe AD in comparison with glucocorticosteroids.
MATERIAL AND METHODS
Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, GREAT database, trials registers and reference lists were searched up to February 2018. Randomised controlled trials of TCI, compared to corticosteroids (TCS), reporting efficacy or safety outcomes were selected. Quality of trials and evidence of each outcome were evaluated according to Cochrane Collaboration recommendations and tools. The primary outcomes were physician's global assessment of improvement and occurrence of adverse events (AEs).
RESULTS
Fourteen trials involving 7376 children and adults with AD were included. Calcineurin inhibitors were significantly more effective than various potency TCS, neither least potent to lower mid-strength nor mid-strength to potent TCS (RR = 1.24, 95% CI: 1.06-1.44). The major AEs were skin burning and pruritus, their incidence was higher in TCI treatment (RR = 3.32, 95% CI: 2.90-3.80; RR = 1.59, 95% CI: 1.34-1.80).
CONCLUSIONS
Calcineurin inhibitors seem to be more effective and contrarily they elicit more AEs than TCS.
引言
钙调神经磷酸酶抑制剂作为新型局部免疫调节剂，在特应性皮炎（AD）局部治疗中可能是糖皮质激素的一种更优替代药物。
目的
与糖皮质激素相比，确定0.3%或0.1%他克莫司以及1%吡美莫司这几种局部钙调神经磷酸酶抑制剂（TCI）制剂治疗中度至重度AD的疗效和安全性。
材料与方法
检索截至2018年2月的Cochrane对照试验中心注册库（CENTRAL）、MEDLINE、EMBASE、GREAT数据库、试验注册库及参考文献列表。选取将TCI与皮质类固醇（TCS）进行比较并报告疗效或安全性结果的随机对照试验。根据Cochrane协作网的建议和工具评估试验质量及各结果的证据。主要结局为医生对改善情况的整体评估以及不良事件（AE）的发生情况。
结果
纳入了14项涉及7376名AD儿童和成人的试验。钙调神经磷酸酶抑制剂比各种效力的TCS显著更有效，无论是最弱效至中效还是中效至强效的TCS（RR = 1.24，95%CI：1.06 - 1.44）。主要不良事件为皮肤烧灼感和瘙痒，其发生率在TCI治疗中更高（RR = 3.32，95%CI：2.90 - 3.80；RR = 1.59，95%CI：1.34 - 1.80）。
结论
钙调神经磷酸酶抑制剂似乎比TCS更有效，但相反地，它们引发的不良事件更多。
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