Efficacy and tolerability of topical pimecrolimus and tacrolimus in the treatment of atopic dermatitis: meta-analysis of randomised controlled trials
Efficacy and tolerability of topical pimecrolimus and tacrolimus in the treatment of atopic dermatitis: meta-analysis of randomised controlled trials
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DOI：
10.1136/bmj.38376.439653.d3
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发表时间：
2005-03-05
影响因子：
105.7
通讯作者：
Williams, HC
中科院分区：
文献类型：
--
作者：
Ashcroft, DM;Dimmock, P;Williams, HC
目的确定外用吡美莫司和他克莫司与其他特应性皮炎治疗方法相比的疗效和耐受性。设计系统性综述和荟萃分析。数据来源电子搜索科克伦图书馆、Medline和Embase。研究选择报告疗效结果或耐受性的外用吡美莫司或他克莫司的随机对照试验。数据提取疗效：研究者对反应的全球评估;患者对反应的总体评估;特应性皮炎发作患者的比例;生活质量的改善。耐受性：总的退出率，由于不良事件退出，皮肤灼伤和皮肤感染患者的比例。数据综合在25个随机对照试验中，6897名参与者中有4186名接受吡美莫司或他克莫司治疗。这两种药物都明显比溶剂对照更有效。在3周时，他克莫司0.1%与强效外用皮质类固醇一样有效，在12周时比0.1%丁酸氢化可的松（强效用于躯干）+1%醋酸氢化可的松（弱用于面部）联合治疗更有效（需要治疗的人数（NNT）= 6）。0.1%他克莫司也比1%醋酸氢化可的松更有效（NNT = 4）。相比之下，他克莫司0.03%比醋酸氢化可的松1%（NNT = 5）更有效，但比丁酸氢化可的松0.1%（NNT =-8）效果差。他克莫司0.03%和他克莫司0.1%的直接比较始终有利于更高规格的制剂，但仅在治疗12周后两种规格之间的疗效存在显著差异（率比0.80，95%置信区间0.65至0.99）。匹美司洛尔的疗效远低于戊酸倍他米松0.1%（3周时NNT =-3）。吡美莫司和他克莫司引起的皮肤灼伤明显多于外用皮质类固醇。比较中的皮肤感染率没有差异。结论外用吡美莫司和外用他克莫司治疗特应性皮炎都比安慰剂更有效，但由于缺乏显示长期安全性提高的研究，与外用皮质类固醇相比的任何优势尚不清楚。外用他克莫司与强效外用皮质类固醇相似，可长期用于局部皮质类固醇副作用可能迅速发生的耐药特应性皮炎患者。在缺乏与轻度皮质类固醇的关键比较的情况下。局部吡美莫司的临床需要尚不清楚。对于局部皮质类固醇治疗无效的患者，这两种治疗方法的有效性也不清楚。
Objective To determine the efficacy and tolerability of topical pimecrolimus and tacrolimus compared with other treatments for atopic dermatitis.Design Systematic review and meta-analysis.Data sources Electronic searches of Cochrane Library, Medline, and Embase.Study selection Randomised controlled trials of topical pimecrolimus or tacrolimus reporting efficacy outcomes or tolerability.Data extraction Efficacy: investigators' global assessment of response; patients' global assessment of response; proportions of patients with flares of atopic dermatitis; and improvements in quality of life. Tolerability: overall rates of withdrawal, withdrawal due to adverse events, and the proportions of patients with burning of the skin and skin infections.Data synthesis 4186 of 6897 participants in 25 randomised controlled trials received pimecrolimus or tacrolimus. Both drugs were significantly more effective than a vehicle control. Tacrolimus 0.1% was as effective as potent topical corticosteroids at three weeks and more effective than combined treatment with hydrocortisone butyrate 0.1% (potent used on trunk) plus hydrocortisone acetate 1% (weak used on face) at 12 weeks (number needed to treat (NNT) = 6). Tacrolimus 0.1% was also more effective than hydrocortis one acetate 1% (NNT = 4). In comparison, tacrolimus 0.03% was more effective than hydrocortisone acetate 1% (NNT = 5) but less effective than hydrocortisone butyrate 0.1% (NNT = - 8). Direct comparisons of tacrolimus 0.03% and tacrolimus 0.1% consistently favoured the higher strength formulation, but efficacy differed significantly between the two strengths only after 12 weeks' treatment (rate ratio 0.80, 95% confidence interval 0.65 to 0.99). Pimecrolinius was far less effective than betamethasone valerate 0.1% (NNT = - 3 at three weeks). Pimecrolimus and tacrolimus caused significantly more skin burning than topical corticosteroids. Rates of skin infections in an), of the comparisons did not differ.Conclusions Both topical pimecrolimus and topical tacrolimus are more effective than placebo treatments for atopic dermatitis, but in the absence of studies that show long term safety gains, any advantage over topical corticosteroids is unclear. Topical tacrolimus is similar to potent topical corticosteroids and may have a place for long term use in patients with resistant atopic dermatitis on sites where side effects from topical corticosteroids might develop quickly. In the absence of key comparisons with mild corticosteroids. the clinical need for topical pimecrolimus is unclear. The usefulness of either treatment in patients who have failed to respond adequately to topical corticosteroids is also unclear.