Tzellos Thrasivoulos George, Kouvelas Dimitrios
Department of Pharmacology, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Eur J Clin Pharmacol. 2008 Apr;64(4):337-41. doi: 10.1007/s00228-007-0421-2. Epub 2007 Dec 20.
Lesions of cutaneous lupus erythematosus (CLE) are refractory to a wide range of topical or systemic therapies. The pathogenesis of CLE is multifactorial and polygenic, and many of its details remain unclear. However, immunologic evidence suggests the possible therapeutic use of tacrolimus and pimecrolimus. CLE is one of the most common dermatological autoimmune disorders worldwide, which includes systemic lupus erythematosus (SLE) with malar rash, subacute cutaneous lupus erythematosus (SCLE) and discoid lupus erythematosus (DLE).
Our aim was to determine the efficacy of topical pimecrolimus and tacrolimus in the treatment of cutaneous lupus erythematosus.
The literature was systematically reviewed. Medline, Embase, and the Cochrane Database were searched for systemic reviews, randomised controlled trials and nonrandomised clinical trials using the search terms "pimecrolimus", "Elidel", "SDZ ASM 981", "tacrolimus", "Protopic", "FK506" and "cutaneous lupus erythematosus". Studies were assessed independently by two authors.
Five studies were eligible for inclusion in this review. Only one of them was a randomised controlled trial (RCT). There was no significant difference between tacrolimus and clobetasol; however, evidence indicates the highest tolerability of tacrolimus compared with corticosteroids. This review indicates the efficacy of tacrolimus and pimecrolimus in, at least initial, cutaneous lesions of SLE. However, in SCLE and DLE lesions, the efficacy appears to be lower, perhaps due to the chronicity of those lesions.
The lack of RCTs is characteristic. Future studies should focus on efficacy, short- and long-term effects and cost-effectiveness. However, tacrolimus and pimecrolimus show efficacy, and such effort is worthwhile.
皮肤型红斑狼疮（CLE）的皮损对多种局部或全身治疗均难治。CLE的发病机制是多因素和多基因的，其许多细节仍不清楚。然而，免疫学证据提示他克莫司和吡美莫司可能具有治疗作用。CLE是全球最常见的皮肤自身免疫性疾病之一，包括伴有蝶形红斑的系统性红斑狼疮（SLE）、亚急性皮肤型红斑狼疮（SCLE）和盘状红斑狼疮（DLE）。
我们的目的是确定外用吡美莫司和他克莫司治疗皮肤型红斑狼疮的疗效。
对文献进行系统综述。在Medline、Embase和Cochrane数据库中检索系统评价、随机对照试验和非随机临床试验，检索词为“吡美莫司”、“爱宁达”、“SDZ ASM 981”、“他克莫司”、“普特彼”、“FK506”和“皮肤型红斑狼疮”。由两位作者独立评估研究。
五项研究符合纳入本综述的条件。其中只有一项是随机对照试验（RCT）。他克莫司和丙酸氯倍他索之间无显著差异；然而，证据表明他克莫司与皮质类固醇相比耐受性最高。本综述表明他克莫司和吡美莫司至少对SLE的初始皮肤损害有效。然而，在SCLE和DLE皮损中，疗效似乎较低，可能是由于这些皮损的慢性病程所致。
缺乏RCT是其特点。未来的研究应关注疗效、短期和长期影响以及成本效益。然而，他克莫司和吡美莫司显示出疗效，这样的努力是值得的。
