Rallis E, Nasiopoulou A, Kouskoukis C, Roussaki-Schulze A, Koumantaki E, Karpouzis A, Arvanitis A
Department of Dermatology, Veterans Administration Hospital (NIMTS) of Athens, Athens, Greece.
Drugs Exp Clin Res. 2005;31(4):141-5.
Tacrolimus is an immunomodulatory agent that inhibits the activation and maturation of T-cells and blocks transcriptional activation of several cytokine genes. It also interferes with the function of Langerhans cells, basophil cells and mast cells. Recent studies have demonstrated the efficacy of topical tacrolimus in inflammatory skin disorders. Our objective was to assess the efficacy of topical treatment with tacrolimus ointment 0.1% in patients with psoriasis on the anogenital region and the face. Included in the study were 10 patients with a long-standing history of genital and facial psoriasis, partially controlled with periodic use of topical corticosteroids. Tacrolimus ointment 0.1% was applied twice daily for 10 days. The patients were followed-up every 3 weeks for a total period of 12 weeks. The severity of psoriasis was evaluated in all patients at baseline (day 0) and at the end of weeks 3, 6, 9 and 12. Clinical severity of erythema, scaling, infiltration and lesional extent were graded using a 0-3 scale indicating none, mild, moderate and severe expression, at baseline and at follow-ups. An overall severity score of 0 (clear), 1-4 (mild), 5-8 (moderate) or 9-12 (severe) was then assigned to each patient by adding the scores for the above parameters. On each visit, every patient was evaluated clinically. The decision to reapply the drug was determined by the clinical response of each patient at each visit. At the end of the study, patients also assessed efficacy, safety and tolerance after topical application of tacrolimus ointment using a 0-5 scale for each parameter: A marked improvement was noticed in all patients at the end of the first week without drug-related adverse effects. There were 15 recurrences during the 12-week period in all patients. In conclusion, tacrolimus ointment 0.1% seems to represent a safe new option for the treatment of genital and facial psoriasis. Further studies are probably needed to specify the therapeutic dosage and maintenance therapy
他克莫司是一种免疫调节剂，可抑制T细胞的激活和成熟，并阻断多种细胞因子基因的转录激活。它还会干扰朗格汉斯细胞、嗜碱性粒细胞和肥大细胞的功能。最近的研究表明局部应用他克莫司对炎症性皮肤病有效。我们的目的是评估0.1%他克莫司软膏局部治疗肛门生殖器区域和面部银屑病患者的疗效。该研究纳入了10例有长期生殖器和面部银屑病病史的患者，他们通过定期使用外用糖皮质激素得到部分控制。0.1%他克莫司软膏每天涂抹两次，共10天。患者每3周随访一次，共随访12周。在基线（第0天）以及第3、6、9和12周结束时对所有患者的银屑病严重程度进行评估。在基线和随访时，使用0-3级对红斑、脱屑、浸润和皮损范围的临床严重程度进行分级，分别表示无、轻度、中度和重度表现。然后通过将上述参数的评分相加，为每位患者分配一个0（清除）、1-4（轻度）、5-8（中度）或9-12（重度）的总体严重程度评分。每次就诊时，对每位患者进行临床评估。是否重新用药由每位患者每次就诊时的临床反应决定。在研究结束时，患者还使用0-5级量表对局部应用他克莫司软膏后的疗效、安全性和耐受性进行了评估：在第一周结束时，所有患者均有明显改善，且无药物相关不良反应。所有患者在12周期间有15次复发。总之，0.1%他克莫司软膏似乎是治疗生殖器和面部银屑病的一种安全的新选择。可能需要进一步研究来确定治疗剂量和维持治疗方案。
