Kawakami T, Soma Y, Morita E, Koro O, Yamamoto S, Nakamura K, Tamaki K, Yajima K, Imaizumi A, Matsunaga R, Murakami N, Kashima M, Mizoguchi M
Department of Dermatology, St. Marianna University School of Medicine, Kawasaki, Japan.
Dermatology. 2001;203(1):32-7. doi: 10.1159/000051700.
Topical corticosteroids are commonly applied in atopic dermatitis (AD) treatment. However, their chronic use may be associated with significant side effects at the application site. Skin atrophy and other undesirable effects are frequently seen after long-term corticosteroid treatment. In addition, when application of corticosteroids is discontinued, a rebound phenomenon in the facial lesions can occur within several days. Topical tacrolimus, an immunosuppressant currently used to prevent rejection after solid-organ transplantation, presents a potential alternative therapeutic agent for AD.
The present study is the first trial designed to evaluate the efficacy and safety of topically applied tacrolimus ointment after corticosteroid discontinuation without a washout phase in severe, long-term facial AD.
PATIENTS/METHODS: Forty-seven patients with facial refractory AD were recruited, of whom 38 had undergone topical corticosteroid treatment for at least 4 weeks before enrollment (group 1) and the other 9 had not received steroid treatment (group 2). All 47 patients received 0.1% tacrolimus ointment, and the severity index and pruritus score were assessed as an AD clinical activity index every week and compared with baseline data.
Both the severity index and pruritus score improved significantly in group 1 after 1 and 2 weeks of application (p < 0.01, respectively). Group 2 showed the greatest improvement at 4 weeks (p < 0.05). In this trial, none of the patients experienced a rebound phenomenon associated with tacrolimus treatment. A transient sensation of burning at the application site was the only adverse event in 31 of the 47 (66%) enrolled patients, but this condition improved after several days. Spectrophotometric assessment of the facial lesion following treatment revealed significant improvement in group 1 (p < 0.05).
The present results indicate that topical tacrolimus treatment following corticosteroid discontinuation is safe and effective in refractory facial AD.
外用糖皮质激素常用于特应性皮炎(AD)的治疗。然而,长期使用可能会在用药部位产生显著的副作用。长期使用糖皮质激素治疗后,皮肤萎缩和其他不良影响很常见。此外,停用糖皮质激素后,面部皮损可能在数天内出现反跳现象。外用他克莫司是一种目前用于预防实体器官移植后排斥反应的免疫抑制剂,是AD潜在的替代治疗药物。
本研究是首个旨在评估在重度、长期面部AD患者停用糖皮质激素且无洗脱期的情况下,外用他克莫司软膏的疗效和安全性的试验。
患者/方法:招募了47例面部难治性AD患者,其中38例在入组前接受了至少4周的外用糖皮质激素治疗(第1组),另外9例未接受过糖皮质激素治疗(第2组)。所有47例患者均接受0.1%他克莫司软膏治疗,每周评估严重程度指数和瘙痒评分作为AD临床活动指数,并与基线数据进行比较。
第1组在用药1周和2周后,严重程度指数和瘙痒评分均显著改善(p值分别<0.01)。第2组在4周时改善最为明显(p<0.05)。在本试验中,没有患者出现与他克莫司治疗相关的反跳现象。用药部位短暂的烧灼感是47例入组患者中31例(66%)唯一的不良事件,但几天后这种情况有所改善。治疗后面部皮损的分光光度评估显示第1组有显著改善(p<0.05)。
目前的结果表明,停用糖皮质激素后外用他克莫司治疗难治性面部AD是安全有效的。