Singalavanija Srisuphaluk, Noppakun Noppadon, Limpongsanuruk Wanida, Wisuthsarewong Wanee, Aunhachoke Kobkul, Chunharas Amornsri, Wananukul Siriwan, Akaraphanth Rutsanee
Dermatology Unit, Queen Sirikit National Institute of Child Health, Bangkok 10400, Thailand.
J Med Assoc Thai. 2006 Nov;89(11):1915-22.
Atopic dermatitis (AD) is an immunological skin disease. It is common in pediatric populations and often requires topical steroid treatment. Moderate to severe AD may not respond to topical steroids. They often require systemic steroids, which may result in growth retardation. Protopic, a non-steroid, tacrolimus based ointment which is a calcinurin inhibitor has been proved to be effective in caucacian with AD.
To evaluate safety and efficacy of 0.03% tacrolimus ointment (Protopic&) in moderate to severe AD in pediatric patients age 2-12 years.
This was a one month multicenter open-label clinical trial using tacrolimus ointment twice daily in 61 subjects with moderate to severe AD from September to December 2004. Efficacy assessments were measured by Physician's Global Evaluation of Clinical Response (PhGECR), Eczema area and Severity Index (EASI), Patient's Global Evaluation of Clinical Response (PaGECR), and Quality of Life (QOL). Safety assessment was measured by incidence rate of adverse events.
Fifty-eight patients completed the studies. Twenty-two patients were male; thirty-nine patients were female. Twenty-nine patients had moderate AD. Thirty-two patients had severe AD. Three cases had discontinued treatment at the third week due to increase in severity. Over all PhGECR were significantly increased, 94% showed moderate improvement in PhGECR at week 4 or end of treatment (EOT)and 83% had better improvement in PaGECR at EOT Within 7 days, tacrolimus demonstrated rapid onset in reduction of EASI score and itch in patients. Mean QOL were significantly decreased at the end of the present study. Incidence of adverse events included application site burning (21%), itching (17%), pruritus (9%), infections(3%), and erythema and folliculitis (2%). Burning sensation, erythema, pruritus and itching were resolved after the first week.
Topical tacrolimus ointment is effective and safe in moderate to severe AD. It significantly improved PhGECR, EASI, PaGECR, and QOL in pediatric patients after the first week of treatment and continued through the end of the study. The major adverse events were burning, itching, and pruritus, which were resolved within the first week of therapy.
特应性皮炎（AD）是一种免疫性皮肤病。它在儿童群体中很常见，通常需要局部使用类固醇治疗。中度至重度AD可能对局部类固醇无反应。它们通常需要全身使用类固醇，这可能导致生长发育迟缓。普特彼（Protopic）是一种非类固醇的、基于他克莫司的软膏，属于钙调神经磷酸酶抑制剂，已被证明对患有AD的白种人有效。
评估0.03%他克莫司软膏（普特彼）对2至12岁中度至重度AD患儿的安全性和有效性。
这是一项为期1个月的多中心开放标签临床试验，于2004年9月至12月对61例中度至重度AD患者每日两次使用他克莫司软膏。疗效评估通过医生对临床反应的整体评估（PhGECR）、湿疹面积和严重程度指数（EASI）、患者对临床反应的整体评估（PaGECR）以及生活质量（QOL）进行测量。安全性评估通过不良事件发生率进行测量。
58例患者完成了研究。22例为男性；39例为女性。29例患有中度AD。32例患有重度AD。3例在第三周因病情加重而停止治疗。总体而言，PhGECR显著提高，94%的患者在第4周或治疗结束时（EOT）显示PhGECR有中度改善，83%的患者在EOT时PaGECR有更好的改善。在7天内，他克莫司在降低患者的EASI评分和瘙痒方面起效迅速。在本研究结束时，平均生活质量显著下降。不良事件的发生率包括用药部位烧灼感（21%）、瘙痒（17%）、瘙痒症（9%）、感染（3%）以及红斑和毛囊炎（2%）。烧灼感、红斑、瘙痒症和瘙痒在第一周后消退。
局部使用他克莫司软膏对中度至重度AD有效且安全。在治疗的第一周后，它显著改善了患儿的PhGECR、EASI、PaGECR和生活质量，并持续到研究结束。主要不良事件为烧灼感、瘙痒和瘙痒症，在治疗的第一周内消退。
Zotero 插件