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标准药物治疗对特应性皮炎患者生活质量的影响。

Effect of standard medication on quality of life of patients with atopic dermatitis.

作者信息

Kawashima Makoto, Harada Shotaro

机构信息

Department of Dermatology, Tokyo Women's Medical University, Shinjuku-ku, Japan.

出版信息

J Dermatol. 2007 Jan;34(1):9-16. doi: 10.1111/j.1346-8138.2007.00209.x.

Abstract

Patients with atopic dermatitis present with debilitating symptoms, including pruritus and subsequent excoriation, which significantly reduces their quality of life (QOL). At present, the standard therapy for atopic dermatitis constitutes a topical steroid and/or a topical immunomodulator, an emollient and an oral antihistamine, although few studies have reported the effect of this treatment regimen on QOL. The current study aimed to verify the efficacy of the standard therapy for both clinical symptom severity and patient QOL, assessed using the validated Skindex-16 questionnaire. Atopic dermatitis patients receiving the standard therapy (n=771) were enrolled in the current phase IV, multicenter, 12-week, open-label study. The Rajka and Langeland scale (used to rate the severity of atopic dermatitis symptoms) and the Skindex-16 QOL questionnaire were completed at weeks 0 (baseline), 4 and 12. Of 415 patients completing the questionnaire at all time points (per-protocol population), 95.2% were prescribed the antihistamine fexofenadine HCl 60 mg. There were significant improvements in symptoms, emotions and functioning scale scores at weeks 4 and 12 compared with baseline (P<0.005). Discomfort associated with itching, as assessed by item 1 on the Skindex-16, improved over the treatment period (score decreased by >or=1 and >or=2 in 75.2% and 50.9% of patients, respectively). Significant (P<0.005) improvements from baseline in global scores were also observed at weeks 4 and 12, and for week 12 compared with week 4. Severity scores improved significantly (P<0.005) from weeks 0-4 and from weeks 4-12. The standard therapy was generally well tolerated with only mild adverse events reported (0.5%). These data suggest that patients with atopic dermatitis and associated pruritus experience significant improvements in both symptom severity and QOL when receiving standard therapy.

摘要

特应性皮炎患者会出现使人衰弱的症状,包括瘙痒及随后的皮肤擦伤,这会显著降低他们的生活质量(QOL)。目前,特应性皮炎的标准治疗包括局部用类固醇和/或局部免疫调节剂、润肤剂和口服抗组胺药,不过很少有研究报告这种治疗方案对生活质量的影响。本研究旨在验证标准治疗对临床症状严重程度和患者生活质量的疗效,使用经过验证的Skindex-16问卷进行评估。接受标准治疗的特应性皮炎患者(n = 771)被纳入了当前的IV期、多中心、12周、开放标签研究。在第0周(基线)、第4周和第12周完成Rajka和Langeland量表(用于评估特应性皮炎症状的严重程度)以及Skindex-16生活质量问卷。在所有时间点完成问卷的415名患者(符合方案人群)中,95.2%的患者被处方了60毫克盐酸非索非那定抗组胺药。与基线相比,在第4周和第12周时,症状、情绪和功能量表评分有显著改善(P < 0.005)。根据Skindex-16的第1项评估,与瘙痒相关的不适在治疗期间有所改善(分别有75.2%和50.9%的患者评分下降≥1和≥2)。在第4周和第12周以及第12周与第4周相比,全球评分与基线相比也有显著(P < 0.005)改善。从第0 - 4周和第4 - 12周,严重程度评分有显著(P < 0.005)改善。标准治疗总体耐受性良好,仅报告了轻度不良事件(0.5%)。这些数据表明,患有特应性皮炎及相关瘙痒的患者在接受标准治疗时,症状严重程度和生活质量均有显著改善。

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