Gola Massimo, Carpentieri Antonio, Loconsole Francesco
Allergological and Occupational Dermatology, Azienda USL Toscana Centro, Florence, Italy -
Department of Dermatology, University of Bari, Bari, Italy.
G Ital Dermatol Venereol. 2017 Dec;152(6):560-564. doi: 10.23736/S0392-0488.17.05704-2.
We have conducted an open label, non-comparative study in order to assess the efficacy and tolerability of Dexyane Med in combination with corticosteroids in patients with chronic hand eczema (CHE) and contact eczema (CE) in a real-life setting.
Twenty patients, 10 with CHE and 10 with CE, have been enrolled in the study. After the enrollment and the baseline evaluation, patients were treated with topical mometasone once daily and Dexyane Med once daily for one week, followed by Dexyane Med twice daily for three weeks. After the enrollment visit, patients were seen at the end of treatment, after four weeks. A telephone contact was foreseen at the second week. During the visits, mTLSS Score (CHE patients only), IGA Score and VAS for pruritus and pain were calculated. Patients' satisfaction was recorded during the phone contact after two weeks of treatment and at the final visit. Tolerability was evaluated at the end of the study.
All patients experienced a remarkable improvement in mTLSS Score, IGA Score (from a mean of 2.8 to 0.5) and VAS (from 4.5 to 0.6 for pruritus and from 2.9 to 0.3 for pain). The treatment was well tolerated and all patients were satisfied or very satisfied either at the second week or at the end of the study.
Our study has shown that the treatment of chronic hand eczema and contact eczema with a medical device administered twice a day for three weeks, following a one week treatment in combination with a topical corticosteroid, is effective in decreasing the burden of symptoms and well tolerated. To confirm our data, further controlled trials are warranted in order to explore the efficacy and tolerability of Dexyane Med in different types of eczema.
我们开展了一项开放标签、非对照研究，以评估在现实生活环境中，德克赛恩（Dexyane Med）联合皮质类固醇对慢性手部湿疹（CHE）和接触性湿疹（CE）患者的疗效和耐受性。
本研究纳入了20例患者，其中10例为慢性手部湿疹患者，10例为接触性湿疹患者。在入组和基线评估后，患者接受每日一次外用莫米松和每日一次德克赛恩治疗一周，随后每日两次使用德克赛恩治疗三周。入组访视后，在治疗结束时、四周后对患者进行观察。预计在第二周进行电话随访。在每次访视时，计算mTLSS评分（仅针对慢性手部湿疹患者）、IGA评分以及瘙痒和疼痛的视觉模拟评分（VAS）。在治疗两周后的电话随访以及最后一次访视时记录患者的满意度。在研究结束时评估耐受性。
所有患者的mTLSS评分、IGA评分（从平均2.8降至0.5）和VAS评分（瘙痒从4.5降至0.6，疼痛从2.9降至0.3）均有显著改善。治疗耐受性良好，所有患者在第二周或研究结束时均表示满意或非常满意。
我们的研究表明，对于慢性手部湿疹和接触性湿疹患者，在联合外用皮质类固醇治疗一周后，使用一种医疗器械每日两次治疗三周，可有效减轻症状负担且耐受性良好。为了证实我们的数据，有必要进一步开展对照试验，以探索德克赛恩在不同类型湿疹中的疗效和耐受性。
