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新型局部用子囊霉素衍生物SDZ ASM 981在正常皮肤应用4周时不会引起皮肤萎缩:一项随机、双盲对照研究。

The new topical ascomycin derivative SDZ ASM 981 does not induce skin atrophy when applied to normal skin for 4 weeks: a randomized, double-blind controlled study.

作者信息

Queille-Roussel C, Paul C, Duteil L, Lefebvre M C, Rapatz G, Zagula M, Ortonne J P

机构信息

Centre de Pharmacologie Clinique Appliquée à la Dermatologie and Service de Dermatologie, Nice University Hospital, 151 route St Antoine de Ginestière, BP3079 Hôpital de L'Archet II, 06202 Nice cedex 3, Nice, France.

出版信息

Br J Dermatol. 2001 Mar;144(3):507-13. doi: 10.1046/j.1365-2133.2001.04076.x.

DOI:10.1046/j.1365-2133.2001.04076.x
PMID:11260007
Abstract

BACKGROUND

SDZ ASM 981 is a selective inhibitor of inflammatory cytokines released from T lymphocytes and mast cells, which has been developed for the treatment of inflammatory skin diseases.

OBJECTIVES

In the present study, the atrophogenic potential of SDZ ASM 981 1% cream in humans was compared with that of medium and highly potent topical steroids, and vehicle.

METHODS

Four different preparations, SDZ ASM 981 1% cream, the corresponding vehicle of SDZ ASM 981 1% cream, betamethasone-17-valerate 0.1% cream and triamcinolone acetonide 0.1% cream, were applied to the volar aspect of the forearms of 16 healthy volunteers, twice daily, 6 days a week, for 4 weeks. Skin thickness was evaluated by ultrasound examination, clinical signs of atrophy by stereomicroscopy, and epidermal thickness was assessed by histology.

RESULTS

Both topical corticosteroids induced a significant reduction in skin thickness, as compared with SDZ ASM 981 1% cream and vehicle, which were shown to be equivalent. The difference in skin thickness (measured by ultrasound examination) between patients treated with SDZ ASM 981 1% cream and those receiving either of the two topical steroids was significant from day 8 onwards. Histological analysis performed at day 29 showed significant epidermal thinning with topical steroids compared with SDZ ASM 981 1% cream or the vehicle. Conclusion The lack of atrophogenic properties of SDZ ASM 981 1% cream in this short-term study demonstrates its potential as long-term treatment for inflammatory skin diseases, thus overcoming a major drawback of topical steroids. This may also be important for the treatment of children, and sensitive areas of skin, such as the face and skin-folds.

摘要

背景

SDZ ASM 981是一种从T淋巴细胞和肥大细胞释放的炎性细胞因子的选择性抑制剂,已被开发用于治疗炎性皮肤病。

目的

在本研究中,将1% SDZ ASM 981乳膏在人体中的致萎缩潜力与中效和强效外用类固醇以及赋形剂进行比较。

方法

将四种不同制剂,即1% SDZ ASM 981乳膏、1% SDZ ASM 981乳膏的相应赋形剂、0.1%倍他米松-17-戊酸酯乳膏和0.1%曲安奈德乳膏,每天两次,每周6天,涂抹于16名健康志愿者前臂的掌侧,持续4周。通过超声检查评估皮肤厚度,通过体视显微镜评估萎缩的临床体征,并通过组织学评估表皮厚度。

结果

与显示等效的1% SDZ ASM 981乳膏和赋形剂相比,两种外用皮质类固醇均导致皮肤厚度显著降低。从第8天起,使用1% SDZ ASM 981乳膏治疗的患者与接受两种外用类固醇之一治疗的患者之间的皮肤厚度差异(通过超声检查测量)显著。在第29天进行的组织学分析显示,与1% SDZ ASM 981乳膏或赋形剂相比,外用类固醇导致明显的表皮变薄。结论在这项短期研究中,1% SDZ ASM 981乳膏缺乏致萎缩特性,证明了其作为炎性皮肤病长期治疗药物的潜力,从而克服了外用类固醇的一个主要缺点。这对于儿童以及面部和皮肤褶皱等皮肤敏感部位的治疗也可能很重要。

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