Kreuter A, Knierim C, Stücker M, Pawlak F, Rotterdam S, Altmeyer P, Gambichler T
Department of Dermatology and Allergology, Ruhr-University Bochum, Gudrunstrasse 56, D-44791 Bochum, Germany.
Br J Dermatol. 2005 Oct;153(4):802-7. doi: 10.1111/j.1365-2133.2005.06762.x.
Necrobiosis lipoidica (NL) is an uncommon granulomatous skin disease with association to diabetes mellitus. To date, no proven effective therapy for NL has been implemented. The standard treatment is topical application of corticosteroids, but numerous agents have been reported for NL, with varying degrees of success. In recent case reports, fumaric acid esters (FAE) have been reported to be effective in granulomatous skin diseases such as granuloma annulare, cutaneous sarcoidosis and NL.
We sought to investigate the efficacy of FAE in a larger number of patients with NL.
Eighteen patients with histopathologically proven NL were consecutively recruited into a prospective noncontrolled study. Dosage of FAE was given according to the standard therapy regimen for psoriasis. FAE were administered for at least 6 months. The treatment outcome was evaluated by means of clinical and histological scoring and 20-MHz ultrasound assessments.
Three patients discontinued therapy with FAE, while the remaining 15 patients finished the study. After a mean +/- SD treatment period of 7.7 +/- 2.9 months, a significant (P < 0.001) decrease in the mean +/- SD clinical score, from 7.4 +/- 1.8 at the beginning to 2.5 +/- 1.3 at the end of therapy, was observed. Significant clinical improvement of NL was accompanied by significant (P = 0.019) increase of dermal density as assessed by means of 20-MHz ultrasound, and significant (P = 0.011) reduction of the histological score. Adverse effects were moderate and consisted mainly of gastrointestinal complaints and flushing. During follow-up of at least 6 months, clinical outcome remained stable in all patients.
The results of this study demonstrate that FAE are beneficial and safe in the treatment of patients with NL.
类脂质渐进性坏死（NL）是一种与糖尿病相关的罕见肉芽肿性皮肤病。迄今为止，尚未实施经证实有效的NL治疗方法。标准治疗是局部应用皮质类固醇，但已有多种药物用于治疗NL，疗效各异。在最近的病例报告中，富马酸酯（FAE）已被报道对环状肉芽肿、皮肤结节病和NL等肉芽肿性皮肤病有效。
我们试图在更多NL患者中研究FAE的疗效。
18例经组织病理学证实为NL的患者连续纳入一项前瞻性非对照研究。FAE的剂量根据银屑病的标准治疗方案给予。FAE给药至少6个月。通过临床和组织学评分以及20兆赫超声评估来评价治疗结果。
3例患者停止使用FAE治疗，其余15例患者完成研究。在平均±标准差为7.7±2.9个月的治疗期后，观察到平均±标准差临床评分显著降低（P<0.001），从治疗开始时的7.4±1.8降至治疗结束时的2.5±1.3。NL的显著临床改善伴随着通过20兆赫超声评估的真皮密度显著增加（P=0.019）以及组织学评分显著降低（P=0.011）。不良反应为中度，主要包括胃肠道不适和潮红。在至少6个月的随访期间，所有患者的临床结果保持稳定。
本研究结果表明，FAE治疗NL患者有益且安全。
Zotero 插件