Department of Pediatrics, First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu 210029, China.
Br J Dermatol. 2013 Jan;168(1):172-8. doi: 10.1111/j.1365-2133.2012.11177.x.
Lipoxins are potential anti-inflammatory mediators and serve as an endogenous 'braking signal' in the inflammatory process. Accumulating evidence has indicated the efficacy of lipoxin A(4) (LXA(4) ) and its analogs in the treatment of many animal models of inflammatory diseases.
This study investigates the efficacy and safety of 15(R/S)-methyl-lipoxin A(4) in the topical treatment of infantile eczema.
In this two-centre, double-blind, placebo-controlled, randomized, parallel-groups comparative study, 60 patients were randomly assigned to receive either the 15(R/S)-methyl-lipoxin A(4) cream, mometasone furoate (Eloson, Schering-Plough, Shanghai, China) or placebo for 10days. The efficacy was determined using the Severity Scale Score (SSS), Eczema Area and Severity Index (EASI) and the Infants' Dermatitis Quality of Life Index (IDQOL). Safety was monitored by physical examination, laboratory investigation and documentation of clinical adverse events.
The treatment of eczema with 15(R/S)-methyl-LXA(4) cream significantly relieved the severity, induced a recovery, and improved the quality of life of the patients, as demonstrated by significantly reduced SSS, EASI and IDQOL, respectively, in a way similar to the efficacy of Eloson. All safety parameters remained within normal limits. No clinical adverse event was found in the three patient groups.
15(R/S)-methyl-LXA(4) was well tolerated, and significantly reduced the severity of eczema. The results of this small exploratory study suggest that 15(R/S)-methyl-LXA(4) warrants further investigation in the treatment of eczema.
脂氧素是潜在的抗炎介质，作为炎症过程中的内源性“制动信号”。越来越多的证据表明脂氧素 A(4)（LXA(4)）及其类似物在治疗许多炎症性疾病的动物模型中具有疗效。
本研究调查 15(R/S)-甲基脂氧素 A(4) 在婴儿湿疹局部治疗中的疗效和安全性。
在这项双中心、双盲、安慰剂对照、随机、平行组比较研究中，60 名患者被随机分配接受 15(R/S)-甲基脂氧素 A(4)乳膏、莫米松糠酸酯（Eloson，Schering-Plough，上海，中国）或安慰剂治疗 10 天。疗效通过严重程度评分（SSS）、湿疹面积和严重程度指数（EASI）和婴儿皮炎生活质量指数（IDQOL）来确定。通过体检、实验室检查和记录临床不良事件来监测安全性。
用 15(R/S)-甲基-LXA(4)乳膏治疗湿疹可显著缓解严重程度，促进恢复，并改善患者的生活质量，这表现在 SSS、EASI 和 IDQOL 分别显著降低，与 Eloson 的疗效相似。所有安全参数均保持在正常范围内。在三个患者组中均未发现临床不良事件。
15(R/S)-甲基-LXA(4)耐受性良好，可显著降低湿疹的严重程度。这项小型探索性研究的结果表明，15(R/S)-甲基-LXA(4)值得进一步研究用于治疗湿疹。
