评价半胱胺 5%乳膏治疗表皮性黄褐斑的疗效：一项随机、双盲、安慰剂对照试验。
Evaluation of the efficacy of cysteamine 5% cream in the treatment of epidermal melasma: a randomized double-blind placebo-controlled trial.
机构信息
Department of Dermatology, Imam Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Skin and Stem Cell Research Center, Tehran University of Medical Sciences, Tehran, Iran.
出版信息
Br J Dermatol. 2015 Jul;173(1):209-17. doi: 10.1111/bjd.13424. Epub 2015 May 29.
BACKGROUND
Melasma is a difficult-to-treat hyperpigmentary disorder. While cysteamine is a known potent depigmenting agent, its efficacy in treating melasma has not been tested.
OBJECTIVES
To study the efficacy of cysteamine 5% cream in the treatment of patients with epidermal melasma.
METHODS
In this double-blind randomized study, participating patients (n = 50) received either placebo (n = 25) or cysteamine cream (n = 25). Cysteamine cream or placebo were applied on the lesions once a day at bedtime over 4 months. The efficacy of treatments was determined through Mexameter skin colorimetry, Melasma Area Severity Index (MASI) score, Investigator's Global Assessment (IGA) and patients' questionnaires, all performed at baseline and after 2 and 4 months of treatment.
RESULTS
At baseline, the mean differences between pigmented and normal skin (calculated by Mexameter) were 75.2 ± 37 and 68.9 ± 31 in the cysteamine and placebo groups, respectively. After 2 and 4 months of application of cysteamine and placebo cream, the mean differences were 39.7 ± 16.6 and 26.2 ± 16 in the cysteamine group, and 63.8 ± 28.6 and 60.7 ± 27.3 in the placebo group, respectively. Statistically significant differences were found between the group outcomes at both points (P = 0.001 and P < 0.001). At the end of the treatment, the MASI scores were significantly lower in the cysteamine group vs. placebo (7.2 ± 5.5 vs. 11.6 ± 7.9, P = 0.02). The IGA and patients' viewpoints indicated significant efficacy of cysteamine cream vs. placebo.
CONCLUSIONS
Cysteamine cream showed significant efficacy in the treatment of melasma.
背景
黄褐斑是一种难以治疗的色素沉着性疾病。半胱胺是一种已知的强效脱色剂，但尚未对其治疗黄褐斑的疗效进行测试。
目的
研究 5%半胱胺乳膏治疗表皮性黄褐斑患者的疗效。
方法
在这项双盲随机研究中，参与研究的患者（n=50）分为安慰剂组（n=25）和半胱胺乳膏组（n=25）。半胱胺乳膏或安慰剂每天睡前涂于皮损处，持续 4 个月。在基线、治疗 2 个月和 4 个月时，通过 Mexameter 皮肤比色仪、黄褐斑面积严重程度指数（MASI）评分、研究者整体评估（IGA）和患者问卷调查评估治疗效果。
结果
在基线时，半胱胺组和安慰剂组色素沉着皮肤与正常皮肤的平均差异（由 Mexameter 计算）分别为 75.2±37 和 68.9±31。在应用半胱胺乳膏和安慰剂乳膏 2 个月和 4 个月后，半胱胺组的平均差异分别为 39.7±16.6 和 26.2±16，安慰剂组分别为 63.8±28.6 和 60.7±27.3。两组结果在这两个时间点均有统计学差异（P=0.001 和 P<0.001）。治疗结束时，半胱胺组的 MASI 评分明显低于安慰剂组（7.2±5.5 对 11.6±7.9，P=0.02）。IGA 和患者观点表明半胱胺乳膏对黄褐斑有显著疗效。
结论
半胱胺乳膏对黄褐斑有显著疗效。
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