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一项随机、双盲、安慰剂对照研究,以评估12%乳酸铵洗剂和0.05%丙酸氯倍他索软膏在银屑病治疗和维持治疗中的安全性和有效性。

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Ammonium Lactate Lotion 12% and Halobetasol Propionate Ointment 0.05% in the Treatment and Maintenance of Psoriasis.

作者信息

Emer Jason J, Frankel Amylynne, Sohn Andrew, Lebwohl Mark

机构信息

Mount Sinai School of Medicine, Department of Dermatology, New York, New York.

出版信息

J Clin Aesthet Dermatol. 2011 Feb;4(2):28-39.

PMID:21386955
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3050619/
Abstract

Consensus recommends a gradual reduction in the frequency or steroid potency of topical corticosteroids following clinical improvement in the treatment of psoriasis, although no established guidelines have been developed. The authors sought to evaluate a combination regimen in the treatment and maintenance of psoriasis. Patients with mild-to-moderate psoriasis were enrolled (n=55) in a randomized, double-blind, placebo-controlled study using ammonium lactate lotion and halobetasol ointment. Those with initial improvement of target plaques after two weeks of combination treatment twice daily were randomized to a maintenance phase (n=41). Patients applied ammonium lactate lotion twice daily everyday and either placebo ointment (n=20) or steroid ointment (n=21) twice daily on weekends only. Forty-one of 55 patients (74.6%) were rated as "clear" (0) or "almost clear" (1) after two weeks of combination treatment. In the maintenance phase, the probability of physician global assessment worsening at six weeks in the steroid group was only 10 percent while in the placebo group the probability rose to 75 percent (p<0.0001). The probability of physician global assessment worsening climbed to 100 percent by 14 weeks in the placebo group while only increasing to 29 percent in the steroid group (p<0.0001). Twelve patients at study termination still had not worsened. Worsening of the physician global assessment index was more likely (HR 7.8 [2.84, 21.43]) in the placebo group than in the steroid group (p<0.0001). No cutaneous side effects, such as steroid atrophy or irritation, were noted. Combination treatment effectively cleared plaque psoriasis initially, and ammonium lactate twice daily everyday with weekend-only applications of halobetasol ointment effectively sustained the initial improvement for a significantly longer period of time when compared with placebo without demonstrating any significant side effects, such as steroid atrophy.

摘要

虽然尚未制定既定指南,但共识建议在银屑病治疗临床改善后逐渐降低外用糖皮质激素的频率或效力。作者试图评估一种联合方案用于银屑病的治疗和维持。轻度至中度银屑病患者(n = 55)被纳入一项使用乳酸铵洗剂和卤倍他索软膏的随机、双盲、安慰剂对照研究。那些在每日两次联合治疗两周后目标斑块有初步改善的患者被随机分为维持阶段(n = 41)。患者每天使用乳酸铵洗剂两次,仅在周末每天使用两次安慰剂软膏(n = 20)或类固醇软膏(n = 21)。55名患者中有41名(74.6%)在联合治疗两周后被评为“清除”(0)或“几乎清除”(1)。在维持阶段,类固醇组在六周时医生整体评估恶化的概率仅为10%,而安慰剂组该概率升至75%(p<0.0001)。安慰剂组在14周时医生整体评估恶化的概率攀升至100%,而类固醇组仅增至29%(p<0.0001)。研究结束时12名患者仍未恶化。安慰剂组医生整体评估指数恶化的可能性比类固醇组更高(风险比7.8 [2.84, 21.43])(p<0.0001)。未观察到皮肤副作用,如类固醇萎缩或刺激。联合治疗最初有效清除斑块状银屑病,与安慰剂相比,每天两次使用乳酸铵并仅在周末使用卤倍他索软膏能有效维持初始改善状态的时间显著更长,且未显示出任何明显的副作用,如类固醇萎缩。

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本文引用的文献

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