1%伊维菌素乳膏与0.33%溴莫尼定凝胶联合治疗酒渣鼻：一项随机、赋形剂对照研究。

Treatment of Rosacea With Concomitant Use of Topical Ivermectin 1% Cream and Brimonidine 0.33% Gel: A Randomized, Vehicle-controlled Study.

作者信息

Gold Linda Stein, Papp Kim, Lynde Charles, Lain Edward, Gooderham Melinda, Johnson Sandra, Kerrouche Nabil

出版信息

J Drugs Dermatol. 2017 Sep 1;16(9):909-916.

Abstract

BACKGROUND

There is currently a lack of data on the simultaneous treatment of different features of rosacea. Individually, ivermectin 1% (IVM) cream and brimonidine 0.33% (BR) gel have demonstrated efficacy on inflammatory lesions and persistent erythema, respectively.

OBJECTIVE

To evaluate the efficacy, safety, patient satisfaction, and optimal timing of administration of IVM associated with BR (IVM+BR) versus their vehicles in rosacea (investigator global assessment [IGA] ≥3).

METHODS

Multicenter, randomized, double-blind study including subjects with rosacea characterized by moderate to severe persistent erythema and inflammatory lesions. The active treatment group included the IVM+BR/12 weeks subgroup (once-daily BR and once-daily IVM for 12 weeks), and the IVM+BR/8 weeks subgroup (once-daily BR vehicle for 4 weeks followed by once-daily BR for the remaining 8 weeks and once-daily IVM for 12 weeks). The vehicle group received once-daily BR vehicle and once-daily IVM vehicle for 12 weeks.

RESULTS

The association showed superior efficacy (IGA success [clear/almost clear]) for erythema and inflammatory lesions in the total active group (combined active subgroups) compared to vehicle (55.8% vs. 36.8%, P=0.007) at week 12. The success rate increased from 32.7% to 61.2% at hour 0 and hour 3, respectively, in the IVM+BR/12 weeks subgroup, and from 28.3% to 50% in the IVM+BR/8 weeks subgroup. Reductions in erythema and inflammatory lesion counts confirmed the additive effect of BR to IVM treatment. Subjects reported greater improvement in the active subgroups than in the vehicle group, and similar rates for facial appearance satisfaction after the first 4 weeks of treatment in both active subgroups. All groups showed similar tolerability profiles.

CONCLUSION

Concomitant administration of IVM cream with BR gel demonstrated good efficacy and safety, endorsing the comprehensive approach to this complex disease. Early introduction of BR, along with a complete daily skin care regimen may accelerate treatment success without impairing tolerability.

J Drugs Dermatol. 2017;16(9):909-916.

摘要

背景

目前缺乏关于同时治疗酒渣鼻不同特征的数据。单独使用时，1%伊维菌素（IVM）乳膏和0.33%溴莫尼定（BR）凝胶分别对炎症性皮损和持续性红斑显示出疗效。

目的

评估IVM联合BR（IVM+BR）与它们的赋形剂相比，在酒渣鼻（研究者整体评估[IGA]≥3）中的疗效、安全性、患者满意度及最佳给药时机。

方法

多中心、随机、双盲研究，纳入有中度至重度持续性红斑和炎症性皮损特征表现的酒渣鼻患者。活性治疗组包括IVM+BR/12周亚组（BR每日一次，IVM每日一次，共12周）和IVM+BR/8周亚组（BR赋形剂每日一次，共4周，之后BR每日一次，共8周，IVM每日一次，共12周）。赋形剂组接受BR赋形剂每日一次和IVM赋形剂每日一次，共12周。

结果

在第12周时，与赋形剂组相比，联合用药在总活性组（合并活性亚组）中对红斑和炎症性皮损显示出更高的疗效（IGA成功[清除/几乎清除]）（55.8%对36.8%，P=0.007）。在IVM+BR/12周亚组中，0小时和3小时时的成功率分别从32.7%增至61.2%，在IVM+BR/8周亚组中从28.3%增至50%。红斑和炎症性皮损计数的减少证实了BR对IVM治疗的增效作用。受试者报告活性亚组的改善程度大于赋形剂组，且两个活性亚组在治疗的前4周后面部外观满意度相似。所有组的耐受性情况相似。