Layton A M, Schaller M, Homey B, Hofmann M A, Bewley A P, Lehmann P, Nohlgård C, Sarwer D B, Kerrouche N, Ma Y M
Harrogate and District NHS Foundation Trust, Harrogate, UK.
Department of Dermatology, Tübingen University Hospital, Tübingen, Germany.
J Eur Acad Dermatol Venereol. 2015 Dec;29(12):2405-10. doi: 10.1111/jdv.13305. Epub 2015 Sep 28.
Facial redness contributes to impaired psychosocial functioning in rosacea patients and the only approved treatment for erythema is topical brimonidine gel 0.33%.
To evaluate patient-reported outcomes, as well as efficacy and safety, in subjects with self-perceived severe erythema treated with brimonidine gel 0.33% compared to vehicle.
An 8-day multicenter, randomized study comparing once-daily brimonidine gel 0.33% with vehicle gel using a facial redness questionnaire, subject satisfaction questionnaire and a patient diary of facial redness control to assess patient-reported outcomes.
Of the 92 included subjects with self-perceived severe erythema, very few were satisfied with their appearance at baseline (4.2% brimonidine group, 0 vehicle group). On Day 8, significantly more brimonidine group subjects were satisfied with their facial appearance compared to vehicle group (36.9% vs. 21.5%; P < 0.05), with the overall treatment effect (69.6% vs. 40.4%; P < 0.01), and with the improvement in their facial redness (67.4% vs. 33.3%; P < 0.001). More brimonidine group subjects were able to control their facial redness daily (e.g. 83.0% vs. 38.9% on Day 1). On Day 8, significantly more brimonidine group subjects than vehicle group had at least a one-grade improvement from baseline in the Clinician Erythema Assessment score (71.7% vs. 35.7%; P = 0.0011) and Patient Self-Assessment score (76.1% vs. 47.6%; P = 0.004). More subjects in the brimonidine group (29.2%) reported treatment-related adverse events than in the vehicle group (15.9%) but most were mild and transient.
Once-daily brimonidine gel 0.33% allowed patients to rapidly control their facial redness and significantly improved patient-reported outcomes in the treatment of persistent facial erythema of rosacea.
面部潮红会导致酒渣鼻患者心理社会功能受损，而唯一获批用于治疗红斑的药物是0.33%的外用溴莫尼定凝胶。
评估与赋形剂相比，0.33%溴莫尼定凝胶治疗自我感觉有严重红斑的受试者的患者报告结局、疗效和安全性。
一项为期8天的多中心随机研究，使用面部潮红问卷、受试者满意度问卷和面部潮红控制患者日记，比较每日一次的0.33%溴莫尼定凝胶与赋形剂凝胶，以评估患者报告结局。
在纳入的92名自我感觉有严重红斑的受试者中，很少有人在基线时对自己的外貌满意（溴莫尼定组为4.2%，赋形剂组为0）。在第8天，与赋形剂组相比，溴莫尼定组中对自己面部外观满意的受试者显著更多（36.9%对21.5%；P<0.05），总体治疗效果更好（69.6%对40.4%；P<0.01），面部潮红改善更明显（67.4%对33.3%；P<0.001）。更多溴莫尼定组受试者能够每天控制面部潮红（例如，第1天为83.0%对38.9%）。在第8天，溴莫尼定组中 Clinician红斑评估评分和患者自我评估评分至少比基线改善一级的受试者显著多于赋形剂组（71.7%对35.7%；P = 0.0011）和（76.1%对47.6%；P = 0.004）。与赋形剂组（15.9%）相比，溴莫尼定组报告治疗相关不良事件的受试者更多（29.2%），但大多数为轻度且短暂。
每日一次的0.33%溴莫尼定凝胶可使患者迅速控制面部潮红，并显著改善酒渣鼻持续性面部红斑治疗中的患者报告结局。
