Department of Dermatology, Xiangya Hospital, Central South University, Changsha, Hunan, China; Hunan Key Laboratary of Aging Biology, Xiangya Hospital, Central South University, Changsha, China; National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Central South University, Changsha, Hunan, China.
Department of Dermatology, General Hospital of Ningxia Medical University, Yinchuan, Ningxia, China.
J Am Acad Dermatol. 2023 Jun;88(6):1300-1307. doi: 10.1016/j.jaad.2023.01.044. Epub 2023 Feb 15.
Patients with refractory erythema of rosacea have limited treatment options.
To evaluate the efficacy and safety of a 12-week course of paroxetine for moderate-to-severe erythema of rosacea.
In a multicenter, randomized, double-blinded, placebo-controlled trial, patients with refractory erythema of rosacea were randomly assigned (1:1) to receive paroxetine 25 mg daily or placebo for 12 weeks.
Overall, 97 patients completed the study (paroxetine: 49; placebo: 48). The primary end point was the proportion of participants achieving Clinical Erythema Assessment success (defined as Clinical Erythema Assessment score of 0, 1, or ≥2-grade improvement from baseline) at week 12; this was significantly greater in the paroxetine group than in the placebo group (42.9% vs 20.8%, P = .02). Some secondary end points were met, such as flushing success with point reductions ≥2 (44.9% vs 25.0%, P = .04) and improvement in overall flushing (2.49 ± 3.03 vs 1.68 ± 2.27, P = .047), burning sensation (46.9% vs 18.8%, P = .003), and depression (P = .041). The most reported adverse events associated with paroxetine were dizziness, lethargy, nausea, dyspepsia, and muscle tremors.
Only a single-dosage regimen of paroxetine within a 12-week study was evaluated.
Paroxetine is an effective and well-tolerated alternative treatment for moderate-to-severe erythema of rosacea.
患有难治性酒渣鼻红斑的患者治疗选择有限。
评估帕罗西汀治疗中重度酒渣鼻红斑 12 周疗程的疗效和安全性。
在一项多中心、随机、双盲、安慰剂对照试验中，将难治性酒渣鼻红斑患者随机（1:1）分配接受帕罗西汀 25mg 每日或安慰剂治疗 12 周。
共有 97 例患者完成了研究（帕罗西汀组：49 例；安慰剂组：48 例）。主要终点是第 12 周时达到临床红斑评估成功的参与者比例（定义为从基线起临床红斑评估评分降低 0、1 或≥2 级）；帕罗西汀组显著高于安慰剂组（42.9% vs 20.8%，P=0.02）。一些次要终点也得到了满足，如潮红成功（点降低≥2 的比例分别为 44.9%和 25.0%，P=0.04）和整体潮红改善（2.49±3.03 vs 1.68±2.27，P=0.047）、烧灼感（46.9% vs 18.8%，P=0.003）和抑郁（P=0.041）。与帕罗西汀相关的最常见不良事件是头晕、嗜睡、恶心、消化不良和肌肉震颤。
仅评估了帕罗西汀在 12 周研究中的单一剂量方案。
帕罗西汀是治疗中重度酒渣鼻红斑的有效且耐受良好的替代疗法。
