背景:难治性红斑痤疮患者的治疗选择有限。
目的:评估12周疗程帕罗西汀治疗中度至重度红斑痤疮的疗效和安全性。
方法:在多中心中,随机化,双盲,安慰剂对照试验,难治性酒渣鼻红斑患者被随机分配(1∶1),分别接受帕罗西汀25mg/d或安慰剂治疗12周.
结果:总体而言,97名患者完成了研究(帕罗西汀:49;安慰剂:48)。主要终点是在第12周时达到临床红斑评估(CEA)成功(定义为CEA评分比基线改善0、1或≥2级)的参与者比例;帕罗西汀组明显高于安慰剂组(42.9%vs.20.8%,P=0.02)。满足了一些次要终点,如冲洗成功,减少点≥2(44.9%与25.0%,p=0.04)和改善整体冲洗(2.49±3.03vs.1.68±2.27,P=0.047),灼烧感(46.9%vs.18.8%,P=0.003),抑郁(P=0.041)。报告最多的与帕罗西汀相关的不良事件是头晕,嗜睡,恶心,消化不良,和肌肉震颤。
结论:仅评估了12周研究中帕罗西汀的单剂量方案。
结论:帕罗西汀是治疗中度至重度红斑的有效且耐受性良好的替代治疗方法。
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.