Center for Dermatology Research, Department of Dermatology, Wake Forest University School of Medicine, Winston-Salem, NC 27157-107, USA.
J Dermatolog Treat. 2012 Dec;23(6):400-3. doi: 10.3109/09546634.2011.588192. Epub 2011 Jul 25.
Clinical experience favors low doses of acitretin to reduce adverse events but still maintain efficacy. We revisited the pivotal acitretin trials to compare the efficacy of high- versus low-dose acitretin.
We analyzed data from two large randomized trials which had an 8-week, double-blinded (DB), placebo-controlled phase followed by a 16-week open-label (OL) phase. During the DB phase, patients received placebo, 10, 25, 50, or 75 mg of acitretin daily. Dose adjustment was allowed during the OL phase, during which high-dose treatment was defined as approximately 50 mg/day and low-dose as approximately 25 mg/day. Primary end points were improvement of psoriasis based on investigator static global assessment (ISGA) and reduction in affected body surface area (BSA).
At the end of the OL phase (week 24), treatment success rates were similar among all groups (29%-33%)--with the exception of the group receiving low-dose treatment for both DB and OL phases (47% success). Decrease in BSA was also highest in this group (73% vs. 28% to 54%).
Individualization of acitretin dosing is crucial to minimize side effects and should lead to improved adherence and efficacy. This analysis supports the utility of low-dose acitretin for psoriasis over extended treatment periods.
临床经验倾向于使用低剂量阿维 A 酯来减少不良反应，但仍能保持疗效。我们重新审视了关键的阿维 A 酯试验，以比较高剂量与低剂量阿维 A 酯的疗效。
我们分析了两项大型随机试验的数据，这些试验均有 8 周的双盲（DB）、安慰剂对照阶段，随后是 16 周的开放标签（OL）阶段。在 DB 阶段，患者接受安慰剂、10、25、50 或 75mg 的阿维 A 酯日剂量。OL 阶段允许调整剂量，在此期间，高剂量治疗定义为约 50mg/天，低剂量为约 25mg/天。主要终点是基于研究者静态整体评估（ISGA）的银屑病改善和受影响的体表面积（BSA）减少。
在 OL 阶段结束时（第 24 周），所有组的治疗成功率相似（29%-33%）——除了 DB 和 OL 阶段均接受低剂量治疗的组（47%成功）。该组的 BSA 减少也最高（73%，而 28%至 54%）。
个体化阿维 A 酯剂量对于减少副作用至关重要，并且应该提高治疗的依从性和疗效。这项分析支持在延长治疗期间使用低剂量阿维 A 酯治疗银屑病的实用性。
