Department of Dermatology, Tufts Medical Center, Tufts University School of Medicine, Boston, Massachusetts 02111, USA.
J Am Acad Dermatol. 2010 Nov;63(5):775-81. doi: 10.1016/j.jaad.2009.10.016.
Calcipotriene has limited efficacy in treating psoriasis. By inhibiting proinflammatory cytokines such as interleukin-12, interleukin-23, and tumor necrosis factor-alfa, nicotinamide may enhance the efficacy of calcipotriene therapy when used in combination.
We sought to determine if the combination of nicotinamide with calcipotriene is more effective than either component alone.
In this randomized, double-blinded, multicenter 7-arm bilateral comparison-controlled trial, patients were randomized to two of 7 treatments--placebo, calcipotriene 0.005% alone, nicotinamide 1.4% alone, calcipotriene plus nicotinamide 0.05%, calcipotriene plus nicotinamide 0.1%, calcipotriene plus nicotinamide 0.7%, or calcipotriene plus nicotinamide 1.4%--each administered to lesions on one side of the body or to one of two lesions at least 5 cm apart, for 12 weeks. Efficacy was measured using a clear to almost clear outcome.
In all, 50.0% of patients in the calcipotriene and nicotinamide 1.4% combination group achieved a clear to almost clear outcome at week 12, compared with only 18.8% of patients treated with placebo (P = .002), 25% of patients treated with nicotinamide 1.4% alone (P = .02), and 31.5% of patients treated with calcipotriene alone (P = .096). A dose-response trend existed for increasing concentrations of nicotinamide, but it was not significant.
The relatively small patient numbers, relatively high placebo effect, and maximum in-life portion of only 12 weeks of dosing are weaknesses of the study.
This study provides evidence that using the combination nicotinamide and calcipotriene may provide additional benefit in the topical treatment for patients with psoriasis and may be an adequate steroid-sparing substitute treatment.
卡泊三醇在治疗银屑病方面疗效有限。烟酰胺通过抑制白细胞介素-12、白细胞介素-23 和肿瘤坏死因子-α等促炎细胞因子，与卡泊三醇联合使用时可能增强其疗效。
我们旨在确定烟酰胺与卡泊三醇联合使用是否比单独使用任何一种药物更有效。
在这项随机、双盲、多中心的 7 臂双侧比较对照试验中，患者被随机分配至 7 种治疗方案中的 2 种——安慰剂、卡泊三醇 0.005%单独使用、烟酰胺 1.4%单独使用、卡泊三醇加烟酰胺 0.05%、卡泊三醇加烟酰胺 0.1%、卡泊三醇加烟酰胺 0.7%或卡泊三醇加烟酰胺 1.4%，每种药物均用于身体一侧的皮损或至少相距 5 cm 的两处皮损，疗程为 12 周。采用皮损基本消退或消退>90%（“Clear to almost clear”）的疗效来评估疗效。
在所有患者中，卡泊三醇与烟酰胺 1.4%联合治疗组在第 12 周时达到“Clear to almost clear”的患者比例为 50.0%，而安慰剂组仅为 18.8%（P =.002）、烟酰胺 1.4%单独治疗组为 25%（P =.02）、卡泊三醇单独治疗组为 31.5%（P =.096）。烟酰胺浓度增加存在剂量反应趋势，但无统计学意义。
本研究的局限性在于患者数量相对较少、安慰剂效应相对较高以及最大疗程仅为 12 周。
本研究为卡泊三醇联合烟酰胺治疗银屑病患者可能提供额外获益提供了证据，并且可能成为一种充足的皮质类固醇节约替代治疗。
