Bruce S, Epinette W W, Funicella T, Ison A, Jones E L, Loss R, McPhee M E, Whitmore C
Department of Dermatology, Baylor College of Medicine, Houston, TX 77030.
J Am Acad Dermatol. 1994 Nov;31(5 Pt 1):755-9. doi: 10.1016/s0190-9622(94)70237-3.
The topical vitamin D analogue calcipotriene has been reported to be an effective treatment for patients with psoriasis. Comparative studies with topical steroids are informative in judging this new therapy.
The purpose of this study was to evaluate the efficacy and safety of calcipotriene ointment 0.005% versus fluocinonide ointment 0.05% in the treatment of plaque psoriasis.
This study was a randomized, double-blind, parallel-group, active-controlled trial in adults who had at least mild overall disease severity and plaque elevation of at least moderate severity. Treatments were applied twice daily for 6 weeks, and subjects were evaluated at weeks 0, 2, 4, and 6. Subjects were graded on a 9-point scale (0 to 8) for scaling, erythema, plaque elevation, and for overall disease severity. A physician's global assessment of improvement/worsening was performed at every visit.
A total of 114 subjects were enrolled at six study sites. Ninety-nine subjects completed the trial. Mean scores for signs of scaling and plaque elevation in calcipotriene-treated subjects were significantly lower by week 2 than in the fluocinonide-treated subjects. These scores continued to be significantly lower than fluocinonide through week 6 (p < 0.05). Mean scores for erythema in calcipotriene-treated subjects were significantly lower than those in fluocinonide-treated subjects at weeks 4 and 6 (p < 0.05). Both the physician's global assessment and overall disease severity showed statistically significant treatment differences in favor of calcipotriene at week 4 (p < 0.05). This superior efficacy continued through week 6. Treatment-related adverse events were observed in 12 calcipotriene-treated subjects and 5 fluocinonide-treated subjects; all were considered minor.
Calcipotriene was superior to fluocinonide in the treatment of plaque psoriasis.
据报道，外用维生素D类似物卡泊三烯对银屑病患者是一种有效的治疗方法。与外用类固醇进行对比研究有助于评判这种新疗法。
本研究旨在评估0.005%卡泊三烯软膏与0.05%氟轻松软膏治疗斑块状银屑病的疗效和安全性。
本研究是一项随机、双盲、平行组、活性药物对照试验，纳入至少有轻度整体疾病严重程度且斑块隆起至少为中度严重程度的成年人。治疗方案为每日两次，持续6周，在第0、2、4和6周对受试者进行评估。对受试者的脱屑、红斑、斑块隆起及整体疾病严重程度按9分制（0至8分）进行评分。每次就诊时由医生进行整体改善/恶化情况评估。
六个研究地点共纳入114名受试者。99名受试者完成了试验。在第2周时，接受卡泊三烯治疗的受试者的脱屑和斑块隆起体征的平均评分显著低于接受氟轻松治疗的受试者。到第6周时，这些评分仍显著低于氟轻松治疗组（p<0.05）。在第4周和第6周时，接受卡泊三烯治疗的受试者的红斑平均评分显著低于接受氟轻松治疗的受试者（p<0.05）。医生的整体评估和整体疾病严重程度在第4周时均显示出有利于卡泊三烯的统计学显著治疗差异（p<0.05）。这种卓越疗效持续到第6周。12名接受卡泊三烯治疗的受试者和5名接受氟轻松治疗的受试者出现了与治疗相关的不良事件；所有不良事件均被认为是轻微的。
在治疗斑块状银屑病方面，卡泊三烯优于氟轻松。
