Tufts Medical Center, Boston, Massachusetts 02111-1533, USA.
J Am Acad Dermatol. 2010 Oct;63(4):580-6. doi: 10.1016/j.jaad.2009.09.049.
Pruritus is a common symptom of psoriasis. In many clinical trials of psoriasis treatments, severity of pruritus is a patient-reported outcome.
We sought to evaluate a patient-reported pruritus self-assessment tool using data from clinical trials of a tumor necrosis factor blocker.
The validity of the patient-reported 6-point pruritus assessment tool (0 = none to 5 = severe) was determined using data from a phase III trial of etanercept, a tumor necrosis factor blocker. The performance of the pruritus assessment tool was then evaluated using data from two large etanercept trials.
The pruritus assessment tool was validated and deemed to have good test-retest reliability (kappa coefficient = 0.71; 95% confidence interval = 0.62-0.80) and responsiveness (standardized response mean = 1.28; effect size = 1.63, responsiveness statistic = 1.54). Improvements in pruritus scores correlated with improvements in Psoriasis Area and Severity Index after 8 weeks of etanercept therapy in two phase III trials.
The pruritus assessment is validated only for patients with moderate to severe plaque psoriasis, and may not be applicable to other patient populations.
The pruritus assessment tool is a valid measurement of pruritus intensity in patients with moderate to severe plaque psoriasis and can discriminate between patients on and off treatment.
瘙痒是银屑病的常见症状。在许多银屑病治疗的临床试验中，瘙痒严重程度是患者报告的结果。
我们试图使用肿瘤坏死因子阻滞剂临床试验的数据来评估一种患者报告的瘙痒自我评估工具。
使用依那西普（一种肿瘤坏死因子阻滞剂）的 III 期临床试验数据来确定患者报告的 6 分瘙痒评估工具（0=无到 5=严重）的有效性。然后，使用来自两项大型依那西普试验的数据评估瘙痒评估工具的性能。
瘙痒评估工具得到了验证，被认为具有良好的重测可靠性（kappa 系数=0.71；95%置信区间=0.62-0.80）和响应性（标准化反应均值=1.28；效应大小=1.63，响应统计量=1.54）。在两项 III 期临床试验中，接受依那西普治疗 8 周后，瘙痒评分的改善与银屑病面积和严重程度指数的改善相关。
瘙痒评估仅针对中重度斑块状银屑病患者进行验证，可能不适用于其他患者群体。
瘙痒评估工具是中重度斑块状银屑病患者瘙痒强度的有效测量工具，可区分治疗中和治疗后的患者。
