Papp Kim A, Henninger Eric
Probity Medical Research, Waterloo, Ontario, Canada.
J Cutan Med Surg. 2005 Dec;9(6):276-83. doi: 10.1007/s10227-005-0121-4.
PASI is an inadequate outcome measure for the assessment of psoriasis treatments. No currently used endpoints provide a benefit: risk assessment of treatment taking into consideration all available efficacy and safety data.
To propose a new outcome measure called "safe psoriasis control" (SPC), which assesses multiple dimensions of the disease in a clinically meaningful way through the combined use of appropriate efficacy, quality of life, and safety data.
Data from 3,500 subjects were used for the purpose of derivation and validation of the SPC endpoint. Advanced statistical methodology was used to evaluate and validate important components in the assessment of therapeutic benefit.
SPC was shown to be a simple but meaningful combined endpoint showing the proportion of patients who had treatment benefit without major side effects.
The SPC endpoint may be a step-forward in providing a composite tool for the evaluation of treatments for psoriasis.
银屑病面积和严重程度指数（PASI）作为评估银屑病治疗效果的指标并不充分。目前使用的终点指标均未考虑所有可用的疗效和安全性数据来提供治疗的获益-风险评估。
提出一种名为“安全银屑病控制”（SPC）的新结局指标，该指标通过综合使用适当的疗效、生活质量和安全性数据，以临床有意义的方式评估疾病的多个维度。
来自3500名受试者的数据用于推导和验证SPC终点指标。采用先进的统计方法来评估和验证治疗获益评估中的重要组成部分。
SPC被证明是一个简单但有意义的综合终点指标，显示了在无重大副作用的情况下获得治疗益处的患者比例。
SPC终点指标可能是向前迈进的一步，为评估银屑病治疗提供了一个综合工具。
