临床疗效研究中的患者报告结局

Application of Patient-Reported Outcomes in Clinical Research on Therapeutic Efficacy

随着社会生物心理医学模式的转变,临床评价的方案和指标有了重大转变,患者报告结局(patient-reported outcomes,PROs)日益受到重视。本文介绍了PROs的概念及其测量研究的现况,认为以症状疗效评价为主的中医药临床疗效评价可以借鉴西方的PROs研究模式,建立中医特色的量表评价体系,使中医药疗效评价达到客观化和定量化,为推进中医药的现代化和国际化做出贡献。

Along with the transition of the socio-bio-psycho-medical mode, important change emerges in the program and criterion of clinical assessment, and the patient-reported outcomes （PROs） has been stressed increasingly. The concept of PROs and its current state of research are introduced in this paper. The authors considered that the PROs researching mode, which takes the symptomatic effect evaluation as the main criterion, could be used as reference for the clinical efficacy assessment of Chinese medicine to create a scale evaluating system with Chinese medicine characteristics, for making its more objective and quantitative. It should contribute to the modernization and JnternatJonalizatJon of ChJnese medicine extensively.