中医复发性口腔溃疡患者报告结局指标量表理论架构探讨

CJI (Traditional Chinese Medicine) - - Chinese Journal Of Information On Traditional Chin -

1 2 2 2,3 2 2 4杨兆硕 ,季伟苹 ,陈沛沛 ,陈燕 ,徐燎宇 ,王勇 ,石美琴

1.复旦大学附属中山医院,上海 200032;2.上海市中医文献馆,上海 200020;

3.上海中医药大学,上海 201203;4.复旦大学附属眼耳鼻喉科医院,上海 200031

摘要:目的 探讨具有中医特色的复发性口腔溃疡量表理论架构,为量表的进一步研制奠定理论基础。方法 依据国际患者报告结局指标( PRO)量表研制流程,结合“以口为主,五脏相关”“形神统一”“天人合一”“七情五志”等中医学理论学说,进行理论模型的探讨。结果 中医复发性口腔溃疡PRO量表理论框架包括 4个维度:生理维度、心理维度、独立性维度、社会自然维度。结论 中医复发性口腔溃疡PRO 量表理论结构模型的建立可为中医复发性口腔溃疡PRO量表的研制奠定基础并提供理论指导。

关键词:复发性口腔溃疡;患者结局报告指标;量表

DOI: 10.3969/j.issn.1005-5304.2017.02.004

中图分类号: R276.815 文献标识码: A 文章编号: 1005-5304(2017)02-0012-03

Discussion on TCM Theoretical Structure Model for Patient Reported Outcome Scale of Recurrent Oral Ulcer

YANG Zhao-shuo1, JI Wei-ping2, CHEN Pei-pei2, CHEN Yan2,3, XU Liao-yu2, WANG Yong2, SHI Mei- qin4 ( 1. Zhongshan Hospital Affiliated to Fudan University, Shanghai 200032, China;

2. Shanghai Archive of Traditional Chinese Medicine, Shanghai 200020, China; 3. Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China; 4. Eye and ENT Hospital Affiliated to Fudan University, Shanghai

200031, China)

Abstract: Objective To discuss theoretical structure model for the scale of recurrent oral ulcer (ROU) with traditional Chinese medicine characteristics; To lay a theoretical foundation for further developing scale. Methods This study followed international patients reported outcome (PRO) scale development specification, combined TCM theories, including the theory of mouth dominate and five internal organs correlation, uniformed spirit and body, correspondence between human and the universe, seven emotions, constructed theoretical structure of PRO scale of ROU. Results The theoretical structure of PRO scale of ROU included four major areas as physiology, psychology, independence, and society and nature. Conclusion Theoretical model of PRO scale of ROU laies the foundation and provides the oretical guidance for the formulation of PRO scale of the ROU.

Key words: recurrent oral ulcer; patient reported outcome; scale

复发性口腔溃疡是以唇、舌、颊、上腭等处黏膜发生单个或多个淡黄色或灰白色溃烂点,伴有疼痛或刺激时疼痛为特征的口腔疾病,本病属中医学“口疮” “口疡”范畴。中医治疗在改善临床症状、减轻局部症状、降低复发率、提高生活质量等方面有一定优势,已成为目前临床治疗复发性口腔溃疡的重要组成部分,但目前尚缺乏评价其疗效的有效工具。

基金项目:

上海市卫生和计划生育委员会中医药科研基金

(2014LP070A)

季伟苹,E-mail:jwp922@163.com

通讯作者:

患者报告结局指标( patients report outcomes, PRO)是一种无医师或其他人影响所进行的患者自身对疾病或健康状况临床结局的测量方法。2006 年,美国食品药品监督管理局( FDA)发布《测量患者临床结局的行业指南》,规定量表的研制主要包括以下流程:①理论架构的假设;②理论架构的修订和量表初稿的建立;③理论框架的确定和其他参数的考评;④

[1]数据的收集、分析及解释;⑤量表的修订 。PRO 量表能较好体现中医的治疗特点和优势,近年来已成为中医疗效评价体系的重要组成部分。研制具有中医学特色的复发性口腔溃疡 PRO 量表,对复发性口腔溃

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