中风病疗效评价指标体系的初步研究

目的为了更科学地反映中医药防治疾病的真正效能，对现有的中风病疗效评价指标进行系统评价，初步建立包括传统的西医疗效评定指标、中医证候疗效评定指标和生存质量指标3个方面在内的、科学系统的、具有一定效度和信度的中风病疗效评价指标体系。方法采取横断面调查与前瞻性随访研究相结合的方法，测量245例次中风病患者的神经功能缺损计分、总的生活能力状态分级、日常生活活动能力、中医中风病诊疗标准、中医证候相关症状、体征及健康调查简表SF-36、生存质量指数，用多元相关、偏相关、线性回归、因子分析、内部一致性α系数、反应度法等方法，分析各健康维度指标的构成及其关系。结果初步形成了含57个指标的中风病疗效评价指标体系，阐明了其构成与分级，经检验有较好的效度和信度；不同的中医证候和中风病患者生存质量的不同维度之间有着强度不等的相关性。结论初步形成的中风病疗效评价指标体系具有较好的效度和信度，可望能更全面、准确地反映中医药应用于中风病患者的真正效能；中风病患者的中医证候指标是和其心理健康、生理健康都相关的一个因子，尤其和心理健康的相关性更大；改善中风病患者的中医证候指标，可能可以改善其生理、心理健康和生存质量。

Preliminary Study on Outcome Assessment System of Treatment of Stroke

In order to scientifically reflect the real efficacy of TCM treatment and to preliminarily establish a definitely valid and reliable assessment system of stroke treatment, with multi-dimensional outcome assessment indexes, including efficacy evaluation system of conventional western medicine, syndrome evaluation criteria in TCM and quality of life assessment system. Methods An integrative approach of cross-sectional survey and prospective follow-up was adopted. Two hundred and forty-five case-episodes of stroke patients were assessed by determining such parameters as nerve functional deficit scale, grading of total status of living ability, activity of daily living (ADL), TCM stroke criteria of diagnosing-treatment, TCM syndrome related symptoms/signs, Health Survey Questionnaire (Short form 36, SF-36), and index of quality of life (QOL) , and their construction and relation were analyzed by such methods as multivariate relation, partial relation, linear regression, factor analysis, Cronbach's a coefficients, and the responsiveness estimation. Results The multi-dimensional assessment system of stroke treatment, containing 57 indexes with clarified constructions and classification, was created, and its validity and reliability confirmed after assessement. Various degrees of relationship were found between different TCM Syndromes and different domains of QOL. Conclusion The assessment system of stroke treatment preliminarily created has satisfied reliability and validity. It could be expected to reflect the real efficacy of TCM treatment more inclusive and accurate. TCM Syndrome indexes are considered to be the factor related to both domains of mental and physical health, particularly with the former, therefore, to improve the TCM Syndrome would imply improvement of the mental health, physical health and QOL of the patients.