帕金森病中医疗效评价评分表的研究

摘要

Objectives:Traditional Chinese medicine rating scale of Parkinson's disease has been developed, it includes major symptom score sheet, liver and kidney deficiency score sheet In this study, its validity and responsiveness were evaluated to examine its applicability of clinical evaluation of traditional Chinese medicine (TCM). Methods: Between September 2008 and December 2009, traditional Chinese medicine rating scale of Parkinson's disease was used to investigate 121 patients from three clinical research centers ( Xuanwu Hospital of Capital Medical University, the Second Hospital of Guangdong Province, Beijing Hospital of Integrated Traditional and Westem Medicine), all patients in this investigation were given informed consent. The unified Parkinson disease rating scale (UPDRS) was used as the criterion, and correlation analysis was conducted to evaluate the criterion validity; subjects were grouped into mild group and moderate group by Hoehn &Yah grade to evaluate the discriminant validity. Paired t test, effect size (ES) and standard response mean (SRM) were used to evaluate the responsiveness. Results: 1 ) the Spearman rank correlation coefficient between traditional Chinese medicine rating scale Parkinson's disease and UPDRS Ⅱ was 0.38 ～ 0.47, the Spearman rank correlation coefficient between traditional Chinese medicine rating scale of Parkinson's disease and the UPDRS Ⅲ was 0.25 ～0.46. 2) Subjects were grouped into mild group and moderate group by Hoehn &Yah grade to compare their scores of traditional Chinese medicine rating scale of Parkinson's disease. Total score of the major symptom score sheet and the score of its mixed symptoms were significantly different( P ＜ 0.05 ). 3 ) Comparing the score difference of traditional Chinese medicine rating scale of Parkinson's disease of treatment group and control group respectively six months ago and after the intervention, except the total score of the major symptom score sheet of the control group had no statistical significance, the scores of the main symptom and mixed symptoms of the major symptom score sheet and the score of liver and kidney deficiency score sheet had varying degrees of statistical significance (P ＜ 0.01 ～ P ＜ 0.001 ). Both effect size (ES) and standard response mean (SRM) of treatment group were more than 0.8. Conclusion: Traditional Chinese medicine rating scale of Parkinson's disease has good validity and responsiveness, and can be used for TCM clinical evaluation of Parkinson's disease.%目的:对研制的帕金森病中医评分表(包括主要症状评分表、肝肾不足证评分表两部分)进行效度和反应度测评,以考察其中医临床疗效评价的适用性.方法:2008年9月-2009年12月,采用帕金森病中医评分表对3个临床研究中心(首都医科大学宣武医院、广东省第二中医院、北京市中西医结合医院)的121例帕金森病患者实施调查,所有研究对象均获得书面知情同意.以帕金森病统一评分量表(UPDRS)作为效标,通过相关分析评价其效标效度;以改良Hoehn &Yahr分级将研究对象分为轻度组、中度组评价其区分效度.采用配对t检验、效应量(ES)和标准反应均数(SRM)评价其反应度.结果:1)帕金森病中医评分表与UPDRSⅡ的Spearman相关系数为0.38～0.47,与UPDRSⅢ的Spearman相关系数为0.25～0.46.2)按改良Hoehn &Yahr分级,将研究对象分为轻度组和中度组进行帕金森病中医评分表得分的比较,主要症状评分表总分和其中的兼症得分有统计学差异(P<0.05).3)从治疗组、对照组干预6个月前后帕金森病中医评分表得分的比较来看,除对照组主要症状评分表的总分无统计学差异外,主要症状评分表的主症得分、兼症得分以及肝肾不足证评分表得分,具有不同程度的统计学差异(P<0.01～P<0.001).治疗组效应量(ES)和标准反应均数(SRM)均>0.8.结论:帕金森病中医评分表具有较好的效度和反应度,可以用于帕金森病中医临床疗效评价.