中医软指标疗效评价模式初步研究

【作者】 朴海垠；

【导师】 谢雁鸣；

【作者基本信息】 中国中医科学院 ， 中西医结合临床， 2006， 博士

【副题名】以原发性骨质疏松症为示范

【摘要】 目的:中医软指标主要是指通过医生的观察采集或患者的自我报告而获得的,无法用仪器或其他手段直接进行精确测量的指标。基于人体和现代疾病的复杂性,以及中医思维的特点,中医软指标具有主观性、非线性、多维性、动态性、模糊性的基本特点,因此应当根据研究的需要采用适宜的评价方法。中医软指标的疗效评价研究可以通过定量研究,定性研究,或定量定性研究相结合进行。中医临床四诊信息所包含的大量中医软指标是中医辨证论治的重要依据,因此以中医症状为主的中医软指标的评价,在中医药的临床疗效评价中具有重要的作用。而中医临床实践内容和诊疗思维的复杂性、非线性以及作为实践和研究主体和客体的人所特有的主观性和复杂性,令中医软指标具有主观性、非线性、多维性、动态性、模糊性的特点,增加了中医软指标的科学测量和客观评价的难度。而且目前在中医临床疗效评价研究中,尚缺乏较为系统的中医软指标疗效评价模式和相应的方法。因此,本研究旨在通过对中医软指标疗效评价方法的系统性研究中,进一步探索中医软指标疗效评价的基本步骤,尝试初步构建中医软指标疗效评价的模式。 方法:本研究尝试从了解中医软指标的特性入手,借鉴社会学、心理学、统计学等多学科、领域的知识和技术,探索适宜的中医软指标疗效评价方法,并通过相对客观的中医软指标筛选、重构和测量,将具有主观性、复杂性特点的中医临床信息进行相对客观的赋权和量化,并进一步采用较为适宜的方法对所得数据进行统计分析,从而构建中医软指标疗效评价的模式,并对模式中的每一环节都通过原发性骨质疏松症肾阳虚证的示范研究,对中医软指标疗效评价模式进行初步验证。 结果:中医软指标的规范是中医临床疗效评价的重要基础。中医软指标的规范可以包括中医软指标名称的规范,语义的规范,医理的规范和习惯用法的规范等内容。但中医软指标的规范要求很高的权威性,而且其难度和工作量都很大,目前有其他大型课题正在进行以其为主的系统性研究,因此本课题不将其列为研究重点。但在本示范研究中所采用的名词术语尽量以文献当中所广泛使用的术语为准,以期尽量贴近中医软指标的规范化要求。 中医软指标的筛选是根据临床研究的目的和干预措施等因素对中医软指标进行初筛和优化的过程。初筛可以通过文献研究,头脑风暴法,德尔菲法,哥顿法,或参照前期临床研究成果进行;软指标的优化除可应用上述指标初筛方法外还可以通过系统评价,临床流行病学调查,条目分析和数理统计等方法来实现。具体使用何种方法进行指标的筛选宜结合研究的实际情况来决定。本示范研究中,以文献调研和临床调查为主,结合专家经验和条目分析方法进行中医软指标的筛选,初步确定原发性骨质疏松症肾阳虚证的基本中医软指标为骨骼疼痛、腰膝酸软、畏寒肢冷、下肢无力、疲倦乏力、动则气促、发槁齿摇、小便清长、夜尿频多等。经条目分析中相关性分析和因子分析结果显示各指标均具有较好的区分度。更多还原

【Abstract】 Objectives: Chinese medical soft indexes are mainly obtained by the doctors’ observation and the patients’ report. They can’t be measured exactly by instruments or other methods. Because of the characteristics of Chinese medical soft index, the appropriate methods should be used in the evaluations according to the require of research. The evaluations of Chinese medical soft index may adopt the methods of quantitative research, qualitative research or integrated quantitative and qualitative research. Information of Chinese four diagnostic methods includes a lot of Chinese medical soft index, which are important bases of differentiation and treatment of symptoms of Chinese medicine. There fore, the evaluation of Chinese medical symptoms and signs, as the main contents of Chinese medical soft index, is very important in clinical evaluation of Chinese medical treatments. The complexity and nonlinearity of the Chinese medical practice and thinking, and the objectivity and complexity of human body make the Chinese medical soft index has the characteristics of subjectivity, nonlinearity, multidimensionality, dynamics, and fuzziness. These add to the difficulty of the accurate measurements and objective evaluations of Chinese medical soft index. But the fact is that the clinical curative research of Chinese medicine is now lack of some systematic mode of evaluation and relative methods. This research is to find the basic processes and key links, and construct the primary mode of evaluation of Chinese medical soft index.Methods: This research started with the characteristics of Chinese medical soft index. By using the knowledge and technology of sociology, psychology and statistics for reference, we try to find the appropriate methods of curative evaluations of Chinese medical soft index. At first, filter, restructure and measure the soft index scientifically and objectively. Then analyze the data with appropriate statistic methods. In each step, the reseach take the primary osteoporosis for example as the demonstration.Outcomes: The criterion of Chinese medical soft index is an important basis of the Chinese medical evaluation of clinical treatment. The criterions of Chinese medical soft index include the criterions of the terms, the meanings, the Chinese medical theory, and the conventional usages of the Chinese medical soft index. Because the research of the criterions is highly systematic and authoritative, it hasn’t been emphasized in our research. But the terms of our research adopted the most widely used terms of literature to approach the requires of the criterions.The filtration of Chinese medical soft index is a process of optimization of the indexes according to the aims and treatments of the clinical trails, which include the primary filter andoptimization of the index. The methods of primary filter include literature research, Brain storming, Delphi, Gordon, and the productions of former research. In the optimization step, the methods of primary filter are also practicable. Besides, methods of systematic research, DME, item analysis and statistics can be adopted. In our demonstrations, we have take the method of literature research, clinical research, and combine the productions of former research and item analysis to filter the Chinese medical soft index. The soft indexes of our research are bone ache, soreness of the waist and knees, intolerance of cold and cold limbs, inability of lower limbs, etc. The results of the correlation analysis and the factor analysis of item analysis showed that they all have acceptable powers of differentiation.The restructure of Chinese medical soft index is to rebuild the structure of the Chinese medical soft index. That is, to define the subsystem of the indexes. The Chinese soft index includes indexes of the physical, psychological and social domain. According to its impact to the curative effect, it can be divided into main indexes and minor indexes, and also the compartmentalization of the dimension of the soft index. Chinese medical soft index usually includes degree of quality, durative time, frequency, relative factors, etc. Now in most clinical CRF the soft indexes were single-dimension designed. But the fact is, in some diseases or syndromes, the changes of soft indexes in different dimensions are different. Their impacts to the end of the diseases are different, ether. So it makes sense to define the dimensions of the soft index. In the demonstration research, we defined the frequency degree and severity degree of part of the symptoms, and compartmentalized the four positions of the bone ache. The measurement of Chinese medical soft index is the key of the mode of the Chinese medical evaluation of clinical treatment, which include observation, visit, examination, questionnaire, etc. The control of the influencing facters is very important. CRF, as one form of the questionnaire, is most commonly used in the clinical research. The rank method is a common method in the CRF. In most clinical research now, the yes-no method, and the "none, slight, median, severe" classifying method is most commonly used. Also the five classifying method and the VAS method are sometime adopted. In the demonstration research, the four classifying was adopted in the doctors’ evaluating, the five classifying and the VAS methods are used together in the patients’ evaluating.The weight of the Chinese medical soft index is a process of compartmentalizing the main indexes and minor indexes by giving weights, which includes the subjective weight methods, the objective weight methods, and the integrated subjective and objective weight methods. Now in the Chinese medical clinical curative evaluations the subjective weight methods are commonly used. The subjective weight methods and the objective weight methods each hasits own strongpoint and shortcomings. And the integrated subjective and objective weight methods can join their strongpoint together and give the at best actual conclusion. In our demonstration research, the integrated subjective and objective weight methods based on RSR was used to give the weights. The SR and the weight of experience were combined to calculate the finale weight. Compared with the subjective weight of experience only, the results are different. The subjective method used separately seems to give the weight results too much subjective will. The introduction of SR can revise the weights of subjective method. So the results based on the experiences can accord with the clinical practice well.The quantification of the Chinese medical soft index now adopt the linear method most, but the nonlinear quantification methods seem to be appropriate because of the nonlinearity of the soft index. In our demonstration research, the four classifying, five classifying and the VAS method, and the linear and nonlinear methods are comparatively used. The M exponent and the power nonlinear methods are adopted. The result shows that although the four classifying method is easier to practice. Its classifying is rough so that can not show some slight changes. In the demonstration research, to most soft indexes its differences showed no statistic meanings. The five classifying method isn’t complex, ether. And its scientificity is proved by the widely use of scale of health related quality of life. In the demonstration research, to part of the indexes its differences showed statistic meanings. The VAS method is in a degree can measure the indexes more exactly, so to most of the indexes its differences showed statistic meanings. The shortcoming of VAS is that it’s necessary to explain to some patients when they have difficulty to understand the method. So in the clinical research, the method should be chose according to the aim and need of research and the characters of the indexes. The M exponent nonlinear quantifying in five classifying showed more differences of statistic meanings than the linear quantifying to the differences of the groups and time. The power nonlinear method didn’t show much difference to the linear method. But whether the effects of checking between the groups can accurately reflect the sceintificity of the quantification methods is up to be proved by abundant clinical research works.In the Chinese medical evaluation of clinical treatment, the criterion of the curative evaluation should be built to evaluate the treatments objectively. The adoptions of the data analysis methods of the Chinese medical soft index should be based to the aims and facts of the research. The analysis methods include transverse data and lengthways data, and the comprehensive assessment method. Which method is appropriate to use should be decided according to the aims and the needs of the research in advance. In our demonstration research, several multi variable lengthways analyze method are adopted. They are derived variablemethod, quasi-MANOVA, and profile analysis. The result shows that the derived variable of regression coefficient can indicate difference of the trends of change between groups by calculated the regression coefficients. The derived variable of the difference value and the revised mean checked out the differences of the different time between groups by calculated the difference values and the revised means. And the revised mean, as a relative value, can used to compare the indexes transversely, which is more suitable for multi-variable analysis. The quasi-MANOVA took the points of time as different indexes and used the MANOVA to analyze the difference of time between groups. The strongpoint of these two methods is that they can be understood and practiced easily. The profile can compare the overall changes by the checks of the parallelism and superposition.Conclusions: The curative evaluation of the Chinese medical soft index can be realized by the criterion, filtration, restructure, measurement, weight, quantification, evaluation mode. In the Chinese clinical curative evaluations, the researchers can adopt these processes emphatically, or choose them purposefully according to the objectives and situations of special researches. In the evaluative demonstration of primary osteoporosis, some evaluative methods were used to be validated. The results were acceptable.更多还原