强直性脊柱炎肾虚督寒证中医疗效评价量表的建立与评价
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摘要
目的：
1.对强直性脊柱炎(ankylosing spondylitis AS)中医药疗效评价文献进行分析,探讨当前中医药治疗AS疗效评价标准的应用现状。
2.基于中医学关于肾虚督寒型As病因病机理论,构建具有中医特点的AS肾虚督寒证中医证候疗效评价量表,并对量表的信度、效度进行科学性考评,为探讨中医药治疗强直性脊柱炎疗效评估的方法学奠定基础。
3.通过检测AS肾虚督寒证患者、健康人、AS非肾虚督寒证患者cAMP、 cGMP、cAMP/cGMP等指标,探讨AS肾虚督寒是否存cAMP/cGMP失衡,进而探讨肾虚督寒证证候积分与之是否具有相关性,是否能够反应肾虚督寒的程度；通过检测TPRACP5b、PKA指标,探讨肾虚督寒证证候积分是否与骨代谢水平具有相关性。方法：
1.中医治疗AS疗效评价标准分析。通过对检索2000-2012年中医药及中西医结合治疗AS的随机对照临床研究的文献,收集文献中涉及到的疗效评价标准,对文献中的疗效评价标准的应用情况进行分析。
2.AS肾虚督寒证中医证候疗效评价量表的初步确立及其科学性考核。通过参考相关文献、书籍形成量表条目池。通过专家咨询及患者调查,初步确立AS肾虚督寒中医疗效评价量表条目池。应用条目分布考察法、离散趋势法、因子分析法、相关系数法、克朗巴赫系数法综合筛选AS肾虚督寒证中医疗效评价量表条目,初步形成强直性脊柱炎肾虚督寒中医证候疗效评价量表,并对量表进行信度、效度考核。
3.选择AS肾虚督寒证患者30例为实验组,同期选择AS非肾虚督寒证患者30例和10例正常健康人作为对照组。分别记录患者的年龄、性别、病程、BASDAI、 BASFI、中医症状积分。清晨空腹采静脉血留取标本。采用酶联免疫吸附法检测AS患者和健康人cAMP、cGMP、cAMP/cGMP、TRACP5b、PKA的水平。比较各指标的区别,分析肾虚督寒积分与各指标的相关性。
结果：
1.文献研究。共纳入符合标准的文献80篇,结果发现,目前现有的强直性脊柱炎疗效评价标准种类较多,但是中医药治疗强直性脊柱炎的疗效评价没有统一的标准,5.75%的文献未采用任何疗效评价标准,23.00%的文献采用自拟标准或参考相关文献,其中2002年《中药新药临床指导原则》应用较为广泛,但也仅占27.59%,其他疗效标准应用也均未超过30%。
2.AS肾虚督寒证中医证候疗效评价量表的初步确立。根据中医理论、参考相关文献、书籍形成条目池。通过专家咨询及患者调查,形成22个条目池,作为AS肾虚督寒证疗效评价量表的备选条目。运用多种数理统计方法,分别对AS肾虚督寒证中医疗效评价流行病学调查资料数据进行统计分析,从不同角度筛选AS肾虚督寒证疗效评价量表的条目。其中,采用条目分布考察法的频率集中趋势方面角度筛选出了16个条目,采用相关系数法是从条目的代表性角度来筛选出了17个条目,离散趋势法从条目的敏感性角度筛选出了10个条目,克朗巴赫系数法筛选出16条条目,采用因子分析法从条目的代表性角度筛选出了21个条目。几种方法综合运用,筛选出由关节疼痛、晨僵、腰背部发冷、畏寒、手或足不温、腰酸或膝软、精神萎靡、自汗、动辄喘促9个条目所组成的AS肾虚督寒证中医疗效评价量表。
AS肾虚督寒证中医证候疗效评价量表的科学性考核。收集多中心肾虚督寒型AS病例200人次,对该量表进行效度、信度的科学性考核,显示量表的可行性较好,具有较好的信度、效度。
3.肾虚督寒AS患者较健康人及非肾虚督寒AS患者血浆cAMP水平降低,cGMP水平升高,cAMP/cGMP比值降低,TRACP5b水平升高、PKA水平无明显变化。结论：
初步建立了具有信度、效度的AS肾虚督寒证中医疗效评价量表。肾虚督寒患者存在cAMP/cGMP失衡,但是肾虚督寒的程度尚不能够通过cAMP/cGMP来反应。患者血清TRACP5b升高,但中医证候积分与骨质破坏无明显相关性。
Objectives
1To analyze the assessment standard usage of literature which treatment ankylosing spondylitis patient with Chinese medicine and to provide the help for the clinical.
2Based on etiopathogenisis and pathogenesis of deficiency in kidney and Du Channel with cold type AS in traditional Chinese Medieine theory, building effacacy scale with Chinese characteristics of ankylosing spondylitis of deficiency in kidney and Du Channel with cold type AS which used to assess the clinical effectiveness in traditional Chinese medical treatment. Examining the reliability, validity and responsibility, search for the methods of clinical evaluation of Chinese medicine.
3Detecting eficiency in kidney and Du Channel with cold type AS patients, healthy people and AS patients with non-eficiency in kidney and Du Channel with cold patients serum cAMP, cGMP, cAMP/cGMP to explore whether there are cAMP/cGMP imbalance in AS patient of eficiency in kidney and Du Channel with cold type, and thus explore cAMP/cGMP whether related with the integralof syndrome of eficiency in kidney and Du Channel with cold type AS. By detecting TPRACP5b, PKA indicators to explore the relevanting of the degree of deficiency in kidney and Du Channel with cold and bone metabolism.
Methods
1. The literature research on evaluation standard of TCM efficacy of AS. Collecting the years2000-2012randomized controlled clinical study of literature which treated AS patient with TCM and Integrative Medicine. Analysis usage situation of the efficacy evaluation of AS
2.Through expert advice and patient investigation, To establish the TCM syndromes evaluation scale for AS of kidney empty and DU Channel cold and examine its scientificainess. Based on previous research, the questionnaire of Chinese medicine syndrome in AS was introduced as index item pool of syndrome outcome assessment for AS. The methods such as subjective evaluation, inspecting the distribution of entry, discrete trend, factor analysis, correlation coefficient, Cronbach's a Coefficient, were applied to sift rating scale entry of Chinese medicine syndrome in AS, of which the reliability, validity and responsiveness were measured.
3.Select30patient of the deficiency kidney the Du channel cold type for the experimental group and non of kidney deficiency cold type AS of30patients and10healthy people as a control group. Record AS patients age, gender, disease duration, BASDAI and BASFI scores of TCM. Fasting venous blood specimens were taken. The enzyme-linked immunosorbent assay in patients with AS and healthy people of cAMP, cGMP, cAMP/cGMP TRACP5b of PKA level. Compare the difference of each index, to analyze the relevance of each indicator and kidney Governor cold integral.
Results
1.The results suggested that there were many kinds of evaluation standards of efficacy of AS. Included80literature, the current efficacy evaluation of diabetic nephropathy is no uniform standard, The utilization of5.75%literature have no standard criteria,23.00%of the literature using self standards or reference, the2002"Principles "is widely used but accounted for only27.59%, other standard utilization of rate was lower than30%.
2AS kidney Governor TCM syndromes cold syndrome rating scale initially established. According to TCM theory and AS-specific entry pool is first formed, through expert advice and patient investigation, the formation of22entries pools, cold syndrome of AS kidney Evaluation Scale Governor candidate entries. Using a variety of methods of mathematical statistics, namely the AS kidney Governor cold syndrome TCM Therapeutic Evaluation epidemiological data for statistical analysis of data from different angles, cold syndrome screening AS kidney Christ Evaluation Scale entries. Among them, the inspection method using the frequency distribution of entries focused perspective on trends in screening out16entries, using the correlation coefficient is a representative from the entry point to filter out of the20entries, discrete trends in France from the entry point of the sensitivity of screening the11entries, Cronbach coefficient method to filter out18entries, using factor analysis representation from the entry point screened out21entries. Integrated use of several methods to filter out by the joint pain, morning stiffness, lower back chills, chills, hands or feet are not warm, backache or knee soft, listlessness, spontaneous, frequently breathlessness9entries consisting of AS TCM.
AS kidney empty and DU Channel cold TCM syndromes cold syndrome rating scale scientific assessment. Governor kidney collecting multi-center case cold type AS200people, the scale for validity, reliability of the scientific assessment, showing the feasibility of scales better, with good reliability and validity.
3Reduce kidney Du channel cold AS patients than in healthy people and non-kidney Governor cold AS patients plasma levels of cAMP and cGMP levels, cAMP/cGMP ratio decreased, TRACP5b increased. Conclusion
Established reliability and validity of AS kidney Governor cold syndrome TCM Therapeutic Assessment Scale. Governor Han patients with kidney cAMP/cGMP imbalance, but the extent is not yet cold kidney Christ through cAMP/cGMP to react. TRACP5b serum increased, but the symptom score and bone destruction was no significant correlation.
Patients with kidney Governor cold presence of cAMP/cGMP imbalance. The cAMP/cGMP level not yet able to reflected Kidney and Du cold "degree". The elevated serum TRACP5b which shows the significance of the renal main "bone" theory, but not capable of reaction to the level of bone destruction and the symptom score.
1.对强直性脊柱炎(ankylosing spondylitis AS)中医药疗效评价文献进行分析,探讨当前中医药治疗AS疗效评价标准的应用现状。
2.基于中医学关于肾虚督寒型As病因病机理论,构建具有中医特点的AS肾虚督寒证中医证候疗效评价量表,并对量表的信度、效度进行科学性考评,为探讨中医药治疗强直性脊柱炎疗效评估的方法学奠定基础。
3.通过检测AS肾虚督寒证患者、健康人、AS非肾虚督寒证患者cAMP、 cGMP、cAMP/cGMP等指标,探讨AS肾虚督寒是否存cAMP/cGMP失衡,进而探讨肾虚督寒证证候积分与之是否具有相关性,是否能够反应肾虚督寒的程度；通过检测TPRACP5b、PKA指标,探讨肾虚督寒证证候积分是否与骨代谢水平具有相关性。方法：
1.中医治疗AS疗效评价标准分析。通过对检索2000-2012年中医药及中西医结合治疗AS的随机对照临床研究的文献,收集文献中涉及到的疗效评价标准,对文献中的疗效评价标准的应用情况进行分析。
2.AS肾虚督寒证中医证候疗效评价量表的初步确立及其科学性考核。通过参考相关文献、书籍形成量表条目池。通过专家咨询及患者调查,初步确立AS肾虚督寒中医疗效评价量表条目池。应用条目分布考察法、离散趋势法、因子分析法、相关系数法、克朗巴赫系数法综合筛选AS肾虚督寒证中医疗效评价量表条目,初步形成强直性脊柱炎肾虚督寒中医证候疗效评价量表,并对量表进行信度、效度考核。
3.选择AS肾虚督寒证患者30例为实验组,同期选择AS非肾虚督寒证患者30例和10例正常健康人作为对照组。分别记录患者的年龄、性别、病程、BASDAI、 BASFI、中医症状积分。清晨空腹采静脉血留取标本。采用酶联免疫吸附法检测AS患者和健康人cAMP、cGMP、cAMP/cGMP、TRACP5b、PKA的水平。比较各指标的区别,分析肾虚督寒积分与各指标的相关性。
结果：
1.文献研究。共纳入符合标准的文献80篇,结果发现,目前现有的强直性脊柱炎疗效评价标准种类较多,但是中医药治疗强直性脊柱炎的疗效评价没有统一的标准,5.75%的文献未采用任何疗效评价标准,23.00%的文献采用自拟标准或参考相关文献,其中2002年《中药新药临床指导原则》应用较为广泛,但也仅占27.59%,其他疗效标准应用也均未超过30%。
2.AS肾虚督寒证中医证候疗效评价量表的初步确立。根据中医理论、参考相关文献、书籍形成条目池。通过专家咨询及患者调查,形成22个条目池,作为AS肾虚督寒证疗效评价量表的备选条目。运用多种数理统计方法,分别对AS肾虚督寒证中医疗效评价流行病学调查资料数据进行统计分析,从不同角度筛选AS肾虚督寒证疗效评价量表的条目。其中,采用条目分布考察法的频率集中趋势方面角度筛选出了16个条目,采用相关系数法是从条目的代表性角度来筛选出了17个条目,离散趋势法从条目的敏感性角度筛选出了10个条目,克朗巴赫系数法筛选出16条条目,采用因子分析法从条目的代表性角度筛选出了21个条目。几种方法综合运用,筛选出由关节疼痛、晨僵、腰背部发冷、畏寒、手或足不温、腰酸或膝软、精神萎靡、自汗、动辄喘促9个条目所组成的AS肾虚督寒证中医疗效评价量表。
AS肾虚督寒证中医证候疗效评价量表的科学性考核。收集多中心肾虚督寒型AS病例200人次,对该量表进行效度、信度的科学性考核,显示量表的可行性较好,具有较好的信度、效度。
3.肾虚督寒AS患者较健康人及非肾虚督寒AS患者血浆cAMP水平降低,cGMP水平升高,cAMP/cGMP比值降低,TRACP5b水平升高、PKA水平无明显变化。结论：
初步建立了具有信度、效度的AS肾虚督寒证中医疗效评价量表。肾虚督寒患者存在cAMP/cGMP失衡,但是肾虚督寒的程度尚不能够通过cAMP/cGMP来反应。患者血清TRACP5b升高,但中医证候积分与骨质破坏无明显相关性。
Objectives
1To analyze the assessment standard usage of literature which treatment ankylosing spondylitis patient with Chinese medicine and to provide the help for the clinical.
2Based on etiopathogenisis and pathogenesis of deficiency in kidney and Du Channel with cold type AS in traditional Chinese Medieine theory, building effacacy scale with Chinese characteristics of ankylosing spondylitis of deficiency in kidney and Du Channel with cold type AS which used to assess the clinical effectiveness in traditional Chinese medical treatment. Examining the reliability, validity and responsibility, search for the methods of clinical evaluation of Chinese medicine.
3Detecting eficiency in kidney and Du Channel with cold type AS patients, healthy people and AS patients with non-eficiency in kidney and Du Channel with cold patients serum cAMP, cGMP, cAMP/cGMP to explore whether there are cAMP/cGMP imbalance in AS patient of eficiency in kidney and Du Channel with cold type, and thus explore cAMP/cGMP whether related with the integralof syndrome of eficiency in kidney and Du Channel with cold type AS. By detecting TPRACP5b, PKA indicators to explore the relevanting of the degree of deficiency in kidney and Du Channel with cold and bone metabolism.
Methods
1. The literature research on evaluation standard of TCM efficacy of AS. Collecting the years2000-2012randomized controlled clinical study of literature which treated AS patient with TCM and Integrative Medicine. Analysis usage situation of the efficacy evaluation of AS
2.Through expert advice and patient investigation, To establish the TCM syndromes evaluation scale for AS of kidney empty and DU Channel cold and examine its scientificainess. Based on previous research, the questionnaire of Chinese medicine syndrome in AS was introduced as index item pool of syndrome outcome assessment for AS. The methods such as subjective evaluation, inspecting the distribution of entry, discrete trend, factor analysis, correlation coefficient, Cronbach's a Coefficient, were applied to sift rating scale entry of Chinese medicine syndrome in AS, of which the reliability, validity and responsiveness were measured.
3.Select30patient of the deficiency kidney the Du channel cold type for the experimental group and non of kidney deficiency cold type AS of30patients and10healthy people as a control group. Record AS patients age, gender, disease duration, BASDAI and BASFI scores of TCM. Fasting venous blood specimens were taken. The enzyme-linked immunosorbent assay in patients with AS and healthy people of cAMP, cGMP, cAMP/cGMP TRACP5b of PKA level. Compare the difference of each index, to analyze the relevance of each indicator and kidney Governor cold integral.
Results
1.The results suggested that there were many kinds of evaluation standards of efficacy of AS. Included80literature, the current efficacy evaluation of diabetic nephropathy is no uniform standard, The utilization of5.75%literature have no standard criteria,23.00%of the literature using self standards or reference, the2002"Principles "is widely used but accounted for only27.59%, other standard utilization of rate was lower than30%.
2AS kidney Governor TCM syndromes cold syndrome rating scale initially established. According to TCM theory and AS-specific entry pool is first formed, through expert advice and patient investigation, the formation of22entries pools, cold syndrome of AS kidney Evaluation Scale Governor candidate entries. Using a variety of methods of mathematical statistics, namely the AS kidney Governor cold syndrome TCM Therapeutic Evaluation epidemiological data for statistical analysis of data from different angles, cold syndrome screening AS kidney Christ Evaluation Scale entries. Among them, the inspection method using the frequency distribution of entries focused perspective on trends in screening out16entries, using the correlation coefficient is a representative from the entry point to filter out of the20entries, discrete trends in France from the entry point of the sensitivity of screening the11entries, Cronbach coefficient method to filter out18entries, using factor analysis representation from the entry point screened out21entries. Integrated use of several methods to filter out by the joint pain, morning stiffness, lower back chills, chills, hands or feet are not warm, backache or knee soft, listlessness, spontaneous, frequently breathlessness9entries consisting of AS TCM.
AS kidney empty and DU Channel cold TCM syndromes cold syndrome rating scale scientific assessment. Governor kidney collecting multi-center case cold type AS200people, the scale for validity, reliability of the scientific assessment, showing the feasibility of scales better, with good reliability and validity.
3Reduce kidney Du channel cold AS patients than in healthy people and non-kidney Governor cold AS patients plasma levels of cAMP and cGMP levels, cAMP/cGMP ratio decreased, TRACP5b increased. Conclusion
Established reliability and validity of AS kidney Governor cold syndrome TCM Therapeutic Assessment Scale. Governor Han patients with kidney cAMP/cGMP imbalance, but the extent is not yet cold kidney Christ through cAMP/cGMP to react. TRACP5b serum increased, but the symptom score and bone destruction was no significant correlation.
Patients with kidney Governor cold presence of cAMP/cGMP imbalance. The cAMP/cGMP level not yet able to reflected Kidney and Du cold "degree". The elevated serum TRACP5b which shows the significance of the renal main "bone" theory, but not capable of reaction to the level of bone destruction and the symptom score.
引文
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