糖尿病肾病中医药疗效综合评价体系研究
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摘要
研究目的
1.对中医药治疗糖尿病肾病疗效评价文献进行分析,探讨当前糖尿病肾病中医疗效评价指标的现状及存在问题,为进一步疗效指标筛选和疗效评价体系的构建提供基础。
2.引入量表研究的方法,形成糖尿病肾病中医证候疗效评价量表。
3.应用综合评价方法,初步确立糖尿病中医药临床疗效综合评价模型,通过中医药全程干预糖尿病肾病的随机对照试验,对该疗效综合评价体系进行验证,初步探索中医药临床疗效综合评价方法的可行性。
研究方法
本研究依托国家“十一五”科技支撑计划课题-—中医药全程干预DN综合方案研究(课题编号：2006BAI04A03-2),主要分三个部分。
第一部分：糖尿病肾病疗效评价文献分析。通过对2000-2010年中医药及中西医结合治疗糖尿病肾病的随机对照临床研究相关文献进行检索,收集文献中涉及到的疗效评价标准、评价指标等,对文献中的疗效评价标准的应用情况以及疗效评价指标的构成情况进行分析。
第二部分：糖尿病肾病中医证候疗效评价量表的初步确立及其科学性考核。以既往的课题研究为基础,以《糖尿病肾病中医证候调查表》作为证候疗效评价指标的条目池,应用主观评价法、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中医证候疗效评价量表条目,并对量表信度、效度、反应度等进行测定。
第三部分：设计糖尿病肾病疗效评价指标调查问卷,采用德尔菲法对各指标是否具有疗效评价意义进行评价,初步筛选出中医药治疗糖尿病肾病疗效评价指标；应用层次分析法结合德尔菲法建立判断矩阵,确定各指标的组合权重,形成糖尿病肾病疗效评价指标体系模型。通过中医药治疗糖尿病肾病的临床随机对照临床试验,对综合评价模型进行临床验证。
研究结果
第一部分共纳入符合标准的文献166篇,通过对文献的质量进行Jadad评分,发现大多数文献得分偏低(小于2分)。目前糖尿病肾病疗效评价没有统一的标准,参考相关标准拟定和完全自行拟定的疗效评价标准在文献中占到了80%以上。使用的评价指标包括理化指标、中医证候或症状指标、安全性指标、生存质量指标以及终点事件指标5个层次。166篇文献中有159篇文献报道了实验室理化指标的疗效情况,46篇文献报道了中医证候或症状指标的疗效情况,33篇文献对临床安全性指标进行了评价。4篇文献对生存质量进行了评价。1篇文献对终点事件指标进行了评价。较少能够对各指标进行全面综合多维度的评价。
第二部分对《糖尿病肾病中医证候调查表》各条目进行筛选,通过主观评定法删除4个条目(条目8、9、28、32),条目分布考察法删除8个条目(条目7、8、22、24、28、30、32、34),离散趋势法删除4个条目(条目24、28、30、32),因子分析法删除3个条目(条目12、29、31),相关系数法(两种,评测条目的代表性和敏感性)删除8个条目(条目8、24、28、30、34、13、18、32),克朗巴赫系数法删除5个条目(条目10、11、12、13、34),对通过5种以上方法的条目予以保留,共有6个条目予以删除(条目8、24、28、30、32、34),其余28条作为合格条目,构成了证候疗效评价量表。
收集多中心糖尿病肾病病例133例,对该量表进行科学性考核,显示量表的可行性较好。重测信度检验显示量表总分及各维度的相关系数均在0.6以上,具有较好的重测信度；总量表克朗巴赫系数为0.776,显示较好的内部一致性信度。因子分析显示累积贡献率为67.14%,说明本量表具有较好的结构效度。
第三部分经过德尔菲法筛选出中医药治疗糖尿病肾病疗效评价指标,包括终点事件指标、理化指标、中医证候指标、生存质量指标、安全性指标5个维度的二级指标和15个三级指标。应用综合评价层次分析法,形成各层次指标判断矩阵,确定各指标的初始权重和组合权重,构建出糖尿病肾病疗效评价体系。结果见图。
应用线性加权法建立糖尿病肾病中医药疗效综合评价体系线性模型：早期糖尿病肾病：GI=0.3439x1+0.3439x2+0.1289x3+0.1289x4+0.0544x5x1=0.2579x11+0.0860x12X2=0.0360x21+0.0888x22+0.2190x23x3=0.1289x31x4=0.0967x41+0.0322x42x5=0.0408x51+0.0136x52
临床期糖尿病肾病：GI=0.3439x1+0.3439x2+0.1289x3+0.1289x4+0.0544x5x1=0.2579x11+0.0860x12X2=0.0187x21+0.0443x22+0.1183x23+0.1183x24+0.0443x25x3=0.1289x31
x4=0.0967x41+0.0322x42
x5=0.0408x51+0.0136x52
其中,GI表示综合评价指数；x1、x2、x3、x4、x5分别表示5个维度的二级指标终点事件指标、理化指标、中医证候指标、生存质量指标、安全性指标；
x11、x12代表x1维度下终点事件发生率、进展到终点事件的时间；
x21、x22、x23、x24、x25分别代表x2维度下5个具体指标空腹血糖、糖化血红蛋白、尿微量白蛋白排泄率或24h尿蛋白定量(临床期DN)、血肌酐(临床期DN)、肾小球滤过率(临床期DN)；
x31代表x3维度下证候疗效评价量表得分；
x41、x42代表x4维度下WHOQOL-BREF量表得分、DQOL量表得分；
x51、x52代表x5维度下不良事件发生率、不良事件严重程度计分。
收集120例糖尿病肾病病例进行随机对照观察,对该指标体系进行验证,结果显示早期糖尿病肾病治疗组综合评分1.13,对照组综合评分0.87,治疗组综合疗效优于对照组。临床期糖尿病肾病治疗组综合评分1.26,对照组综合评分0.74,治疗组综合疗效优于对照组,初步验证了糖尿病肾病疗效综合评价体系的可行性。
研究结论
1当前糖尿病肾病中医疗效评价标准应用较为混乱,疗效评价仍以理化指标为主,停留在生物医学模式层次,中医药治疗糖尿病肾病的疗效缺乏客观科学的疗效评价指标体系来展示。应形成全面多维度的糖尿病肾病疗效评价体系。
2初步确立了糖尿病肾病证候疗效评价量表。该量表具有较好的可行性、信度、效度、反应度,能够应用于临床对糖尿病肾病的证候疗效进行评价。
3应用层次分析综合评价方法,构建了糖尿病肾病疗效综合评价体系。通过临床随机对照试验验证,该疗效评价体系可用于对糖尿病肾病临床疗效进行整体评价,具有可行性。
Objective
1.To research the literature about efficacy evaluation in the treatment of diabetic nephropathy, so as to explore the status and problems in the Chinese medicine treatment of diabetic nephropathy, and to provide a basis for selecting efficacy evaluating index and constructing the efficacy evaluating system.
2. To introduce the methods of scale research, and combine with expert advice and preliminary basis for the work, so as to form the Chinese Medicine Syndrome rating scale.
3. To establish comprehensive efficacy assessment model of DN with comprehensive evaluation, and a randomized controlled trial of DN intervened by Chinese medicine was performed to explore the feasibility of the model.
Methods
There were three main parts as follow in this study which depended on the project of national technology support program in "Eleventh Five-Year"
Part I:To research the literature for treatment evaluation of DN. The literatures from the year of2000to2010for Chinese medicine and integrated Chinese and western medicine treatment of DN were searched, so as to collect the efficacy evaluation criteriaes and evaluation index, and the frequencies of which were counted and analyzed.
Part II:To establish the TCM Syndromes Evaluation Scale for DN and examine its scientificainess. Based on previous research, the questionnaire of Chinese medicine syndrome in DN was introduced as index item pool of syndrome outcome assessment for DN. 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 DN, of which the reliability, validity and responsiveness were measured.
Part III:The efficacy assessment index Questionnaire of Chinese Medicine Treating DN was designed, and the efficacy evaluation significance of index was evaluated with the Delphi method, so as to sift the efficacy assessment index of Chinese medicine treating DN. The methods of Analyzing Hierarchically and Delphi method were using to build the judgment matrix in order to the combined weights of each index, so as to forming the efficacy assessment system of Chinese medicine treating DN. The system was validated through a randomized controlled clinical trial of Chinese medicine treating DN.
Results
687articles about traditional Chinese medicine treating DN were obtained, from which we selected166accordance with the inclusion criteria. We evaluated the quality of literatures with Jadad score, and found most articles has a low score on Jadad (less than2score).
There was not a unified standard of efficacy evaluation of DN. Effective evaluation standards made according to some related-standards and self-made standards were more than80%of all applied standards. The index included physical and chemical index, syndrome or symptom index, safety index, quality of life index and endpoint index. There were159articles reported44physical and chemical index.46articles reported syndrome or symptom index of TCM.33articles reported safety index,4articles reported quality of life index.1article reported endpoint index. Most articles evaluated effects only from one aspects, only a few articles evaluated effects from multiple dimensions.
Using subjective evaluation method,4items (the item8、9、28、32)were deleted. Using inspecting the distribution of entry method,8items (the item7、8、22、24、28、30、32、34)were deleted. Using discrete trend method,4items(the item24,28、30、32) were deleted. Using factor analysis method,3items(the item12、29、31) were deleted. Using correlation method of corrdlates,8items (the item8、24、28、30、34、13、18、32)were deleted. Using Cronbach a Coefficient,5items (the item10、11、12、13、34) were deleted. Finally,6items(the item8、24、28、30、32、34) were deleted,while other28items passed through5methods and composed the Syndromes Evaluation Scale for DN.133cases were collected to exam the scale. The results showed that the scale had a good feasibility. The test-retest reliability coefficients of the whole scale and the every dimension were all over0.6,showing a good test-retest reliability; The Cronbach a Coefficient of the whole scale was0.776,showing a good internal homogeneity reliability. Factor analysis showed the cumulative contribution rate was67.14%, showing a good construct validity.
By Delphi method we selected the effect index of TCM treating DN including5second index which were endpoint index, physical and chemical index, syndrome or symptom index, quality of life index and safety index, and15third index. By using Analytic Hierarchy Process, the judgment matrix of index was determined to get the initial weight and the combination weight of index. The result was given in fig.
Using the weighted linear method, we got the outcome assessment system model of treatment of DN by Chinese Medicine:
Early Diabetic Nephropathy:
GI=0.3439x1+0.3439x2+0.1289x3+0.1289x4+0.0544x5
x1=0.2579x11+0.0860x12
X2=0.0360x21+0.0888x22+0.2190x23
x3=0.1289x31
x4=0.0967x41+0.0322x42
x5=0.0408x51+0.0136x52
Clinical Diabetic Nephropathy:
GI=0.3439x1+0.3439x2+0.1289x3+0.1289x4+0.0544x5
x1=0.2579x11+0.0860x12
X2=0.0187x21+0.0443x22+0.1183x23+0.1183x24+0.0443x25
x3=0.1289x31
x4=0.0967x41+0.0322x42
x5=0.0408x51+0.0136x52
GI meant synthetic evaluation scores. x1、x2、x3、x4、x5meant the five dimensions:endpoint index, physical and chemical index, syndrome or symptom index, quality of life index and safety index.
x11、x12meant the2index under X1dimension which were the incidence of endpoint and he time develop to the endpoint
x21、x22、x23、x24、x25meant the5index under X2dimension which were FBG、 HbA1C、UAER/24hours urinary protein (clinical DN)、the blood SCr (clinical DN)、 GFR (clinical DN)
x31meant the index under X3dimension which was the Syndromes Evaluation Scale for DN.
X41、x42meant the2index under X4dimension which were WHOQOL-BREF and DQOL score.
x51、x52meant the index under X5dimension which were the incidence of adverse events and the Severity of adverse events.
A Randomized Controlled Trial in which120cases were collected to validate the system. And the results showed the GI score of treatment group was1.13with the GI score of controlled group0.87in early DN,and the GI score of treatment group was1.26with the GI score of controlled group0.74in clinical DN. The score of treatment group was better than controlled group. It showed the feasibility of comprehensive outcome assessment system of treatment of DN.
Conclusions
1.The outcomes assessment criterion of Chinese medicine treating DN were relatively confusing, and physical and chemical indicators were main index for therapeutic effects, which remained at the level of the biomedical model, and could not be fully and accurately reflect the efficacy of Chinese medicine. The outcome assessment of Chinese medicine treating DN requires objective and scientific outcome assessment system to display the efficacy advantage of Chinese medicine, and which will be comprehensive and multi-dimensional and should pay attention to the end of the event and quality of life.
2. The syndrome outcome rating scale of Chinese medicine treating DN tentatively established had a good feasibility,reliability,validity and responsiveness, and could be applied to evaluate the syndrome outcome of Chinese medicine treating DN.
3. After validated by the randomized controlled clinical trial of Chinese medicine treating DN, the comprehensive efficacy assessment system of Chinese medicine treating DN was considered to have the feasibility in evaluating comprehensively the clinical efficacy of Chinese medicine treating DN.
1.对中医药治疗糖尿病肾病疗效评价文献进行分析,探讨当前糖尿病肾病中医疗效评价指标的现状及存在问题,为进一步疗效指标筛选和疗效评价体系的构建提供基础。
2.引入量表研究的方法,形成糖尿病肾病中医证候疗效评价量表。
3.应用综合评价方法,初步确立糖尿病中医药临床疗效综合评价模型,通过中医药全程干预糖尿病肾病的随机对照试验,对该疗效综合评价体系进行验证,初步探索中医药临床疗效综合评价方法的可行性。
研究方法
本研究依托国家“十一五”科技支撑计划课题-—中医药全程干预DN综合方案研究(课题编号：2006BAI04A03-2),主要分三个部分。
第一部分：糖尿病肾病疗效评价文献分析。通过对2000-2010年中医药及中西医结合治疗糖尿病肾病的随机对照临床研究相关文献进行检索,收集文献中涉及到的疗效评价标准、评价指标等,对文献中的疗效评价标准的应用情况以及疗效评价指标的构成情况进行分析。
第二部分：糖尿病肾病中医证候疗效评价量表的初步确立及其科学性考核。以既往的课题研究为基础,以《糖尿病肾病中医证候调查表》作为证候疗效评价指标的条目池,应用主观评价法、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中医证候疗效评价量表条目,并对量表信度、效度、反应度等进行测定。
第三部分：设计糖尿病肾病疗效评价指标调查问卷,采用德尔菲法对各指标是否具有疗效评价意义进行评价,初步筛选出中医药治疗糖尿病肾病疗效评价指标；应用层次分析法结合德尔菲法建立判断矩阵,确定各指标的组合权重,形成糖尿病肾病疗效评价指标体系模型。通过中医药治疗糖尿病肾病的临床随机对照临床试验,对综合评价模型进行临床验证。
研究结果
第一部分共纳入符合标准的文献166篇,通过对文献的质量进行Jadad评分,发现大多数文献得分偏低(小于2分)。目前糖尿病肾病疗效评价没有统一的标准,参考相关标准拟定和完全自行拟定的疗效评价标准在文献中占到了80%以上。使用的评价指标包括理化指标、中医证候或症状指标、安全性指标、生存质量指标以及终点事件指标5个层次。166篇文献中有159篇文献报道了实验室理化指标的疗效情况,46篇文献报道了中医证候或症状指标的疗效情况,33篇文献对临床安全性指标进行了评价。4篇文献对生存质量进行了评价。1篇文献对终点事件指标进行了评价。较少能够对各指标进行全面综合多维度的评价。
第二部分对《糖尿病肾病中医证候调查表》各条目进行筛选,通过主观评定法删除4个条目(条目8、9、28、32),条目分布考察法删除8个条目(条目7、8、22、24、28、30、32、34),离散趋势法删除4个条目(条目24、28、30、32),因子分析法删除3个条目(条目12、29、31),相关系数法(两种,评测条目的代表性和敏感性)删除8个条目(条目8、24、28、30、34、13、18、32),克朗巴赫系数法删除5个条目(条目10、11、12、13、34),对通过5种以上方法的条目予以保留,共有6个条目予以删除(条目8、24、28、30、32、34),其余28条作为合格条目,构成了证候疗效评价量表。
收集多中心糖尿病肾病病例133例,对该量表进行科学性考核,显示量表的可行性较好。重测信度检验显示量表总分及各维度的相关系数均在0.6以上,具有较好的重测信度；总量表克朗巴赫系数为0.776,显示较好的内部一致性信度。因子分析显示累积贡献率为67.14%,说明本量表具有较好的结构效度。
第三部分经过德尔菲法筛选出中医药治疗糖尿病肾病疗效评价指标,包括终点事件指标、理化指标、中医证候指标、生存质量指标、安全性指标5个维度的二级指标和15个三级指标。应用综合评价层次分析法,形成各层次指标判断矩阵,确定各指标的初始权重和组合权重,构建出糖尿病肾病疗效评价体系。结果见图。
应用线性加权法建立糖尿病肾病中医药疗效综合评价体系线性模型：早期糖尿病肾病：GI=0.3439x1+0.3439x2+0.1289x3+0.1289x4+0.0544x5x1=0.2579x11+0.0860x12X2=0.0360x21+0.0888x22+0.2190x23x3=0.1289x31x4=0.0967x41+0.0322x42x5=0.0408x51+0.0136x52
临床期糖尿病肾病：GI=0.3439x1+0.3439x2+0.1289x3+0.1289x4+0.0544x5x1=0.2579x11+0.0860x12X2=0.0187x21+0.0443x22+0.1183x23+0.1183x24+0.0443x25x3=0.1289x31
x4=0.0967x41+0.0322x42
x5=0.0408x51+0.0136x52
其中,GI表示综合评价指数；x1、x2、x3、x4、x5分别表示5个维度的二级指标终点事件指标、理化指标、中医证候指标、生存质量指标、安全性指标；
x11、x12代表x1维度下终点事件发生率、进展到终点事件的时间；
x21、x22、x23、x24、x25分别代表x2维度下5个具体指标空腹血糖、糖化血红蛋白、尿微量白蛋白排泄率或24h尿蛋白定量(临床期DN)、血肌酐(临床期DN)、肾小球滤过率(临床期DN)；
x31代表x3维度下证候疗效评价量表得分；
x41、x42代表x4维度下WHOQOL-BREF量表得分、DQOL量表得分；
x51、x52代表x5维度下不良事件发生率、不良事件严重程度计分。
收集120例糖尿病肾病病例进行随机对照观察,对该指标体系进行验证,结果显示早期糖尿病肾病治疗组综合评分1.13,对照组综合评分0.87,治疗组综合疗效优于对照组。临床期糖尿病肾病治疗组综合评分1.26,对照组综合评分0.74,治疗组综合疗效优于对照组,初步验证了糖尿病肾病疗效综合评价体系的可行性。
研究结论
1当前糖尿病肾病中医疗效评价标准应用较为混乱,疗效评价仍以理化指标为主,停留在生物医学模式层次,中医药治疗糖尿病肾病的疗效缺乏客观科学的疗效评价指标体系来展示。应形成全面多维度的糖尿病肾病疗效评价体系。
2初步确立了糖尿病肾病证候疗效评价量表。该量表具有较好的可行性、信度、效度、反应度,能够应用于临床对糖尿病肾病的证候疗效进行评价。
3应用层次分析综合评价方法,构建了糖尿病肾病疗效综合评价体系。通过临床随机对照试验验证,该疗效评价体系可用于对糖尿病肾病临床疗效进行整体评价,具有可行性。
Objective
1.To research the literature about efficacy evaluation in the treatment of diabetic nephropathy, so as to explore the status and problems in the Chinese medicine treatment of diabetic nephropathy, and to provide a basis for selecting efficacy evaluating index and constructing the efficacy evaluating system.
2. To introduce the methods of scale research, and combine with expert advice and preliminary basis for the work, so as to form the Chinese Medicine Syndrome rating scale.
3. To establish comprehensive efficacy assessment model of DN with comprehensive evaluation, and a randomized controlled trial of DN intervened by Chinese medicine was performed to explore the feasibility of the model.
Methods
There were three main parts as follow in this study which depended on the project of national technology support program in "Eleventh Five-Year"
Part I:To research the literature for treatment evaluation of DN. The literatures from the year of2000to2010for Chinese medicine and integrated Chinese and western medicine treatment of DN were searched, so as to collect the efficacy evaluation criteriaes and evaluation index, and the frequencies of which were counted and analyzed.
Part II:To establish the TCM Syndromes Evaluation Scale for DN and examine its scientificainess. Based on previous research, the questionnaire of Chinese medicine syndrome in DN was introduced as index item pool of syndrome outcome assessment for DN. 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 DN, of which the reliability, validity and responsiveness were measured.
Part III:The efficacy assessment index Questionnaire of Chinese Medicine Treating DN was designed, and the efficacy evaluation significance of index was evaluated with the Delphi method, so as to sift the efficacy assessment index of Chinese medicine treating DN. The methods of Analyzing Hierarchically and Delphi method were using to build the judgment matrix in order to the combined weights of each index, so as to forming the efficacy assessment system of Chinese medicine treating DN. The system was validated through a randomized controlled clinical trial of Chinese medicine treating DN.
Results
687articles about traditional Chinese medicine treating DN were obtained, from which we selected166accordance with the inclusion criteria. We evaluated the quality of literatures with Jadad score, and found most articles has a low score on Jadad (less than2score).
There was not a unified standard of efficacy evaluation of DN. Effective evaluation standards made according to some related-standards and self-made standards were more than80%of all applied standards. The index included physical and chemical index, syndrome or symptom index, safety index, quality of life index and endpoint index. There were159articles reported44physical and chemical index.46articles reported syndrome or symptom index of TCM.33articles reported safety index,4articles reported quality of life index.1article reported endpoint index. Most articles evaluated effects only from one aspects, only a few articles evaluated effects from multiple dimensions.
Using subjective evaluation method,4items (the item8、9、28、32)were deleted. Using inspecting the distribution of entry method,8items (the item7、8、22、24、28、30、32、34)were deleted. Using discrete trend method,4items(the item24,28、30、32) were deleted. Using factor analysis method,3items(the item12、29、31) were deleted. Using correlation method of corrdlates,8items (the item8、24、28、30、34、13、18、32)were deleted. Using Cronbach a Coefficient,5items (the item10、11、12、13、34) were deleted. Finally,6items(the item8、24、28、30、32、34) were deleted,while other28items passed through5methods and composed the Syndromes Evaluation Scale for DN.133cases were collected to exam the scale. The results showed that the scale had a good feasibility. The test-retest reliability coefficients of the whole scale and the every dimension were all over0.6,showing a good test-retest reliability; The Cronbach a Coefficient of the whole scale was0.776,showing a good internal homogeneity reliability. Factor analysis showed the cumulative contribution rate was67.14%, showing a good construct validity.
By Delphi method we selected the effect index of TCM treating DN including5second index which were endpoint index, physical and chemical index, syndrome or symptom index, quality of life index and safety index, and15third index. By using Analytic Hierarchy Process, the judgment matrix of index was determined to get the initial weight and the combination weight of index. The result was given in fig.
Using the weighted linear method, we got the outcome assessment system model of treatment of DN by Chinese Medicine:
Early Diabetic Nephropathy:
GI=0.3439x1+0.3439x2+0.1289x3+0.1289x4+0.0544x5
x1=0.2579x11+0.0860x12
X2=0.0360x21+0.0888x22+0.2190x23
x3=0.1289x31
x4=0.0967x41+0.0322x42
x5=0.0408x51+0.0136x52
Clinical Diabetic Nephropathy:
GI=0.3439x1+0.3439x2+0.1289x3+0.1289x4+0.0544x5
x1=0.2579x11+0.0860x12
X2=0.0187x21+0.0443x22+0.1183x23+0.1183x24+0.0443x25
x3=0.1289x31
x4=0.0967x41+0.0322x42
x5=0.0408x51+0.0136x52
GI meant synthetic evaluation scores. x1、x2、x3、x4、x5meant the five dimensions:endpoint index, physical and chemical index, syndrome or symptom index, quality of life index and safety index.
x11、x12meant the2index under X1dimension which were the incidence of endpoint and he time develop to the endpoint
x21、x22、x23、x24、x25meant the5index under X2dimension which were FBG、 HbA1C、UAER/24hours urinary protein (clinical DN)、the blood SCr (clinical DN)、 GFR (clinical DN)
x31meant the index under X3dimension which was the Syndromes Evaluation Scale for DN.
X41、x42meant the2index under X4dimension which were WHOQOL-BREF and DQOL score.
x51、x52meant the index under X5dimension which were the incidence of adverse events and the Severity of adverse events.
A Randomized Controlled Trial in which120cases were collected to validate the system. And the results showed the GI score of treatment group was1.13with the GI score of controlled group0.87in early DN,and the GI score of treatment group was1.26with the GI score of controlled group0.74in clinical DN. The score of treatment group was better than controlled group. It showed the feasibility of comprehensive outcome assessment system of treatment of DN.
Conclusions
1.The outcomes assessment criterion of Chinese medicine treating DN were relatively confusing, and physical and chemical indicators were main index for therapeutic effects, which remained at the level of the biomedical model, and could not be fully and accurately reflect the efficacy of Chinese medicine. The outcome assessment of Chinese medicine treating DN requires objective and scientific outcome assessment system to display the efficacy advantage of Chinese medicine, and which will be comprehensive and multi-dimensional and should pay attention to the end of the event and quality of life.
2. The syndrome outcome rating scale of Chinese medicine treating DN tentatively established had a good feasibility,reliability,validity and responsiveness, and could be applied to evaluate the syndrome outcome of Chinese medicine treating DN.
3. After validated by the randomized controlled clinical trial of Chinese medicine treating DN, the comprehensive efficacy assessment system of Chinese medicine treating DN was considered to have the feasibility in evaluating comprehensively the clinical efficacy of Chinese medicine treating DN.
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