| Objective1.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.MethodsThere 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+0.0544x5x1=0.2579x11+0.0860x12X2=0.0360x21+0.0888x22+0.2190x23x3=0.1289x31x4=0.0967x41+0.0322x42x5=0.0408x51+0.0136x52Clinical Diabetic Nephropathy: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=0.1289x31x4=0.0967x41+0.0322x42x5=0.0408x51+0.0136x52GI 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 endpointx21、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.Conclusions1.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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