| Effect of traditional Chinese medicine (TCM) on diabetic nephropathy (DN) is getting more and more concerns in the world. But the previous studies on DN was always deficient in the rigorous experimental design and uniform standard of syndrome differentiation, so the conclusion of the study was always not authentic and it had become a major for the application of the TCM treatment to the world. It is necessary to sum up experience of treatment on DN and get the progress on the standardization and normalization of the DN treatment. At the first, different types of syndrome is one of the most important works to investigate.ObjectiveThe study follows the rule of evidence-based medicine and combined with the characteristics of TCM, and based on DN clinical date and TCM theoretical research, experiences was collected from experts, According the analysis of regional treating program of DN, and the research of multi-center epidemiological clinical syndrome types of DN with large sample, distribution rule and clinical syndrome types of DN was investigated. Then the program of syndrome types research in DN will be set up for clinical treatment.MethodsThe literature research in the past 20 years on the DN was used with qualitative and quantitative methods; Experiences from experts collected by Delphi method; Analysis of regional clinics program was used by qualitative research methods; The program of syndrome type research in DN used by multivariate statistical analysis, such as descriptive statistics, principal component analysis statistical methods and so on; Traditional and modern literature about DN was summarized for theoretical research.Results1 Literature researchQualitative study of the literature showed that DN syndrome types up to more than 60 species. Syndrome types were classified by different stages or other ways. Patterns of differentiation syndrome were classified by qi blood yin yang, by organs, or by xu shi. They were derived from practice, and had some rationality. Each had its characteristics, different laws, and different emphases.The study on quantitative evaluation of literature was made use of meta analysis of principle. 2182 cases of DN was collected, DN Syndromes were up to 40 kinds of types. The top five TCM syndromes were: qi-yin deficiency type (33.91%), yin-yang deficiency type (20.90%), Yang deficiency type (12.56%), yin deficiency type (11.32%), extreme heat with yin deficiency type (5.32%).2 The experiences of DN syndromes from experts collected with Delphi methodTCM is a medicine based on experiences, the experiences from experts in most cases can be considered the gold standard. The opinions of experts may be reasonably collected by Delphi method.From the summary of first round results, Experts achieved highly consensus in TCM syndromes and disease location. Many entries had lower coefficient of variation and a higher degree of coordination. Experts agree on that TCM syndromes appear with compound symptomes and multiple zang-fu diseases.From the results of the second round questionnaire, we found that the variation coefficient of major entries were about 0.5. We got a conclusion: experts' opinions tended to be uniform. Experts agreed to opinions of the disease location, nature of disease, disease pathogenesis. DN was primary deficiency-secondary excess syndrome, the primary deficiency syndromes involved qi deficiency, blood deficiency, yin deficiency, yang deficiency; the secondary excess syndrome involved blood stasis, qi stagnation, phlegm turbid, turbid dampness. Qi-yin deficiency, blood stasis, turbid dampness accounted for a larger proportion of the DN syndromes.3 DN regional clinics programs analysis with qualitative research method13 DN clinic programs from kidney specialist of National Administration of Traditional Chinese Medicine, represent the domestic level of DN treatment. They can be used as evidences to evidence-based medicine research. By qualitative analysis we concluded that: although the DN syndrome programs diversification, opinions of the disease location, nature of disease, disease pathogenesis were the same. The DN syndromes were made up a larger proportion of qi-yin deficiency, qi deficiency, yin-yang deficiency, blood stasis, turbid dampness. Blood stasis existed in the whole development of DN syndromes. Different treatment by stage had become a trend, it could reflect the dynamic changes of DN, and easy to be accepted in the exchanges between Chinese and Western medicine.4 Epidemiological investigation on DN TCM syndromes308 cases were collected from 10 national centers for the epidemiological investigation on DN TCM syndromes. We discovered that the law of the distribution and evolution of DN syndromes showed some regularity.The incidences of syndrome factors in DNⅢstage were as follows: qi deficiency＞blood stasis＞yin deficiency＞yang deficiency＞phlegm＞turbid dampness＞blood deficiency. The incidences of syndrome factor in DNⅣstage were as follows: qi deficiency＞blood stasis＞yin deficiency＞yang deficiency＞turbid dampness＞phlegm＞blood deficiency. The incidences of syndrome factor in DNⅤstage were as follows: qi deficiency＞yang deficiency＞turbid dampness＞blood deficiency＞blood stasis＞phlegm＞yin deficiency.From the results combination of syndromes, each stage had many combinations. In DNⅢ, a single syndrome is the total 6.6%, combination of two syndromes is 15.1%, combination of three syndromea is the total 29.3%, combination of four syndromes is the total 20.8%, combination of five syndromes is the total 16.9%, combination of six syndromes is the total 8.5%, combination of seven syndromes is the total 2.3%. In DNⅣ, a single syndrome is the total 1.3%, combination of two syndromes is 9.7%, combination of three syndromes is the total 24.5%, combination of four syndromes is the total 26.5%, combination of five syndromes is the total 20.0 %, combination of six syndromes is the total 12.9%, combination of seven syndromes is the total 5.2%. In DN V, combination of three syndromes is the total 6.4%, combination of four syndromes is the total 25.5%, combination of five syndromes is the total 14.9%, combination of six syndromes is the total 31.9%, combination of seven syndromes is the total 21.3 %.The seven symptom factors were statistically analyzed by principal component analysis, we selected the three principal components according to the contribution rate and professional knowledge. The formula of the three principal components is:Z1=0.315X1+0.267X2-0.213X3+0.431X4+0.275X5+0.435X6 +0.431X7Z2=0.304X1+0.172X2+0.712X3-0.418X4+0.351X5+0.248X6-0.112X7Z3=-0.424X1+0.242X2+0.442X3+0.381X4-0.629X5+0.144X6+0.342X7We use our professional knowledge to analysis the three principal components. The first principal component was close relationship with qi deficiency, yang deficiency, phlegm, turbid dampness. The second principal component was close relationship with qi deficiency, yin deficiency, yang deficiency, blood stasis, phlegm. The third principal component was close relationship with qi deficiency, yin deficiency, yang deficiency, blood stasis, turbid dampness.5 Theoretical researchAccording to the analysis of traditional and modern literatures, we got a conclusion: the happening, development, and changing of DN could be explained by DM basic pathological mechanism of "hot hurt qi and yin" and DN pathological hypothesis of "micro-Zhengjia". This theory could be directional for the differentiation of DN syndrome types.The onset and development of DN is the delay and the improper treatment of DM, which leaded the injury of the yin and qi, even the yin and yang. The cementation of the sputum, qi stagnation, heat, and blood stasis in the kidney collaterals which called"micro-Zhengjia" was formed.Conclusions:①Syndrome types in DN showed diversification and complication.②Experiences from experts can be reasonable collected by Delphi method.③Syndromes differentiation for different stage of DN has become a trend.④The distribution and evolution of DN syndromes had some regularity.⑤The statistical methods such as principal component analysis can be used in the investigation of syndrome types of DN.⑥DM basic pathological mechanism of "hot hurt qi and yin" and DN pathological hypothesis of "micro-Zhengjia" has showed significance for the differentiation of DN syndrome types.
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