| Objective:To investigate the relationship between dynamic changes of syndromes in the early and clinical stages of diabetic nephropathy (DN) and important parameters of renal function and quality of life, and the effects of different intervention protocols on dynamic changes of each symptom in the elements of syndromes of DN, in order to provide evidence for the understanding of the nature of traditional Chinese medicine (TCM) syndromes in DN, and provide more reliable evidence for the study on standardization and changes of TCM syndromes in DN.Methods:With the support from "11th five-year" National KeyTechnology Research and Development Program-the Study on the Comprehensive Protocol of Whole-course TCM Intervention for the Development of DN, the cases were enrolled from10institutions (Dongzhimen Hospital of Beijing University of Chinese Traditional Medicine and Peking University First Hospital etc.); according to survey forms established strictly, the general condition, comorbidities, the information of four TCM diagnostic methods at zero time point and8time points after interventions of TCM and western med i c ine(a total of2years), biochemical indexes and scores of quality of life in patients at early and clinical stages of DN were collected, input into the database, and examined and verified unmistakably.First study:The change trend of34symptoms of7syndrome elements at the early and clinical stages of DN after two different kinds of intervention at9time points was examined, including score differences (the difference between the score at the enrollment and that at each time point) and rank sum test.Second study:the relationship between dynamic changes of syndromes in early and clinical stages of DN at9time points and score changes of quality of life were examined. The ad justed diabetes of life measure (A-DQOL) was used as the scale for quality of life, and linear mixed effects model was used for regression analysis of longitudinal data being measured repeatedly; in terms of variables being considered, besides score of TCM syndromes, other variables, such as age, sex and complications, were also analyzed together.Third study:the relationship between dynamic changes of syndromes in early and clinical stages of DN at9time points and changes of major parameters of renal function was examined. Linear mixed effects model was used for regression analysis of longitudinal data being measured repeatedly, and variables that may affect the parameters of renal function, such as age, sex and complications, were also analyzed together.ResultsFirst study:1At9time points, the comparison of score changes of34symptoms at early and clinical stages of DN (7syndrome elements) by two different interventions showed that, the symptom scores of TCM were improved in both groups, but at some time points, the improvement was greater in TCM group than that in the irbesartan group with significant differences between the two groups; but at other time points (after treatment), there was no significant difference between these two groups. At the time point of the end of observation (time point of8), the improvement of scores of18symptoms in TCM group was greater than that in irbesartan group, with significant difference.2The score improvement of some symptoms in TCM group was greater than that in irbesartan group. In terms of score difference of symptoms, the improvement of phlegm-dampness4(fatigue of whole body) in TCM group was greater than that in irbesartan group, with significant difference, at all of8time points after treatment; at7time points after the end of the fifth course of treatment, the improvement of blood stasis(purple or dark purple lips and tongue, petechia, purple and engorged sublingual collaterals) in TCM group was greater than that in irbesartan group, with significant difference.3During the2nd, third and fourth course of treatment, the improvement of only6symptoms in TCM group was greater than that in irbesartan group at6time points, with significant differences at each time point; however, during the6th,7th and8th course of treatment, the improvement of24symptoms in TCM group was greater than that in irbesartan group at47time points, with significant differences at each time point.Second Study:1The correlation between the change of total score of DN syndromes and that of DQOL:The change of total score of DN syndromes was positively correlated with that of DQOL, and hyper1ipidemia in patients was negatively correlated with the change of total score of DQOL.2The correlation between the change of total score of DN syndromes and the score changes of four sub-functions of DQOL:1.The change of total score of DN syndrome was positively correlated with the score change of effects of physiologic function in DQOL.2. The change of total score of DN syndromes was positively correlated with the score change of psychological/mental effects in DQOL, and age, hyper1ipidemia in patients were negatively correlated with the score change of psychological/mental effects.3. The change of total score of DN syndromes was positively correlated with the score change of effects of social relationship in DQOL, and age, hyperlipidemia and coronary heart disease in patients were negatively correlated with the score change of effects of social relationship.4. The change of total score of DN syndromes was positively correlated with the effects of treatment on patients in DQOLThird Study:1The correlation between the change of total score of DN syndromes and changes of parameters of renal function:1. Age, and hypertension in patients were negatively correlated with the change of GFR. The change of total score of DN syndromes was not closely related with the change of GFR.2. The change of total score of syndromes and age were positively correlated with the change of BUN.3. Age and hypertension in patients were positively correlated with the change of Scr. Sex was negatively correlated with the change of Scr. The change of total score of DN syndromes was not closely related with the change of Scr.4. The change of total score of DN syndromes and hypertension in patients were positively correlated with the change of urinary albumin excretion rate (UAER).2The correlation between the changes of total scores of DN syndrome elements and the changes of parameters of renal function:1. The change of total score of yang-deficiency syndrome elements, age and hypertension in patients were negatively correlated with the change of GFR.2. The total score changes of syndrome elements of qi-deficiency, blood-deficiency, yang-deficiency, phlegm-dampness and damp-turbidity, sex, and hypertension in patients were positively correlated with the change of BUN.3. The total score change of syndrome elements of qi-deficiency and yang-deficiency, age and hypertension in patients were positively correlated with the change of Scr, and sex was negatively correlated with the change of Scr.4. Hypertension in patients was positively correlated with the change of UAER, and the change of total score of all syndrome elements was not closely related with the change of UAER.Conclus ion:1In terms of symptom score, the comparison of score changes of34DN symptoms by two different intervention protocols at9time points demonstrated that TCM treatment was better than irbesartanon the basis of diet therapy and symptomatic treatment of modern medicine, which was in accordance with the results of syndrome efficacy. In addition, the study on the dynamic changes of symptoms showed that the improvement of all symptoms by TCM was not greater than that by irbesartan at all time points, but the improvement of some symptoms by TCM was more prominent, which should be further investigated. In terms of the temporal distribution of the improvement by TCM, it was more often significant during the latter half of treatment course, which indicated that the long-term treatment of TCM should be emphasized.2The study indicated that the change of total score of DN syndromes was correlated with the score change of DQOL, which demonstrated that the improvement of TCM syndromes could reflect that of quality of life in patients and related study on quality of life could be used as important supplement for the study of TCM syndrome and be helpful for the objective evaluation of TCM efficacy and standardization of TCM syndrome.3The correlational study between the change of DN syndromes and the change of parameters of renal function indicated that, the metabolites, such as BUN and Scr may also be related with syndromes of healthy energy deficiency, such as qi-deficiency and yang-deficiency, which was different from the traditional concept that the metabolites were more related with phlegm-dampness and damp-turbidity. This showed that the pathogenesis of excess due to deficiency was more prominent in the late stage of DN, so during the treatment not only dispelling turbidity and detoxification should be emphasized, but also strengthening healthy-qi should be stressed, in order to strengthen vital qi to eliminate pathogenic factors; it also demonstrated the rationality and scientificness of the concept of prescription that the treatment of dissolving stasis and softening lump should be established with the emphasis on the strengthening of health-qi. The study is also helpful for further investigation into the nature of TCM syndromes of DN.
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