Clinical Study On Stage Ⅳ Diabetic Nephropathy With The Method Of Tonifying Qi And Yin And Activating Blood And Removing Stasis

Objective: To provide an effective method of intervention to treat DiabeticNephropathy4thstage (DN Ⅳ) according to the clinical effect that is based on theprinciple of tonifying qi and yin and activating blood and removing stasis and theapplication of Qi zhi jiang tang Capsules.Methods:80appropriate DN patients of4thstage who had experienced washout fortwo weeks were divided into two groups-test group and control group-in a1:1ratioaccording to the order of their treatments, hence40cases are contained in each group. Thetest group was treated with Qi zhi jiang tang Capsules (2.5g/times, three times a day), andthe control group valsartan capsules (80mg/times, once daily), both groups were treatedfor12weeks. Related indexes were compared before and after the treatments within4weeks,8weeks, and12weeks in and between the groups, and the TCM symptoms integralbefore and after the treatments as well. Related indexes include24hour urinary protein (24h-UTP) thatused for therapeutic effect index, and urinary albumin creatinine ratio (UACR), cystatin C,serum creatinine, blood urea nitrogen, triglycerides esters, total cholesterol, high densitylipoprotein, low density lipoprotein, fibrinogen, D-dimer, fasting glucose, glycosylatedhemoglobin, hemoglobin, serum albumin, serum prealbumin and C reactive protein and soon.Results:39cases in each group respectively completed the observation.(1) Both the related indexes and the TCM symptoms integral were not statisticallysignificant before the treatments (all P>0.05).(2) After the treatments, the24h-UTP and UACR levels lowered gradually, the condition promoted in the4thweek and possessed the statistical significance (P <0.05or P<0.01). After12weeks’ treatments,24h-UTP in test group improved to possess thestatistical significance compared with the control group(P <0.05).(3) The Cystatin C level of both groups lowered gradually after the treatments, and thecondition improved to possess statistical significance in the8thweek in test group (P <0.05or P<0.01), while the control group possessed statistical significance with the improvementafter12weeks’ treatments (P<0.05). The comparison of serum creatinine and blood ureanitrogen levels in and between two groups within the same period was not statisticallysignificant (all P>0.05).(4) After the treatments, C-reactive protein decreased in test group, and8weeks laterthe group possessed the statistical significance (P<0.05), while the fluctuation ofC-reactive protein in control group showed no statistical significance (all P>0.05).(5) The fibrinogen and D-dimer levels lowered gradually in test group aftertreatments, among which the fibrinogen level was statistically significant in the12thweek(P<0.01), and D-dimer level the4thweek (P <0.05or P <0.01); while the control groupshowed no significant change in these indexes (all P>0.05).(6) The serum albumin and pre-albumin levels rise gradually in test group aftertreatments, and the serum albumin level improved to be statistically significant after8weeks’ treatments (P<0.01), while the rise of pre-albumin level and the hemoglobinfluctuations were of no statistical significance (all P>0.05); the blood albumin level incontrol group possessed the statistical significance (P<0.05); the rise trend of serumprealbumin level was not statistically significant (P>0.05); both the hemoglobin and Creactive protein levels decreased, but possessed statistical significance (all P>0.05).(7) After the treatments, the triglycerides, total cholesterol and LDL levels loweredgradually in test group. The improvement of triglycerides and LDL levels in the8thweekwas statistically significant (P <0.05or P <0.01), and the total cholesterol level improvedafter4weeks to be statistically significant (P<0.05).The control group showed nosignificant change in the above indexes after treatments (all P>0.05).(8) The contents of both fasting plasma glucose and glycosylated hemoglobin decreased gradually after treatments in test group, which the fasting plasma glucosecondition significantly improved after4weeks (P<0.01), and the glycosylated hemoglobincondition12weeks (P<0.01); while the fluctuations in control group of the above twoindexes possessed no statistical significance (P>0.05).(9) The improvement rate of TCM symptoms and signs reached79.5%in test groupafter12weeks of treatments, which was much higher than the control group’s33.3%(P<0.01).(10) After treatments, the total effective rate of test group was76.9%, and the controlgroup56.4%, which showed higher efficiency in the former than the latter (P<0.05).Conclusion: Qi zhi jiang tang Capsules for appropriate DN patients the4thstage canreduce urinary protein, delay the kidney function progress, improve hemorheology andinflammatory indices, improve glucose and lipid metabolic disorder and deficiency of bothqi and yin, blood stasis of TCM symptoms and signs, which are more effective thanvalsartan capsules; but its role to improve or change the nutritional status and hemoglobinis not exact.