Effect Of Zhuangshengujing Formula On Proteinuria In Treating Chronic Nephritis

BackgoundZhuangshengujing Formula (Zhuangshenyihao Granule),the granule of Chinese traditional medicine, is made based on many years of clinical experience of Liu Xin, chief physician. It has the functions of tonifying Kidney, benefiting Spleen, containing and astricting essence, romoting blood circulation, arresting bleeding and relieving swelling. So it is applied to treat the diseases of renal hematuria and albuminuria, which are deficiency of Spleen-kidney Qi. clinically, Zhuangshengujing Formula, a nosocomial preparation now, has been used for over 10 years, and gets satisfying results.ObjectivesThe primacy purpose of this study was to observe the clinical effect of Zhuangshengujing Formula on proteinuria in treating chronic nephritis. The related results and conclusions can serve as references for the further clinical application and promotion.MethodsIn accordance with diagnostic criteria, inclusion criteria and exclusion criteria, we chose 60 cases with proteinuria of chronic nephritis and deficiency of Spleen-kidney Qi, including outpatients and the patients hospitalized in Nephrology department of Zhuhai hospital of Guangdong Provincail Hospital of TCM from September,2008 to March,2011. All of the patients were divided into two groups:normal renal function group and renal function impairment group according to serum creatinine(Scr). And there were 33 patients in normal renal function group whose serum creatinine was not more than 120 umol/L, while 27 patients in renal function impairment group whose serum creatinine was from 120 to 442 umol/L. Zhuangshengujing Formula was used to treat for three weeks, supplemented by pattern identification of Chinese medicine when necessary. Monitored and compared the changes of Proteinuria, serum creatinine (Scr), blood urea nitrogen (BUN), and creatinine clearance (Ccr) before and after treatment, the two groups separately and as a whole. All datas were tested and analyzed with concise statistical software 10.34 and SPSS13.0, making 0.05 the boundary of statistical significance. According to the request of the Chinese herbal medicine new medicine clinic research guideline, revised in 2002, evaluated the therapeutic effects of proteinuria and disease. In addition, observed the side effect and toxicity of Zhuangshengujing Formula during the treatment.Results(1)the therapeutic effects of proteinuria were as follows:The clinically basic recovery rate and the effective rate in normal renal function group and renal function impairment group respectively were 36.4% and 72.7%,11.1% and 37.0%, and the total rates were 25.0% and 56.7%. When compared with the two groups, the distributions of proteinuria's effects were different (P=0.0031). the total clinical effects in normal renal function group were better (P=0.0055),and the effective rate was 35.7 percent over renal function impairment group. There were 36 patients deficiency of Spleen-kidney Qi, and with turbid damp and blood stasis, whose effective rate of proteinuria was 47.2%. (2)Changes were observed in indexes of serum creatinine (Scr), blood urea nitrogen(BUN), creatinine clearance rate(Ccr). Compared with the above three indexes before and after treatment respectively, normal renal function group and renal function impairment group there were no significant difference for both groups (P>0.05).But as a whole.before and after treatment there were significant differences for both Scr (P=0.023) and BUN (P=0.023), while with no difference for Ccr (P=0.328). (3) There were some differences with Ccr and Scr in evaluating the renal function. The conditions before and after treatment were compared as follows:In normal renal function group, there were 11 cases and 10 cases respectively whose Scr were not more than 120 umol/L while whose Ccr were from 50ml/min to 80ml/min. It suggested that their renal function insufficiency were mild. Aslo,6 cases and 7 cases respectively, whose Scr were more than 120 and less than 177 umol/L while whose Ccr were from 20ml/min to 50ml/min, implied that their renal function insufficiency were moderate.In addition, the number of the cases whose Scr were from 177umol/L to 442umol/L while Ccr were from 10ml/min to 200ml/min was 9 and 8 respectively. That seemed to imply that their renal function insufficiency were severe. (4)As for the effect of the disease of chronic nephritis, the effective rates in normal renal function group and renal function impairment group were 72.7% and 29.6% respectively, and the total rate was 53.0%. (4) Drug safety was observed during the whole time of the treatment, and no side effect was found.Conclusion(1)Based on the effects of the proteinuria and the disease of chronic nephritis, it was safety and effective to treat the proteinuria of chronic nephritis with Zhuangshengujing Formula Jiawei,and those patients were deficiency of Spleen-kidney Qi. It worthed studying further and promoting in clinical.(2)For the effect of proteinuria, normal renal function group treated with Zhuangshengujing Formula may achieve more satisfying results on the whole,, and its effective rate was higer than renal function impairment group. (3)Generally, Zhuangshengujing Formula haved the function of reducing the levels of Scr and BUN, but for this study, there was no significant difference for Ccr. And to treat chronic nephritis in normal renal function group and renal function impairment group respectively, the influences of Zhuangshengujing Formula on Scr,BUN,Ccr aslo were remained to be studied further with large sample for a truly long time, and made a long-term follow-up study for the prognosis. (4) The differences with Ccr and Scr in evaluating the renal function seemed to imply that Ccr may be more sensitive, and their correspondence relations were very necessary for us to make further steps.