| Objective:The clinical trial is designed to concentrate on the therapeutic effect and safety of Zhiling mycelia capsule combined with Jiahua tablet among the sufferers with chronic nephritis proteinuria,and explore the combined effect of the two.Through this study,we aim to provide relevant basis for the extensive clinical application of Cordyceps sinensis and its preparations,and further optimize the clinical program for the treatment of chronic nephritis proteinuria.Methods:The 90 sufferers with chronic nephritis,both diagnosed with spleen and kidney qi deficiency and damp heat syndrome,were had drug therapy in Jiangsu Province Hospital of Chinese Medicine,and were assigned into two different groups,with 45 cases in each group using a randomized controlled research method.Both groups were under the treatment premise of adjusting diet structure and controlling strictly blood pressure.Zhiling mycelia capsule combined with Jiahua tablets were taken in the treatment group,while another group took orally Jiahua tablets.Before treatment and after 4 week,8 week and 12 week treatment,to observe the treatment efficacy,scores of TCM syndromes,24h-hour protein quantitation,urine microalbumin creatinine ratio,kidney function(Scr,BUN),the levels of serum lipid(TC,TG,HDL-L,LDL-L)and liver function(ALT,AST).Results:1.Total clinical efficacy:the total response rate of the two drug combination group was 91.2%,and 82.2%in the Jiahua tablets group after treatment,which was significantly different between the two groups(P<0.05).2.the effective ratio of TCM syndromes:the effective ratio of TCM syndromes remission was 88.9%and 80.0%respectively,and it showed statistics difference(P<0.05).3.the integrals of TCM syndrome:TCM symptom integrals decreased before treatment among two groups,especially in lumbar spine soreness,lassitude,abdominal fullness,mouth and throat dryness,the evidence demonstrated these four clinical features was obviously ameliorated than those in the control group(P<0.05).4.24h-hour protein quantitation:after the treatment for 4 weeks,8 weeks and 12 weeks,the 24h-Up of the two groups both decreased than before,After 12 weeks of treatment,the 24h-Up of Zhiling mycelia capsule combined with Jiahua tablet group was obviously decreased,which was with statistical difference compared with that of the Jiahua tablet group(P<0.05).5.urine microalbumin creatinine ratio:compared between the two groups after 12 weeks of treatment,Zhiling mycelia capsule combined with Jiahua tablet group can improve urinary microalbumin creatinine ratio more effectively than Jiahua tablet group(P<0.05).6.renal function:in terms of renal function,both groups improved the serum creatinine level,but there was no statistical significance(P>0.05);however,the level of creatinine in Zhiling mycelia capsule combined with Jiahua tablet group was much improved than that in the Jiahua tablet group after treatment.After 12 weeks of treatment,the level of blood urea nitrogen in Zhiling mycelia capsule combined with Jiahua tablet group was much better than that in another group(P<0.05).7.serum lipid:After12 weeks of treatment,there was no major change in the blood lipid aspect(P>0.05),but after 12 weeks of treatment with Zhiling mycelium capsule,the level of total cholesterol and low-density lipoprotein cholesterol were much lower than before with statistical difference(P<0.05).Conclusion:Zhiling mycelia capsule combined with Jiahua tablet and only Jiahua tablet are effective and safe in the treatment of chronic nephritis proteinuria,especially spleen kidney qi deficiency and damp heat syndrome.The combined use of the two drugs can significantly reduce the proteinuria,improve the clinical symptoms,and improve the quality of life of patients.After 12 weeks,the combined effect of the two drugs can be better played.Zhiling mycelia capsule can protect renal function and improve serum lipid to a certain extent,but it needs further large sample and multi cycle trial to prove. |
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