Objective:To evaluate the clinical efficacy and safety of Qizhi Yishen capsule in the treatment of diabetic kidney disease(Qi and Yin deficiency type).Methods:478 patients from 11 hospitals were randomly divided into experimental group and control group by random coding table method.The treatment period was 24 weeks.The experimental group received Qizhi Yishen Cap-sule simulator orally(5 capsules per time,3 times a day),and the control group received Qizhi Yishen Capsule simulator orally(5 capsules per time,3 times a day).The treatment lasted 24 weeks.The 24 h urinary albumin excretion rate(UAER)was taken as the main therapeutic index.24 h urine protein,serum creatinine,glomerular filtration rate,traditional Chinese medicine syndrome score and occurrence of adverse events were also assessed.Results:UAER in both the treatment group and the control group was de-creased.However,the UAER was significantly lower in the treatment group than in the control group 12 weeks and 24 weeks after treatment.The reduction ratio of UAER in The treatment group and in the control group were 35.81%vs 20.36%(P<0.05)and 46.08%vs 27.28%(P<0.01),while the individuals had a more than 50%decreased UAER were 90(34.88%)vs 25(26.32%)(P<0.05)and 120(46.51%)vs 30(31.58%)(P<0.05)12 weeks and24 weeks after treatment respectively.The24 h urinary protein quantification in the treatment group and in the control group was 90.00 mg vs 131.68 mg(P<0.01)24 weeks after treat-ment.The effective rate of TCM syndrome was 84.50%vs 45.26%(P<0.01)between the two groups24 weeks after treatment.There was no significant difference in the change of glomerular filtration rate between the two groups(P>0.05)24 weeks after treat-ment.There was no no significant difference of adverse events between the two groups(P>0.05)during the study.Conclusion:Qizhi Yishen capsule is has good efficacy effective and safety in the treatment of diabetic kidney disease nephropathy(qi-Yin deficiency type).
Qizhi Yishen capsuleDiabetic kidney diseaseQi-Yin deficiencyTraditional Chinese medicine
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