| Objective: To observe the efficacy of Kunxian Capsule in the treatment of proteinuria in the area of primary glomerular disease nephropathy,and to observe its adverse effects and safety.Methods: A self-contrast controlled trial was included in the diagnosis and treatment of primary glomerular disease in the outpatient and inpatient department of Shengjing Hospital affiliated to China Medical University from October 2017 to November 2018.There were 30 patients with urine protein more than 3.5 g / d.Indicators which the patients' blood white blood cells,serum albumin,24 h urine protein quantification,urine ?1 microglobulin and other tests,adverse drug reactions and discontinuations were observed at 1,3,6,9,and 12 months after treatment to assess clinical response and drug safety at different time points.Results:1.The total effective rate was 73.33% for 1 month of treatment;the total effective rate was 70.00% for 3 months of treatment;the total effective rate was 53.33% for 6 months of treatment;the total effective rates for 9 months of treatment and 12 months of treatment both were 43.33%.2.The quantification of 24 h urinary protein decreased significantly from the beginning of 1 month after treatment and continued until the end of treatment,P <0.01.Serum albumin decreased after 1 month of treatment,with marked difference as compared with that before treatment(P <0.05).At 12 months of treatment,as the dose of Kunxian capsules was further reduced or discontinued,serum albumin increased significantly,compared with 1 month and 3 months of treatment.They looked significantly different compared with 6 months and 9 months(P <0.01);There were no significant changes in BUN,Scr,and cystatin C before and after treatment(P> 0.05).3.A total incidence was about 33.3%(10/30)with adverse drug reactions occurred during the treatment in this study.Among them,abnormal liver function was the main cause,with an incidence of about 16.7%(5/30),and also included a serious gastrointestinal reaction was about 3.3%(1/30),hair loss was about 3.3%(1/30),skin itching was about 3.3%(1/30),and menstrual disorders were about 18.2%(2/11).4.Urinary ?1 microglobulin increased at 1 month of treatment,3 months of treatment,,and 6 months of treatment,compared with before treatment,P> 0.05,the difference was not statistically significant.It decreased after 9 months of treatment with marked difference as compared with that 3 months of treatment(P <0.01)and 6 months of treatment(P <0.05).At 12 months of treatment,as the dose of Kunxian capsules was further reduced to discontinuation,U?1-MG decreased compared to before,1 month of treatment,3 months of treatment,6 months of treatment and 9 months of treatment,P <0.01,the difference was statistically significant;There was no significant change in WBC,RBC,Hb,PLT,ALT,AST,TBIL,UBIL,CD4 +,CD4 + / CD8 + compared with that before and after treatment(P>0.05).Conclusions:1.For patients with hormonal contraindications or refusal of hormonal therapy,Kunxian Capsule has the characteristic of rapid onset of urinary protein.2.Kunxian capsule has liver side effects,which can inhibit liver protein synthesis.With the decrease of urinary protein in the short term after treatment,there is no obvious rise in albumin,but in the long-term medication,the amount of albumin can gradually increase as the drug is reduced to withdrawal.Kunxian Capsules can also cause transaminase elevation,and the drug dose needs to be adjusted in time.3.Women of childbearing age need to observe the menstrual situation and reduce the drug and stop the medicine in time.4.By observing the dynamic changes of urinary ?1 microglobulin,it is suggested that there is no obvious renal tubular injury in the dose and observation course of the present study. |
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