Clinical Observation Of The Effect Of Wuzhi Soft Capsules On The Concertration Of FK506 In MN Patients

Objective: To investigate the association of synergistic effects of Wuzhi capsules on tacrolimus with CYP3A5 Gene polymorphism in patients with membranous nephropathy and to provide basis for individualized treatment.Methods:.From January 2017 to January 2018,75 patients with idiopathic membranous nephropathy with nephrotic syndrome were treated with oral tacrolimus at an inpatient or outpatient clinic at the First Affiliated Hospital of Henan University of Traditional Chinese Medicine.The clinical manifestations were nephrotic syndrome.Patients diagnosed with idiopathic membranous nephropathy by renal puncture 75 For example,the initial dose of tacrolimus 1 mg Bid po was used for treatment,and the plasma concentration was always low after detection.Patients were divided into two groups according to whether the CYP3A5 gene metabolizing enzyme was expressed or not(group A)CP3A5 metabolic enzyme function expression type CYP3A5*1/*1 type,CYP3A5*1/*3 type,and(B group)CP3A5 metabolic enzyme function non-expression type In the CYP3A5*3/*3 group,the initial dose of tacrolimus was 1 mg Bid po,and was taken orally at 1 hour before breakfast and dinner(interval 12 h),and then 0.5 g Tid po was added to the drug.,Orally within three hours after three meals.We measured and recorded the plasma concentration of FK506,the urinary total protein 24 h,and the biochemical indexes of ALB,Scr,AST,ALT,GLU before and after administration of pentaester soft capsule,and observed whether there was infection and blood sugar elevation during the use of medication.Higher adverse reactions.Results:A total of 75 patients completed the follow-up treatment and the cases did not fall off.Among 75 patients,6 were CYP3A5*1/*1,accounting for 8.0%,37 were CYP3A5*1/*3,accounting for 49.3%,and 32 were CYP3A5*3/*3,accounting for 42.7%.Cases,accounting for 57.3%,32 cases in group B,accounting for 42.7%;A,B two groups of five ester soft capsules after treatment with tacrolimus plasma concentrations were higher than before treatment,the difference was statistically significant(P <0.05);Take the same dose of tacrolimus,A,B two groups of patients plus five ester soft capsules after FK506 blood concentration than before taking the five ester soft capsules increased(3.051 ± 0.774)ng / mL,before and after the use of statistically significant Difference(P <0.05);Before and after treatment,the concentration of FK506 in group A was lower than that in group B,and the difference was statistically significant(P <0.05);A and B groups before and after the use of pentaester soft capsule After 24 weeks of treatment,biochemical indicators such as urinary total protein,ALB,Scr,AST,ALT,GLU were not statistically significant(P > 0.05).Conclusion:Wuzhi soft capsules can significantly increase the plasma concentration of tacrolimus in patients with membranous nephropathy.When patients use pentacapsule soft capsules to increase the blood concentration of tacrolimus,CYP3A5 genotyping should be considered.In clinical medication,patients should be appropriately added for CYP3A5*1/*1 and CYP3A5*1/*3 types.The initial dose of large FK506,but for patients with CYP3A5*3/*3 type can be appropriately reduced the initial dose of tacrolimus to avoid adverse reactions.