| BackgroundIn recent years,the incidence rate of Idiopathic membranous nephropathy(IMN)has increased year by year,which accounts for 20%～40% of the adult primary nephrotic syndrome.Because of the diverse clinical outcomes of IMN and the varying sensitivity to drug therapy,there is no generally accepted best treatment plan.Cyclophosphamide and Tripterygium wilfordii are effective in the treatment of IMN,but its wide application is limited by the side effects of gonadal inhibition,liver damage and bone marrow suppression;Cyclosporine A and Tacrolimus have obvious hepatorenal toxicity and high recurrence rate,it is necessary to closely monitor the blood drug concentration during medication,and the cost is expensive,which leads to certain limitations in the clinical application of these drugs.At present,there is no report about Kunxian capsule in the treatment of IMN.ObjectiveTo study the efficacy and safety of Kunxian Capsule combined with Prednisolone Acetate in the treatment of IMN,and to provide a new theoretical basis for the treatment of IMN.MethodsA total of 111 patients with IMN treated in the First People’s Hospital of Xinxiang City from May 2017 to January 2020 were selected and randomly divided into treatment group(55 cases)and control group(56 cases)using digital table method.The patients were treated with Angiotensin converting enzyme inhibitor(ACEI)/ Angiotensin II receptor blockers(ARB),low salt(<6g/d,edema<3g/d),low fat,normal high quality protein0.8～1.0g/(kg·d)diet,and give symptomatic treatment,such as diuresis,detumescence,anticoagulation and others.The treatment group was treated with Kunxian Capsule combined with medium dose Prednisolone Acetate therapy,Kunxian Capsule(Manufacturer:Guangzhou Baiyunshan Chen Liji Pharmaceutical Factory Co.,Ltd.,Approval number: Chinese medical standard character Z20060267)0.3g per capsule,0.6g each time,3 times a day,and gradually reduced to discontinuation after 3 months,combined with Prednisolone Acetate Tablets(Manufacturer: Shanghai Shangyao Xinyi Pharmaceutical Factory Co.,Ltd.,Approval number: Chinese medical standard character H31020771)5mg each tablet,0.5mg/(kg·d),decreased gradually after oral medication for 8 weeks,decreasing by 5 mg every 2weeks,until 10mg/d was maintained for 3 months.The control group was treated with Cyclophosphamide Injection(Manufacturer:Tonghua Maoxiang Pharmaceutical Co.,Ltd.,Approval number: Chinese medical standard character H22022234)each dose 0.2 g,combined with adequate Prednisolone Acetate therapy,Cyclophosphamide 200 mg,every other day intravenous injection;or oral medication Cyclophosphamide Tablets(Manufacturer: Tonghua Maoxiang Pharmaceutical Co.,Ltd.,Approval number: Chinese medical standard character H22026738),every piece of 50 mg,50 mg each time,twice a day,the cumulative dose was 6～8g,combined with Prednisolone Acetate Tablets 1mg/(kg·d),the maximum dose was 60mg/d,and gradually reduced after 8 weeks,reducing 10% of the original dose every semimonthly.Two groups were treated for no less than 12 months.During the treatment period,we regularly followed up to the First People’s Hospital of Xinxiang City,two groups of patients improved blood routine,liver function,renal function,blood sugar,blood fat,urinalysis,24-hour urinary protein quantification,phospholipase A2 receptor(PLA2R)releted laboratory examinations,and observed the changes of the two groups of patients’ condition,and compared the efficacy and safety of the two groups of patients.Results1.Comparison with the same group: after 1 month of treatment,the levels of serum total protein and serum albumin in the treatment group were no significantly different from those pre-treatment(P>0.05);the level of serum total protein in the control group was higher than that pre-treatment,the difference was statistically significant(P<0.05),and the level of serum albumin in the control group was significantly higher than that pre-treatment(P<0.01);after 3 and 6 months of treatment,the two groups of the levels of serum total protein and serum albumin in the treatment group were significantly higher than those pre-treatment(all P<0.01).2.Comparison between the two groups: pre-treatment and after 1 month of treatment,there was no significant difference in the levels of serum total protein and serum albumin between the two groups(all P>0.05);after 3 months of treatment,the level of serum total protein in the treatment group was higher than that in the control group(P<0.05),and the level of serum albumin in the treatment group was significantly higher than that in the control group(P<0.01);after 6 months of treatment,there was no significant difference in the levels of serum total protein and serum albumin between the two groups(all P>0.05).3.Comparison with the same group: after 1,3 and 6 months of treatment,the 24-hour urinary protein of the treatment group and the control group were significantly decreased compared with that pre-treatment,and the differences were significant(all P<0.01).4.Comparison between the two groups: there was no significant difference in 24 hours urinary protein between the two groups pre-treatment(P>0.05);after 1 and 3 months of treatment,24 hours urinary protein in the treatment group was significantly lower than that in the control group,and the differences were significant(all P<0.05);after 6 months of treatment,24 hours urinary protein in the treatment group was significantly lower than that in the control group(P<0.01).5.After 6 months of treatment,there were no significant differences in the number of complete remission cases,partial remission cases,invalid cases and total remission rate between the two groups(all P>0.05).6.The total incidence of adverse reactions in the treatment group(10%)was lower than that of the control group(28%),and the difference was statistically significant(P<0.05).Conclusions1.The effect of reducing hypouric protein in the Kunxian Capsule treatment group is faster and more effective than that in the Cyclophosphamide control group,but the total remission rate of the two groups is similar after 6 months of treatment.2.Kunxian Capsule treatment group do not increase serum total protein and serum albumin at the early stage of IMN treatment(1 month),but the effect of increase serum total protein and serum albumin is obvious after 3 months of treatment.3.The adverse reactions of Kunxian Capsule treatment group are less than those of Cyclophosphamide control group. |
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