关键词: 糖尿病, 特发性膜性肾病, 环磷酰胺, 他克莫司, 药物经济学分析, 治疗结果

Abstract: Background　Glucocorticoids combined with immunosuppressive agents is are common treatment for idiopathic membranous nephropathy（IMN），but the use of short-term，long-acting hormones combined with cyclophosphamide（CTX）to treat diabetes with idiopathic membranous nephropathy has been rarely reported.Objective　To explore the clinical efficacy of dexamethasone combined with CTX in the treatment of middle-aged and elderly type 2 diabetes patients with IMN，and evaluate its safety and pharmacoeconomic value.Methods　According to the random number table method，86 patients hospitalized in the Department of Nephrology，the First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine from 2014 to 2016 with type 2 diabetes and IMN who were divided into treatment group（41 cases）and control group（45 cases）.In the control group，2 patients had serious adverse reactions and withdrew from the trial，and finally 43 patients were included.The treatment group received 10 mg of dexamethasone sodium phosphate injection and 100 ml of 0.9% sodium chloride injection by intravenous drip every month，once a day，for 3 consecutive days；0.4 g of CTX for injection was added to 250 ml 0.9% sodium chloride injection by intravenous drip 1 time/d，for 2 consecutive days，the monthly dosage is 0.8 g，and the total amount reaches 8 g.The control group was given prednisone 1 mg•kg-1•d-1 combined with tacrolimus capsule 0.05 mg•kg-1•d-1，and the tacrolimus blood concentration need to maintain at 3-5 μg/L.After 8 weeks，the dose of prednisone was gradually reduced by 5 mg every 2 weeks until it reduced to 0.5 mg•kg-1•d-1 for maintaining 4 weeks，and the dose reduction was stopped at 10 mg/d for no less than 6 months.Test the liver function，blood routine，24 hour urinary protein，plasma albumin，serum creatinine（Scr），blood sugar，glycosylated hemoglobin and other indicators before treatment and 1，3，and 6 months after treatment，and compare the clinical efficacy，conduct drug reactions and pharmacoeconomic value between the two groups.Results　The incidence of adverse reactions in the treatment group 〔12.02%（5/41）〕was lower than that in the control group 〔44.2%（19/43）〕（χ2=10.525，P=0.001）.The 24 hour urinary protein of the treatment group was higher than the control group after 1 month and 3 months of treatment，and the plasma albumin level was lower than the control group（P<0.05）；the 24 hour urinary protein of the treatment group was lower than the pre-treatment after 3 months and 6 months of treatment，plasma albumin was higher than the pre-treatment（P<0.05）；24 hour urinary protein in the control group was lower than the pre-treatment after 1 month，3 months and 6 months of treatment，and plasma albumin was higher than pre-treatmen（P<0.05））.The blood glucose levels of patients of the treatment group were lower than the control group after 1 month，3 months of treatment（P<0.05）；the blood glucose and HbA1c levels of the control group were higher than pre-treatment（P<0.05）after 1 month and 3 months of treatment.The complete remission rate and total effective rate of the treatment group after 3 months of treatment were lower than the control group，and the inefficiency was greater than the control group（P<0.05）.There was no significant difference in each index and clinical efficacy between the two groups after 6 months of treatment（P>0.05）. The cost-effectiveness analysis results showed that the control group had a significantly higher cost-effectiveness ratio（164.75）than the treatment group（30.51）.Conclusion　The clinical efficacy of dexamethasone combined with CTX in the treatment of middle-aged and elderly patients with type 2 diabetes with IMN is equivalent to that of hormone combined with tacrolimus，C/E is significantly reduced，and the effect on blood sugar is small.

Key words: Idiopathic membranous nephropathy, Diabetes, Cyclophosph-amide, Tacrolimus, Pharmacoeconomic analysis, Treatment outcome