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

摘要： 背景　糖皮质激素联合免疫抑制剂是治疗特发性膜性肾病（IMN）的常用方案，但糖皮质激素对中老年糖尿病患者血糖有影响，而采用短疗程、长效激素联合环磷酰胺（CTX）冲击治疗糖尿病合并IMN鲜见报道。目的　探讨地塞米松联合CTX冲击治疗中老年2型糖尿病合并IMN患者的临床疗效，评价其安全性及药物经济学价值。方法　选择2014—2016年在广西中医药大学第一附属医院肾病科住院的2型糖尿病合并IMN患者86例为研究对象。通过随机数字表法，将其分为治疗组41例及对照组45例，对照组中有2例患者出现严重不良反应退出试验，最终纳入43例患者。治疗组每月使用地塞米松磷酸钠注射液10 mg加入0.9%氯化钠注射液100 ml静脉滴注，1次/d，连续3 d；注射用CTX 0.4 g加入0.9%氯化钠注射液250 ml静脉滴注，1次/d，连续2 d，每月用量0.8 g，总量达到8 g停药。对照组给予泼尼松1 mg•kg-1•d-1+他克莫司胶囊 0.05 mg•kg-1•d-1，维持他克莫司血液浓度在3~5 μg/L，8周后泼尼松逐渐减量，每2周减少5 mg，至0.5 mg•kg-1•d-1时维持4周，至10 mg/d 停止减量，维持时间不少于6个月。检测治疗前及治疗后1、3、6个月患者肝功能、血常规、24 h尿蛋白定量、血浆清蛋白、血清肌酐（Scr）、血糖、糖化血红蛋白（HbA1c）等指标，比较两组间是否有差异，并对两组进行成本-效果分析。结果　治疗组不良反应发生率〔12.02%（5/41）〕低于对照组〔44.2%（19/43）〕（χ2=10.525，P=0.001）。治疗组治疗1、3个月后24 h尿蛋白定量高于对照组，血浆清蛋白水平低于对照组（P<0.05）；治疗组治疗3、6个月后24 h尿蛋白定量低于治疗前，血浆清蛋白高于治疗前（P<0.05）；对照组治疗1、3、6个月后24 h尿蛋白定量低于治疗前，血浆清蛋白高于治疗前（P<0.05）。治疗组患者治疗1、3个月后血糖水平低于对照组（P<0.05）；对照组治疗1、3个月后血糖、HbA1c水平高于治疗前（P<0.05）。治疗组治疗3个月后完全缓解率、总有效率低于对照组，无效率高于对照组（P<0.05）。两组治疗6个月后各指标及临床疗效比较，差异均无统计学意义（P>0.05）。成本-效果分析结果显示，对照组成本-效果比（164.75）高于治疗组（30.51）。结论　地塞米松联合CTX治疗中老年2型糖尿病合并IMN患者临床疗效与激素联合他克莫司相当，成本-效果比明显下降，对血糖影响小，患者耐受性好。

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