吗替麦考酚酯联合激素治疗膜性肾病的疗效及安全性观察

目的 评价吗替麦考酚酯(MMF)联合激素治疗特发性膜性肾病(IMN)的疗效及安全性.方法 46例激素抵抗型IMN患者完全随机分为观察组(23例,MMF+泼尼松口服)和对照组(23例,环磷酰胺静脉滴注+泼尼松口服),疗程12个月.观察患者治疗前、治疗6及12个月尿蛋白、血白蛋白、Cr、TG及TC水平变化,评价治疗疗效及不良反应.结果 观察组治疗6及12个月后尿蛋白[(4.6±2.2)、(3.3±1.5)g/d]、TG[(2.4±1.7)、(2.2±1.3) mmol/L]及TC[(6.5±2.2)、(6.2 ±2.1) mmol/L]较治疗前[(6.8±1.5)g/d、(2.9±1.6) mmol/L、(9.1 ±2.5) mmol/L]明显降低,差异有统计学意义(P＜O.05或P＜O.01)；血白蛋白[(35±5)、(39±4)g/L]较治疗前[(23±5) g/L]明显升高(均P＜0.05)；治疗前后Cr无明显变化[(102±46)、(97±43)、(92±41) μmol/L,P＞O.05].观察组治疗6、12个月各指标与对照组[尿蛋白:(4.8±3.1)、(3.6±2.1)g/d；血白蛋白:(32±5)、(38±5)/L；Cr:(99±41)、(94±38)μmol/L；TG(2.5±1.4)、(2.3±1.6) mmol/L；TC:(6.7±2.7)、(6.3±2.9) mmol/L]比较,差异无统计学意义(均P＞0.05).观察组与对照组患者治疗6及12个月时的总有效率差异无统计学意义[65.2％(15/23)比60.9％( 14/23)、73.9％( 17/23)比69.6％( 16/23),均P＞O.05],但12个月内不良反应发生率[8.7％(2/23)]明显低于对照组[34.8％ (8/23)],差异有统计学意义(P＜0.01).结论 MMF联合激素治疗激素抵抗型IMN在达到相似临床疗效的基础上,副作用小,患者耐受性好,值得进一步深入研究.

Efficacy and safety of Mycophenolate mofetile combined with hormone in the treatment of membranous nephropathy

Objective To evaluate the efficacy and safety of Mycophenolate mofetile （MMF） combined with hormone in the treatment of idiopathic membranous nephropathy （IMN）. Methods A total of 46 patients with hormone-resistant IMN were admitted and randomly divided into observation group （23 patients, orally administered with MMF combined with Prednisone） and control group （intravenously infused with Cyclophosphamide combined with orally administered with Prednisone） and received 6-month therapy. The changes of urine protein, blood albu- min, serum creatinine, triacylglycerol and cholesterol before treatment and 6 months, 12 months after treatment were observed, and the efficacy as well as adverse drug reactions （ADR） were also evaluated. Results After treated for 6 and 12 months the urine protein[ （4.6 ± 2.2） g/d, （3.3 ± 1.5） g/d], triacylglycerol [ （2.4 ± 1.7） mmol/L, （ 2.2 ± 1.3 ） mmol/L ] and cholesterol [ （6.5 ± 2.2） mmol/L, （6.2 ± 2.1 ） mmol/L ] of observation group were sig- nificandy decreased than those before treatment [ （6.8 ± 1.5 ） g/d, （ 2.9 ± 1.6 ） mmol/L, （ 9.1 ± 2.5 ） mmol/L ] （ P 〈 0.05 or P 〈 0.01 ）, the blood albumin [ （ 35 ± 5 ） g/L, （ 39 ± 4） g/L ] was significantly increased [ （ 23 ± 5）g/L] （P 〈0.05）, and no difference in serum creatinine were observed [ （102 ±46）μmol/L, （97 ±43）ttmol/L, （92 ± 41 ）μmol/L, （P 〉 0.05 ） ]. No differences in the above indexes were observed between observation group and control group [ urine albumin ： （4.8 ± 3.1 ） g/d, （ 3.6 ± 2.1 ） g/d; blood albumin： （ 32 ± 5 ） g/L, （ 38 ± 5 ） g/L; serum creatinine ： （ 99 ± 41 ） μmol,/L, （ 94± 38 ） μmol/L; triaeylglycerol （ 2.5 ± 1.4 ） mmol/L, （ 2.3 ± 1.6 ） mmo]/L; cholesterol ： （ 6.7 ± 2.7 ） mmol/L, （6.3 ± 2.9 ） mmol/L （ P 〉 0.05 ） ]. There were similar efficacies between observation group and control group 6 and 12 months after treatment [65.2% （ 15/23 ） vs 60.9% （ 14/23 ）, 73.9% （ 17/ 23 ） vs 69.6% （ 16/23 ） ; P 〉 0.05 ]. But the incidence of ADR in observation group 8.7% （2/23） ） was obviously lower than that in control group [ 34.8% （8/23） ] （ P 〈 0.01 ）. Conclusion MMF combined with hormone has a good efficacy with limited side effects and good tolerance in treating hormone-resistant IMN.