环孢霉素A与环磷酰胺联合激素治疗膜性肾病的疗效比较

Comparison on the Therapeutic Effect of Cyclosporin A and Cyclophosphamide in the Treatment of Idiopathic Membranous Nephropathy

目的:比较环孢霉素A(CSA)与环磷酰胺(CTX)联合激素治疗成年人特发性膜性肾病(IMN)的疗效和安全性。方法:76例原发性肾病综合征患者经肾活检确诊为IMN,在诊断上排除了继发性膜性肾病,单用激素治疗无效或复发,随机分两组分别予CSA联用糖皮质激素治疗(CSA组)或CTX联用糖皮质激素治疗(CTX组),疗程至少12个月。观察各组的24h尿蛋白定量、血浆白蛋白、肾功能、血糖、白细胞总数及其不良反应,以及治疗前后的完全缓解率、部分缓解率。全部患者且在正式进入研究治疗前未用或已停用类固醇激素和细胞毒药物达半年以上。结果:治疗3个月末,CsA组的24h尿蛋白、胆固醇、三酰甘油显著低于CTX组(P均<0.01),血清白蛋白显著高于CTX组(P<0.01)。两组患者的血肌酐比较差异无统计学意义(P>0.05),而CTX组的WBC显著低于CsA组(P<0.01)。CsA组完全缓解率显著高于CTX组(χ2=4.6317,P<0.05)。治疗12个月末两组的完全缓解率差异无统计学意义(χ2=1.2575,P>0.05)。CsA组的不良反应发生率(8/40=20.0%)显著低于CTX组(15/36=41.7%)(χ2=4.2146,P<0.05)。结论:与CTX相比,CsA联用糖皮质激素对IMN治疗12个月的总体疗效相当,但CsA起效更快,近期疗效更好,不良反应更小。CsA≤5mg.kg-1.d-1用于肾功能正常IMN患者是安全有效的。

Objective：To compare the efficacy and safety of cyclosporin A （CSA） and cyclophosphamide （CTX） combined hormone in the treatment of Idiopathic membranous nephropathy（IMN）.Methods：76 patients with primary nephrotic syndrome were diagnosed by renal biopsy in IMN,excluded in the diagnosis of secondary membranous nephropathy,alone or relapsed hormone therapy,were randomly divided into two groups to CSA combined with glucocorticoid treatment （CSA group） or CTX combined with glucocorticoid treatment （CTX group）,treatment for at least 12 months.To observe 24 h urinary protein,serum albumin,renal function,blood glucose,WBC and its side effects in each group,and complete response rates before and after treatment,partial remission rate.All patients entered the study and treatment in a formal or disabled without using steroids and cytotoxic drugs for six months or more.Results：Treatment after 3 months,CsA group,24 hours urine protein,cholesterol,triglycerides were significantly lower than the CTX group （P all 0.01）,serum albumin was significantly higher than the CTX group （P0.01）.Comparison of two groups of serum creatinine in patients with no significant difference （P0.05）,while the CTX group,WBC was significantly lower than CsA group （P0.01）.CsA complete remission rate was significantly higher than that of CTX group （χ2=4.631 7,P0.05）.The end of the treatment of 12 complete remission rate in both groups no significant difference （χ2=1.257 5,P0.05）.CsA group,the incidence of adverse reactions （8/40=20.0%） was significantly lower than the CTX group （15/36=41.7%） （χ2=4.214 6,P0.05）.Conclusion：Compared with CTX,CsA combined with glucocorticoid treatment for 12 months on the IMN overall efficacy equivalent,but CsA faster onset,better curative effect,less adverse reactions.CsA≤5 mg·kg-1·d-1） for the IMN patients with normal renal function is safe and effective.