五酯胶囊对特发性膜性肾病患者环孢素A全血浓度的影响研究

Effect of Wuzhi Capsule on Whole Blood Concentration of Cyclosporine A in Patients with Idiopathic Membranous Nephropathy

目的了解五酯胶囊对特发性膜性肾病(idiopathic membranous nephropathy,IMN)患者环孢素A(cyclosporine A,CsA)全血浓度的影响,探讨其临床应用意义。方法于2013年1月—2014年3月,选取在第二军医大学附属长征医院肾内科确诊并常规随访治疗的IMN患者48例。按随机数字表法,将其分为对照组27例和试验组21例。对照组采用口服CsA和泼尼松治疗;试验组在对照组治疗的基础上,口服五酯胶囊。比较2组患者治疗前、治疗3个月后及治疗6个月后的尿蛋白定量、血清蛋白(ALB)及肝肾功能;记录并比较2组患者治疗1周后、治疗1个月后及治疗3个月后的CsA全血浓度和CsA给药剂量;评价并比较2组患者的临床治疗效果。结果 (1)治疗前、治疗3个月后及治疗6个月后,2组患者尿蛋白定量、ALB、血肌酐(SCr)、丙氨酸氨基转移酶(ALT)及天冬氨酸氨基转移酶(AST)比较,差异均无统计学意义(P>0.05)。治疗3个月后和治疗6个月后,2组患者尿蛋白定量和ALB与治疗前比较,差异有统计学意义(P<0.05);SCr、ALT及AST与治疗前比较,差异无统计学意义(P>0.05)。(2)根据患者CsA全血浓度调整其给药剂量,治疗1个月后和治疗3个月后,试验组达到治疗窗CsA全血浓度时的给药剂量低于对照组,差异有统计学意义(P<0.05)。(3)2组患者的临床治疗有效率分别为70.3%(19/27)和71.4%(15/21),差异无统计学意义(χ2=0.01,P>0.05)。结论五酯胶囊可以提高IMN患者的CsA全血浓度,减少患者CsA给药剂量。

Objective To investigate the effect and clinical significance of Wuzhi capsules on whole blood concentration of Cyclosporine A（ CsA） in patients with idiopathic membranous nephropathy. Methods A total of 48 patients with idiopathic membranous nephropathy receiving double therapy regime（ CsA ＋ Prednisone） were randomly assigned to the Wuzhi capsule group（ n = 21） and control group（ n = 27）. Patients in Wuzhi capsule group took Wuzhi capsules simultaneously,and those in control group didn＇t take Wuzhi capsules. Urine protein,serum albumin,hepatic function and renal function were compared between the two groups before treatment,three months and six months after treatment; CsA dosage to therapeutic concentration window was compared between the two groups one week,one month and three months after treatment;the effects of treatment of the two groups were compared and evaluated. Results（ 1） There was no statistically significant difference（ P〉 0. 05） in urine protein,ALB,SCr,ALT,and AST between the two groups before treatment,3 months and 6months after treatment; the urine protein and ALB of the two groups before treatment was statistically different（ P〈 0. 05） from 3months and 6 months after treatment,while the statistical difference didn＇ t exist for SCr, ALT and AST.（ 2） According to whole blood concentration and dosage of CsA,the CsA dosage to therapeutic concentration window of Wuzhi capsule group was significantly less（ P〈 0. 05） than that of control group.（ 3） The effective rate of clinic treatment of the two groups were 70. 3%（ 19 /27） and 71. 4%（ 15 /21）,no statistical significance between them（ χ^2= 0. 01, P〉 0. 05）. Conclusion Wuzhi capsules can increase the concentration of Cyclosporine A in patients with idiopathic membranous nephropathy with reduction in dosage.