Efficacy and safety of tacrolimus versus cyclosporine in adults with idiopathic membranous nephropathy

Abstract

Abstract: AIM: To compare the clinical efficacy and side-effects in patients with idiopathic membranous nephropathy who received Tacrolimus (TL) or Cyclophosphamide (CTX) . METHODS: 30 patients with primary nephrotic syndrome admitted to our hospital, diagnosed by renal biopsy in IMN, excluded in the diagnosis of secondary membranous nephropathy, were randomly divided into Tacrolimus combined with glucocorticoid treatment (TL group, 0.07-0.1 mg·kg^-1·d^-1, n=15) or CTX combined with glucocorticoid treatment ( CTX group, 0.75-1.0 g/m² body surface area, every month for 6 months, n=15) . All patients received variable doses of prednisolone concomitant with TL or CTX therapy, at a dose of 1.0 mg·kg^-1·d^-1 initially and maintained at 0.2-0.3 mg·kg^-1·d^-1.The planned duration of study to assess treatment efficacy was at least 6 months.The effect of TL was observed by the change of 24 h urinary protein, serum albumin, blood lipid, blood glucose, liver and kidney function and its adverse effects in each group, and complete response rate and partial remission rate. RESULTS: Significant clinical improvement in IMN patients was observed after TL or CTX treatment and the most noticeable effect was found at 6 months of therapy. TL significantly alleviate proteinuria, serum albumin and blood lipids a month later, while CTX need two months.At the end of 6 months, the complete remission rate and total remission rate in TL group was significantly higher than these in the CTX group (40.0% vs 13.3%, 93.3% vs 60.0%, respectively). Adverse effects in the TL group: gastrointestinal discomfort (13.3%), glucose intolerance (6.7%), bacterial pneumonia (13.3%), shingles (6.7%), serum creatinine increased (6.7%), transaminase increased (6.7%), alopecia (13.3%). In the CTX group: gastrointestinal discomfort (13.3%), bacterial pneumonia(13.3%), shingles(6.7%), myelosuppression (13.3%), transaminase increased (20.0%), chemical cystitis (13.3%), alopecia (40.0%). CONCLUSION: The study suggests that a 6-month course of TL is a safe and effective treatment of IMN. As compared with CTX treatment, TL possibly results in a faster resolution of proteinuria and a higher remission rate of IMN.

Key words: Tacrolimus, Cyclophosphamide, Idiopathic membranous nephropathy, Treatment

CLC Number:

R692

LI Yi, WANG Shuai, ZHAO Jing-hong, HUANG Yun-jian. Efficacy and safety of tacrolimus versus cyclosporine in adults with idiopathic membranous nephropathy[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2012, 17(7): 797-801.

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