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接受霉酚酸酯和环孢素治疗的肾移植受者停用类固醇的前瞻性随机试验。

Prospective, randomized trial of steroid withdrawal in kidney recipients treated with mycophenolate mofetil and cyclosporine.

作者信息

Pelletier Ronald P, Akin Baris, Ferguson Ronald M

机构信息

Division of Transplantation, Department of General Surgery, The Ohio State University College of Medicine, Columbus, OH, USA.

出版信息

Clin Transplant. 2006 Jan-Feb;20(1):10-8. doi: 10.1111/j.1399-0012.2005.00430.x.

DOI:10.1111/j.1399-0012.2005.00430.x
PMID:16556147
Abstract

UNLABELLED

Our transplant centre began a prospective, randomized trial of steroid withdrawal in low risk renal transplant recipients on triple immunosuppression consisting of mycophenolate mofetil (MMF), microemulsion cyclosporine (CSA), and prednisone. One hundred and twenty patients were randomized either to discontinue or remain on steroids (60 patients per group). Study design consisted of analyses of 1-yr outcomes after study entry. This report includes the 1-yr results plus results at last follow-up (mean follow-up 3.7 yr). There were no significant differences in rates of patient and graft survival at 1 yr or at last follow-up. Additionally, the incidences of acute and chronic rejection as well as graft function were the same at 1 yr and at last follow-up. Significant improvement was noted in total serum cholesterol and bone density at 1 yr and last follow-up. Initial improvement in patient weight at 1 yr was not sustained at last follow-up. No significant impact of steroid withdrawal on serum triglycerides, blood pressure, or post-transplant diabetes mellitus was observed. To date, we have observed no immunologic risk, and some significant benefit in regards to side effects, of steroid withdrawal between 6 and 36 months after transplantation in low risk renal transplant recipients maintained on prednisone, MMF, and microemulsion CSA.

CONCLUSION

Steroid withdrawal in low risk kidney transplant recipients is safe and ameliorates many of the unwanted sides effects of steroid use.

摘要

未标注

我们的移植中心开展了一项前瞻性随机试验,研究在接受由霉酚酸酯(MMF)、微乳环孢素(CSA)和泼尼松组成的三联免疫抑制治疗的低风险肾移植受者中停用类固醇的情况。120名患者被随机分为停用或继续使用类固醇两组(每组60名患者)。研究设计包括对入组后1年结局的分析。本报告包括1年结果以及末次随访结果(平均随访3.7年)。1年时或末次随访时患者和移植物存活率无显著差异。此外,1年时和末次随访时急性和慢性排斥反应的发生率以及移植物功能相同。1年时和末次随访时总血清胆固醇和骨密度有显著改善。1年时患者体重的初始改善在末次随访时未持续。未观察到停用类固醇对血清甘油三酯、血压或移植后糖尿病有显著影响。迄今为止,我们发现在接受泼尼松、MMF和微乳CSA治疗的低风险肾移植受者中,移植后6至36个月停用类固醇没有免疫风险,且在副作用方面有一些显著益处。

结论

低风险肾移植受者停用类固醇是安全的,可改善类固醇使用带来的许多不良副作用。

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