他克莫司与环磷酰胺联合激素治疗特发性膜性肾病的疗效比较

中国临床药理学与治疗学 ›› 2012, Vol. 17 ›› Issue (7): 797-801.

他克莫司与环磷酰胺联合激素治疗特发性膜性肾病的疗效比较

李艺, 王帅, 赵景宏, 黄云剑

第三军医大学新桥医院肾内科,重庆 400037

收稿日期:2012-02-10 修回日期:2012-05-11 发布日期:2012-07-17
通讯作者: 黄云剑,男,教授,硕师生导师,主要从事肾小球肾炎的发病机制及治疗研究工作E-mail: h55769@yahoo.com.cn
作者简介:李艺,女,硕士研究生,主要从事肾小球肾炎临床治疗的研究工作。E-mail:liyi813816@126.com
基金资助:
第三军医大学临床科研基金(2010年)

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

LI Yi, WANG Shuai, ZHAO Jing-hong, HUANG Yun-jian

Department of Nephrology, Xinqiao Hospital, Third Military Medical College, Chongqing 400037, China

Received:2012-02-10 Revised:2012-05-11 Published:2012-07-17

摘要/Abstract

摘要： 目的: 比较他克莫司( Tacrolimus, TL)与环磷酰胺( Cyclophosphamide, CTX)联合激素治疗特发性膜性肾病(idiopathic membranous nephropathy, IMN)的疗效及安全性。 方法: 选择本院原发性肾病综合征经肾活检确诊为IMN的30例患者, 排除继发性膜性肾病,随机分为两组,分别给予TL联合激素治疗[TL组,0.07～0.1 mg·kg^-1·d^-1,n=15]或CTX联合激素治疗[CTX组,0.75~1.0 g/m²,1次/月,n=15],疗程为6个月。主要观察治疗前后24小时尿蛋白、血清白蛋白、血脂、血糖、肝肾功的变化和不良反应发生率,以及治疗后的完全缓解率、部分缓解率。 结果: TL或CTX治疗6个月后疗效指标均出现明显的改善。TL组1月后24小时蛋白尿、血清白蛋白和血脂出现明显缓解,而CTX组2月后才出现明显缓解。治疗6个月后TL组完全缓解率高于CTX组(40.0% vs 13.3%),总缓解率高于CTX组(93.3% vs 60.0%)。TL组副作用主要有:胃肠不适2例(13.3%),血糖升高1例 (6.7%)、细菌性肺炎1例 (6.7%) 、带状疱疹1例 ( 6.7% ) ,血清肌酐升高1例 ( 6.7% )、轻度肝转氨酶升高1例 (6.7% )、脱发2例(13.3%)。CTX组的副作用:胃肠道不适2例(13.3%),肺部感染2例(13.3%),带状疱疹1例(6.7%),骨髓抑制2例(13.3%),肝功能损害3例(20.0%),化学性膀胱炎2例(13.3%),脱发6例(40.0%)。 结论: TL联合激素治疗膜性肾病是有效和安全的。与CTX相比,TL能迅速缓解膜性肾病患者蛋白尿,并有更高的IMN缓解率。

关键词: 他克莫司, 环磷酰胺, 特发性膜性肾病, 治疗

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

中图分类号:

R692

李艺, 王帅, 赵景宏, 黄云剑. 他克莫司与环磷酰胺联合激素治疗特发性膜性肾病的疗效比较[J]. 中国临床药理学与治疗学, 2012, 17(7): 797-801.

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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