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接受抗胸腺细胞球蛋白、霉酚酸酯及6个月疗程类固醇治疗的肾移植受者中,西罗莫司与环孢素的比较

Sirolimus versus cyclosporine in kidney recipients receiving thymoglobulin, mycophenolate mofetil and a 6-month course of steroids.

作者信息

Büchler M, Caillard S, Barbier S, Thervet E, Toupance O, Mazouz H, Hurault de Ligny B, Le Meur Y, Thierry A, Villemain F, Heng A-E, Moulin B, Morin M P, Noël C, Lebranchu Y

机构信息

Francois Rabelais University, Department of Nephrology and Clinical Immunology, Bretonneau Hospital, CHU Tours, France.

出版信息

Am J Transplant. 2007 Nov;7(11):2522-31. doi: 10.1111/j.1600-6143.2007.01976.x. Epub 2007 Sep 14.

Abstract

To evaluate the efficacy and tolerance of a calcineurin inhibitor (CNI)-free regimen, 145 renal recipients were prospectively randomized to receive either sirolimus (n = 71) or cyclosporine (CsA; n = 74). All patients received polyclonal antilymphocyte antibodies, mycophenolate mofetil (MMF) and steroids (6 months). The primary endpoint, estimated glomerular filtration rate (eGFR) was not significantly different at 12 months comparing sirolimus- and CsA-treated patients (60 +/- 27 vs. 57 +/- 21 mL/min). At 12 months, patient and graft survival, incidence of biopsy-proven rejection and rates of steroid withdrawal were not statistically different (97% vs. 97%; 90% vs. 93%; 14.3% vs. 8.6% and 82.8% vs. 84.1%, respectively). Delayed and slow graft function (SGF) was not significantly different (18.6% vs. 12.3% and 11.4% vs. 13.7%, respectively). In patients who remained on treatment according to protocol at 12 months, eGFR was significantly higher with sirolimus (69 +/- 19 vs. 60 +/- 14 mL/min, p = 0.01). Overall study drug discontinuation rates were 28.2% with sirolimus and 14.9% with CsA. Adverse events (wound complications, mouth ulcers, diarrhea, hypokalemia, bronchopneumonia) and proteinuria >0.5 g/24h (38.8% vs. 5.6%, p < 0.001) were significantly more frequent in sirolimus-treated patients. Cytomegalovirus (CMV) infections were significantly less frequent with sirolimus (6% vs. 23%, p < 0.01). A CNI-free regimen using sirolimus-MMF can achieve excellent renal function, but patients on sirolimus experienced a high rate of adverse events and study drug discontinuation.

摘要

为评估无钙调神经磷酸酶抑制剂(CNI)方案的疗效和耐受性,145例肾移植受者被前瞻性随机分为两组,分别接受西罗莫司治疗(n = 71)或环孢素(CsA;n = 74)治疗。所有患者均接受多克隆抗淋巴细胞抗体、霉酚酸酯(MMF)和类固醇治疗(6个月)。主要终点指标,即估计肾小球滤过率(eGFR)在12个月时,接受西罗莫司治疗和接受CsA治疗的患者之间无显著差异(分别为60±27与57±21 mL/分钟)。在12个月时,患者和移植物存活率、活检证实的排斥反应发生率以及停用类固醇的比例在统计学上无差异(分别为97%对97%;90%对93%;14.3%对8.6%以及82.8%对84.1%)。移植肾功能延迟恢复和缓慢恢复(SGF)无显著差异(分别为18.6%对12.3%以及11.4%对13.7%)。在12个月时仍按照方案接受治疗的患者中,接受西罗莫司治疗的患者eGFR显著更高(69±19与60±14 mL/分钟,p = 0.01)。总体而言,研究药物停用率西罗莫司组为28.2%,CsA组为14.9%。西罗莫司治疗的患者不良事件(伤口并发症、口腔溃疡、腹泻、低钾血症、支气管肺炎)和蛋白尿>0.5 g/24小时(38.8%对5.6%,p < 0.001)明显更常见。西罗莫司治疗的患者巨细胞病毒(CMV)感染明显更少(6%对23%,p < 0.01)。使用西罗莫司 - MMF的无CNI方案可实现良好的肾功能,但接受西罗莫司治疗的患者不良事件发生率和研究药物停用率较高。

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