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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >A comparative study of sirolimus tablet versus oral solution for prophylaxis of acute renal allograft rejection.
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A comparative study of sirolimus tablet versus oral solution for prophylaxis of acute renal allograft rejection.

机译：西罗莫司片与口服液预防急性同种异体移植排斥反应的比较研究。

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摘要

This multicenter, open-label study compared the efficacy, safety, and pharmacokinetic parameters of sirolimus (rapamycin) tablet and liquid formulations for prevention of efficacy failure. A total of 477 renal allograft recipients were randomly assigned (1:1) to receive either tablet or solution formulations of sirolimus for 12 months, plus cyclosporine (CsA) and steroids. Pharmacokinetic parameters were analyzed based on trough concentrations and 24-hour pharmacokinetic profiles. There were no significant differences in efficacy failure at 3 or 12 months between tablet and solution groups. Graft survival, patient survival, rate of first biopsy-confirmed acute rejection, time to and severity of acute rejection, and laboratory parameters were not significantly different between groups. Mean steady-state sirolimus and CsA pharmacokinetic parameters on days 30 and 90 were not significantly different by formulation, except for longer sirolimus t(max) after tablet administration. Multivariate logistic regression analysis indicated that low sirolimus C(min,TN) and more human leukocyte antigen mismatches were predictors of acute rejection. The tablet and solution formulations of sirolimus demonstrated therapeutic equivalence.
机译：这项多中心，开放标签的研究比较了西罗莫司（雷帕霉素）片剂和液体制剂的功效，安全性和药代动力学参数，以预防功效衰竭。总共477名同种异体肾移植受者被随机分配（1：1），以接受西罗莫司的片剂或溶液制剂治疗12个月，以及环孢素（CsA）和类固醇。根据谷浓度和24小时药代动力学曲线分析药代动力学参数。片剂和溶液组之间在3或12个月的功效失败方面无显着差异。两组之间的移植物存活率，患者存活率，首次活检确认的急性排斥反应的发生率，急性排斥反应的发生时间和严重程度以及实验室参数均无显着差异。除片剂给药后更长的西罗莫司t（max）外，第30天和第90天的平均稳态西罗莫司和CsA药代动力学参数无明显差异。多因素logistic回归分析表明，西罗莫司C（min，TN）低和人类白细胞抗原失配更多是急性排斥反应的预测因素。西罗莫司的片剂和溶液剂具有治疗等效性。

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