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日本肾移植受者接受他克莫司免疫抑制治疗后的安全性分析:1500 多名患者的 5 年结果

Safety analysis after tacrolimus immunosuppression in renal transplant recipients in Japan: 5-year results in >1500 patients.

作者信息

Yoshimura N, Takahara S, Uchida K, Takahashi K, Toma H, Oshima S, Sonoda T

机构信息

Organ Transplant and Endocrine Surgery, Kyoto Prefectural University of Medicine, Kawaramachi-Hirokoji, Kyoto, Japan.

出版信息

Transplant Proc. 2005 May;37(4):1764-6. doi: 10.1016/j.transproceed.2005.02.083.

DOI:10.1016/j.transproceed.2005.02.083
PMID:15919458
Abstract

Tacrolimus was approved in Japan in April 1996 for the prevention of allograft rejection in patients receiving kidney transplants. There has been a concern that immunosuppressive therapy may be associated with cardiovascular and metabolic complications, including hyperlipidemia, hypertension, and posttransplant diabetes mellitus. A multicenter (59 institutions) study was conducted in Japan in patients who underwent renal transplantation and received tacrolimus immunosuppression. Patients were followed for >5 years, from April 1996 to December 2002. Of the 1569 patients enrolled, 1542 were evaluated. In this analysis, graft survival rate and medication usage patterns of antihyperlipidemics, antihypertensives, insulin, and oral hypoglycemics were observed for >5 years in patients receiving tacrolimus immunosuppression. The graft survival rates of patients requiring antihyperlipidemic therapy and experiencing acute rejection were significantly lower compared with all other patients (P < .05). The risk of graft rejection was significantly greater in patients with cardiovascular complications requiring antihyperlipidemics or antihypertensives. Graft survival was significantly lower in patients with acute rejection and antihyperlipidemic therapy than in other patients.

摘要

他克莫司于1996年4月在日本获批,用于预防接受肾移植患者的同种异体移植排斥反应。一直有人担心免疫抑制治疗可能与心血管和代谢并发症相关,包括高脂血症、高血压和移植后糖尿病。在日本对接受肾移植并接受他克莫司免疫抑制治疗的患者进行了一项多中心(59个机构)研究。从1996年4月至2002年12月,对患者进行了超过5年的随访。在纳入的1569例患者中,对1542例进行了评估。在该分析中,观察了接受他克莫司免疫抑制治疗患者超过5年的移植物存活率以及抗高脂血症药物、抗高血压药物、胰岛素和口服降糖药的用药模式。与所有其他患者相比,需要抗高脂血症治疗且发生急性排斥反应的患者的移植物存活率显著降低(P<.05)。需要抗高脂血症药物或抗高血压药物治疗的心血管并发症患者发生移植排斥反应的风险显著更高。发生急性排斥反应且接受抗高脂血症治疗的患者的移植物存活率显著低于其他患者。

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Safety analysis after tacrolimus immunosuppression in renal transplant recipients in Japan: 5-year results in >1500 patients.日本肾移植受者接受他克莫司免疫抑制治疗后的安全性分析:1500 多名患者的 5 年结果
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引用本文的文献

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A limited sampling strategy for tacrolimus in renal transplant patients.肾移植患者他克莫司的有限采样策略
Br J Clin Pharmacol. 2008 Oct;66(4):467-72. doi: 10.1111/j.1365-2125.2008.03251.x. Epub 2008 Jun 28.