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Clinical outcomes after conversion from brand-name tacrolimus (prograf) to a generic formulation in renal transplant recipients: a retrospective cohort study.肾移植受者从品牌他克莫司（普乐可复）转换为仿制药后的临床结局：一项回顾性队列研究。
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2
A single-centre comparison of the clinical outcomes at 6 months of renal transplant recipients administered Adoport or Prograf preparations of tacrolimus.一项关于接受他克莫司Adoport制剂或Prograf制剂治疗的肾移植受者6个月临床结局的单中心比较。
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Evaluation of clinical and safety outcomes associated with conversion from brand-name to generic tacrolimus in transplant recipients enrolled in an integrated health care system.评估在接受整合医疗保健系统治疗的移植受者中，从品牌名药物转换为通用他克莫司相关的临床和安全性结局。
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Clinical outcomes associated with conversion from brand-name to generic tacrolimus in hospitalized kidney transplant recipients.与住院肾移植受者由商品名他克莫司转换为通用名他克莫司相关的临床结局。
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Nationwide conversion to generic tacrolimus in pediatric kidney transplant recipients.在儿科肾移植受者中进行全国范围内的他克莫司通用转换。
Pediatr Nephrol. 2017 Nov;32(11):2125-2131. doi: 10.1007/s00467-017-3707-3. Epub 2017 Jun 28.
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Conversion of stable kidney transplant recipients from a twice daily Prograf-based regimen to a once daily modified release tacrolimus-based regimen.将稳定的肾移植受者从基于普乐可复的每日两次给药方案转换为基于他克莫司缓释制剂的每日一次给药方案。
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Impact of conversion from Advagraf to twice-daily generic tacrolimus in kidney transplant recipients: a single-center study.肾移植受者从Advagraf转换为每日两次的他克莫司仿制药的影响：一项单中心研究。
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Physiochemical properties of generic formulations of tacrolimus in Mexico.墨西哥他克莫司普通制剂的物理化学性质
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Budget impact of switching from an immediate-release to a prolonged-release formulation of tacrolimus in renal transplant recipients in the UK based on differences in adherence.基于依从性差异，英国肾移植受者从他克莫司速释制剂转换为缓释制剂的预算影响。
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Safety and efficacy of conversion from twice-daily tacrolimus (prograf) to once-daily prolonged-release tacrolimus (graceptor) in stable kidney transplant recipients.在稳定的肾移植受者中，将每日两次的他克莫司（普乐可复）转换为每日一次的缓释他克莫司（恩瑞舒）的安全性和有效性。
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Nationwide conversion to generic tacrolimus in pediatric kidney transplant recipients.在儿科肾移植受者中进行全国范围内的他克莫司通用转换。
Pediatr Nephrol. 2017 Nov;32(11):2125-2131. doi: 10.1007/s00467-017-3707-3. Epub 2017 Jun 28.
5
Efficacy and safety of a conversion from the original tacrolimus and mycophenolate mofetil to the generics Tacpan and Mowel after liver transplantation.肝移植后将原他克莫司和霉酚酸酯转换为仿制药Tacpan和Mowel的疗效及安全性。
Drug Des Devel Ther. 2015 Nov 17;9:6139-49. doi: 10.2147/DDDT.S92490. eCollection 2015.
6
Generic immunosuppression in solid organ transplantation: systematic review and meta-analysis.实体器官移植中的通用免疫抑制：系统评价和荟萃分析。
BMJ. 2015 Jun 22;350:h3163. doi: 10.1136/bmj.h3163.

本文引用的文献

1
Evaluation of clinical and safety outcomes associated with conversion from brand-name to generic tacrolimus in transplant recipients enrolled in an integrated health care system.评估在接受整合医疗保健系统治疗的移植受者中，从品牌名药物转换为通用他克莫司相关的临床和安全性结局。
Pharmacotherapy. 2012 Nov;32(11):981-7. doi: 10.1002/phar.1130. Epub 2012 Oct 16.
2
A randomized pharmacokinetic study of generic tacrolimus versus reference tacrolimus in kidney transplant recipients.一项在肾移植受者中进行的 generic tacrolimus 与 reference tacrolimus 的随机药代动力学研究。
Am J Transplant. 2012 Oct;12(10):2825-31. doi: 10.1111/j.1600-6143.2012.04174.x. Epub 2012 Jul 3.
3
A multicenter experience with generic tacrolimus conversion.多中心他克莫司转换的经验。
Transplantation. 2011 Sep 27;92(6):653-7. doi: 10.1097/TP.0b013e31822a79ad.
4
The impact of conversion from prograf to generic tacrolimus in liver and kidney transplant recipients with stable graft function.在稳定移植物功能的肝、肾移植受者中，从普乐可复转换为他克莫司 generic 制剂的影响。
Am J Transplant. 2011 Sep;11(9):1861-7. doi: 10.1111/j.1600-6143.2011.03615.x. Epub 2011 Jun 30.
5
KDIGO clinical practice guideline for the care of kidney transplant recipients.KDIGO 临床实践指南：肾移植受者的护理。
Am J Transplant. 2009 Nov;9 Suppl 3:S1-155. doi: 10.1111/j.1600-6143.2009.02834.x.
6
Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration.比较仿制药和创新药：对美国食品药品监督管理局12年生物等效性数据的综述
Ann Pharmacother. 2009 Oct;43(10):1583-97. doi: 10.1345/aph.1M141. Epub 2009 Sep 23.
7
Generic tacrolimus (Pan Graf) in renal transplantation: an experience of 155 recipients in India.肾移植中应用的他克莫司普通制剂（泛可复）：印度155例受者的经验
Transplant Proc. 2008 Sep;40(7):2237-9. doi: 10.1016/j.transproceed.2008.07.084.
8
Immunosuppression with generic tacrolimus and mycophenolate mofetil in renal transplant recipients: preliminary report in Chile.肾移植受者使用普通他克莫司和霉酚酸酯进行免疫抑制：智利的初步报告
Transplant Proc. 2008 Apr;40(3):705-7. doi: 10.1016/j.transproceed.2008.02.056.
9
The clinical impact of 1:1 conversion from Neoral to a generic cyclosporine (Gengraf) in renal transplant recipients with stable graft function.在移植肾功能稳定的肾移植受者中，将新山地明（Neoral）等量转换为环孢素普通制剂（金格福，Gengraf）的临床影响。
Clin Transplant. 2006 May-Jun;20(3):313-7. doi: 10.1111/j.1399-0012.2005.00483.x.
10
Does bioequivalence between modified cyclosporine formulations translate into equal outcomes?改良型环孢素制剂之间的生物等效性是否意味着疗效相同？
Transplantation. 2005 Dec 15;80(11):1633-5. doi: 10.1097/01.tp.0000188688.15639.03.

肾移植受者从品牌他克莫司（普乐可复）转换为仿制药后的临床结局：一项回顾性队列研究。

Clinical outcomes after conversion from brand-name tacrolimus (prograf) to a generic formulation in renal transplant recipients: a retrospective cohort study.

作者信息

Marfo Kwaku, Aitken Samuel, Akalin Enver

出版信息

P T. 2013 Aug;38(8):484-8.

PMID:24222980
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3814440/
Abstract

After kidney transplant recipients who received Prograf were switched to generic tacrolimus, most differences in the safety and effectiveness of the medications were not considered clinically relevant.

摘要

接受普乐可复（Prograf）治疗的肾移植受者改用他克莫司仿制药后，两种药物在安全性和有效性方面的大多数差异在临床上被认为不具有相关性。