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Bioequivalence of twice-daily oral tacrolimus in transplant recipients: More evidence for consensus?口服他克莫司在移植受者中每日 2 次的生物等效性：更多共识的证据？
PLoS Med. 2017 Nov 14;14(11):e1002429. doi: 10.1371/journal.pmed.1002429. eCollection 2017 Nov.
2
Bioequivalence between innovator and generic tacrolimus in liver and kidney transplant recipients: A randomized, crossover clinical trial.创新型与仿制药他克莫司在肝肾移植受者中的生物等效性：一项随机交叉临床试验。
PLoS Med. 2017 Nov 14;14(11):e1002428. doi: 10.1371/journal.pmed.1002428. eCollection 2017 Nov.
3
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.
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Use of generic tacrolimus in elderly renal transplant recipients: precaution is needed.老年肾移植受者中使用通用他克莫司：需要谨慎。
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Transition from brand to generic tacrolimus is associated with a decrease in trough blood concentration in pediatric heart transplant recipients.从品牌他克莫司转换为通用型他克莫司与小儿心脏移植受者的血药谷浓度降低有关。
Pediatr Transplant. 2015 Dec;19(8):911-7. doi: 10.1111/petr.12608. Epub 2015 Oct 25.
6
Generic tacrolimus in solid organ transplantation.实体器官移植中的他克莫司通用制剂
Clin Transplant. 2014 May;28(5):623-32. doi: 10.1111/ctr.12336. Epub 2014 Apr 21.
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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。
Am J Health Syst Pharm. 2013 Sep 1;70(17):1507-12. doi: 10.2146/ajhp120783.
8
Differences in Peripheral Blood Lymphocytes between Brand-Name and Generic Tacrolimus Used in Stable Liver Transplant Recipients.稳定肝移植受者使用的原研他克莫司与仿制药他克莫司在外周血淋巴细胞方面的差异
Med Princ Pract. 2017;26(3):221-228. doi: 10.1159/000455861. Epub 2017 Jan 9.
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Real-life Bioequivalence of Tacrolimus in Patients With Living-Related Donor De Novo Renal Transplantation: An Observational Study.活体亲属供体初次肾移植患者中他克莫司的真实生物等效性：一项观察性研究。
Transplant Proc. 2020 Jul-Aug;52(6):1715-1717. doi: 10.1016/j.transproceed.2020.03.017. Epub 2020 May 21.
10
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.

引用本文的文献

1
Meeting Regulatory Requirements for Drugs with a Narrow Therapeutic Index: Bioequivalence Studies of Generic Once-Daily Tacrolimus.满足窄治疗指数药物的监管要求：仿制一日一次他克莫司的生物等效性研究
Drug Healthc Patient Saf. 2020 Sep 8;12:151-160. doi: 10.2147/DHPS.S256455. eCollection 2020.
2
Generic Tacrolimus (Tacrobell) Shows Comparable Outcomes to Brand-Name Tacrolimus in the Long-Term Period After Adult Deceased Donor Liver Transplantation.通用型他克莫司（Tacrobell）在成人尸体供肝移植后的长期随访中显示出与品牌名他克莫司相当的疗效。
Drug Des Devel Ther. 2019 Dec 31;13:4431-4438. doi: 10.2147/DDDT.S229114. eCollection 2019.

本文引用的文献

1
Bioequivalence between innovator and generic tacrolimus in liver and kidney transplant recipients: A randomized, crossover clinical trial.创新型与仿制药他克莫司在肝肾移植受者中的生物等效性：一项随机交叉临床试验。
PLoS Med. 2017 Nov 14;14(11):e1002428. doi: 10.1371/journal.pmed.1002428. eCollection 2017 Nov.
2
Tacrolimus Trough Concentration Variability and Disparities in African American Kidney Transplantation.他克莫司谷浓度变异性与非裔美国肾移植患者的差异
Transplantation. 2017 Dec;101(12):2931-2938. doi: 10.1097/TP.0000000000001840.
3
Socioeconomic factors explain suboptimal adherence to antiretroviral therapy among HIV-infected Australian adults with viral suppression.社会经济因素解释了澳大利亚病毒得到抑制的HIV感染成年患者对抗逆转录病毒疗法依从性欠佳的原因。
PLoS One. 2017 Apr 3;12(4):e0174613. doi: 10.1371/journal.pone.0174613. eCollection 2017.
4
High Intrapatient Variability of Tacrolimus Concentrations Predicts Accelerated Progression of Chronic Histologic Lesions in Renal Recipients.患者内他克莫司浓度变异性高可预测肾移植受者慢性组织学病变的加速进展。
Am J Transplant. 2016 Oct;16(10):2954-2963. doi: 10.1111/ajt.13803. Epub 2016 Apr 21.
5
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.
6
European Society for Organ Transplantation Advisory Committee recommendations on generic substitution of immunosuppressive drugs.欧洲器官移植学会咨询委员会关于免疫抑制药物通用名替换的建议。
Transpl Int. 2011 Dec;24(12):1135-41. doi: 10.1111/j.1432-2277.2011.01378.x. Epub 2011 Oct 28.
7
Monitoring nonadherence and acute rejection with variation in blood immunosuppressant levels in pediatric renal transplantation.监测小儿肾移植中血免疫抑制剂水平变化与不依从和急性排斥反应的关系。
Transplantation. 2011 Oct 27;92(8):918-22. doi: 10.1097/TP.0b013e31822dc34f.
8
Cost-related immunosuppressive medication nonadherence among kidney transplant recipients.肾移植受者的与费用相关的免疫抑制药物不依从。
Clin J Am Soc Nephrol. 2010 Dec;5(12):2323-8. doi: 10.2215/CJN.04220510. Epub 2010 Sep 16.
9
How can we achieve global equity in provision of renal replacement therapy?我们如何在提供肾脏替代治疗方面实现全球公平？
Bull World Health Organ. 2008 Mar;86(3):229-37. doi: 10.2471/blt.07.041715.
10
Reduced exposure to calcineurin inhibitors in renal transplantation.肾移植中钙调神经磷酸酶抑制剂暴露量的减少。
N Engl J Med. 2007 Dec 20;357(25):2562-75. doi: 10.1056/NEJMoa067411.

口服他克莫司在移植受者中每日 2 次的生物等效性：更多共识的证据？

Bioequivalence of twice-daily oral tacrolimus in transplant recipients: More evidence for consensus?

机构信息

Department of Nephrology, Queen Elizabeth Hospital Birmingham, Birmingham, United Kingdom.

Institute of Immunology and Immunotherapy, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom.

出版信息

PLoS Med. 2017 Nov 14;14(11):e1002429. doi: 10.1371/journal.pmed.1002429. eCollection 2017 Nov.

DOI:10.1371/journal.pmed.1002429
PMID:29135980
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5685474/
Abstract

In this Perspective on the clinical trial by Rita Alloway and colleagues, Simon Ball explains the benefits to healthcare systems and individual patients of the bioequivalence established between generic and brand-name formulations of an immunosuppressive drug in transplant recipients.

摘要

在丽塔·阿洛韦（Rita Alloway）和同事的这篇临床试验观点文章中，西蒙·鲍尔（Simon Ball）解释了在接受移植的患者中，建立免疫抑制剂的仿制药和品牌药之间的生物等效性对医疗保健系统和个体患者的好处。