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Generic Substitution Issues: Brand-generic Substitution, Generic-generic Substitution, and Generic Substitution of Narrow Therapeutic Index (NTI)/Critical Dose Drugs.通用名替换问题:品牌药与通用名药替换、通用名药之间的替换以及窄治疗指数(NTI)/临界剂量药物的通用名替换
Maedica (Bucur). 2011 Jan;6(1):52-8.
2
Generic Versions of Narrow Therapeutic Index Drugs: A National Survey of Pharmacists' Substitution Beliefs and Practices.窄治疗指数药物的仿制药:全国药师对替代的信念和实践的调查。
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3
Bioequivalence, Drugs with Narrow Therapeutic Index and The Phenomenon of Biocreep: A Critical Analysis of the System for Generic Substitution.生物等效性、治疗指数狭窄的药物与生物蠕变现象:对通用名药物替换系统的批判性分析
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J Am Geriatr Soc. 2013 Sep;61(9):1586-91. doi: 10.1111/jgs.12399. Epub 2013 Sep 3.
7
Potential problems and recommendations regarding substitution of generic antiepileptic drugs: a systematic review of literature.关于通用型抗癫痫药物替代的潜在问题与建议:文献系统综述
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Bioequivalence and switchability of generic antiseizure medications (ASMs): A re-appraisal based on analysis of generic ASM products approved in Europe.基于在欧洲获批的仿制药抗癫痫药物(ASMs)产品分析的再评估:仿制药的生物等效性和可互换性。
Epilepsia. 2021 Feb;62(2):285-302. doi: 10.1111/epi.16802. Epub 2021 Jan 10.
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Generic substitution for brand name antiepileptic drugs: a survey.品牌名抗癫痫药物的通用名替代:一项调查
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Skin rash during treatment with generic itraconazole.使用通用型伊曲康唑治疗期间出现皮疹。
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本文引用的文献

1
Generic drugs--safe, effective, and affordable.仿制药——安全、有效且价格亲民。
Dermatol Ther. 2009 May-Jun;22(3):229-40. doi: 10.1111/j.1529-8019.2009.01236.x.
2
Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis.心血管疾病中使用的仿制药和品牌药的临床等效性:一项系统评价和荟萃分析。
JAMA. 2008 Dec 3;300(21):2514-26. doi: 10.1001/jama.2008.758.
3
Prescription drug product substitution decision support.处方药产品替代决策支持。
J Am Pharm Assoc (2003). 2007 May-Jun;47(3):328-38. doi: 10.1331/JAPhA.2007.07502.
4
[Drug interchangeability: clinical approach and consumer's point of view].[药物互换性:临床方法与消费者视角]
Rev Saude Publica. 2006 Oct;40(5):921-7. doi: 10.1590/s0034-89102006000600024.
5
Are there potential problems with generic substitution of antiepileptic drugs? A review of issues.抗癫痫药物的通用名替换存在潜在问题吗?相关问题综述。
Seizure. 2006 Apr;15(3):165-76. doi: 10.1016/j.seizure.2005.12.010. Epub 2006 Feb 28.
6
Adverse drug reaction-related hospitalisations: a nationwide study in The Netherlands.药物不良反应相关住院情况:荷兰的一项全国性研究。
Drug Saf. 2006;29(2):161-8. doi: 10.2165/00002018-200629020-00006.
7
What are the obstacles to generic substitution? An assessment of the behaviour of prescribers, patients and pharmacies during the first year of generic substitution in Sweden.仿制药替代的障碍有哪些?瑞典仿制药替代第一年开处方者、患者和药房行为评估。
Pharmacoepidemiol Drug Saf. 2005 May;14(5):341-8. doi: 10.1002/pds.1055.
8
Generic substitution: issues for problematic drugs.通用名替换:问题药物的相关问题
South Med J. 2001 Jan;94(1):16-21.
9
Formulation substitution and other pharmacokinetic variability: underappreciated variables affecting antiarrhythmic efficacy and safety in clinical practice.剂型替代及其他药代动力学变异性:临床实践中影响抗心律失常疗效和安全性但未得到充分重视的变量。
Am J Cardiol. 2000 May 25;85(10A):46D-52D. doi: 10.1016/s0002-9149(00)00906-1.
10
Management of narrow therapeutic index drugs.窄治疗指数药物的管理
J Thromb Thrombolysis. 1999 Apr;7(2):137-43. doi: 10.1023/a:1008829403320.

通用名替换问题:品牌药与通用名药替换、通用名药之间的替换以及窄治疗指数(NTI)/临界剂量药物的通用名替换

Generic Substitution Issues: Brand-generic Substitution, Generic-generic Substitution, and Generic Substitution of Narrow Therapeutic Index (NTI)/Critical Dose Drugs.

作者信息

Paveliu Marian Sorin, Bengea Simona, Paveliu Fraga Silvia

机构信息

"Titu Maiorescu" University, Bucharest, Romania.

出版信息

Maedica (Bucur). 2011 Jan;6(1):52-8.

PMID:21977191
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3150029/
Abstract

Doctors accuse individual variability or lack of quality of generic drugs for adverse reactions or lack of efficacy. The variability of effect of generic substitution, although accepted by clinicians as possible, is little discussed or even understood by them. The situation is really serious in the case of generic substitution of drugs with narrow therapeutic index (NTI) or critical dose. In this paper we review the basic notions of variability and effectiveness of generic medication and change of attitude that would improve the use of these drugs.

摘要

医生们指责仿制药存在个体差异或质量欠佳,从而导致不良反应或疗效不佳。尽管临床医生认可仿制药替代可能存在效果差异,但对此讨论甚少,甚至理解不足。对于治疗指数窄(NTI)或剂量关键的药物进行仿制药替代时,情况尤为严峻。在本文中,我们回顾了仿制药的变异性、有效性以及观念转变等基本概念,这些转变将有助于改善此类药物的使用。