期刊文献+

国外对原研药和仿制药的临床治疗等同性评价研究进展 被引量:16

Clinical Equivalence Study of Generic and Brand Drugs in Foreign Countries
下载PDF
导出
摘要 目的: 介绍国外近年来对原研药和仿制药临床治疗等同性的评价研究。方法: 通过文献调研,从心血管病药物、抗抑郁药、抗感染药物、抗骨质疏松药、抗癫痫药和抗精神病药等方面进行分析总结。结果与结论:目前关于原研药和仿制药的治疗等同性方面仍然存在众多不一致的结论,系统而严格的临床研究尚需进一步开展。期望理论在评价仿制药与原研药的治疗等同性领域可发挥重要作用。临床医务人员和患者在原研药治疗过程中替换为仿制药时仍然应该十分谨慎。 Objective: To review the studies on clinical equivalence between generic and brand drugs in foreign countries. Methods: Based on the literature and case analysis, the following kinds of drugs were summarized: cardiovascular drugs, antidepressants, anti-infection drugs, anti-osteoporosis drugs, anticonvulsants and antipsychotics. Results and conclusion: There is no definite and consistent evidence that generic substitutes are less safe or less effective than brand drugs. Systemic randomized controlled studies are necessary to rigorously evaluate clinical equivalence of generic and brand drugs, in which expectancy theory can be introduced. Caution should still be exercised when medication has been switched from brand to generic drugs.
作者 张程亮 杜光
出处 《药品评价》 CAS 2010年第20期23-27,共5页 Drug Evaluation
关键词 原研药 仿制药 临床评价 期望理论 Brand drugs Generic drugs Clinical evaluation Expectancy theory
  • 相关文献

参考文献18

  • 1Ortiz M, Simons LA, Calcino G. Generic substitution of commonly used medications: Australia-wide experience, 2007-2008 [J]. Med J Australia. 2010; 192(7): 370-3.
  • 2Kesselheim AS, Misono AS, Lee JL, et al. Clinical Equivalence of Generic and Brand-Name Drugs Used in Cardiovascular Disease A Systematic Review and Meta-analysis [J]. Jama-J Am Med Assoc. 2008; 300(21 ): 2514-26.
  • 3Carter BL. Equivalence of generic and brand-name drugs for cardiovascular disease [J]. JAMA. 2009; 301(16): 1654; author reply 5-6.
  • 4Howland RH. Are generic medications safe and effective [J]. J Psychosoc Nurs Ment Health Serv. 2010; 48(3): 13-6.
  • 5Chenu F, Batten LA, Zernig G, et al. Comparison of pharmacokinetic profiles of brand-name and generic formulations of citalopram and venlafaxine: a crossover study [J]. J Clin Psychiatry. 2009; 70(7): 958-66.
  • 6Del Tacca M, Pasqualetti G, Di Paolo A, et al. Lack of pharmacokinetic bioequivalence between generic and branded amoxicillin formulations. A post-marketing clinical study on healthy volunteers [J]. Brit J Clin Pharmaco. 2009; 68( 1 ): 34-42.
  • 7Izuwa Y, Ueshima S, Sato T, et al. Frequency of decreased renal function between patients treated with brand and generic products of vancomycin hydrochloride injection [J]. Yakugaku Zasshi-Journal of the Pharmaceutical Society of,Japan. 2008; 128(10): 1493 -8.
  • 8Silva E, Diaz JA, Arias M J, et al. Comparative in vitro study of the antimicrobial activities of different commercial antibiotic products for intravenous administration [J]. BMC Clin Pharmacol. 2010; 10: 3.
  • 9Grima DT, Papaioannou A, Airia P, et al. Adverse events, bone mineral density and discontinuation associated with generic alendronate among postmenopausal women previously tolerant of brand alendronate: a retrospective cohort study [J]. BMC Musculoskelet Disord. 2010:11:68.
  • 10Sankar R, Glauser TA. Understanding therapeutic equivalence in epilepsy [J]. CNS Spectr. 2010; 15(2): 112-23.

同被引文献102

引证文献16

二级引证文献148

相关作者

内容加载中请稍等...

相关机构

内容加载中请稍等...

相关主题

内容加载中请稍等...

浏览历史

内容加载中请稍等...
;
使用帮助 返回顶部