目的 简述药品可互换性的基本概念,并探讨药品互换过程中涉及的问题及我国和其他国家药品替代使用的现状。方法 搜集有关药品可互换性、仿制药与原研药等方面的文献,对其中涉及有关药品可互换性、药品替代使用等方面的信息分析、归纳后进行综述。结果 仿制药替代原研药使用时涉及生物等效性、治疗等效性、利与弊等方面的问题。我国和其他国家为实现仿制药替代原研药使用采取了相应的措施。结论 仿制药可以替代原研药使用,但要遵循一定的规则,才能更好地在临床中保障用药安全。
Abstract
OBJECTIVE To describe the basic concepts of pharmaceutical inter-changeability and to discuss issues involved in the process of medicine substitution as well as the present situation of medicine substitution in our and other countries. METHODS Collecting literatures on pharmaceutical inter-changeability, generic medicines and brand-name medicines, after analyzing and summarizing the information on pharmaceutical inter-changeability and medicine substitution were reviewed. RESULTS The substitution of generic medicines with brand-name medicines involves in issues about bioequivalence, therapeutic equivalence, benefit, harm and so on. Our and other countries take appropriate measures to carry out the substitution of generic medicines with brand-name medicines. CONCLUSION With following certain rules, generic medicines can substitute for brand-name medicines. This can be better to ensure the safety of drug use in clinical practice.
关键词
药品可互换性 /
仿制药 /
原研药 /
药品替代
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Key words
pharmaceutical inter-changeability /
generic medicine /
brand-name medicine /
medicine substitution
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中图分类号：
R979
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