国外对原研药和仿制药的临床治疗等同性评价研究进展

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。

Clinical Equivalence Study of Generic and Brand Drugs in Foreign Countries

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.