摘要
目的:从临床疗效的角度对原研药与仿制药的区别进行介绍并探讨引起疗效差别可能的原因。方法:在ISI Web of Knowledge、PubMed、Science Direct和中国知网数据库中检索原研药与仿制药对比的相关中英文文献,并对文章进行分析。结果:通过对检索到的相关文献进行分析,我们发现在癫痫、帕金森、精神疾病、器官移植、心血管和感染疾病方面的仿制药与原研药相比存在一定差异。结论:对于部分药物而言,作为评价仿制药上市的标准——生物等效性(bioequivalence,BE)试验尚不能替代临床疗效的等效性。制剂因素是两种药品疗效差异的根本原因。
Objective： To introduce the difference between therapeutic effectiveness for branded and generic drugs, and to explore the reasons of these differences. Methods： Articles for comparative studies of branded and generic drugs were retrieved from the databases of ISI Web of Knowledge, PubMed, ScienceDirect and CNKI, and which were arranged and analyzed. Results： Compared with branded drugs, generic drugs got the poor treatment effects in a variety of treatment fields, such as antiepileptic, anti-parkinson, anti-psychotic, immunodepressant, cardiovascular drugs, antibiotics. Conclusion： Although bioequivalence is the legal standard, it can＇t take place of therapeutic efficacy. Pharmaceutics is the key factor for the difference.
出处
《药品评价》
CAS
2013年第12期8-12,21,共6页
Drug Evaluation
基金
"药物管理平台"子课题
国家科技部"脑血管病创新药物临床评价技术平台"重大专项基金
编号:2008ZX09312-008
关键词
原研药
仿制药
生物等效
疗效
Branded Drugs
Generic Drugs
Bioequivalence
Treatment Effect
