低治疗指数/严格剂量药物的等效性评价和临床合理使用  

Equivalence evaluation and rational use of narrow therapeutic index/critical dose drugs

作　　者：毛俊俊 焦正 钟明康 MAO Jun-jun;JIAO Zheng;ZHONG Ming-kang(Department of Pharmacy,Huashan Hospital,Fudan University,Shanghai 200040,China)

机构地区：[1]复旦大学附属华山医院药剂科,上海200040

出　　处：《中国医院药学杂志》2020年第11期1278-1282,共5页Chinese Journal of Hospital Pharmacy

基　　金：国家自然科学基金资助项目(编号:81573505)。

摘　　要：目的:总结低治疗指数/严格剂量药物(narrow therapeutic index/critical dose drugs,NTI/CD Drugs)仿制药在临床使用中可能存在的风险以指导临床合理用药。方法:通过文献调研,从NTI/CD药物生物等效性评价和临床评价研究角度,以抗癫痫药、免疫抑制剂、心血管系统药物为代表进行总结分析。结果:NTI/CD药物原研药和仿制药临床是否等效仍存在较大争议。结论:临床治疗过程中,NTI/CD药物的替换应尽量避免。NTI/CD药物仿制药的审批制度有待进一步完善。OBJECTIVE To summarize the possible risks of generic drugs with narrow therapeutic index/critical dose(NTI/CD drugs)in clinical practice to guide the rational use of these drugs.METHODS From the perspective of bioequivalence evaluation and clinical evaluation of NTI/CD drugs,antiepileptic drugs,immunosuppressive agents and drugs of cardiovascular system were summarized and analyzed.RESULTS Whether the NTI/CD generic drug is equivalence to original drug in clinic is still controversial.CONCLUSION Replacement of NTI/CD drugs should be avoided during clinical treatment.The review and approval system for generic drugs of NTI/CD drugs needs to be further improved.

关 键 词：NTI/CD药物 仿制药 生物等效性 临床合理使用 

分 类 号：R969[医药卫生—药理学]