Chien C P, Labrie R, Park C G, Cole J O, Werner W M
Am J Psychiatry. 1976 Dec;133(12):1377-81. doi: 10.1176/ajp.133.12.1377.
The clinical inequivalence of generic versus trade-name drugs has been reported for nonpsychiatric drugs but rarely for psychotropic drugs. Recent expiration of patents on some psychotropic drugs has made the evaluation of the clinical equivalence of generic versus trade-name drugs a matter of interest from methodological, sociopolitical, and economic aspects. The authors discuss these points, with emphasis on methodology, in their report of a double-blind study of the efficacy of chlorpromazine and Thorazine in the treatment of 54 acute schizophrenic patients. An analysis designed to infer the maximum possible advantage of Thorazine over generic chlorpromazine indicated that differences between the two were clinically insignificant.
非精神类药物中已报道过通用名药物与商品名药物在临床疗效上的不等效性，但精神类药物方面却鲜有报道。近期一些精神类药物的专利到期，使得从方法学、社会政治和经济等方面评估通用名药物与商品名药物的临床等效性成为一个备受关注的问题。作者在其关于氯丙嗪和三氟拉嗪治疗54例急性精神分裂症患者疗效的双盲研究报告中讨论了这些要点，重点是方法学。一项旨在推断三氟拉嗪相对于通用名氯丙嗪的最大可能优势的分析表明，两者之间的差异在临床上无显著意义。
