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新药疗效评价主要依赖于临床实践所得的结果.对于常见病来说,只要通过严格的临床验证,即可得出科学的结论.但对于那些平时十分罕见、发病机理尚未完全明瞭的疾病,临床评价将是一个十分困难的问题.本文拟根据有关实践资料和目前的认识,提一些尚待进一步证实的看法,供共同讨论.一、关于药物安全性的评价新药安全性评价主要根据正常和患病机体临床试用结果.在同一给药条件下,患病机体有时可出现敏感性的改变.对于同一药物,受照射动物和病人有时亦可出现敏感性的不同.在没有急性放射病人可供验证的情况下,大多数学者认为可以通过“原因不明”的白细胞减少症病人、局部放射治疗病人和全身化疗病人的试用结果进行推断.
The evaluation of new drug efficacy mainly depends on the results of clinical practice.For common diseases, as long as through rigorous clinical validation, you can draw scientific conclusions.But for those usually very rare, the pathogenesis is not yet fully understood the disease, clinical evaluation Will be a very difficult issue.This paper is based on the relevant practical information and current understanding, to raise some yet to be further confirmed the views for joint discussion.An evaluation of drug safety New drug safety evaluation mainly based on normal and sick Clinical trial of the body results in the same drug delivery conditions, the affected body can sometimes appear sensitive to change for the same drug, irradiated animals and patients may sometimes appear sensitive to differences in the absence of acute radiation for verification Most scholars believe that this can be extrapolated from trial results of leukemic patients with “unexplained” leukemia, local radiotherapy and systemic chemotherapy.