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基因重组药物的研究与开发是生物工程中发展最快的领域之一,1995年美国上市的基因重组药物仅24种,同年FDA对这类药物制定了新的政策,使其上市速度快速增长,今年已达67种之多,其中有些药物已成为肿瘤生物治疗,尤其是辅助治疗不可缺少的药物,我国在这一领域尚存差距.1 国外研究与开发现状目前美国、日本、欧洲各国争相研究与开发基因重组药物.美国研究最早,技术最先进,批准上市药物也最多.而且其中大部分为独创品种.并对已上市的老品种,开展了众多适应症的研究,如rHuIFN-α已在临床上试验治疗十多种肿瘤,其中疗效最好的是慢性粟性白血病.rHuIFN-β治疗脑胶质瘤效果好,尤其在手术切除后使用,有防止复发作用.
The research and development of gene recombinant drugs is one of the fastest growing fields in bioengineering. In 1995, there were only 24 kinds of gene recombinant drugs listed in the United States. In the same year, the FDA set forth a new policy on such drugs and made it marketed rapidly. This year has reached 67 kinds of many, some of which have become tumor biological treatment, especially in adjuvant therapy indispensable drugs, our country in this area there is a gap.1 The status quo of foreign research and development Currently the United States, Japan, European countries competing Research and development of gene recombinant drugs.Urban earliest research, the most advanced technology, approved the listing of drugs is also the most.And most of them are original varieties.And have been listed on the old varieties, to carry out a number of indications, such as rHuIFN-α In clinical trials for the treatment of more than 10 kinds of tumors, of which the best effect is chronic myeloid leukemia.rHuIFN-β treatment of glioma effect is good, especially after the surgical resection, to prevent recurrence.