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重组技术与促性腺激素生产:生殖医学的新时代。

Recombinant technique and gonadotropins production: new era in reproductive medicine.

作者信息

Shoham Z, Insler V

机构信息

Department of Obstetrics and Gynecology, Kaplan Hospital, Rehovot, Israel.

出版信息

Fertil Steril. 1996 Aug;66(2):187-201. doi: 10.1016/s0015-0282(16)58437-4.

Abstract

OBJECTIVE

To review current knowledge regarding recombinant DNA technology and its safety and efficacy in relation to recombinant gonadotropin production.

DATA IDENTIFICATION AND SELECTION

Studies that relate specifically to recombinant DNA technology, method of laboratory production, and the clinical aspects of using recombinant gonadotropins were identified through literature and Medline searches.

RESULTS

Recent developments in recombinant DNA technology have resulted in a rapidly expanding range of new diagnostic and therapeutic opportunities. This technology paves the way to the identification, isolation, cloning, and production of specific proteins. Recently, recombinant human gonadotropins became available for clinical use. The pharmacokinetics, receptor availability, pharmacodynamics, and safety were studied extensively and the drugs were found to be identical if not superior to urinary gonadotropins that have been used in reproductive medicine for the last 30 years. It is clear today that the use of recombinant human gonadotropins is expected to provide better batch-to-batch consistency, steady supply, and most importantly, a purified compound with high specific activity, which accounts for >99% of the preparation's protein content, allowing SC administration.

CONCLUSION

There is no doubt that recombinant gonadotropins produced by genetic engineering technology are here to stay and will represent an important treatment modality in various fertility disturbances.

摘要

目的

回顾关于重组DNA技术及其在重组促性腺激素生产方面的安全性和有效性的现有知识。

资料识别与选择

通过文献检索和医学在线数据库搜索,确定了与重组DNA技术、实验室生产方法以及使用重组促性腺激素的临床方面具体相关的研究。

结果

重组DNA技术的最新进展带来了迅速扩展的一系列新的诊断和治疗机会。这项技术为特定蛋白质的识别、分离、克隆和生产铺平了道路。最近,重组人促性腺激素已可用于临床。对其药代动力学、受体可用性、药效学和安全性进行了广泛研究,发现这些药物即便不比过去30年在生殖医学中使用的尿促性腺激素更优越,也与之一致。如今很明显,使用重组人促性腺激素有望实现更好的批次间一致性、稳定供应,最重要的是,提供一种具有高比活性的纯化化合物,其占制剂蛋白质含量的>99%,允许皮下给药。

结论

毫无疑问,通过基因工程技术生产的重组促性腺激素将会持续存在,并将成为各种生育障碍的一种重要治疗方式。

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