我国开展药物流行病学研究的时机和可能

PharmacoepidemiolQgy in China:Opportunities and Possibilities

我国是发展中国家,整体用药水平与国外发达国家相比有一定差距,药物流行病学研究刚处于起步阶段。但随着我国的改革开放和经济的高速发展,人民的卫生健康事业正在登上新的台阶,这为在我国开展药物流行病学研究创造了良好的契机,提供了实际的可能性。本文从我国近期的重大战略举措对药品开发和研究的影响出发,阐述了药物安全性监控在开发研制我国自创新药过程中的必要性,分析了在我国开展药物流行病学研究的时机和可能。

Pharmacoepidemiology has been introduced into China for several years. The new discipline still waits opportunity to show its positive effect on improving rational use of drugs in medicational practice. Analysing the government's recent important strategies, such as giving drug-developers a patent right and applying for rejoining the GATT, it is expected that in the near future pharmacoepidemiology study will be necessary in the development of Chinese origin new chemical entities as well as in optimal use of medicines. There are actual possibilities for conducting pharmacoepidemiology study in China: More and more health care professionals recognize the importance of safety, efficacy, and appropriate use of pharma-ceuticals. Spontaneous reporting system of adverse drug reactions has been established for more than ten years. The largest population in the world could provide sufficient drug exposure patients to discover any rare adverse drug-related event in short term. Some pioneers have reported their study results of drug epidemiology, which will stir other Chinese reserchers to further efforts.