中药上市后特殊人群有效性及安全性评价的若干思考

Thought on several problems of post-marketing herbs clinical evaluation in special populations

我国中药在上市后,缺乏特殊人群使用的有关疗效、安全性的相关数据。作者从多个角度对中药上市后特殊人群相关研究进行思考,发现中药说明书关于特殊人群的用药标示极少;安全性评价研究方法有文献评价、数据挖掘、临床研究、药物监测,但缺乏独立性、长期性;有效性评价相对成熟,要特别关注儿童、老年人、孕妇、哺乳期妇女、肝肾功能损害者合理使用中成药。

The re-evaluation of chnical Post-marketing herbs in special populations, such as children, the aged, pregnant women, lactating women, has attracted attention in our country. The media is drug adverse reaction reports and package insert. The safety of combined administration in aged and children＇s growth Should have been taken long-term follow-up study. Perfecting traditional chinese medicine FDA system will be beneficial to the＇ re-evaluation of clinical postmarketing herbs in pregnant women. Dose-effect study in children also should cause the concern of researchers.