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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。
Chinese medicine in the market, the lack of special populations used in the efficacy, safety of the relevant data. The author thinks from several angles about the research on the special population after the listing of traditional Chinese medicine and found that there are few indications of medication for the special population in the manual of traditional Chinese medicine. There are literature evaluation, data mining, clinical research and drug monitoring for the safety evaluation methods, but lack of independence , Long-term; effectiveness evaluation is relatively mature, with special attention to children, the elderly, pregnant women, lactating women, liver and kidney dysfunction, rational use of proprietary Chinese medicines.