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中药上市后特殊人群有效性及安全性评价的若干思考
引用本文:周霭,连凤梅.中药上市后特殊人群有效性及安全性评价的若干思考[J].中国中药杂志,2011,36(20):2776-2778.
作者姓名:周霭  连凤梅
作者单位:中国中医科学院广安门医院,北京,100053
基金项目:国家"重大新药创制"科技重大专项(2009ZX09502-030)
摘    要: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.

关 键 词:特殊人群  中药  上市后再评价  有效性  安全性
收稿时间:8/6/2011 12:00:00 AM

Thought on several problems of post-marketing herbs clinical evaluation in special populations
ZHOU Ai and LIAN Fengmei.Thought on several problems of post-marketing herbs clinical evaluation in special populations[J].China Journal of Chinese Materia Medica,2011,36(20):2776-2778.
Authors:ZHOU Ai and LIAN Fengmei
Affiliation:Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China;Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China
Abstract:The re-evaluation of clinical 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.
Keywords:special populations  Chinese medicine  post-marketing re-evaluation  safety  effectiveness
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