| 摘要: |
| 文章對目前我國中成藥臨床安全性評價現狀進行了客觀闡述。中成藥安全性問題已經引起社會的廣泛關注，既往的中成藥臨床安全性評價存在各種局限性，缺乏科學證據，因此，上市后中成藥臨床安全性評價工作刻不容緩。目前，國家監管部門、科研院所、醫藥企業等各方面正積極探索，開展相關工作，取得了可喜成績。但其中仍存在諸如相關規范、頂層設計、質量控制、利益相關性等各方面的問題，需要進一步完善中成藥安全性評價體系。 |
| 關鍵詞: 臨床評價 安全性 中成藥 上市后 |
| DOI：10.11656/j.issn.1673-9043.2017.05.04 |
| 分類號:R2-03 |
| 基金項目: |
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| Present status, problems and outlook of safety evaluation for the proprietary Chinese medicine |
|
ZHENG Wen-ke
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Tianjin Branch of the Ministry of Education Virtual Research Center for Evidence-Based Medicine, Tianjin 300193, China
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| Abstract: |
| The article objectively discusses the present status of safety evaluation for the proprietary Chinese medicine in China. Traditional Chinese medicines' security issues have been caused extensive concern by society, there are many limitations of proprietary Chinese medicine in safety evaluation, for lack of scientific evidence, the post-marketing safety evaluation work of TCM is urgently needed. At present, the goverment, institutes, pharmaceutical companies of TCM and so on are actively exploring and carrying out related works, and have made gratifying achievements. But there still exist various aspects of related questions, such as the relevant specification, the top-level design, quality control, benefit and so on. There are some more work for further improving the safety evaluation system of proprietary Chinese medicine. |
| Key words: clinical assessment safety Chinese patent medicine post-marketing |
