中药注射剂临床安全性评价方法比较与分析(4)
China Academy of Traditional Chinese Medicine， Beijing 100700， China；
2. Chengdu University of Traditional Chinese Medicine Affiliated Hospital， Chengdu 610072， China；
3. Chengdu University of Traditional Chinese Medicine， Chengdu 610075， China)
[Abstract] Parenterally administered Chinese medicine is widely applied in clinic. It particularly plays an important role in the treatment of cardiovascular and cerebrovascular disease， acute infectious diseases and malignant tumors. With the expansion of the scope of the clinical application of parenterally administered Chinese medicine adverse event reports also increase day by day. Thus， parenterally administered Chinese medicine has come to the attention of management departments， medical staff and the public. By the end of 2012， the national adverse drug reaction monitoring database has collected more than 5 million adverse drug reactions/events reports. Parenterally administered Chinese medicine accounted for more than half of the total number of adverse reactions to Chinese medicine. Therefore， it is essential that epidemiological methods are used to analyze the national database for all references to parenterally administered Chinese medicine. Our research aims to analyze the advantages and disadvantages of various safety monitoring methods for parenterally administered Chinese medicine and offer guidance in safety evaluation analysis.
[Key words] parenterally administered Chinese medicine； safety evaluation
doi：10.4268/cjcmm20131812, http://www.100md.com(阎博华 彭成 谢雁鸣 王永炎)
2. Chengdu University of Traditional Chinese Medicine Affiliated Hospital， Chengdu 610072， China；
3. Chengdu University of Traditional Chinese Medicine， Chengdu 610075， China)
[Abstract] Parenterally administered Chinese medicine is widely applied in clinic. It particularly plays an important role in the treatment of cardiovascular and cerebrovascular disease， acute infectious diseases and malignant tumors. With the expansion of the scope of the clinical application of parenterally administered Chinese medicine adverse event reports also increase day by day. Thus， parenterally administered Chinese medicine has come to the attention of management departments， medical staff and the public. By the end of 2012， the national adverse drug reaction monitoring database has collected more than 5 million adverse drug reactions/events reports. Parenterally administered Chinese medicine accounted for more than half of the total number of adverse reactions to Chinese medicine. Therefore， it is essential that epidemiological methods are used to analyze the national database for all references to parenterally administered Chinese medicine. Our research aims to analyze the advantages and disadvantages of various safety monitoring methods for parenterally administered Chinese medicine and offer guidance in safety evaluation analysis.
[Key words] parenterally administered Chinese medicine； safety evaluation
doi：10.4268/cjcmm20131812, http://www.100md.com(阎博华 彭成 谢雁鸣 王永炎)