Chinese Journal of Pharmacovigilance ›› 2016, Vol. 13 ›› Issue (10): 602-605.

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Summary and Analysis of Safety Warning on Clinical Application of Chinese Patent Medicine Preparations for Coronary Heart Disease

YANG Qian1, 2, 3, SUN Rong1, *   

  1. 1.Shandong Academy of Chinese Medicine, Shandong Jinan 250014, China;
    2.Rizhao City Hospital of Traditional Chinese Medicine, Shandong Rizhao 276800, China;
    3.Shandong University of Traditional Chinese Medicine, Shandong Jinan 250355, China
  • Received:2016-11-23 Revised:2016-11-23 Online:2016-10-20 Published:2016-11-23

Abstract: Objective To summarize and analyze the safety warning on clinical application of Chinese patent medicine preparations for coronary heart disease systematically, so as to promote safe and rational use of the Chinese patent medicine preparations for coronary heart disease. Methods All the Chinese patent medicine preparations for coronary heart disease recorded in Clinical Medication Information of China Pharmacopoeia were looked up and the safety warning contents including toxicology research, adverse reactions and precautions for use were summarized and analyzed. Results There were 97 Chinese patent medicine preparations for coronary heart disease recorded in Clinical Medication Information of China Pharmacopoeia, in which 16 kinds of drugs contained toxic traditional Chinese medicine, but the toxicology research can be seen in instructions of only 4 kinds of drugs. Besides 36 Chinese patent medicine preparations for coronary heart disease which have a clear adverse reaction data, most of the adverse reactions were unclear. For aspects of contraindications including syndrome, compatibility, special groups and diets were introduced in precautions for use. Conclusion There are still safety risks in the use of Chinese patent medicine preparations for coronary heart disease because lacking of safety information in instructions. In order to ensure safe medication, we should pay close attention to post-marketing safety evaluation of Chinese patent medicine preparations for coronary heart disease and improve the adverse reactions reporting and monitoring system further.

Key words: coronary heart disease, Chinese patent medicine preparations, safety warning

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