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ORIGINAL RESEARCH article

Front. Pharmacol.
Sec. Ethnopharmacology
Volume 15 - 2024 | doi: 10.3389/fphar.2024.1324509

'Risk-benefit' assessment for comprehensive safety evaluation of Chinese patent medicines containing four common toxic ingredients: an analysis of clinical risk factors

Provisionally accepted
Changming Zhong Changming Zhong 1Nan Zhang Nan Zhang 1Guoxiu Liu Guoxiu Liu 1Siyu Li Siyu Li 1Li Lin Li Lin 1Namin Wei Namin Wei 1Yu Song Yu Song 2Xiaoqing Wan Xiaoqing Wan 2Yanping Wang Yanping Wang 3Yongyan Wang Yongyan Wang 3Wanlin Wu Wanlin Wu 4Zhongzhi Qian Zhongzhi Qian 5Huaqiang Zhai Huaqiang Zhai 1*
  • 1 Beijing University of Chinese Medicine, Beijing, Beijing Municipality, China
  • 2 Wansheng Pharmaceutical Co.Ltd, Guizhou, China
  • 3 China Academy of Chinese Medical Sciences, Beijing, Beijing Municipality, China
  • 4 Centre France Chine de la Médecine Chinoise, Seine, France
  • 5 Chinese Pharmacopoeia Commission, Beijing, China

The final, formatted version of the article will be published soon.

    Background: Chinese patent medicines are specialty preparations in China that are produced using traditional prescriptions processed by modern pharmaceutical technology. They contain complex ingredients and much attention is paid to their clinical safety. Demonstrating the clinical safety of Chinese patent medicines containing toxic ingredients in modern pharmacological studies has become one of the urgent issues to be solved for the safe use of clinical medicines.The aim of this research is to evaluate the safety of Chinese patent medicines containing toxic ingredients by applying the risk-benefit assessment method.Additionally, a database of 'toxic ingredients -toxic Chinese herbal medicines-adverse reactions' will be established to explore the relationship between toxic ingredients and adverse reactions. This will lay the foundation for the rational clinical use of Chinese patent medicines containing toxic ingredients.Methods: 1) Establish a database of 'toxic Chinese herbal medicines -toxic ingredients -toxic Chinese patent medicines' to count the Chinese patent medicines containing toxic ingredients in the 2020 edition of Chinese Pharmacopoeia. 2) Filtered the clinical studies, extracted the drug-related ADEs, and analyzed the characteristics and correlations of these ADEs. 3) Finally, this section summarizes the causes of ADEs related to Chinese patent medicines containing toxic ingredients and extracts the main risk factors to provide a reference for further study.Outcomes: 1) There are four main types of Chinese patent medicines containing toxic ingredients. These include medicines with diester aconitine metabolites, mineral composition, Araceae metabolites, and hydrogen cyanide. 2) Digestive system, skin and its appendages, and allergic reactions were the main types of ADEs related to four types of Chinese patent medicines containing toxic ingredients. 3) There are four primary risk factors associated with the clinical use of Chinese patent medicines containing toxic ingredients: medicine, medication, individual and regulatory factors.

    Keywords: ADEs, adverse events, ADRs, adverse reactions, TCM, traditional Chinese medicine, NCADRM, National Center for Adverse Drug Reaction Monitoring, CHMs, Chinese herbal medicines；CPMs, Chinese patent medicines, AA, aristolochic acid, CNKI, the China National Knowledge Infrastructure, ENT Reaction, Ear, Nose, and Throat Reaction Chinese patent medicines containing toxic ingredients, clinical risk factors, TCM supervision, pharmacovigilance

    Received: 20 Oct 2023; Accepted: 01 Aug 2024.

    Copyright: © 2024 Zhong, Zhang, Liu, Li, Lin, Wei, Song, Wan, Wang, Wang, Wu, Qian and Zhai. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Huaqiang Zhai, Beijing University of Chinese Medicine, Beijing, 100029, Beijing Municipality, China

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.