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关于“有毒”外用中药安全性的思考

[Thinking on safety of "toxic" traditional Chinese medicine for external use].

作者信息

Xiang Li-Ling, Miao Ming-San, Cao Li-Hua, Li Yan

机构信息

Henan University of Chinese Medicine Zhengzhou 450046,China.

出版信息

Zhongguo Zhong Yao Za Zhi. 2019 Apr;44(8):1710-1714. doi: 10.19540/j.cnki.cjcmm.20190116.008.

Abstract

In recent years,the safety of " toxic" traditional Chinese medicine has received great attention. Similarly,the safety of " toxic" Chinese medicines for external use should not be ignored. In this paper,the adverse reactions of toxic Chinese medicine for external use were systematically studied; the causes for adverse reactions were analyzed; and the key problems on the external use of toxic Chinese medicine in modern clinical practice were put forward. For example,usage dosage(time,area),specific efficacy of external use,early warning index of toxicity,toxic dose,adverse effects,toxic symptoms and corresponding treatment measures all had no reference basis,lacking a systematic toxicity evaluation medication criteria for clinical external use of toxic Chinese medicine. Attention shall be paid to the toxicity of toxic Chinese medicine for external use,and the theory of toxicity evaluation should be established for the external use of " toxic" traditional Chinese medicine under specific conditions. The early warning mechanism for toxic and adverse effects were clarified,and relevant early warning sensitive indicators applicable to clinical use were established in this study to control its risk factors. The study on the mechanism of pharmacodynamics and toxicology of " toxic" traditional Chinese medicine for external use was strengthened to clarify the usage and specific effects of external use. On the basis of this,the study of synergism and reduction of toxicity was carried out to maximize the efficacy of external use of traditional Chinese medicine under specific conditions. A toxicity standard of " toxic" Chinese medicines for external use was put forward,which was of great significance to guide clinical safety,rationality,effectiveness as well as the research and development of new dosage forms for external use of traditional Chinese medicine.

摘要

近年来,“有毒”中药的安全性受到极大关注。同样,“有毒”外用中药的安全性也不容忽视。本文系统研究了有毒外用中药的不良反应,分析了不良反应产生的原因,并提出了现代临床实践中有毒中药外用的关键问题。例如,用法用量(时间、面积)、外用的具体功效、毒性预警指标、中毒剂量、不良反应、中毒症状及相应治疗措施均无参考依据,缺乏系统的有毒中药临床外用毒性评价用药标准。应重视有毒外用中药的毒性,针对特定条件下“有毒”中药外用建立毒性评价理论。本研究阐明了毒性及不良反应的预警机制,建立了适用于临床的相关预警敏感指标以控制其危险因素。加强对“有毒”外用中药的药效学和毒理学机制研究,明确外用的用法及具体作用。在此基础上,开展增效减毒研究,以在特定条件下最大限度发挥中药外用疗效。提出了“有毒”外用中药的毒性标准,对指导临床安全、合理、有效用药以及中药外用新剂型的研发具有重要意义。

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