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为了探讨中成药临床应用中的安全性风险因素及风险控制措施,从药品本身及临床应用两大方面,在综合文献资料基础上,对中成药进行安全性风险因素的归纳、总结和分析,提出合理规避中成药安全性风险因素的具体措施。实践证明中成药在中药材本身、饮片炮制方法、制备工艺、药品质控标准以及说明书安全信息等许多方面的风险因素都客观存在,尤其在“中药无毒,有病治病,无病健身”不良观念影响下,过度使用(或滥用)中成药,致使相关不良反应/事件频繁发生,甚至发生死亡事件。因此,临床使用中成药风险客观存在,加强风险管理任重道远,中成药要在中医药理论指导下合理使用,才能减少不良反应,保证临床用药安全、有效。
In order to explore the safety risk factors and risk control measures in the clinical application of proprietary Chinese medicines, this paper summarizes and analyzes the safety risk factors of proprietary Chinese medicines on the basis of the comprehensive literature, both from the aspects of the drug itself and its clinical application Rational measures to avoid risk factors of proprietary Chinese medicines safety measures. Practice has proved that proprietary Chinese medicines in the Chinese herbal medicine itself, Pieces concocted methods, preparation techniques, quality control standards and manual safety information and many other risk factors are objective, especially in the “non-toxic traditional Chinese medicine, disease treatment, disease-free fitness ”Under the influence of bad ideas, excessive use (or abuse) of proprietary Chinese medicines, resulting in frequent occurrence of adverse reactions / events, or even deaths. Therefore, the clinical use of proprietary Chinese medicine risk objective existence, a long way to go to strengthen risk management, proprietary Chinese medicine under the guidance of the theory of traditional Chinese medicine in order to reduce adverse reactions to ensure the safety and effectiveness of clinical medication.