摘要
近年来,以肝损伤为代表的中药安全性问题和事件频发,其中,何首乌是千百年来广泛应用且认为"无毒"的补益类中药,但近年来其肝损伤事件频频报道,引起国内外的广泛关注,为中医药事业及其国际化发展带来不利影响。有学者发现何首乌肝损伤的易感基因,为合理制定何首乌及其相关制剂肝损伤风险综合防控对策奠定了科学基础,但在临床应用中,何首乌不良反应有哪些风险信号?自发呈报系统是药品上市后药物不良反应(adverse drug reaction,ADR)监测及发现ADR信号的重要方式,能够及时有效地发现不良反应信号,进而有效预防和避免药害事件的发生。目前,数据挖掘技术已逐步成为国内外药物不良反应/事件报告分析与评价的主要方法。其中,贝叶斯法中贝叶斯置信传播神经网络是常用的风险信号预警分析方法。该文采用BCPNN法挖掘含何首乌中药制剂心元胶囊的不良反应风险信号为恶心、腹泻、皮疹、头晕、呕吐、腹痛、头痛、肝细胞损害等,为临床安全合理用药提供循证证据。
In recent years, the safety problems and events of traditional Chinese medicine represented by liver injury have occurred frequently. In particular, Polygonum multiflorum has been widely used and considered as a "non-toxic" tonic traditional Chinese medicine for thousands of years. However, in recent years, frequent reports of liver injury events have attracted widespread attention at home and abroad, which has made unfavorable impacts on traditional Chinese medicine and its international development. Some scho-lars have found that susceptible genes of P. multiflorum on liver injury lay a scientific foundation for formulating rational comprehensive prevention and control measures for liver injury risk of P. multiflorum and its relevant preparations. But what are the risk signals of adverse reactions of P. multiflorum in clinical application? Spontaneous reporting system is an important way to monitor and find adverse drug reaction(ADR) signals after the drug is launched in the market. It can find the ADR signals in time and effectively, and then effectively prevent and avoid the occurrence of adverse drug events. At present, the data mining technique has gradually become the main method of ADR/adverse event(AE) report analysis and evaluation at home and abroad. Specifically, Bayesian confidence propagation neural network in Bayesian method is a commonly used risk signal early warning analysis method. In this paper, BCPNN method was used to excavate the risk signals of adverse reactions of Xinyuan Capsules, a traditional Chinese medicine preparation containing P. multiflorum, such as nausea, diarrhea, rash, dizziness, vomiting, abdominal pain, headache, liver cell damage, so as to provide evidence-based evidence for clinical safe and rational use of drugs.
作者
王连心
谢雁鸣
程文秀
钟柔
庄鋆妮
王淇
WANG Lian-xin;XIE Yan-ming;CHENG Wen-xiu;ZHONG Rou;ZHUANG Yun-ni;WANG Qi(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;Shandong University of Traditional Chinese Medicine,Ji'nan 250355,China;School of Statistics,Renmin University of China,Beijing 100872,China)
出处
《中国中药杂志》
CAS
CSCD
北大核心
2020年第10期2310-2315,共6页
China Journal of Chinese Materia Medica
基金
国家“重大新药创制”科技重大专项(2015ZX09501004-001-002)
国家自然科学基金面上项目(81973982)
国家重点研发计划项目(2018YFC1707400,2018YFC1707410)。
关键词
心元胶囊
自发呈报系统
药物不良反应
不良事件
肝损伤
风险信号
Xinyuan Capsules
spontaneous reporting system
adverse drug reaction
adverse event
liver injury
risk signal