578例山豆根不良反应文献分析  

Literature Analysis of 578 Cases of Adverse Drug Reactions Induced by Sophora tonkinensis Gagnep

作　　者：杨雪[1] 夏东胜[2] 高建超[2] 田春华[2] 李岚[2] 

机构地区：[1]北京中医药大学,北京100029 [2]国家食品药品监督管理总局药品评价中心,北京100045

出　　处：《中国药物警戒》2017年第4期235-241,共7页Chinese Journal of Pharmacovigilance

摘　　要：目的探讨山豆根临床毒性特点及安全风险因素,为其安全使用提供文献依据。方法检索1953年1月至2016年4月山豆根不良反应相关文献,在建立数据库并进行分项统计与分析基础上,提取山豆根毒性特点及安全性影响因素。结果口服山豆根所致不良反应可致多脏器损害,以神经系统损害和消化系统损害为主。此外也包括代谢及营养障碍、肝胆系统损害、视觉损害、呼吸系统损害、运动神经系统损害等。山豆根不良反应的主要风险因素有:自身毒性、超剂量用药、品种误用、配伍不当、使用方法不当以及用于预防疾病等。结论应重视山豆根毒性,控制其风险因素,严防误用并有效防止不良反应的发生。Objective To explore the clinical toxicity characteristics and risk factors o f Sophora tonkinensis Gagnep, in order to offer literature basis for clinical safety medication. Methods The adverse reactions o f Sophora tonkinensis Gagnep on literatures from January 1st, 1953 to April 1st, 2016 were summarized, and the toxicity characteristics and risk factors for clinical use were analyzed. Results Oral use of Sophora tonkinensis Gagnep causes multiple organ damage, the main damages are nervous system damage and digestive damage. And other damages are dysmetabolism, hepatobiliory system damage, visual impairment, respiratory system injury, disorder of motor nerve. The main risk factors of adverse reactions of Sophora tonkinensis Gagnep are toxicity, drug overdose, misuse of different varieties, improper compatibility, using out of the direction of doctor and preventing disease. Conclusion Toxicity of Sophora tonkinensis Gagnep should be paid attention to in the clinical use, so as to control the risk factors and prevent the happening of the adverse drug reaction.

关 键 词：山豆根 不良反应 文献分析 

分 类 号：R994.11[医药卫生—毒理学]