决明子的安全性评价与风险控制措施的探讨
投稿时间:2017-08-19    责任编辑:  点此下载全文
引用本文:赵艺萌,吴丽,张烁,张力,高学敏,孙晓波,王淳.决明子的安全性评价与风险控制措施的探讨[J].中国中药杂志,2017,42(21):4074.
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作者中文名作者英文名单位中文名单位英文名E-Mail
赵艺萌 ZHAO Yi-meng 北京中医药大学 中医学院, 北京 100029 College of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, China  
吴丽 WU Li 北京中医药大学 中医学院, 北京 100029 College of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, China  
张烁 ZHANG Shuo 北京中医药大学 中医学院, 北京 100029 College of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, China  
张力 ZHANG Li 北京中医药大学 东方医院, 北京 100078 Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, Beijing 100078, China  
高学敏 GAO Xue-min 北京中医药大学 中医学院, 北京 100029 College of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, China  
孙晓波 SUN Xiao-bo 中国医学科学院 药用植物研究所, 北京 100094 Institute of Medicinal Plants, Chinese Academy of Medical Sciences, Beijing 100193, China  
王淳 WANG Chun 北京中医药大学 中医学院, 北京 100029 College of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, China wangchun08@126.com 
基金项目:国家中医药管理局中医药行业科研专项(201507004-1)
中文摘要:该研究通过查阅国内外文献,对决明子源流考证、古籍研究、古今文献毒性记载、临床不良反应及近年来相关实验研究进行了系统回顾,初步总结了与决明子安全性相关的临床病例特点及影响因素,发现决明子安全风险主要在于以乏力、纳差、厌油,尿黄如浓茶水样,大便灰白为主要临床特点的肝肾系统损伤、以腹泻、腹胀、恶心、大便松软为主要临床特点的消化系统损伤、以阴道流血为主要临床特点的生殖系统损伤,以口舌发麻、皮肤瘙痒、恶心呕吐、腹泻里急、喘憋、口唇紫绀为主要临床特点的过敏反应临床不良事件亦有报道,并从急性毒性实验、亚急性毒性试验、亚慢性毒性试验、慢性毒性实验等毒性机制的实验报道方面对决明子有毒成分进行了毒理研究。危险因素可能包括患者因素,配伍因素和医师因素。医师用药应该严格遵守药典规定,注意合理配伍,用量要适当,用法要正确,炮制要恰如其分,控制其用量为15 g以内避免超量服用,严格控制疗程,避免长期用药引起的蓄积中毒。同时,临床医生要注意留心最新研究进展,更新知识结构,从临床实践、科学研究及药物信息等大量文献信息中快速找到最新的、有用的有关资料,并对资料进行评价、判断,建立中药情报信息库,要有预警意识,加强不良反应的防控。笔者建议应规范决明子临床用药,避免非医嘱误食误用或过量服用,临床医师开具处方用法用量方应严格遵照药典推荐,并于临床中注重安全信号积累,同时加强毒性物质基础、毒性机制研究,在充分发挥决明子临床疗效的同时减少其不良反应。
中文关键词:决明子  安全性评价  不良反应  风险控制
 
Safety evaluation and risk control measures of Cassiae Semen
Abstract:In this study, the authors reviewed domestic and foreign literatures, conducted the textual research on origin and developmentof Cassia Semen, studied records in ancient books and ancient and modern literatures, clinical adverse reactions and relevant experimental studies in recent years, and summarized the clinical features and influencing factors related to the safety of Cassiae Semen. According to the findings,Cassia Semen's safety risks are mainly liver and kidney system damages, with the main clinical features of fatigue, anorexia, disgusting of oil, yellow urine and gray stool; digestive system injury, with the main clinical features of diarrhea, abdominal distension, nausea andloose stool; reproductive system damage, with the main clinical features of vaginal bleeding. Allergic reactions and clinical adverse events, with the main clinical features for numb mouth, itching skin, nausea and vomiting, diarrhea, wheezing and lip cyanosis were also reported. The toxicological studies on toxic components of Cassiae Semen obtusifolia were carried out through acute toxicity test, subacute toxicity test, subchronic toxicity test and chronic toxicity test. Risk factors might include patients, compatibility and physicians. Physicians should strictly abide by the medication requirements in the Pharmacopoeia, pay attention to rational compatibility, appropriate dosage,correct usage and appropriate processing, control the dosage below 15 g to avoid excessive intake, strictly control the course of treatment to avoid accumulated poisoning caused by long-term administration. At the same time, clinicians should pay attention to the latest research progress, update the knowledge structure, quickly find the latest and useful materials from clinical practice, scientific research and drug information and other literatures, make evaluation andjudgment for the materials, establish a traditional Chinese medicine intelligence information library, and strengthen the control over adverse effects with a pre-warning consciousness. The authors suggested standardizing clinical medication of Cassiae Semen, and avoiding misuse or excessive use; clinicians should prescribe it in strict accordance with there commended usage and dosage in the Pharmacopoeia, and focus on the safety signal accumulation in clinic, while strengthening studies for toxic substance basis and toxicity mechanism, in order to give full play to Cassiae Semen's clinical efficacy and reduce its adverse reactions.
keywords:Cassiae Semen  safety evaluation  adverse reaction  risk control
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