千里光临床不良反应成因分析

中国药物警戒 ›› 2015, Vol. 12 ›› Issue (3): 160-163.

千里光临床不良反应成因分析

尹利顺¹，²,李晓宇¹,孙蓉¹*

1山东省中医药研究院，山东济南 250014;
2山东中医药大学，山东济南 250355

收稿日期:2014-09-24 出版日期:2015-03-08 发布日期:2015-07-28
通讯作者: 孙蓉，女，博士，研究员?博导，中药药理与毒理研究。
作者简介:尹利顺，女，博士，药师，临床药学。
基金资助:
国家重点基础研究发展计划（973）中医基础理论专项资助项目课题2（2009CB522802）；国家自然科学基金课题（81073148， 30672649）；山东省自然科学基金重点课题（2011ZRB14333）。

Analysis of the Causes of Senecio Scandens Clinical Adverse Reactions

YIN Li-shun¹,²,LI Xiao-yu¹,SUN Rong¹*

1Shandong Academy of Chinese Medicine, Shandong Jinan 250014, China;
2Shandong University of Traditional Chinese Medicine, Shandong Jinan 250355, China

Received:2014-09-24 Online:2015-03-08 Published:2015-07-28

摘要/Abstract

摘要： 目的分析千里光发生临床不良反应的原因，为进一步安全性评价提供文献依据和研究思路。方法通过近十多年来国内外相关文献对千里光临床不良反应的报道，进行整理、分析与归纳。结果千里光主要临床不良反应为肝脏损伤，其发生与长期使用、使用剂量、品种混用、配伍使用、制备工艺和个体差异等原因有关，尤其是长期服用是千里光致肝损伤、甚至产生死亡的主要原因；千里光所含的吡咯里西啶类生物碱（pyrrolizidine alkaloids, PAs）是导致肝毒性的主要物质基础。结论针对千里光临床不良反应，应亟待加强千里光药材及其中成药中肝损伤毒性规律和物质基础研究，进而通过明晰肝毒物质基础的体内过程和“TD-TK”关联评价，制订体内安全限度，完善并提高质量标准，保证临床用药安全。

关键词: 千里光, 不良反应, 成因

Abstract: Objective To review the research status of Senecio scandens clinical adverse reactions, in order to offer accordance and study ideas for further safety evaluation. Methods References in the last decades at home and abroad about Senecio scandens clinical reports of adverse reactions were collated, analyzed and summarized. Results The most serious adverse reaction of Senecio scandens is hepatotoxicity, which is related to the long-term use, dosage, a mixture of varieties, compatibility, preparation technology and the difference of individual, and especially long-term use is the main cause of death of clinical cases. Studies have shown that pyrrolizidine alkaloids (PAs) contained in Senecio scandens are the main material basis of hepatotoxicity. Conclusion For the causes of Senecio scandens clinical adverse reactions, the hepatotoxicity damage regularity and material basis of Senecio scandens and its Chinese traditional patent medicine should be urgently studied, and intracorporal process of toxic substances and "toxicodynamics-toxicokinetics" relevance evaluation are distinguished, to formulate safety margin of the body, perfect and improve the quality standards as well as ensure clinical medication safety.

Key words: Senecio scandens, adverse reactions, causes

中图分类号:

R994.11
R282

尹利顺,李晓宇,孙蓉. 千里光临床不良反应成因分析[J]. 中国药物警戒, 2015, 12(3): 160-163.

YIN Li-shun,LI Xiao-yu,SUN Rong. Analysis of the Causes of Senecio Scandens Clinical Adverse Reactions[J]. Chinese Journal of Pharmacovigilance, 2015, 12(3): 160-163.

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