| 0期临床试验与中药注射剂上市后临床安全性再评价 |
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| 引用本文： | 谢雁鸣,魏戌,张占军,王永炎.0期临床试验与中药注射剂上市后临床安全性再评价[J].中国中药杂志,2011,36(20):2874-2876. |
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| 作者姓名： | 谢雁鸣 魏戌 张占军 王永炎 |
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| 作者单位： | 1. 中国中医科学院中医临床基础医学研究所,北京,100700
2. 北京师范大学认知神经科学与学习国家重点实验室,北京,100875 |
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| 基金项目： | 国家"重大新药创制"科技重大专项(2009ZX09502-030);中国中医科学院自主选题研究项目(Z0133) |
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| 摘 要： | 中药注射剂不良反应时有发生,临床安全性问题亟待解决,需要进行上市后临床安全性再评价,过敏反应是不良反应评价的主要内容之一.对含有毒药材的中成药、有安全问题的中药注射剂需要开展0期临床试验,0期临床试验使用“微剂量”研究周期内收集必要的药物安全性及药代动力学试验数据,微剂量可以反映中药注射剂的致敏情况.0期临床试验为上市后中药注射剂的安全性再评价提供了新的方法,是否进行0期临床试验,应依据品种是否有安全性问题而定,中药注射剂初始剂量以及样本含量的确定是研究设计的关键问题.
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| 关 键 词： | 0期临床试验 微剂量 中药注射剂 上市后临床安全性再评价 |
| 收稿时间： | 8/6/2011 12:00:00 AM |
Phase 0 clinical trials and post-marketed re-evaluation of clinical safety in injection of traditional Chinese medicine |
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| WEI Xu,ZHANG Zhanjun,XIE Yanming and WANG Yongyan.Phase 0 clinical trials and post-marketed re-evaluation of clinical safety in injection of traditional Chinese medicine[J].China Journal of Chinese Materia Medica,2011,36(20):2874-2876. |
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| Authors: | WEI Xu ZHANG Zhanjun XIE Yanming and WANG Yongyan |
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| Institution: | Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China;Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China;National Key Laboratory of Cognitive Neuroscience and Learning, Beijing Normal University, Beijing 100875, China;Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China |
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| Abstract: | Adverse drug reaction induced by injection of traditional Chinese medicine(TCM) often occurs. Post-marketed re-evaluation of clinical safety in injection of TCM is indispensable,in order to solve the clinical safety problems. It is necessary to conduct Phase 0 clinical trials for containing toxic medicine and injection of TCM. Phase 0 clinical trials,involving very limited human exposure,and using microdose of drugs,are intended to collect the necessary safety and pharmacokinetic data in limited period. Microdose reflects allergies of injection of TCM. Phase 0 clinical trials provide a new method for post-marketed re-evaluation of safety in injection of TCM. Its use depends on whether there is a safety problem for injection of TCM,and the determination of initial dose and sample size are key questions in study design. |
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| Keywords: | phase 0 clinical trials microdose injection of traditional Chinese medicine post-marketed re-evaluation of clinical safety |
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