| 引用本文:王连心1 谢雁鸣1 常艳鹏1，2 易丹辉3.主动监测在中药注射剂上市后临床安全性评价的应用及范例[J].世界中医药,2014,9(09):. |
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| 主动监测在中药注射剂上市后临床安全性评价的应用及范例 |
| Clinical Application and Example of Active Post-marketing Safety Surveillance of Traditional Chinese Medicine |
| 投稿时间：2014-08-06 |
| DOI：10.3969/j.issn.1673-7202.2014.09.006 |
| 中文关键词: 中药注射剂 安全性 主动监测 巢式病例对照 真实世界 |
| English Keywords:TCM injections Safety Active Surveillance Nested case-control design Real world |
| 基金项目:国家中医药管理局中医药行业科研专项资助项目（编号：200907001-5-6）；“重大新药创制”科技重大专项“中药上市后再评价关键技术研究”（编号：2009ZX09502-030）；中国中医科学院科技创新团队建设项目(编号：PY1303) |
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| 中文摘要: |
| 目的：以三种清热解毒类中药注射剂为例，为其上市后临床安全性评价及方法学研究提供范例。方法：基于前瞻性、多中心、大样本主动监测嵌套巢式病例对照设计的方法，监测使用三种中药注射剂的患者，探索不良反应发生率、发生特征及过敏反应可能的影响因素。结果：监测10 029例患者，共发生26例ADR，包括5例过敏反应，经过人体免疫毒理学指标检测，患者的IgE皆有所升高。结论：基于监测数据计算总体ADR发生率为0.26%，属于偶见（0.1％～1％），过敏反应可能由IgE介导，这也为此类问题的研究探索了方法学范式。 |
| English Summary: |
| To explore and evaluate the post-marketing safety evaluation methods with the example of three heat-clearing and detoxifying injections of traditional Chinese medicine.Methods：We monitored patients taken the above injections based on active surveillance methods. It is a prospective, multi-center, large sample and nested case-controlled design, to investigate the incidence, characteristics and influencing factors of adverse reaction (ADR). Results：Among 10,029 patients monitored, 26 patients had ADR, 5 of them experienced allergic reactions. IgE of the 5 patients who had allergic reactions was elevated. Conclusion： The overall ADR incidence rate is 0.26% (0.1% ～ 1%) and allergic reactions are probably mediated by IgE. |
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