|
|||||
|
|
| 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 | |
| 引用本文： | 王连心 谢雁鸣 常艳鹏,易丹辉. 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(9): 1132-1136 |
| 作者姓名： | 王连心 谢雁鸣 常艳鹏 易丹辉 |
| 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. 中国中医科学院中医临床基础医学研究所，北京，100700; 沈阳市骨科医院，沈阳，110044 3. 中国人民大学，北京，100872 |
| 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 |
| 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。 |
| 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 |
| 收稿时间： | 2014-08-06 |
Clinical Application and Example of Active Post-marketing Safety Surveillance of Traditional Chinese Medicine |
|
| Wang Lianxin,Xie Yanming,Chang Yanpeng,Yi Danhui. Clinical Application and Example of Active Post-marketing Safety Surveillance of Traditional Chinese Medicine[J]. World Chinese Medicine, 2014, 9(9): 1132-1136 | |
| Authors: | Wang Lianxin Xie Yanming Chang Yanpeng Yi Danhui |
| Affiliation: | Wang Lianxin, Xie Yanming, Chang Yanpeng, Yi Danhui ( 1 Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China; 2 Shenyang Orthopaedic Hospital, Shenyang 110044, China ; 3 Renmin University of China, Beifing 100872, China) |
| Abstract: | Objective：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 surveil-lance methods.It is a prospective,multi-center,large sample and nested case-controlled design,to investigate the incidence,character-istics 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. |
| Keywords: | TCMinjections Safety Active Surveillance Nested case-control design Real world |
| 本文献已被 CNKI 维普 万方数据 等数据库收录！ | |
| 点击此处可从《世界中医药》浏览原始摘要信息 | |
| 点击此处可从《世界中医药》下载全文 | |