注册登记研究在痰热清注射液适应病证及用药特征分析中的应用Registration study on analysis of adaptation syndromes and medication characteristics of Tanreqing injection
谢鹏扬;谢雁鸣;王连心;常艳鹏;尤丽;张小利;
XIE Peng-yang;XIE Yan-ming;WANG Lian-xin;CHANG Yan-peng;YOU Li;ZHANG Xiao-li;Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences;College Information and Computer Science,Shanghai Business School;Shenyang Orthopaedic Hospital;Renmin University of China;Shanghai Kaibao Pharmaceutical Co.,Ltd;
摘要(Abstract):
痰热清注射液适用于肺炎早期、急性支气管炎、慢性支气管炎急性发作以及上呼吸道感染属痰热阻肺证者,为了解其上市后临床适应病证及用药特征的实际情况,采用前瞻性、多中心、大样本、注册登记式医院集中监测的方法,监测2012年9月—2013年10月4家医院使用痰热清注射液的患者,分析患者一般信息、诊断信息及临床用药特征等,为临床实践及用药决策产生证据,并为其合理使用奠定基础。
Tanreqing injection is suitable for early pneumonia,acute bronchitis,acute exacerbations of chronic,and upper respiratory tract infection which are classified with phlegm-heat obstructing lung syndrome of traditional Chinese medicine.To understand the clinical adaptation syndromes and medication characteristics of the post-market Tanreqing injection,the research team of the paper monitored the patients who are used with Tanreqing injection from September 2012 to October 2013 in four leader hospitals based on the method——prospective,multi-center,large sample,registration-type hospital centralized monitoring,and analyzes the general information,diagnostic information and medication characteristics of patients,in order to produce evidence for clinical practice and medication decisions and to establish the foundation of rational drug use.
关键词(KeyWords):
痰热清注射液;注册登记研究;医院集中监测;临床用药特征;前瞻性研究
Tanreqing injection;registration research;hospital centralized monitoring;medication characteristics;prospective study
基金项目(Foundation): 国家“重大新药创制”科技重大专项(2009ZX09502030);; 国家中医药管理局中医药行业科研专项(200907001-5-6)
作者(Authors):
谢鹏扬;谢雁鸣;王连心;常艳鹏;尤丽;张小利;
XIE Peng-yang;XIE Yan-ming;WANG Lian-xin;CHANG Yan-peng;YOU Li;ZHANG Xiao-li;Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences;College Information and Computer Science,Shanghai Business School;Shenyang Orthopaedic Hospital;Renmin University of China;Shanghai Kaibao Pharmaceutical Co.,Ltd;
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- 痰热清注射液
- 注册登记研究
- 医院集中监测
- 临床用药特征
- 前瞻性研究
Tanreqing injection - registration research
- hospital centralized monitoring
- medication characteristics
- prospective study
- 谢鹏扬
- 谢雁鸣
- 王连心
- 常艳鹏
- 尤丽
- 张小利
XIE Peng-yang- XIE Yan-ming
- WANG Lian-xin
- CHANG Yan-peng
- YOU Li
- ZHANG Xiao-li
- Institute of Basic Research in Clinical Medicine
- China Academy of Chinese Medical Sciences
- College Information and Computer Science
- Shanghai Business School
- Shenyang Orthopaedic Hospital
- Renmin University of China
- Shanghai Kaibao Pharmaceutical Co.
- Ltd
- 谢鹏扬
- 谢雁鸣
- 王连心
- 常艳鹏
- 尤丽
- 张小利
XIE Peng-yang- XIE Yan-ming
- WANG Lian-xin
- CHANG Yan-peng
- YOU Li
- ZHANG Xiao-li
- Institute of Basic Research in Clinical Medicine
- China Academy of Chinese Medical Sciences
- College Information and Computer Science
- Shanghai Business School
- Shenyang Orthopaedic Hospital
- Renmin University of China
- Shanghai Kaibao Pharmaceutical Co.
- Ltd