Methodological approaches to developing and establishing the body of evidence on post-marketing chinese medicine safety

Xing Liao; Nicola Robinson

doi:10.1007/s11655-013-1502-y

Your Location：

Home >

Browse articles >

Methodological approaches to developing and establishing the body of evidence on post-marketing chinese medicine safety

Updated：2021-08-27

- Methodological approaches to developing and establishing the body of evidence on post-marketing chinese medicine safety
- Chinese Journal of Integrative Medicine Vol. 19, Issue 7, Pages: 494-497(2013)
- Affiliations：
  
  1. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences,Beijing,China
  2. Faculty of Health and Social Care, London South Bank, University,UK
- Author bio：
- Funds：
  
  Supported by National Natural Science Foundation of China (General Program, No. 81202776) and the Sixth-Science Foundation of Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences (No. Z0215)
- DOI：10.1007/s11655-013-1502-y
  CLC：
- Published：2013，
  
  Published Online：2 July 2013，
Scan for full text
LIao, X., Robinson, N. Methodological approaches to developing and establishing the body of evidence on post-marketing chinese medicine safety., Chin. J. Integr. Med. 19, 494–497 (2013). https://doi.org/10.1007/s11655-013-1502-y

Xing Liao, Nicola Robinson. Methodological approaches to developing and establishing the body of evidence on post-marketing chinese medicine safety. [J]. Chinese Journal of Integrative Medicine 19(7):494-497(2013)
LIao, X., Robinson, N. Methodological approaches to developing and establishing the body of evidence on post-marketing chinese medicine safety., Chin. J. Integr. Med. 19, 494–497 (2013). https://doi.org/10.1007/s11655-013-1502-y DOI：

Xing Liao, Nicola Robinson. Methodological approaches to developing and establishing the body of evidence on post-marketing chinese medicine safety. [J]. Chinese Journal of Integrative Medicine 19(7):494-497(2013) DOI： 10.1007/s11655-013-1502-y.

摘要

Evidence based medicine demands the highest form of scientific evidence to demonstrate the efficacy and clinical effectiveness for any therapeutic intervention in order to provide best care. It is however accepted that in the absence of scientific evidence

personal experience and expert opinion together with professional judgement are critical. Obtaining evidence for drug safety

postmarketing surveillance (PMS) has focussed on follow up of observational cohorts exposed to a particular drug in order to estimate the incidence of adverse drug reactions (ADRs). Evidence on PMS of Chinese herbal products is still limited

in particular for herbal injections. The aim of this article is to suggest a new model of ascertaining the safety of Chinese medicine using a more comprehensive approach for collecting data. To collect safety data on the Chinese herbal injection

Kudiezi

a mixed methods approach is proposed using 18 hospital information systems to detect ADRs in order to prospectively observe 30

000 patients over 3 years. Evidence will also be collected using a questionnaire survey and through a sample of semi structured interviews. This information based on the expert opinion and the experience of clinicians will produce additional data on the frequency and types of side effects in clinical practice. Furthermore semi structured interviews with a random sample of patients receiving the injection will be carried out to ascertain any potential side effects missed. It is hoped that this comprehensive approach to data collection will accumulate wider evidence based on individual traditional Chinese medicine care and treatment and provide important feedback to the national data collection system to ensure completeness of ADR data recording

monitoring and any potential wider effects through developing improved ADR guidelines.

Abstract

personal experience and expert opinion together with professional judgement are critical. Obtaining evidence for drug safety

Kudiezi

a mixed methods approach is proposed using 18 hospital information systems to detect ADRs in order to prospectively observe 30

monitoring and any potential wider effects through developing improved ADR guidelines.

关键词

post-marketing medicineChinese Medicineobservational studyexpert opinionevidence

Keywords

post-marketing medicineChinese Medicineobservational studyexpert opinionevidence

references

Claridge J, Fabian T. History and development of evidence based medicine. World J Surg 2005;29:547–553.

Sackett DL, Strauss SE, Richardson WS, Rosenberg W, Haynes RB. Evidence-based medicine: how to practice and teach EBM. 2nd ed. Edinburgh: Churchill Livingstone; 2000.

Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn’t. BMJ 1996;312:71–72.

Evidence-Based Medicine Working Group. Evidence-based medicine. A new approach to teaching the practice of medicine. JAMA 1992;268:2420–2425.

“Evidence-based health care and systematic reviews”. The Cochrane Collaboration. http://www.cochrane.org/about-us/evidence-based-health-care. Retrieved 4 January 2013.

“What is EBM?”. CEBM — Centre for Evidence Based Medicine. http://www.cebm.net/?o=1014. Retrieved Retrieved 4 January 2013.

Tonelli MR. In defense of expert opinion. Acad Med 1999;74:1187–1192.

Rawlins M. De testimonio: on the evidence for decisions about the use of therapeutic interventions. Lancet 2008;372:2152–2161.

Li NY, Abbott KV, Rosen C, An G, Hebda PA, Vodovotz Y. Translational systems biology and voice pathophysiology. Laryngoscope 2010;120:511–515.

McNeil JJ, Piccenna L, Ronaldson K, Ioannides-Demos LL. The value of patient-centred registries in phase IV drug surveillance. Pharm Med 2010;24:281–288.

Wang H, Ye X, Gao Q, Wu C, Qian Y, Luo B, et al. Pharmacovigilance in traditional Chinese medicine safety surveillance. Pharmacoepidemiol Drug Safety (Chin) 2009;18:357–361.

Lu QL, Fang JJ. A survey of twenty years ADR caused by traditioonal Chinese medicine. Adverse Drug Reactions J (Chin) 2001;91:18–21.

Zhang LL. Research on marketing strategy of Tong Hua Die mai ling. Masters Thesis (Chin) 2007;F830:33.

Liao X, Shen H, Xie YM, Zhang W, Yang W, LU ZG. Literature review report on safety evaluation about Kudiezi injection. China J Chin Mate Med (Chin) 2012;18:2786–2788.

Zuo ZJ, Huang QM. A systematic review of Kudiezi Injection in the treatment of angina pectoris. China Med Herald (Chin) 2011;4:32–35,73.

Jiang YB, Chen KJ.Systematic evaluation on the effect of Diemaining Injection in treating acute cerebral infarction. Chin J Clin Rehabil (Chin) 2006;27:100–101.

FULL TEXT LINK

More>

Views

946

Downloads

CSCD

Alert me when the article has been cited

Submit

Tools

Publicity Resources

Diagnosis and management of knee osteoarthritis: Chinese medicine expert consensus (2015)

Future view and development of immunology: Exploring the immunology based on Chinese medicine and culture

Cost-effectiveness analysis of combined Chinese medicine and Western medicine for ischemic stroke patients

Objective tongue inspection on 142 liver cancer patients with damp-heat syndrome

Effect of Ermiao Recipe (二妙方) with medicinal guide Angelicae Pubescentis Radix on promoting the homing of bone marrow stem cells to treat cartilage damage in osteoarthritis rats

Related Author

No data

Related Institution

The Third Department of Osteoarthrosis, Wangjing Hospital, China Academy of Chinese Medical Sciences

Research Institute of Integrated Chinese and Western Medicine, Fujian University of Traditional Chinese Medicine

Department of Orthopedics and Traumatology, The First Affiliated Hospital of Zhejiang Chinese Medical University

Department of Orthopedics and Traumatology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Georg-August-Universität Göttingen, Göttingen

Address：1 Caochang, xiyuan, Beijing, People's Republic of China Postal code：100091
Tel：010-62886827, 62877592 Fax：010-62874291
Technical support is provided by Beijing Founder electronics co., LTD 京ICP备05067934号-1 京公网安备11010802024621
It is recommended to read the content of this site in Chrome&IE9+. Please switch to extreme mode in browser 360.
Cookies We use cookies to help provide and enhance our service and tailor content. By continuing, you agree to the use of cookies.

⁰