Review of Adverse Reactions to Chinese Medicine Injections△_Chinese Journal of Evidence-Based Medicine

Authors：

 BIAN ZhaoXiang ¹ , SHANG HongCai ² , WU TaiXiang ³ , LI YouPing ³ , ZHANG BoLi ²

1. School of Chinese Medicine, Hong Kong Baptist University, Hong Kong, China; 2. Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China;3. Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, China;

Corresponding author：

BIAN ZhaoXiang, Email: bzxiang@hkbu.edn.hk

Keywords：

Chinese medicine injection; Adverse drug reaction; Aduerse event; Retrospection

DOI：

10.7507/1672-2531.20100287

Video：

Export PDF Favorites Scan Get Citation

Abstract Full text Figures/Tables Video References Cited by

Using Chinese Materia Medica (CM) as injections is an innovation that is proving effective in extensive clinical use in Mainland China. However, recent reports have focused on adverse reactions, ignoring the considerable successes of these preparations. In order to achieve balance in the media and in the minds of the public, we suggest the first step is to clarify the concepts of and differences between adverse drug reactions (ADR) and adverse events (AE) for all concerned—the public, medical practitioners, government officials, and lawmakers. Second, the State Food and Drug Administration should raise the requirements for Chinese Medicine Injection (CMI) registration and license approval and emphasize the importance of evidence-based CMI development and evidence-based CMI license approval. Thirdly, drug companies and institutions should reinforce basic research about the quality control of herbs and CMI-drug interactions. Fourth, the Government should clarify the legal responsibilities for CMI approval agencies, CMI developers, medical doctors, and patients. Fifth, the medical association and Government should enhance training for health care professionals concerning the usage of CMIs. And finally sixth, State Food and Drug Administration should monitor the content and quality of the directions for use of CMI.

Citation： BIAN ZhaoXiang,SHANG HongCai,WU TaiXiang,LI YouPing,ZHANG BoLi. Review of Adverse Reactions to Chinese Medicine Injections△. Chinese Journal of Evidence-Based Medicine, 2010, 10(2): 116-121. doi: 10.7507/1672-2531.20100287 Copy

1.	Chinese Pharmacopoeia Commission. Pharmacopoeia of the People’ s Republic of China. (2005th ed.) Vol. 1. Beijing, China: People’s Medical Pub. House, 2005.
2.	Zhou X, Gu XJ. Approval and adverse drug reaction of traditional Chinese medicine injection. Shanghai Medical & Pharmaceutical Journal, 2009, 30(8): 363-5.
3.	Jin CH. Traditional Chinese medicine injection goes out the crisis of confidence. Every One is Well, 2009, 9: 11.
4.	Tang RR, Bian Y, Wang YT. Discussion on the current situation, prevention and monitoring of adverse drug reaction of Chinese herbal medicine in China. LiShiZhen Medicine and Materia Medica Research, 2009, 20(2): 492-494.
5.	Zhao W, Lu J, Lin T. Aggregate analysis on literature of ADRs Induced by Chinese Materia Medica during 2000-2008. China Pharmacy, 2009, 20(6): 461-463.
6.	State Food and Drug Administration. Announcement on the publication of Basic Technical Requirements for TCM and Natural Medicine Injection. http://www.sda.gov.cn/WS01/CL0237/27058. html.
7.	Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis and management. Lancet, 2000, 356(9237): 1255-1259.
8.	Cornelius VR,Perrio MJ,Shakir SA,Smith LA,Systematic reviews of adverse effects of drug interventions: a survey of their conduct and reporting quality. Pharmacoepidemiol Drug Saf, 2009, 18: 1223-1231.
9.	Good Clinical Practice. http://chinabioethics.netfirms.com/ bioethics/main/code/20021206185003.htm.
10.	The Measures for the Administration on Report and Monitoring of the Side Effect of Pharmaceuticals (Docket No. 7). http://www.sda. gov.cn/WS01/CL0053/24477.html.
11.	Zhang BL, Weng WL. Adverse drug reaction and reasonable usage of Chinese medicine. Beijing, China: Tsinghua University Press, 2007.
12.	Shen JL, Peng X. Discussion on safety affair of traditional Chinese medicine on the basis of management angle. Acta Universitatis Medicinalis Nanjing (Social Science), 2009, 36(3): 177-180.
13.	Wang W. Causes and prevention measures for the adverse drug reaction of traditional Chinese medicine injection. Guide of China Medicine, 2009, 7(2): 63-65.
14.	Ye JF. One reported case on allergic reaction for YuXingCao ZhuSheYe. Chinese Remedies & Clinics, 2003, 3(3): 272.
15.	Huang W, Meng FR, Meng X, Mao XH, Zhang WX. Scienitific thinking on bottleneck question of GAP production status and developing process for Chinese herbal medicine in China. Chinese Journal of Pharmaceutical Technology Economics and Management, 2008, 2(12): 48-54.
16.	Tang YS. Physical and chemical prohibited combination for intravenous infusion commonly used. Strait Pharmaceutical Journal, 2008, 20(7): 35-37.
17.	Yang WX, Wu LJ, Guo HL. Analysis on the current situation and common unreasonable combination for traditional Chinese medicine injection. Practical Clinical Journal of Integrated Traditional Chinese and Western Medicine, 2009, 9(2): 92-94.
18.	Precaution on the serious adverse event of ShuangHuangLian ZhuSheYe. Information notification on adverse drug reaction. Vol 22.
19.	Bai XJ. Problem analysis on the insert sheet of traditional Chinese medicine injection. Pharmacology and Clinics of Chinese Materia Medica, 2009, 25(1): 67-70.

1. Chinese Pharmacopoeia Commission. Pharmacopoeia of the People’ s Republic of China. (2005th ed.) Vol. 1. Beijing, China: People’s Medical Pub. House, 2005.
2. Zhou X, Gu XJ. Approval and adverse drug reaction of traditional Chinese medicine injection. Shanghai Medical & Pharmaceutical Journal, 2009, 30(8): 363-5.
3. Jin CH. Traditional Chinese medicine injection goes out the crisis of confidence. Every One is Well, 2009, 9: 11.
4. Tang RR, Bian Y, Wang YT. Discussion on the current situation, prevention and monitoring of adverse drug reaction of Chinese herbal medicine in China. LiShiZhen Medicine and Materia Medica Research, 2009, 20(2): 492-494.
5. Zhao W, Lu J, Lin T. Aggregate analysis on literature of ADRs Induced by Chinese Materia Medica during 2000-2008. China Pharmacy, 2009, 20(6): 461-463.
6. State Food and Drug Administration. Announcement on the publication of Basic Technical Requirements for TCM and Natural Medicine Injection. http://www.sda.gov.cn/WS01/CL0237/27058. html.
7. Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis and management. Lancet, 2000, 356(9237): 1255-1259.
8. Cornelius VR,Perrio MJ,Shakir SA,Smith LA,Systematic reviews of adverse effects of drug interventions: a survey of their conduct and reporting quality. Pharmacoepidemiol Drug Saf, 2009, 18: 1223-1231.
9. Good Clinical Practice. http://chinabioethics.netfirms.com/ bioethics/main/code/20021206185003.htm.
10. The Measures for the Administration on Report and Monitoring of the Side Effect of Pharmaceuticals (Docket No. 7). http://www.sda. gov.cn/WS01/CL0053/24477.html.
11. Zhang BL, Weng WL. Adverse drug reaction and reasonable usage of Chinese medicine. Beijing, China: Tsinghua University Press, 2007.
12. Shen JL, Peng X. Discussion on safety affair of traditional Chinese medicine on the basis of management angle. Acta Universitatis Medicinalis Nanjing (Social Science), 2009, 36(3): 177-180.
13. Wang W. Causes and prevention measures for the adverse drug reaction of traditional Chinese medicine injection. Guide of China Medicine, 2009, 7(2): 63-65.
14. Ye JF. One reported case on allergic reaction for YuXingCao ZhuSheYe. Chinese Remedies & Clinics, 2003, 3(3): 272.
15. Huang W, Meng FR, Meng X, Mao XH, Zhang WX. Scienitific thinking on bottleneck question of GAP production status and developing process for Chinese herbal medicine in China. Chinese Journal of Pharmaceutical Technology Economics and Management, 2008, 2(12): 48-54.
16. Tang YS. Physical and chemical prohibited combination for intravenous infusion commonly used. Strait Pharmaceutical Journal, 2008, 20(7): 35-37.
17. Yang WX, Wu LJ, Guo HL. Analysis on the current situation and common unreasonable combination for traditional Chinese medicine injection. Practical Clinical Journal of Integrated Traditional Chinese and Western Medicine, 2009, 9(2): 92-94.
18. Precaution on the serious adverse event of ShuangHuangLian ZhuSheYe. Information notification on adverse drug reaction. Vol 22.
19. Bai XJ. Problem analysis on the insert sheet of traditional Chinese medicine injection. Pharmacology and Clinics of Chinese Materia Medica, 2009, 25(1): 67-70.

Previous Article
Avoiding Adverse Drug Reactions to Chinese Medicine Injections△
Next Article
Current Status of Multinational Clinical Trials in East Asia——Results of the Survey Using ClinicalTrials.gov

Chinese Journal of Evidence-Based Medicine

Review of Adverse Reactions to Chinese Medicine Injections△

Abstract Full text Figures/Tables Video References Cited by

Previous Article

Next Article

Format

Content