How to focus on the safety assessment of herb-drug interaction in real world studies_Chinese Journal of Evidence-Based Medicine

Authors：

HU Zhichao ¹ ^# , GE Lida ² ^# , LIU Tao ³ ,  ZHONG Lidan ^1,3,4

1. School of Chinese Medicine, Hong Kong Baptist University, Hong Kong, 999077, P.R.China;
2. Department of Hepatobiliary Surgery, the First People's Hospital of Xiaoshan District, Hangzhou, Zhejiang Province, Hangzhou, 311200, P.R.China;
3. Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, P.R.China;
4. Hong Kong Chinese Medicine Clinical Study Center, Hong Kong Baptist University, Hong Kong, 999077, P.R.China;

Corresponding author：

ZHONG Lidan, Email: ldzhong@hkbu.edu.hk

Keywords：

Real-world studies; Herb-drug interaction; Safety assessment; Active surveillance

DOI：

10.7507/1672-2531.201805045

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Real-world studies (RWSs) data are based on real medical scenes and reflect clinical facts. Besides, RWSs adapts to the characteristics of therapeutic principles of traditional Chinese medicine and the medical reality of the combination of Western and traditional Chinese medicine, which makes the safety assessment of herb-drug interaction more efficient and economical. During RWSs, more attention should be paid on the validity and reliability of data, especially the standardization of the data collection process and its contents. The safety assessment of herb-drug interaction will combine the methods of active surveillance study, big data analysis, and be based on precision medicine in the future

Citation： HU Zhichao, GE Lida, LIU Tao, ZHONG Lidan. How to focus on the safety assessment of herb-drug interaction in real world studies. Chinese Journal of Evidence-Based Medicine, 2018, 18(11): 1158-1162. doi: 10.7507/1672-2531.201805045 Copy

1.	王思成, 刘保延, 熊宁宁, 等. 真实世界临床研究伦理问题及策略探讨. 中国中西医结合杂志, 2013, 33(4): 437-442.
2.	付玲, 周学平, 李国春. " 真实世界研究”-中医药科研新思路. 浙江中医药大学学报, 2013, 37(9): 1127-1129.
3.	Sherman RE, Anderson SA, Dal Pan GJ, et al. Real-world evidence-what is it and what can it tell us? N Engl J Med, 2016, 375: 2293-2297.
4.	21st Century Cures Act, H. R. 34, 114^th Cong. 2015. Available at: https://www.congress.gov/bill/114th-congress/house-bill/34/.
5.	Use of real-world evidence to support regulatory decision- making for medical devices. U. S. Food and Drug Administration. 2017. Available at: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm513027.pdf.
6.	Kramer JM, Schulman KA. Envisioning a transformed clinical trials enterprise in the United States: establishing an agenda for 2020: workshop summary. Appendix F-Discussion paper: transforming the economics of clinical trials. Washington (DC): National Academies Press (US). 2012. Available at: http://www.ncbi.nlm.nih.gov/books/NBK114653/.
7.	张润顺, 王映辉, 刘保延, 等. 基于共享系统的真实世界中医临床研究范式初步实施方案的设计. 中医杂志, 2014, 55(18): 1551-1154.
8.	高毅超, 刘妮波, 郝彧. 基于CNKI数据库对真实世界研究临床应用的文献计量学分析. 中医药导报, 2017, 23(13): 82-85.
9.	董珍宇, 高颖, 吴圣贤. 基于真实世界的松龄血脉康胶囊治疗原发性高血压研究. 中西医结合心脑血管病杂志, 2013, 11(3): 274-275.
10.	付玲, 周学平, 李国春, 等. 中西药联合治疗类风湿关节炎真实世界研究. 中国中西医结合杂志, 2016, 36(11): 1319-1322.
11.	杜婧, 杨薇, 易丹辉, 等. 基于HIS" 真实世界”的丹红注射液治疗冠心病患者合并用药分析. 中国中药杂志, 2011, 36(20): 2821-2824.
12.	招远祺, 冯婧, 招敏娟, 等. 基于真实世界的临床研究方法研究中药注射剂的安全性. 新中医, 2016, 48(9): 160-163.
13.	忻凌, 刘健, 刘春, 等. 基于真实世界的名老中医学术经验数字化平台研究. 中医药管理杂志, 2016, 24(4): 5-7.
14.	Natural Health Products Directorate-Health Canada. Natural Health Product Tracking Survey-2010 final report. Ipsos- Reid. 2011. Available at: http://epe.lac-bac.gc.ca/100/200/301/pwgsc-tpsgc/por-ef/health/2011/135-09/report.pdf.
15.	38% of doctors now suggest natural health products: survey. Canadian Healthcare Network. 2011. Available at: http://www.canadianhealthcarenetwork.ca/pharmacists/clinical/health-indextherapeutics/alternative-medicine/38-of-doctors-now-suggest-naturalhealth-products-survey-11135.
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17.	Chen KJ, Lu AP. Situation of integrative medicine in China: results from a national survey in 2004. Chin J Integr Med, 2006, 2(3): 161-165.
18.	罗静, 焦阳, 于美丽, 等. 冠心病中西医结合真实世界研究的实践与思考. 北京中医药, 2013, 32(11): 806-810.
19.	Hu Z, Yang X, Ho PC, et al. Herb- drug interactions: a literature review. Drugs, 2005, 65(9): 1239-1282.
20.	Chen KC, Lu R, Iqbal U, et al. Interactions between traditional Chinese medicine and western drugs in Taiwan: a population-based study. Comput Methods Programs Biomed, 2015, 122(3): 462-470.
21.	Kutt A, Girard L, Necyk C, et al. Natural health product- drug interaction tool: a scoping review. Can Pharm J, 2016, 149(2): 75-82.
22.	Necyk C, Khamba B, Chue P, et al. Study of natural health product-drug adverse reactions (S. O. N. A. R.) in patients seeking mental health services. Curr Med Res Opin, 2016, 32(8): 1335-1343.
23.	Cvijovic K, Boon H, Barnes J, et al. A tool for rapid identification of potential herbal medicine-drug interactions. Can Pharm J, 2009, 142(5): 224-227.
24.	Zorzela L, Mior S, Boon H, et al. Tool to assess causality of direct and indirect adverse events associated with therapeutic interventions. Curr Med Res Opin, 2018, 34(3): 407-414.
25.	刘保延, 周雪忠, 李平, 等. 个体诊疗临床科研信息一体化平台. 中国数字医学, 2007, 2(6): 31-36.
26.	De Lusignan S, Crawford L, Munro N. Creating and using real-world evidence to answer questions and about clinical effectiveness. J Innov Health Inform, 2015, 22(3): 368-373.

1. 王思成, 刘保延, 熊宁宁, 等. 真实世界临床研究伦理问题及策略探讨. 中国中西医结合杂志, 2013, 33(4): 437-442.
2. 付玲, 周学平, 李国春. " 真实世界研究”-中医药科研新思路. 浙江中医药大学学报, 2013, 37(9): 1127-1129.
3. Sherman RE, Anderson SA, Dal Pan GJ, et al. Real-world evidence-what is it and what can it tell us? N Engl J Med, 2016, 375: 2293-2297.
4. 21st Century Cures Act, H. R. 34, 114^th Cong. 2015. Available at: https://www.congress.gov/bill/114th-congress/house-bill/34/.
5. Use of real-world evidence to support regulatory decision- making for medical devices. U. S. Food and Drug Administration. 2017. Available at: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm513027.pdf.
6. Kramer JM, Schulman KA. Envisioning a transformed clinical trials enterprise in the United States: establishing an agenda for 2020: workshop summary. Appendix F-Discussion paper: transforming the economics of clinical trials. Washington (DC): National Academies Press (US). 2012. Available at: http://www.ncbi.nlm.nih.gov/books/NBK114653/.
7. 张润顺, 王映辉, 刘保延, 等. 基于共享系统的真实世界中医临床研究范式初步实施方案的设计. 中医杂志, 2014, 55(18): 1551-1154.
8. 高毅超, 刘妮波, 郝彧. 基于CNKI数据库对真实世界研究临床应用的文献计量学分析. 中医药导报, 2017, 23(13): 82-85.
9. 董珍宇, 高颖, 吴圣贤. 基于真实世界的松龄血脉康胶囊治疗原发性高血压研究. 中西医结合心脑血管病杂志, 2013, 11(3): 274-275.
10. 付玲, 周学平, 李国春, 等. 中西药联合治疗类风湿关节炎真实世界研究. 中国中西医结合杂志, 2016, 36(11): 1319-1322.
11. 杜婧, 杨薇, 易丹辉, 等. 基于HIS" 真实世界”的丹红注射液治疗冠心病患者合并用药分析. 中国中药杂志, 2011, 36(20): 2821-2824.
12. 招远祺, 冯婧, 招敏娟, 等. 基于真实世界的临床研究方法研究中药注射剂的安全性. 新中医, 2016, 48(9): 160-163.
13. 忻凌, 刘健, 刘春, 等. 基于真实世界的名老中医学术经验数字化平台研究. 中医药管理杂志, 2016, 24(4): 5-7.
14. Natural Health Products Directorate-Health Canada. Natural Health Product Tracking Survey-2010 final report. Ipsos- Reid. 2011. Available at: http://epe.lac-bac.gc.ca/100/200/301/pwgsc-tpsgc/por-ef/health/2011/135-09/report.pdf.
15. 38% of doctors now suggest natural health products: survey. Canadian Healthcare Network. 2011. Available at: http://www.canadianhealthcarenetwork.ca/pharmacists/clinical/health-indextherapeutics/alternative-medicine/38-of-doctors-now-suggest-naturalhealth-products-survey-11135.
16. 陈章明, 陈敏燕. 香港病患者与中西疗法偏好研究. 紫荆论坛, 2004, 17: 78-83.
17. Chen KJ, Lu AP. Situation of integrative medicine in China: results from a national survey in 2004. Chin J Integr Med, 2006, 2(3): 161-165.
18. 罗静, 焦阳, 于美丽, 等. 冠心病中西医结合真实世界研究的实践与思考. 北京中医药, 2013, 32(11): 806-810.
19. Hu Z, Yang X, Ho PC, et al. Herb- drug interactions: a literature review. Drugs, 2005, 65(9): 1239-1282.
20. Chen KC, Lu R, Iqbal U, et al. Interactions between traditional Chinese medicine and western drugs in Taiwan: a population-based study. Comput Methods Programs Biomed, 2015, 122(3): 462-470.
21. Kutt A, Girard L, Necyk C, et al. Natural health product- drug interaction tool: a scoping review. Can Pharm J, 2016, 149(2): 75-82.
22. Necyk C, Khamba B, Chue P, et al. Study of natural health product-drug adverse reactions (S. O. N. A. R.) in patients seeking mental health services. Curr Med Res Opin, 2016, 32(8): 1335-1343.
23. Cvijovic K, Boon H, Barnes J, et al. A tool for rapid identification of potential herbal medicine-drug interactions. Can Pharm J, 2009, 142(5): 224-227.
24. Zorzela L, Mior S, Boon H, et al. Tool to assess causality of direct and indirect adverse events associated with therapeutic interventions. Curr Med Res Opin, 2018, 34(3): 407-414.
25. 刘保延, 周雪忠, 李平, 等. 个体诊疗临床科研信息一体化平台. 中国数字医学, 2007, 2(6): 31-36.
26. De Lusignan S, Crawford L, Munro N. Creating and using real-world evidence to answer questions and about clinical effectiveness. J Innov Health Inform, 2015, 22(3): 368-373.

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How to focus on the safety assessment of herb-drug interaction in real world studies

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