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

Video：

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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, 劉保延, 熊寧寧, 等. 真實世界臨床研究倫理問題及策略探討. 中國中西醫結合雜志, 2013, 33(4): 437-442.
2.	付玲, 周學平, 李國春. " 真實世界研究”-中醫藥科研新思路. 浙江中醫藥大學學報, 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.	張潤順, 王映輝, 劉保延, 等. 基于共享系統的真實世界中醫臨床研究范式初步實施方案的設計. 中醫雜志, 2014, 55(18): 1551-1154.
8.	高毅超, 劉妮波, 郝彧. 基于CNKI數據庫對真實世界研究臨床應用的文獻計量學分析. 中醫藥導報, 2017, 23(13): 82-85.
9.	董珍宇, 高穎, 吳圣賢. 基于真實世界的松齡血脈康膠囊治療原發性高血壓研究. 中西醫結合心腦血管病雜志, 2013, 11(3): 274-275.
10.	付玲, 周學平, 李國春, 等. 中西藥聯合治療類風濕關節炎真實世界研究. 中國中西醫結合雜志, 2016, 36(11): 1319-1322.
11.	杜婧, 楊薇, 易丹輝, 等. 基于HIS" 真實世界”的丹紅注射液治療冠心病患者合并用藥分析. 中國中藥雜志, 2011, 36(20): 2821-2824.
12.	招遠祺, 馮婧, 招敏娟, 等. 基于真實世界的臨床研究方法研究中藥注射劑的安全性. 新中醫, 2016, 48(9): 160-163.
13.	忻凌, 劉健, 劉春, 等. 基于真實世界的名老中醫學術經驗數字化平臺研究. 中醫藥管理雜志, 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.	陳章明, 陳敏燕. 香港病患者與中西療法偏好研究. 紫荊論壇, 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.	羅靜, 焦陽, 于美麗, 等. 冠心病中西醫結合真實世界研究的實踐與思考. 北京中醫藥, 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.	劉保延, 周雪忠, 李平, 等. 個體診療臨床科研信息一體化平臺. 中國數字醫學, 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, 劉保延, 熊寧寧, 等. 真實世界臨床研究倫理問題及策略探討. 中國中西醫結合雜志, 2013, 33(4): 437-442.
2. 付玲, 周學平, 李國春. " 真實世界研究”-中醫藥科研新思路. 浙江中醫藥大學學報, 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. 張潤順, 王映輝, 劉保延, 等. 基于共享系統的真實世界中醫臨床研究范式初步實施方案的設計. 中醫雜志, 2014, 55(18): 1551-1154.
8. 高毅超, 劉妮波, 郝彧. 基于CNKI數據庫對真實世界研究臨床應用的文獻計量學分析. 中醫藥導報, 2017, 23(13): 82-85.
9. 董珍宇, 高穎, 吳圣賢. 基于真實世界的松齡血脈康膠囊治療原發性高血壓研究. 中西醫結合心腦血管病雜志, 2013, 11(3): 274-275.
10. 付玲, 周學平, 李國春, 等. 中西藥聯合治療類風濕關節炎真實世界研究. 中國中西醫結合雜志, 2016, 36(11): 1319-1322.
11. 杜婧, 楊薇, 易丹輝, 等. 基于HIS" 真實世界”的丹紅注射液治療冠心病患者合并用藥分析. 中國中藥雜志, 2011, 36(20): 2821-2824.
12. 招遠祺, 馮婧, 招敏娟, 等. 基于真實世界的臨床研究方法研究中藥注射劑的安全性. 新中醫, 2016, 48(9): 160-163.
13. 忻凌, 劉健, 劉春, 等. 基于真實世界的名老中醫學術經驗數字化平臺研究. 中醫藥管理雜志, 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. 陳章明, 陳敏燕. 香港病患者與中西療法偏好研究. 紫荊論壇, 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. 羅靜, 焦陽, 于美麗, 等. 冠心病中西醫結合真實世界研究的實踐與思考. 北京中醫藥, 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. 劉保延, 周雪忠, 李平, 等. 個體診療臨床科研信息一體化平臺. 中國數字醫學, 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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