国家食品药品监督管理总局关于发布中药新药临床研究一般原则等4个技术指导原则的通告 ...

2022-12-14 18:46| 发布者: 享瑾美| 查看: 3673| 评论: 0

摘要: 本则是为中药新药临床试验的设计、实施和评价提供一般性方法学指导,是在2002年《中药新药临床研究指导原则(试行)》的基础上,结合近年来中医药学、现代医学、临床流行病学、医学统计学等的新进展,参考国内外相关 ...



 十三、参考文献

1.《中药新药临床研究指导原则》(试行),中国医药科技出版社,2002.

2E1-E10  ICHInternational Conference on Harmaonisation of Technical Requirements for Registration of Pharmaceuticals for Human use ICH Harmonised   Tripartite Guaidline.

3.Danan G, Benichou C. Causality assessment of adverse reactions to drugs-I.A novel method based on the conclusions of international consensus meetings: application to drug-induced liver injuries. J Clin Epidemiol 1993; 46: 13231330.

4.Tajiri K,Shimizu Y. Practical guidelines for diagnosis and early management of drug-induced liver injury[J].World J Gastroenterol,2008,14(44):6774-6785.

5.De Valle MB,Av Klinteberg V,Alem N,et al.Drug-induced liver injury in a Swedish University hospital outpatient hepatologyclinic[J].Aliment Pharmacol Ther,2006,24,1187-1195.

6Larrey D. Epidemiology and individual susceptibility to adverse drug reactions affecting the liver. Seminars In  Liver Dis. 2002;22(2):145-155.

7.International Consensus Meeting. Criteria of drug-induced liver disorders. J Hepatol 1990; 11:272-276.

8Chalasani N P, Hayashi P H, Bonkovsky H L, et al. ACG Clinical Guideline: the diagnosis and management of idiosyncratic drug-induced liver injury. Am J Gastroenterol, 2014, 109(7): 950-966.

9Hayashi PH, Fontana RJ. Clinical features, diagnosis, and natural history of drug-induced liver injury. Semin Liver Dis, 2014, 34(2):134-144.

10Leise MD, Poterucha JJ, Talwalkar JA. Drug-induced liver injury. Mayo Clin Proc, 2014, 89(1):95-106.

11.Fontana RJ, Seeff  LB, Andrade RJ,et al. Standardization of nomenclature and causality assessment in drug-induced liver injury: summary of a clinical research workshop. Hepotology,2010,52(2):730-742.

12.Zimmerman, HJ, 1978,Drug-Induced Liver Disease, in:Hepatotoxicity, The Adverse Effects of Drugs and Other Chemicas on the Liver,1st ed.pp.351-3, Appleton-Centu ry -Crofts, New York.

13.Zimmerman, HJ, 1999, Drug-Induced Liver Disease, in:Hepatotoxicity, The Adverse Effects of Drugs and Other Chemicals on the Liver, 2nd ed.pp.428-33, Lippincott Williams & Wilkins, Philadelphia.

14.http://www.fda.gov/cher/guidelines.htm

15.Temple,R,2001,Hepatotoxicity Through the Years: Impact on the FDA, presented/12/2001, http://www.fda.gov/downloads/

Drugs/ScienceResearch/ResearchAreas /ucm122149.pdf.

16.Reuben, A, 2004, Hy’s Law, Hepatology, 39(2):574-8.

17Guidance for Industry Drug-Induced Liver Injury:

Premarketing Clinical Evaluation. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER),Center for Biologics Evaluation and Research (CBER). July 2009, Drug Safety (http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. )

18The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256.

19ftp://ftp1.nci.nih.gov/pub/cacore/EVS/CTCAE/Archive/CTCAE_4.0_2009-05-29_QuickReference_8.5x11.pdf.

20http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E14/E14_Guideline.pdf

21http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073161.pdf

22陈冀莹. 心肌损伤标记物的应用及临床意义. 国外医学放射医学核医学分册 2004; 28: 216-219.

23Kilickap S, Barista I, Akgul E, et al. Ctnt can be a useful marker for early detection of anthracycline cardiotoxicity. Annals of Oncol 2002; 13: 699.

24Maisel S, Koon J, Krishnaswamy P, et al. Utility of BNP as a rapid, point of care test for screening patients undergoing echocardiography to determine left ventricular dysfunction. Am Heart J 2001; 14(30): 367

25Lee HS, Son CB, Shin SH, et al. Clinical correlation between brain natriuretic peptide and anthracyclin-induced cardiac toxicity. Cancer Res Treat 2008; 40(3): 121-126.

26Okumura H, Iuchi K, Yoshida T, et al. Brain natriuretic peptide is a predictor of anthracyclin-induced cardiotoxicity. Acta Haematol 2000; 104(4): 158-163.

27张思洁,崔彦芝. 脑钠肽检测在蒽环类药物化疗心脏毒性患者中的意义. 疑难病杂志 2011; 10(6): 444-445.

28Feola M, Garrone O, Occelli M, et al. Cardiotoxicity after anthracycline chemotherapy in breast carcinoma: Effects on left ventricular ejection fraction, troponin I and brain natriuretic peptide. Int J Cardiol 2011; 148: 194-198.

29Marchandise B, Schroeder E, Bosly A, et al. Early detection of doxorubicin cardiotoxicity: interest of Doppler echocardiographic analysis of left ventricular filling dynamics. Am Heart J. 1989; 118: 92-98.



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