The Off-Label Drug Use of Bevacizumab for Eye Diseases: The Perspective of Evidence-based Medicine_Chinese Journal of Evidence-Based Medicine

Authors：

 GAOYu-ting ¹ ^# ,  WANGXiao-qin ^2,3,4,5 ^# , SONGXiao-yang ¹ , WANGQi ^2,3,4 , XIAOShu-jun ¹ , DENGWei ⁶ , YANGNan ⁷ ,  CHENYao-long ^2,3,4

1. School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, China;
2. Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, China;
3. Key Laboratory of Evidence-Based Medicine and Knowledge Translation of Gansu Province, Lanzhou 730000, China;
4. Chinese GRADE Center, Lanzhou University, Lanzhou 730000, China;
5. Institute of Pathogenic Biology of Lanzhou University, Lanzhou 730000, China;
6. The Second Medical School of Lanzhou University, Lanzhou 730000, China;
7. The First Medical School of Lanzhou University, Lanzhou 730000, Chin;

Corresponding?author：

CHENYao-long, Email: chenyaolong21@163.com

Keywords：

Off-label drug use; Bevacizumab; Eye disease; Evidence-based medicine

DOI：

10.7507/1672-2531.20150241

Video：

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With the perspective of evidence-based medicine, this review aims to investigate the effectiveness and safety of off-label drug use of bevacizumab for eye disease, and explore the barriers to further study. And then, suggestions for the supported evidence and clinical use of off-label drug use will be provided based on this case.

Citation： GAOYu-ting, WANGXiao-qin, SONGXiao-yang, WANGQi, XIAOShu-jun, DENGWei, YANGNan, CHENYao-long. The Off-Label Drug Use of Bevacizumab for Eye Diseases: The Perspective of Evidence-based Medicine. Chinese Journal of Evidence-Based Medicine, 2015, 15(12): 1479-1483. doi: 10.7507/1672-2531.20150241 Copy

1.	American Society of Hospital Pharmacists. ASHP statement on the use of medications for unlabeled uses. Am J Hosp Pharm, 1992, 49(8):2006.
2.	張鈺瑩, 于麗. 超說明書用藥理與法的考量. 中國處方藥, 2010, 103(10):20.
3.	文愛東. 超說明書用藥的倫理學認知. 2014全國藥物流行病學年會暨《中國藥師》第五屆編委會會議論文匯編. 中國藥師雜志, 2014, 15.
4.	專家指出:我國超說明書用藥現象突出. Available at:http://health.people.com.cn/n/2014/0806/c14739-25416552.html?from=timeline&isappinstalled=0.
5.	Conroy S, Anker JVD. Survey of unlicensed and off label drug use in paediatric wards in European countries. BMJ, 2000, 320(7227):79-82.
6.	Herring C, Mcmanus A, Weeks A. Off-label prescribing during pregnancy in the UK:an analysis of 18,000 prescriptions in Liverpool Women's Hospital. Int J Pharm Pract, 2010, 18(4):226-229.
7.	陳萬年. 新藥貝伐單抗的臨床應用進展. 中國腫瘤, 2010, 19(8): 534-539.
8.	崔斐, 李軍, 羅榮城. 貝伐單抗在腫瘤臨床治療中的研究進展. 河北醫學, 2008, 11(6):741-746.
9.	李貞, 倪衛杰. 視網膜新生血管生物藥物治療研究進展. 國際眼科雜志, 2007, 7(4):1119-1123.
10.	Michels S, Rosenfeld PJ, Puliafito CA, et al. Systemic bevacizumab (Avastin) therapy for neovascular age-related macular degeneration: twelve-week results of an uncontrolled open-label clinical study. Ophthalmology, 2005, 112(6):1035-1047.
11.	Rosenfeld PJ, Moshfeghi AA, Puliafito CA. Optical coherence tomography findings after an intravitreal injection of bevacizumab (avastin) for neovascular age-related macular degeneration. Ophthalmic Surg Lasers Imaging, 2005, 36(4):331-335.
12.	Thomas Meek. Avastin safe in eye disease, says Cochrane. Available at:www.pmlive.com/pharma_news/avastin_safe_in_eye_disease,_says_cochrane_599068.
13.	CATT Research Group. Ranibizumab and bevacizumab for neovascular age-related macular degeneration. N Engl J Med, 2011, 364(20):1897.
14.	Martin DF, Maguire MG, Fine SL, et al. Ranibizumab and bevacizumab for treatment of neovascular age-related macular degeneration:two-year results. Ophthalmology, 2012, 119(7):1388-1398.
15.	Grisanti S, Ziemssen F. Bevacizumab:off-label use in ophthalmology. Indian J ophthalmol, 2007, 55(6):417.
16.	Ben Adams.UK doctors call on NHS to use Avastin for wet AMD. Available at:www.pmlive.com/pharma_news/uk_doctors_call_on_nhs_to_use_avastin_forwet_amd_661157.
17.	姚文琴, 林季建. Bevacizumab在眼科治療中的進展. 國際眼科縱覽, 2008, 32(4):261-267.
18.	替罪羊安維汀. Available at:discover.news.163.com/special/ avastin/.
19.	姜浩, 趙堪興. 玻璃體內注射bevacizumab治療糖尿病視網膜病變. 眼科研究, 2009, 27(4):349-352.
20.	Iturralde D, Spaide RF, Meyerle CB, et al. Intravitreal bevacizumab(Avastin) treatment of macularedema in central retinal vein occlusion:a short-term study. Retina, 2006, 26(3):279-284.
21.	Iliev ME, Domig D, Wolf-Schnurrbursch U, et al. Intravitreal bevacizumab (Avastin) in the treatment of neovascular glaucoma.Am J Ophthalmol, 2006, 142(6):1054-1056.
22.	于同利, 畢宏生. Avastin在眼科應用的研究進展. 國際眼科雜志, 2008, 8(4):810-812.
23.	Moja L, Lucenteforte E, Kwag KH, et al. Systemic safety of bevacizumab versus ranibizumab for neovascular age-related macular degeneration. Cochrane Database Syst Rev, 2014, 9: CD011230.
24.	Raftery J, Clegg A, Jones J, et al. Ranibizumab (Lucentis) versus bevacizumab (Avastin):modelling cost effectiveness. Br J Ophthalmol, 2007, 91(9):1244-1246.
25.	Magdelaine-Beuzelin C, Pinault C, Paintaud G, et al. Therapeutic antibodies in ophthalmology:old is new again//MAbs. Taylor & Francis, 2010, 2(2):176-180.
26.	Rosenfeld PJ, Brown DM, Heier JS, et al. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med, 2006, 355(14):1419-1431.
27.	李文生. 貝伐單抗和雷珠單抗治療濕性AMD有效性和安全性的 meta分析. 第十六屆全國眼底病學術會議. Available at:http://www.coretina1.net/?act=detail&id=1556.
28.	Ronan SM, Yoganathan P, Chien FY, et al. Retinal pigment epithelium tears after intravitreal injection of bevacizumab (avastin) for neovascular age-related macular degeneration. Retina, 2007, 27(5):535-540.
29.	Wong LJ, Desai RU, Jain A, et al. Surveillance for potential adverse events associated with the use of intravitreal bevacizumab for retinal and choroidal vascular disease. Retina, 2008, 28(8):1151-1158.
30.	張鐳, 譚玲, 陸進. 超說明書用藥專家共識. 藥物不良反應雜志, 2015, 17(2):101-103.
31.	Cohen D. Attacks on publicly funded trials:what happens when industry does not want to know the answer. BMJ, 2015, 350:h1701.
32.	張伶俐, 李幼平, 黃亮, 等. 四川大學華西第二醫院兒科門診處方超藥品說明書用藥情況調查. 中國循證醫學雜志, 2011, 11(10): 1120-1124.
33.	徐蓉, 孫新欣, 邵明立. 風險規制視域下的美國超說明書用藥法律探討. 中國新藥雜志, 2014, 23(22):2597-2650.
34.	李玉堂, 楊昌云, 李炎丹, 等. 超說明書用藥的審核分級與綜合處理. 中國藥房, 2011, 22(17):1574-1576.
35.	張伶俐, 李幼平, 曾力楠, 等. 15國超說明書用藥政策的循證評價. 中國循證醫學雜志, 2012, 12(4):426-435.
36.	宋儒亮. 我國超說明書用藥的法定界限. 中國處方藥, 2012, 103(11):10.
37.	邵振, 盧軍鋒. 超藥品說明書用藥的相關法律責任問題研究. 中國衛生法制, 2010, 18(6):16-19.
38.	向彥, 蒲川, 蔣祎, 等. 論超藥品說明書用藥的法律責任. 中國保健營養旬刊, 2012, (7):38.

1. American Society of Hospital Pharmacists. ASHP statement on the use of medications for unlabeled uses. Am J Hosp Pharm, 1992, 49(8):2006.
2. 張鈺瑩, 于麗. 超說明書用藥理與法的考量. 中國處方藥, 2010, 103(10):20.
3. 文愛東. 超說明書用藥的倫理學認知. 2014全國藥物流行病學年會暨《中國藥師》第五屆編委會會議論文匯編. 中國藥師雜志, 2014, 15.
4. 專家指出:我國超說明書用藥現象突出. Available at:http://health.people.com.cn/n/2014/0806/c14739-25416552.html?from=timeline&isappinstalled=0.
5. Conroy S, Anker JVD. Survey of unlicensed and off label drug use in paediatric wards in European countries. BMJ, 2000, 320(7227):79-82.
6. Herring C, Mcmanus A, Weeks A. Off-label prescribing during pregnancy in the UK:an analysis of 18,000 prescriptions in Liverpool Women's Hospital. Int J Pharm Pract, 2010, 18(4):226-229.
7. 陳萬年. 新藥貝伐單抗的臨床應用進展. 中國腫瘤, 2010, 19(8): 534-539.
8. 崔斐, 李軍, 羅榮城. 貝伐單抗在腫瘤臨床治療中的研究進展. 河北醫學, 2008, 11(6):741-746.
9. 李貞, 倪衛杰. 視網膜新生血管生物藥物治療研究進展. 國際眼科雜志, 2007, 7(4):1119-1123.
10. Michels S, Rosenfeld PJ, Puliafito CA, et al. Systemic bevacizumab (Avastin) therapy for neovascular age-related macular degeneration: twelve-week results of an uncontrolled open-label clinical study. Ophthalmology, 2005, 112(6):1035-1047.
11. Rosenfeld PJ, Moshfeghi AA, Puliafito CA. Optical coherence tomography findings after an intravitreal injection of bevacizumab (avastin) for neovascular age-related macular degeneration. Ophthalmic Surg Lasers Imaging, 2005, 36(4):331-335.
12. Thomas Meek. Avastin safe in eye disease, says Cochrane. Available at:www.pmlive.com/pharma_news/avastin_safe_in_eye_disease,_says_cochrane_599068.
13. CATT Research Group. Ranibizumab and bevacizumab for neovascular age-related macular degeneration. N Engl J Med, 2011, 364(20):1897.
14. Martin DF, Maguire MG, Fine SL, et al. Ranibizumab and bevacizumab for treatment of neovascular age-related macular degeneration:two-year results. Ophthalmology, 2012, 119(7):1388-1398.
15. Grisanti S, Ziemssen F. Bevacizumab:off-label use in ophthalmology. Indian J ophthalmol, 2007, 55(6):417.
16. Ben Adams.UK doctors call on NHS to use Avastin for wet AMD. Available at:www.pmlive.com/pharma_news/uk_doctors_call_on_nhs_to_use_avastin_forwet_amd_661157.
17. 姚文琴, 林季建. Bevacizumab在眼科治療中的進展. 國際眼科縱覽, 2008, 32(4):261-267.
18. 替罪羊安維汀. Available at:discover.news.163.com/special/ avastin/.
19. 姜浩, 趙堪興. 玻璃體內注射bevacizumab治療糖尿病視網膜病變. 眼科研究, 2009, 27(4):349-352.
20. Iturralde D, Spaide RF, Meyerle CB, et al. Intravitreal bevacizumab(Avastin) treatment of macularedema in central retinal vein occlusion:a short-term study. Retina, 2006, 26(3):279-284.
21. Iliev ME, Domig D, Wolf-Schnurrbursch U, et al. Intravitreal bevacizumab (Avastin) in the treatment of neovascular glaucoma.Am J Ophthalmol, 2006, 142(6):1054-1056.
22. 于同利, 畢宏生. Avastin在眼科應用的研究進展. 國際眼科雜志, 2008, 8(4):810-812.
23. Moja L, Lucenteforte E, Kwag KH, et al. Systemic safety of bevacizumab versus ranibizumab for neovascular age-related macular degeneration. Cochrane Database Syst Rev, 2014, 9: CD011230.
24. Raftery J, Clegg A, Jones J, et al. Ranibizumab (Lucentis) versus bevacizumab (Avastin):modelling cost effectiveness. Br J Ophthalmol, 2007, 91(9):1244-1246.
25. Magdelaine-Beuzelin C, Pinault C, Paintaud G, et al. Therapeutic antibodies in ophthalmology:old is new again//MAbs. Taylor & Francis, 2010, 2(2):176-180.
26. Rosenfeld PJ, Brown DM, Heier JS, et al. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med, 2006, 355(14):1419-1431.
27. 李文生. 貝伐單抗和雷珠單抗治療濕性AMD有效性和安全性的 meta分析. 第十六屆全國眼底病學術會議. Available at:http://www.coretina1.net/?act=detail&id=1556.
28. Ronan SM, Yoganathan P, Chien FY, et al. Retinal pigment epithelium tears after intravitreal injection of bevacizumab (avastin) for neovascular age-related macular degeneration. Retina, 2007, 27(5):535-540.
29. Wong LJ, Desai RU, Jain A, et al. Surveillance for potential adverse events associated with the use of intravitreal bevacizumab for retinal and choroidal vascular disease. Retina, 2008, 28(8):1151-1158.
30. 張鐳, 譚玲, 陸進. 超說明書用藥專家共識. 藥物不良反應雜志, 2015, 17(2):101-103.
31. Cohen D. Attacks on publicly funded trials:what happens when industry does not want to know the answer. BMJ, 2015, 350:h1701.
32. 張伶俐, 李幼平, 黃亮, 等. 四川大學華西第二醫院兒科門診處方超藥品說明書用藥情況調查. 中國循證醫學雜志, 2011, 11(10): 1120-1124.
33. 徐蓉, 孫新欣, 邵明立. 風險規制視域下的美國超說明書用藥法律探討. 中國新藥雜志, 2014, 23(22):2597-2650.
34. 李玉堂, 楊昌云, 李炎丹, 等. 超說明書用藥的審核分級與綜合處理. 中國藥房, 2011, 22(17):1574-1576.
35. 張伶俐, 李幼平, 曾力楠, 等. 15國超說明書用藥政策的循證評價. 中國循證醫學雜志, 2012, 12(4):426-435.
36. 宋儒亮. 我國超說明書用藥的法定界限. 中國處方藥, 2012, 103(11):10.
37. 邵振, 盧軍鋒. 超藥品說明書用藥的相關法律責任問題研究. 中國衛生法制, 2010, 18(6):16-19.
38. 向彥, 蒲川, 蔣祎, 等. 論超藥品說明書用藥的法律責任. 中國保健營養旬刊, 2012, (7):38.

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