激素类抗肿瘤药物的超说明书用药进展_West China Medical Journal

Authors：

尹茜 , 占美 , 张莹 ,  徐珽

四川大学华西医院临床药学部（药剂科）（成都 610041）;

Corresponding author：

徐珽, Email: tingx2009@163.com

Keywords：

激素类抗肿瘤药物; 超说明书用药; 促排卵; 乳腺增生; 卵巢保护; 他莫西芬

DOI：

10.7507/1002-0179.201603080

Video：

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激素类抗肿瘤药物包括雌激素、孕激素、雄激素及其拮抗剂，其作用机制决定了此类药物不仅可以在抗肿瘤治疗中发挥作用，也可以在其他一些激素相关的疾病中达到良好的治疗效果，而药品说明书往往落后于临床实际，从而导致了一些超说明书用药情况的发生。该文就激素类抗肿瘤药物在临床应用已较为广泛的促排卵治疗、乳腺增生、卵巢保护、中枢性性早熟等的超说明书用药情况进行了综述。

Citation： 尹茜, 占美, 张莹, 徐珽. 激素类抗肿瘤药物的超说明书用药进展. West China Medical Journal, 2017, 32(11): 1818-1820. doi: 10.7507/1002-0179.201603080 Copy

1.	中国药理学会治疗药物监测研究专业委员会药品风险管理学组. 超说明书用药专家共识. 药物不良反应杂志, 2015, 17(2): 101-102.
2.	中华医学会生殖医学分会. 辅助生殖促排卵药物治疗专家共识. 生殖与避孕, 2015, 35(4): 211-223.
3.	Homburg R. Clomiphene citrate--end of an era? A mini-review. Hum Reprod, 2005, 20(8): 2043-2051.
4.	Tulay MD, Musrafa MD. Comparision of the effects of letrozole and clomiphene citrate on ovarian follicles, endometrium and hormonelevels in the rat. Fertil Steril, 2003, 80(6): 1330-1332.
5.	Brueggemeier RW. Update on the use of aromatase inhibitors in breast cancer. Expert Opin Pharmacother, 2006, 7(14): 2000-2011.
6.	林洪波, 钱卫平, 李蓉, 等. 来曲唑微刺激促排卵方案在卵巢反应低下患者的临床应用探讨. 华西医学, 2015, 30(3): 502-504.
7.	肖劲松, 陈双陨, 张春莲. 来曲唑促排卵治疗有效性的系统性评价. 中国循证医学杂志, 2010, 10(6): 718-723.
8.	Shaaban MM, Morad F, Hassan Ael R. Treatment of fibrocystic mastopathy by an antiestrogen, tamoxifen. Int J Gynaecol Obstet, 1980, 18(5): 348-350.
9.	王晓东, 陈玉娟, 金显峰, 等. 枸橼酸他莫昔芬片与中成药在乳腺良性增生的近期疗效对比. 华西医学, 2011, 26(7): 1082-1083.
10.	中华预防医学会妇女保健分会乳腺保健与疾病防治学组. 乳腺增生症的诊治共识(讨论稿). (2013-03-18)[2017-09-28]. http://www.ccmtv.cn/article/1280/12226.html.
11.	邹群, 童晓文. 比较托瑞米芬与他莫西芬治疗绝经前中重度乳腺增生症的疗效观察. 外科理论与实践, 2008, 13(6): 587-589.
12.	von Wolff M, Montag M, Dittrich R, et al. Fertility preservation in women--a practical guide to preservation techniques and therapeutic strategies in breast cancer, Hodgkin’s lymphoma and borderline ovarian tumours by the fertility preservation network FertiPROTEKT. Arch Gynecol Obstet, 2011, 2(84): 427-435.
13.	Badawy A, Elnashar A, El-Ashry M, et al. Gonadotropin-releasing hormone agonists for prevention of chemotherapy-induced ovarian damage: prospective randomized study. Fertil Steril, 2009, 91(3): 694-697.
14.	Kletter GB, Klein KO, Wang YY. A Pediatrician’s guide to central precocious puberty. Clin Pediatr (Phila), 2015, 54(5): 414-424.
15.	Willemsen RH, Elleri D, Williams RM, et al. Pros and cons of GnRHa treatment for early puberty in girls. Nat Rev Endocrinol, 2014, 10(6): 352-363.
16.	赵岫, 张琴. 来曲唑治疗特发性中枢性性早熟男童的临床观察. 中国当代儿科杂志, 2014, 16(4): 397-400.
17.	中华医学会儿科学分会内分泌遗传代谢学组, 《中华儿科杂志》编辑委员会. 中枢性性早熟诊断与治疗共识(2015). 中华儿科杂志, 2015, 53(6): 412-418.
18.	Carel JC, Eugster EA, Rogol A, et al. Consensus statement on the use of gonadotropin-releasing hormone analogs in children. Pediatrics, 2009, 123(4): e752-e762.
19.	Chishoem A. Exploring UK attitudes towards unlicensed medicines use: a questionnaire-based study of menbers of the general public and physicians. Int J Gen Med, 2012, 5: 27-40.
20.	国家食品药品监督管理局. 药品说明书和标签管理规定(局令第 24 号). (2006-03-15)[2016-03-30]. http://www.sda.gov. cn/WS01/CL0053/24522.html.
21.	唐蕾, 韦炳华, 何秋毅, 等. 超说明书用药的现状及其法律风险. 中国药房, 2014, 25(45): 4225-4228.
22.	张钰莹, 于丽. 超说明书用药理与法的考量. 中国处方药, 2010, 103(3): 71-72.
23.	张伶俐, 李幼平, 曾力楠, 等. 15 国超说明书用药政策的循证评价. 中国循证医学杂志, 2012, 12(4): 426-435.
24.	Aguggia M, Cavallini M, Varetto L. Medical-legal issues in headache: penal and civil Italian legislation, working claims, social security, off-label prescription. Neurol Sci, 2006, 27(Suppl 2): S198-S202.
25.	Kendall M, Enringt D. An agenda for UK clinical pharmacology provision of medicine information: the example of the British National Formulary. Br J Clin Pharmacol, 2012, 73(6): 934-938.

1. 中国药理学会治疗药物监测研究专业委员会药品风险管理学组. 超说明书用药专家共识. 药物不良反应杂志, 2015, 17(2): 101-102.
2. 中华医学会生殖医学分会. 辅助生殖促排卵药物治疗专家共识. 生殖与避孕, 2015, 35(4): 211-223.
3. Homburg R. Clomiphene citrate--end of an era? A mini-review. Hum Reprod, 2005, 20(8): 2043-2051.
4. Tulay MD, Musrafa MD. Comparision of the effects of letrozole and clomiphene citrate on ovarian follicles, endometrium and hormonelevels in the rat. Fertil Steril, 2003, 80(6): 1330-1332.
5. Brueggemeier RW. Update on the use of aromatase inhibitors in breast cancer. Expert Opin Pharmacother, 2006, 7(14): 2000-2011.
6. 林洪波, 钱卫平, 李蓉, 等. 来曲唑微刺激促排卵方案在卵巢反应低下患者的临床应用探讨. 华西医学, 2015, 30(3): 502-504.
7. 肖劲松, 陈双陨, 张春莲. 来曲唑促排卵治疗有效性的系统性评价. 中国循证医学杂志, 2010, 10(6): 718-723.
8. Shaaban MM, Morad F, Hassan Ael R. Treatment of fibrocystic mastopathy by an antiestrogen, tamoxifen. Int J Gynaecol Obstet, 1980, 18(5): 348-350.
9. 王晓东, 陈玉娟, 金显峰, 等. 枸橼酸他莫昔芬片与中成药在乳腺良性增生的近期疗效对比. 华西医学, 2011, 26(7): 1082-1083.
10. 中华预防医学会妇女保健分会乳腺保健与疾病防治学组. 乳腺增生症的诊治共识(讨论稿). (2013-03-18)[2017-09-28]. http://www.ccmtv.cn/article/1280/12226.html.
11. 邹群, 童晓文. 比较托瑞米芬与他莫西芬治疗绝经前中重度乳腺增生症的疗效观察. 外科理论与实践, 2008, 13(6): 587-589.
12. von Wolff M, Montag M, Dittrich R, et al. Fertility preservation in women--a practical guide to preservation techniques and therapeutic strategies in breast cancer, Hodgkin’s lymphoma and borderline ovarian tumours by the fertility preservation network FertiPROTEKT. Arch Gynecol Obstet, 2011, 2(84): 427-435.
13. Badawy A, Elnashar A, El-Ashry M, et al. Gonadotropin-releasing hormone agonists for prevention of chemotherapy-induced ovarian damage: prospective randomized study. Fertil Steril, 2009, 91(3): 694-697.
14. Kletter GB, Klein KO, Wang YY. A Pediatrician’s guide to central precocious puberty. Clin Pediatr (Phila), 2015, 54(5): 414-424.
15. Willemsen RH, Elleri D, Williams RM, et al. Pros and cons of GnRHa treatment for early puberty in girls. Nat Rev Endocrinol, 2014, 10(6): 352-363.
16. 赵岫, 张琴. 来曲唑治疗特发性中枢性性早熟男童的临床观察. 中国当代儿科杂志, 2014, 16(4): 397-400.
17. 中华医学会儿科学分会内分泌遗传代谢学组, 《中华儿科杂志》编辑委员会. 中枢性性早熟诊断与治疗共识(2015). 中华儿科杂志, 2015, 53(6): 412-418.
18. Carel JC, Eugster EA, Rogol A, et al. Consensus statement on the use of gonadotropin-releasing hormone analogs in children. Pediatrics, 2009, 123(4): e752-e762.
19. Chishoem A. Exploring UK attitudes towards unlicensed medicines use: a questionnaire-based study of menbers of the general public and physicians. Int J Gen Med, 2012, 5: 27-40.
20. 国家食品药品监督管理局. 药品说明书和标签管理规定(局令第 24 号). (2006-03-15)[2016-03-30]. http://www.sda.gov. cn/WS01/CL0053/24522.html.
21. 唐蕾, 韦炳华, 何秋毅, 等. 超说明书用药的现状及其法律风险. 中国药房, 2014, 25(45): 4225-4228.
22. 张钰莹, 于丽. 超说明书用药理与法的考量. 中国处方药, 2010, 103(3): 71-72.
23. 张伶俐, 李幼平, 曾力楠, 等. 15 国超说明书用药政策的循证评价. 中国循证医学杂志, 2012, 12(4): 426-435.
24. Aguggia M, Cavallini M, Varetto L. Medical-legal issues in headache: penal and civil Italian legislation, working claims, social security, off-label prescription. Neurol Sci, 2006, 27(Suppl 2): S198-S202.
25. Kendall M, Enringt D. An agenda for UK clinical pharmacology provision of medicine information: the example of the British National Formulary. Br J Clin Pharmacol, 2012, 73(6): 934-938.

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