激素類抗腫瘤藥物的超說明書用藥進展_West China Medical Journal

Authors：

尹茜 , 占美 , 張瑩 ,  徐珽

四川大學華西醫院臨床藥學部（藥劑科）（成都? 610041）;

Corresponding?author：

徐珽, Email: tingx2009@163.com

Keywords：

激素類抗腫瘤藥物; 超說明書用藥; 促排卵; 乳腺增生; 卵巢保護; 他莫西芬

DOI：

10.7507/1002-0179.201603080

Video：

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激素類抗腫瘤藥物包括雌激素、孕激素、雄激素及其拮抗劑，其作用機制決定了此類藥物不僅可以在抗腫瘤治療中發揮作用，也可以在其他一些激素相關的疾病中達到良好的治療效果，而藥品說明書往往落后于臨床實際，從而導致了一些超說明書用藥情況的發生。該文就激素類抗腫瘤藥物在臨床應用已較為廣泛的促排卵治療、乳腺增生、卵巢保護、中樞性性早熟等的超說明書用藥情況進行了綜述。

Citation： 尹茜, 占美, 張瑩, 徐珽. 激素類抗腫瘤藥物的超說明書用藥進展. West China Medical Journal, 2017, 32(11): 1818-1820. doi: 10.7507/1002-0179.201603080 Copy

1.	中國藥理學會治療藥物監測研究專業委員會藥品風險管理學組. 超說明書用藥專家共識. 藥物不良反應雜志, 2015, 17(2): 101-102.
2.	中華醫學會生殖醫學分會. 輔助生殖促排卵藥物治療專家共識. 生殖與避孕, 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, 錢衛平, 李蓉, 等. 來曲唑微刺激促排卵方案在卵巢反應低下患者的臨床應用探討. 華西醫學, 2015, 30(3): 502-504.
7.	肖勁松, 陳雙隕, 張春蓮. 來曲唑促排卵治療有效性的系統性評價. 中國循證醫學雜志, 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.	王曉東, 陳玉娟, 金顯峰, 等. 枸櫞酸他莫昔芬片與中成藥在乳腺良性增生的近期療效對比. 華西醫學, 2011, 26(7): 1082-1083.
10.	中華預防醫學會婦女保健分會乳腺保健與疾病防治學組. 乳腺增生癥的診治共識(討論稿). (2013-03-18)[2017-09-28]. http://www.ccmtv.cn/article/1280/12226.html.
11.	鄒群, 童曉文. 比較托瑞米芬與他莫西芬治療絕經前中重度乳腺增生癥的療效觀察. 外科理論與實踐, 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.	趙岫, 張琴. 來曲唑治療特發性中樞性性早熟男童的臨床觀察. 中國當代兒科雜志, 2014, 16(4): 397-400.
17.	中華醫學會兒科學分會內分泌遺傳代謝學組, 《中華兒科雜志》編輯委員會. 中樞性性早熟診斷與治療共識(2015). 中華兒科雜志, 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.	國家食品藥品監督管理局. 藥品說明書和標簽管理規定(局令第 24 號). (2006-03-15)[2016-03-30]. http://www.sda.gov. cn/WS01/CL0053/24522.html.
21.	唐蕾, 韋炳華, 何秋毅, 等. 超說明書用藥的現狀及其法律風險. 中國藥房, 2014, 25(45): 4225-4228.
22.	張鈺瑩, 于麗. 超說明書用藥理與法的考量. 中國處方藥, 2010, 103(3): 71-72.
23.	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.
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. 中國藥理學會治療藥物監測研究專業委員會藥品風險管理學組. 超說明書用藥專家共識. 藥物不良反應雜志, 2015, 17(2): 101-102.
2. 中華醫學會生殖醫學分會. 輔助生殖促排卵藥物治療專家共識. 生殖與避孕, 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, 錢衛平, 李蓉, 等. 來曲唑微刺激促排卵方案在卵巢反應低下患者的臨床應用探討. 華西醫學, 2015, 30(3): 502-504.
7. 肖勁松, 陳雙隕, 張春蓮. 來曲唑促排卵治療有效性的系統性評價. 中國循證醫學雜志, 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. 王曉東, 陳玉娟, 金顯峰, 等. 枸櫞酸他莫昔芬片與中成藥在乳腺良性增生的近期療效對比. 華西醫學, 2011, 26(7): 1082-1083.
10. 中華預防醫學會婦女保健分會乳腺保健與疾病防治學組. 乳腺增生癥的診治共識(討論稿). (2013-03-18)[2017-09-28]. http://www.ccmtv.cn/article/1280/12226.html.
11. 鄒群, 童曉文. 比較托瑞米芬與他莫西芬治療絕經前中重度乳腺增生癥的療效觀察. 外科理論與實踐, 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. 趙岫, 張琴. 來曲唑治療特發性中樞性性早熟男童的臨床觀察. 中國當代兒科雜志, 2014, 16(4): 397-400.
17. 中華醫學會兒科學分會內分泌遺傳代謝學組, 《中華兒科雜志》編輯委員會. 中樞性性早熟診斷與治療共識(2015). 中華兒科雜志, 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. 國家食品藥品監督管理局. 藥品說明書和標簽管理規定(局令第 24 號). (2006-03-15)[2016-03-30]. http://www.sda.gov. cn/WS01/CL0053/24522.html.
21. 唐蕾, 韋炳華, 何秋毅, 等. 超說明書用藥的現狀及其法律風險. 中國藥房, 2014, 25(45): 4225-4228.
22. 張鈺瑩, 于麗. 超說明書用藥理與法的考量. 中國處方藥, 2010, 103(3): 71-72.
23. 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.
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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