乳房植入體產品的臨床試驗及上市后臨床隨訪_《華西醫學》

作者：

趙鵬 ,  史新立 , 劉文博

國家食品藥品監督管理局醫療器械技術審評中心（北京，100044）;

關鍵詞：

乳房植入體人工乳房整形硅橡膠硅凝膠注冊申報臨床試驗設計上市后臨床隨訪

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乳房植入體作為植入性整形醫療器械，其安全性和有效性直接影響著受術者的生活質量，是國家重點監管的醫療器械品種之一，注冊申報時需提交規范的臨床試驗資料以支持其安全性和有效性。此類產品臨床試驗持續時間較長，需收集的數據內容較多，對于此類產品如何進行科學的臨床試驗設計，如何選擇合理的臨床評價標準，如何按照不同的產品適應證界定臨床試驗單元，如何對臨床數據進行充分的分析，以及對于已上市的產品如何進行臨床隨訪數據的收集，是企業和臨床試驗機構共同關注的問題。

引用本文： 趙鵬,史新立,劉文博. 乳房植入體產品的臨床試驗及上市后臨床隨訪. 華西醫學, 2012, 27(9): 1421-1426. doi: 復制

1.	國家食品藥品監督管理局. 《醫療器械注冊管理辦法》（局令第16號）[EB/OL]. (2004-08-09)[2012-07-30]. http://www.sda.gov.cn/WS01/CL0053/25844.html.
2.	國家食品藥品監督管理局. 《醫療器械臨床試驗規定》（局令第5號）[EB/OL]. (2004-01-17) [2012-07-30]. http://www.sda.gov.cn/WS01/CL0053/24475.html.
3.	國家食品藥品監督管理局. 無源植入性醫療器械產品注冊申報資料指導原則[EB/OL]. (2009-12-30) [2012-07-30]. http://www.sda.gov.cn/WS01/CL0274/59893.html.
4.	國家食品藥品監督管理局. 乳房植入體產品注冊技術審查指導原則[EB/OL]. (2011-03-24) [2012-07-30]. http://www.sda.gov.cn/WS01/CL0274/60443.html.
5.	FDA. Guidance for industry and FDA staff saline, silicone gel, and alternative breast implants[EB/OL]. (2006-11-17) [2012-07-30]. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071233.pdf.
6.	Gampper TJ, Khoury H, Gottlieb W, et al. Silicone gel implants in breast augmentation and reconstruction[J]. Ann Plast Surg, 2007, 59(5): 581-590.
7.	Kreymerman P, Patrick RJ, Rim A, et al. Guideline for using breast magnetic resonance imaging to evaluate implant integrity[J]. Ann Plast Surg, 2009, 62(4): 355-357.
8.	Bondurant S, Ernster V, Herdman R. Safety of silicone breast implants[M]. Washington, D.C: National Academy Press, 2000: 114-178.
9.	Hölmich LR, Fryzek JP, Kjøller K, et al. The diagnosis of silicone breast-implant rupture: clinical findings compared with findings at magnetic resonance imaging[J]. Ann Plast Surg, 2005, 54(6): 583-589.
10.	Hölmich LR, Vejborg I, Conrad C, et al. The diagnosis of breast implant rupture: MRI findings compared to findings at explantation[J]. Eur J Radiol, 2005, 53(2): 213-225.
11.	Rosenberg M, Dobson, Siber. Society and the adolescent self-image[M]. Princeton NJ: Princeton University Press, 1979: 84-85.
12.	Fitts W. Tennessee Self-Concept Scale: Manual[M]. Los Angeles, CA: Western Psychological Services, 1988: 1-168.
13.	Franzoi SL, Shields SA. The Body Esteem Scale: multidimensional structure and sex differences in a college population[J]. J Pers Assess, 1984, 48(2): 173-178.
14.	Ware JE, Snow KK, Kosinski M, et al. SF-36 health survey: manual and interpretation guide[M]. Boston, MA: The Health Institute, New England Medical Center, 1993: 1-12.
15.	Stewart AL, Hays RD, Ware JE Jr. The MOS Short-Form General Health Survey. Reliability and validity in a patient population[J]. Med Care, 1988, 26(7): 724-735.

1. 　國家食品藥品監督管理局. 《醫療器械注冊管理辦法》（局令第16號）[EB/OL]. (2004-08-09)[2012-07-30]. http://www.sda.gov.cn/WS01/CL0053/25844.html.
2. 　國家食品藥品監督管理局. 《醫療器械臨床試驗規定》（局令第5號）[EB/OL]. (2004-01-17) [2012-07-30]. http://www.sda.gov.cn/WS01/CL0053/24475.html.
3. 　國家食品藥品監督管理局. 無源植入性醫療器械產品注冊申報資料指導原則[EB/OL]. (2009-12-30) [2012-07-30]. http://www.sda.gov.cn/WS01/CL0274/59893.html.
4. 　國家食品藥品監督管理局. 乳房植入體產品注冊技術審查指導原則[EB/OL]. (2011-03-24) [2012-07-30]. http://www.sda.gov.cn/WS01/CL0274/60443.html.
5. 　FDA. Guidance for industry and FDA staff saline, silicone gel, and alternative breast implants[EB/OL]. (2006-11-17) [2012-07-30]. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071233.pdf.
6. 　Gampper TJ, Khoury H, Gottlieb W, et al. Silicone gel implants in breast augmentation and reconstruction[J]. Ann Plast Surg, 2007, 59(5): 581-590.
7. 　Kreymerman P, Patrick RJ, Rim A, et al. Guideline for using breast magnetic resonance imaging to evaluate implant integrity[J]. Ann Plast Surg, 2009, 62(4): 355-357.
8. 　Bondurant S, Ernster V, Herdman R. Safety of silicone breast implants[M]. Washington, D.C: National Academy Press, 2000: 114-178.
9. 　Hölmich LR, Fryzek JP, Kjøller K, et al. The diagnosis of silicone breast-implant rupture: clinical findings compared with findings at magnetic resonance imaging[J]. Ann Plast Surg, 2005, 54(6): 583-589.
10. 　Hölmich LR, Vejborg I, Conrad C, et al. The diagnosis of breast implant rupture: MRI findings compared to findings at explantation[J]. Eur J Radiol, 2005, 53(2): 213-225.
11. 　Rosenberg M, Dobson, Siber. Society and the adolescent self-image[M]. Princeton NJ: Princeton University Press, 1979: 84-85.
12. 　Fitts W. Tennessee Self-Concept Scale: Manual[M]. Los Angeles, CA: Western Psychological Services, 1988: 1-168.
13. 　Franzoi SL, Shields SA. The Body Esteem Scale: multidimensional structure and sex differences in a college population[J]. J Pers Assess, 1984, 48(2): 173-178.
14. 　Ware JE, Snow KK, Kosinski M, et al. SF-36 health survey: manual and interpretation guide[M]. Boston, MA: The Health Institute, New England Medical Center, 1993: 1-12.
15. 　Stewart AL, Hays RD, Ware JE Jr. The MOS Short-Form General Health Survey. Reliability and validity in a patient population[J]. Med Care, 1988, 26(7): 724-735.

《華西醫學》

乳房植入體產品的臨床試驗及上市后臨床隨訪

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《華西醫學》

乳房植入體產品的臨床試驗及上市后臨床隨訪

摘要 全文 圖表 視頻 參考文獻 施引文獻 補充材料

Format

Content

摘要全文圖表視頻參考文獻施引文獻補充材料