乳房植入体产品的临床试验及上市后临床随访_West China Medical Journal

Authors：

赵鹏 ,  史新立 , 刘文博

Corresponding author：

史新立, Email: 163zhaopeng@163.com

Keywords：

乳房植入体; 人工乳房; 整形; 硅橡胶; 硅凝胶; 注册申报; 临床试验设计; 上市后临床随访

Video：

Export PDF Favorites Scan Get Citation

Abstract Full text Figures/Tables Video References Cited by

乳房植入体作为植入性整形医疗器械，其安全性和有效性直接影响着受术者的生活质量，是国家重点监管的医疗器械品种之一，注册申报时需提交规范的临床试验资料以支持其安全性和有效性。此类产品临床试验持续时间较长，需收集的数据内容较多，对于此类产品如何进行科学的临床试验设计，如何选择合理的临床评价标准，如何按照不同的产品适应证界定临床试验单元，如何对临床数据进行充分的分析，以及对于已上市的产品如何进行临床随访数据的收集，是企业和临床试验机构共同关注的问题。

Citation： 赵鹏,史新立,刘文博. 乳房植入体产品的临床试验及上市后临床随访. West China Medical Journal, 2012, 27(9): 1421-1426. doi: Copy

1.	国家食品药品监督管理局. 《医疗器械注册管理办法》（局令第16号）[EB/OL]. (2004-08-09)[2012-07-30]. http://www.sda.gov.cn/WS01/CL0053/25844.html.
2.	国家食品药品监督管理局. 《医疗器械临床试验规定》（局令第5号）[EB/OL]. (2004-01-17) [2012-07-30]. http://www.sda.gov.cn/WS01/CL0053/24475.html.
3.	国家食品药品监督管理局. 无源植入性医疗器械产品注册申报资料指导原则[EB/OL]. (2009-12-30) [2012-07-30]. http://www.sda.gov.cn/WS01/CL0274/59893.html.
4.	国家食品药品监督管理局. 乳房植入体产品注册技术审查指导原则[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. 　国家食品药品监督管理局. 《医疗器械注册管理办法》（局令第16号）[EB/OL]. (2004-08-09)[2012-07-30]. http://www.sda.gov.cn/WS01/CL0053/25844.html.
2. 　国家食品药品监督管理局. 《医疗器械临床试验规定》（局令第5号）[EB/OL]. (2004-01-17) [2012-07-30]. http://www.sda.gov.cn/WS01/CL0053/24475.html.
3. 　国家食品药品监督管理局. 无源植入性医疗器械产品注册申报资料指导原则[EB/OL]. (2009-12-30) [2012-07-30]. http://www.sda.gov.cn/WS01/CL0274/59893.html.
4. 　国家食品药品监督管理局. 乳房植入体产品注册技术审查指导原则[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.

West China Medical Journal

乳房植入体产品的临床试验及上市后临床随访

Abstract Full text Figures/Tables Video References Cited by

Format

Content