乳房植入體作為植入性整形醫(yī)療器械，其安全性和有效性直接影響著受術(shù)者的生活質(zhì)量，是國(guó)家重點(diǎn)監(jiān)管的醫(yī)療器械品種之一，注冊(cè)申報(bào)時(shí)需提交規(guī)范的臨床試驗(yàn)資料以支持其安全性和有效性。此類產(chǎn)品臨床試驗(yàn)持續(xù)時(shí)間較長(zhǎng)，需收集的數(shù)據(jù)內(nèi)容較多，對(duì)于此類產(chǎn)品如何進(jìn)行科學(xué)的臨床試驗(yàn)設(shè)計(jì)，如何選擇合理的臨床評(píng)價(jià)標(biāo)準(zhǔn)，如何按照不同的產(chǎn)品適應(yīng)證界定臨床試驗(yàn)單元，如何對(duì)臨床數(shù)據(jù)進(jìn)行充分的分析，以及對(duì)于已上市的產(chǎn)品如何進(jìn)行臨床隨訪數(shù)據(jù)的收集，是企業(yè)和臨床試驗(yàn)機(jī)構(gòu)共同關(guān)注的問題。
引用本文： 趙鵬,史新立,劉文博. 乳房植入體產(chǎn)品的臨床試驗(yàn)及上市后臨床隨訪. 華西醫(yī)學(xué), 2012, 27(9): 1421-1426. doi: 復(fù)制
| 1. | 國(guó)家食品藥品監(jiān)督管理局. 《醫(yī)療器械注冊(cè)管理辦法》（局令第16號(hào)）[EB/OL]. (2004-08-09)[2012-07-30]. http://www.sda.gov.cn/WS01/CL0053/25844.html. |
| 2. | 國(guó)家食品藥品監(jiān)督管理局. 《醫(yī)療器械臨床試驗(yàn)規(guī)定》（局令第5號(hào)）[EB/OL]. (2004-01-17) [2012-07-30]. http://www.sda.gov.cn/WS01/CL0053/24475.html. |
| 3. | 國(guó)家食品藥品監(jiān)督管理局. 無源植入性醫(yī)療器械產(chǎn)品注冊(cè)申報(bào)資料指導(dǎo)原則[EB/OL]. (2009-12-30) [2012-07-30]. http://www.sda.gov.cn/WS01/CL0274/59893.html. |
| 4. | 國(guó)家食品藥品監(jiān)督管理局. 乳房植入體產(chǎn)品注冊(cè)技術(shù)審查指導(dǎo)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(guó)家食品藥品監(jiān)督管理局. 《醫(yī)療器械注冊(cè)管理辦法》（局令第16號(hào)）[EB/OL]. (2004-08-09)[2012-07-30]. http://www.sda.gov.cn/WS01/CL0053/25844.html.
- 2. 國(guó)家食品藥品監(jiān)督管理局. 《醫(yī)療器械臨床試驗(yàn)規(guī)定》（局令第5號(hào)）[EB/OL]. (2004-01-17) [2012-07-30]. http://www.sda.gov.cn/WS01/CL0053/24475.html.
- 3. 國(guó)家食品藥品監(jiān)督管理局. 無源植入性醫(yī)療器械產(chǎn)品注冊(cè)申報(bào)資料指導(dǎo)原則[EB/OL]. (2009-12-30) [2012-07-30]. http://www.sda.gov.cn/WS01/CL0274/59893.html.
- 4. 國(guó)家食品藥品監(jiān)督管理局. 乳房植入體產(chǎn)品注冊(cè)技術(shù)審查指導(dǎo)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.