2019 你必须掌握的抗癌编年史
2019/2/26 19:55:00 丁香园
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长度537厘米
阅读约6分钟
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文末附独家医学彩蛋
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注:
1. 肿瘤电场治疗(TTFields)已在美国、欧洲、日本、中国香港等地区上市用于治疗胶质母细胞瘤(GBM),但目前尚未在中国大陆上市;
2. 文中出现的数据和文献资料均由再鼎医药提供支持;
3. 关于美国FDA医疗器械审评标准“上市前审批(PMA, premarket approval)”(来自FDA官网):PMA,即上市前审批,是FDA要求最严格的医疗器械上市申请方式,医疗器械上市前必须获得FDA对其PMA申请的批准。只有当FDA认为PMA申请中包含了充分有效的科学证据、能确保医疗器械的安全性和有效性,才会批准PMA申请。
参考文献:
[1]Smith, A. D. (2018). Tumor-Treating Field Therapy Looks Beyond Brain Cancer. OncologyLive, 19(15).
[2]Miller, J. (2007). Electric fields have potential as a cancer treatment. Physics Today, 60(8), 19-20. doi:10.1063/1.2774085
[3]Gutin PH, Wong ET. Am Soc Clin Oncol Educ Book. 2012;32:126-131.
[4]Premarket Approval (PMA). (2019, February 18). Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=p100034
[5]Premarket Approval (PMA). (2019, February 18). Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100034S013
[6]National Comprehensive Cancer Network. Central Nervous System Cancers (Version 1.2013).
[7]National Comprehensive Cancer Network. Central Nervous System Cancers (Version 1.2018).
[8]《脑胶质瘤诊疗规范(2018年版)》Retrieved from https://www.91360.com/201812/76/1093.html
[9]Stupp, R., Taillibert, S., Kanner, A., Read, W., Steinberg, D. M., Lhermitte, B., … Ram, Z. (2017). Effect of Tumor-Treating Fields Plus Maintenance Temozolomide vs Maintenance Temozolomide Alone on Survival in Patients With Glioblastoma. JAMA, 318(23), 2306. doi:10.1001/jama.2017.18718
[10]Toms, S. A., Kim, C. Y., Nicholas, G., & Ram, Z. (2018). Increased compliance with tumor treating fields therapy is prognostic for improved survival in the treatment of glioblastoma: a subgroup analysis of the EF-14 phase III trial. Journal of Neuro-Oncology, 141(2), 467-473. doi:10.1007/s11060-018-03057-z
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