用大数据还原宫颈癌腹腔镜手术的真相:需要中国的声音
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摘要
<正>2018年妇科内镜界发生了一件大事,或者说宫颈癌治疗领域发生了一件大事,就是两个同期发表于《新英格兰医学杂志》临床研究结果都认为宫颈癌腹腔镜手术与经典的开腹手术相比,病死率更高、复发率更高、生存率更低。文章颠覆了NCCN指南、FIGO指南、EMSO指南等多个指南中推荐的腹腔镜技术可用于早期宫颈癌手术治疗的建议。在国际妇科肿瘤学界引起巨大反响,质疑声四起。尤其在中国引起的反响更大,质疑声更为强烈,究其原因有二:第一,中国是宫颈癌大国,
引文
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[6]李红.腹腔镜下子宫颈癌根治术2例报告[J].中国现代医学杂志,2003,13(3):108-109.
[7] Choi CH,Lee JW,Lee YY,et al.Comparison of laparoscopic-assisted radical vaginal hysterectomy and laparoscopic radical hysterectomy in the treatment of cervical cancer[J].Ann Surg Oncol,2012,19(12):3839-3848.
[8] Lin F,Pan L,Li L,et al.Effects of a simulated CO2pneumoperitoneum environment on the proliferation,apoptosis,and metastasis of cervical cancer cells in vitro[J].Med Sci Monit,2014,20:2497-2503.
[9] Besselink MG,van Santvoort HC,Buskens E,et al. Probiotic prophylaxis in predicted severe acute pancreatitis:a randomised,double-blind,placebo-controlled trial[J].Lancet,2008,371(9613):651-659.
[10] Mcclave SA,Heyland DK,Wischmeyer PE.Comment on:probiotic prophylaxis in predicted severe acute pancreatitis:a randomized,double-blind,placebo-controlled trial[J].JPEN J Parenter Enteral Nutr,2009,33(4):444-446.
[11]陈春林.中国宫颈癌临床诊疗与大数据[J].中国实用妇科与产科杂志,2018,34(1):25-29.
[12]陈春林,李朋飞.从中国宫颈癌真实世界研究临床大数据看宫颈癌术前化疗存在的问题和对策[J].中国实用妇科与产科杂志,2018,34(11):1185-1189.
[2] Melamed A,Margul DJ,Chen L,et al.Survival after minimally invasive radical hysterectomy for early-stage cervical cancer[J].N Engl J Med,2018.DOI:10.1056/NEJMoa1804923.
[3] Sherman RE,Anderson SA,Dal Pan GJ,et al.Real-world evidence-what is it and what can it Tell Us?[J].N Engl J Med,2016,375(23):2293-2297.
[4] Food and Drug Administration. Use of real-world evidence to supportregulatory decision-making for medical devices:draft guidance for industry and Food and Drug Administration staff[EB/OL].http://www.fda.gov/downloads/Medical Devices/Device RegulationandGuidance/Guidance Documents/UCM513027.pdf.2016.
[5] Nezhat CR,Burrell MO,Nezhat FR,et al.Laparoscopic radical hysterectomy with paraaortic and pelvic node dissection[J].Am J Obstet Gynecol,1992,166(3):864-865.
[6]李红.腹腔镜下子宫颈癌根治术2例报告[J].中国现代医学杂志,2003,13(3):108-109.
[7] Choi CH,Lee JW,Lee YY,et al.Comparison of laparoscopic-assisted radical vaginal hysterectomy and laparoscopic radical hysterectomy in the treatment of cervical cancer[J].Ann Surg Oncol,2012,19(12):3839-3848.
[8] Lin F,Pan L,Li L,et al.Effects of a simulated CO2pneumoperitoneum environment on the proliferation,apoptosis,and metastasis of cervical cancer cells in vitro[J].Med Sci Monit,2014,20:2497-2503.
[9] Besselink MG,van Santvoort HC,Buskens E,et al. Probiotic prophylaxis in predicted severe acute pancreatitis:a randomised,double-blind,placebo-controlled trial[J].Lancet,2008,371(9613):651-659.
[10] Mcclave SA,Heyland DK,Wischmeyer PE.Comment on:probiotic prophylaxis in predicted severe acute pancreatitis:a randomized,double-blind,placebo-controlled trial[J].JPEN J Parenter Enteral Nutr,2009,33(4):444-446.
[11]陈春林.中国宫颈癌临床诊疗与大数据[J].中国实用妇科与产科杂志,2018,34(1):25-29.
[12]陈春林,李朋飞.从中国宫颈癌真实世界研究临床大数据看宫颈癌术前化疗存在的问题和对策[J].中国实用妇科与产科杂志,2018,34(11):1185-1189.