Iscoe N A, Naylor C D, Williams J I, DeBoer G, Morgan M W, Fehringer G, Holowaty E
Toronto Bayview Regional Cancer Centre, Ontario Cancer Treatment and Research Foundation.
CMAJ. 1994 Apr 1;150(7):1109-15.
To assess the effect of a single randomized clinical trial, the National Surgical Adjuvant Breast Project (NSABP) B-06, on the surgical management of breast cancer in women.
Retrospective cohort study.
All hospitals in Ontario.
A consecutive sample of 37,447 women with breast cancer newly diagnosed from Jan. 1, 1980, to Dec. 31, 1989, linked to a surgical procedure record in the Ontario Cancer Registry.
The most invasive surgical procedure used within 90 days of diagnosis.
Unilateral breast-ablative surgery (BAS) was performed in 57.3% of the women and breast-conserving surgery (BCS) in 31.6%. The annual rate of BAS declined from 77.5% in 1980 to 44.2% in 1989 and the rate of BCS rose from 12.5% in 1980 to 43.5% in 1989. The decline was linear from 1980 to 1984 and then accelerated significantly in 1985 (p < 0.0001), after the results of the NSABP B-06 trial were published.
One randomized clinical trial can have an immediate and profound effect on medical practice.
评估一项单一随机临床试验——国家乳腺癌辅助治疗项目(NSABP)B - 06对女性乳腺癌手术治疗的影响。
回顾性队列研究。
安大略省所有医院。
选取1980年1月1日至1989年12月31日期间新诊断出乳腺癌的37447名女性的连续样本,这些样本与安大略癌症登记处的手术记录相关联。
诊断后90天内采用的最具侵入性的手术方式。
57.3%的女性接受了单侧乳房切除术(BAS),31.6%的女性接受了保乳手术(BCS)。BAS的年发生率从1980年的77.5%降至1989年的44.2%,BCS的发生率从1980年的12.5%升至1989年的43.5%。1980年至1984年呈线性下降,在NSABP B - 06试验结果公布后的1985年下降显著加速(p < 0.0001)。
一项随机临床试验可对医疗实践产生即时且深远的影响。