Hardcastle J D, Chamberlain J O, Robinson M H, Moss S M, Amar S S, Balfour T W, James P D, Mangham C M
Department of Surgery, University Hospital, Queen's Medical Centre, Nottingham, UK.
Lancet. 1996 Nov 30;348(9040):1472-7. doi: 10.1016/S0140-6736(96)03386-7.
There is growing evidence that faecal-occult-blood (FOB) screening may reduce colorectal cancer (CRC) mortality, but this reduction in CRC mortality has not been shown in an unselected population-based randomised controlled trial. The aim of this study was to assess the effect of FOB screening on CRC mortality in such a setting.
Between February, 1981, and January, 1991, 152,850 people aged 45-74 years who lived in the Nottingham area of the UK were recruited to our study. Participants were randomly allocated FOB screening (76,466) or no screening (controls; 76,384). Controls were not told about the study and received no intervention. Screening-group participants were sent a Haemoccult FOB test kit with instructions from their family doctor. FOB tests were not rehydrated and dietary restrictions were imposed only for retesting borderline results. Individuals with negative FOB tests at the first screening, together with those who tested positive but in whom no neoplasia was found on colonoscopy, were invited to take part in further screening every 2 years. Screening was stopped in February, 1995, by which time screening-group participants had been offered FOB tests between three and six times. Screening-group participants who had a positive test were offered full colonoscopy. All participants were followed up until June, 1995. The primary outcome measure was CRC mortality.
Of the 152,850 individuals recruited to the study, 2599 could not be traced or had emigrated and were excluded from the analysis. Thus, there were 75,253 participants in the screening group and 74,998 controls. 44,838 (59.6%) screening-group participants completed at least one screening. 28,720 (38.2%) of these individuals completed all the FOB tests they were offered and 16,118 (21.4%) completed at least one screening but not all the tests they were offered. 30,415 (40.4%) did not complete any test. Of 893 cancers (20% stage A) diagnosed in screening-group participants (CRC incidence of 1.49 per 1000 person-years), 236 (26.4%) were detected by FOB screening, 249 (27.9%) presented after a negative FOB test or investigation, and 400 (44.8%) presented in non-responders. The incidence of cancer in the control group (856 cases, 11% stage A) was 1.44 per 1000 person-years. Median follow-up was 7.8 years (range 4.5-14.5). 360 people died from CRC in the screening group compared with 420 in the control group-a 15% reduction in cumulative CRC mortality in the screening group (odds ratio=0.85 [95%; CI 0.74-0.98], p = 0.026).
Our findings together with evidence from other trials suggest that consideration should be given to a national programme of FOB screening to reduce CRC mortality in the general population.
越来越多的证据表明，粪便潜血（FOB）筛查可能降低结直肠癌（CRC）死亡率，但在一项基于未选择人群的随机对照试验中，尚未证实这种CRC死亡率的降低。本研究的目的是评估在这种情况下FOB筛查对CRC死亡率的影响。
1981年2月至1991年1月期间，招募了居住在英国诺丁汉地区的152,850名45 - 74岁的人参与我们的研究。参与者被随机分配接受FOB筛查（76,466人）或不接受筛查（对照组；76,384人）。对照组未被告知该研究，也未接受任何干预。筛查组的参与者从他们的家庭医生那里收到一个隐血FOB检测试剂盒及说明书。FOB检测不进行复水，仅在重新检测临界结果时实行饮食限制。首次筛查FOB检测结果为阴性的个体，以及检测结果为阳性但结肠镜检查未发现肿瘤的个体，被邀请每2年参加一次进一步筛查。1995年2月停止筛查，此时筛查组的参与者已接受了三到六次FOB检测。检测结果为阳性的筛查组参与者接受了全结肠镜检查。所有参与者随访至1995年6月。主要结局指标是CRC死亡率。
在招募到该研究中的152,850名个体中，2599人无法追踪或已移民，被排除在分析之外。因此，筛查组有75,253名参与者，对照组有74,998名。44,838名（59.6%）筛查组参与者完成了至少一次筛查。其中28,720名（38.2%）个体完成了他们所接受的所有FOB检测，16,118名（21.4%）完成了至少一次筛查但未完成所有所接受的检测。30,415名（40.4%）未完成任何检测。在筛查组参与者中诊断出893例癌症（20%为A期）（CRC发病率为每1000人年1.49例），其中236例（26.4%）通过FOB筛查检测到，249例（27.9%）在FOB检测或检查结果为阴性后出现，400例（44.8%）在未响应者中出现。对照组的癌症发病率（856例，11%为A期）为每1000人年1.44例。中位随访时间为7.8年（范围4.5 - 14.5年）。筛查组有360人死于CRC，而对照组有420人——筛查组的累积CRC死亡率降低了15%（比值比 = 0.85 [95%；置信区间0.74 - 0.98]，p = 0.026）。
我们的研究结果以及其他试验的证据表明，应考虑实施全国性的FOB筛查计划，以降低普通人群中的CRC死亡率。
