Kronborg O, Fenger C, Olsen J, Jørgensen O D, Søndergaard O
Department of Surgery A, Odense University Hospital, Denmark.
Lancet. 1996 Nov 30;348(9040):1467-71. doi: 10.1016/S0140-6736(96)03430-7.
Case-control studies and a voluntary-based follow-up study have suggested that repeated screening with faecal-occult-blood (FOB) tests can lead to a reduction in mortality from colorectal cancer (CRC). The aim of this randomised study was to compare mortality rates after FOB tests every 2 years during a 10-year period with those of unscreened similar controls.
140,000 people aged 45-75 years lived in Funen, Denmark, in August, 1985, and were considered for inclusion in our study. Before randomisation we excluded individuals who had CRC or precursor adenomas and those who had taken part in a previous pilot study. Randomisation of 137,485 people in blocks of 14 allocated three per 14 to the screening group (30,967), three per 14 to the control group (30,966), and eight not to be enrolled in the study (75,552). Controls were not told about the study and continued to use health-care facilities as normal. Hemoccult-II blood tests (with dietary restrictions but without rehydration) were sent to screening-group participants. Only those participants who completed the first screening round were invited for further screening--five rounds of screening during a 10-year period. Participants with positive tests were asked to attend to full examination and were offered colonoscopy whenever possible. The primary endpoint was death from CRC.
Of the 30,967 screening-group participants, 20,672 (67%) completed the first screening round and were invited for further screening; more than 90% accepted repeated screenings. During the 10-year study, 481 people in the screening group had a diagnosis of CRC, compared with 483 unscreened controls. There were 205 deaths attributable to CRC in the screening group, compared with 249 deaths in controls. CRC mortality, including deaths attributable to complications from CRC treatment, was significantly lower in the screening group than in controls (mortality ratio 0.82 [95% CI 0.68-0.99]) p = 0.03).
Our findings indicate that biennial screening by FOB tests can reduce CRC mortality. This study is being continued to improve its statistical power and to assess the effect of the removal of more precursor adenomas in the screening-group participants than in controls on CRC incidence.
病例对照研究以及一项基于自愿参与的随访研究表明，反复进行粪便潜血（FOB）检测可降低结直肠癌（CRC）的死亡率。这项随机研究的目的是比较在10年期间每2年进行一次FOB检测后的死亡率与未接受筛查的类似对照组的死亡率。
1985年8月，丹麦菲英岛有140000名年龄在45至75岁之间的人被纳入本研究的考虑范围。在随机分组之前，我们排除了患有CRC或癌前腺瘤的个体以及那些曾参与过先前试点研究的个体。对137485人按每14人一组进行随机分组，每14人中3人被分配到筛查组（30967人），3人被分配到对照组（30966人），8人不参与本研究（75552人）。对照组未被告知本研究情况，继续正常使用医疗保健设施。向筛查组参与者发送Hemoccult-II血液检测（有饮食限制但无复水）。只有那些完成第一轮筛查的参与者才被邀请进行进一步筛查——在10年期间进行5轮筛查。检测呈阳性的参与者被要求接受全面检查，并尽可能接受结肠镜检查。主要终点是死于CRC。
在30967名筛查组参与者中，20672人（67%）完成了第一轮筛查并被邀请进行进一步筛查；超过90%的人接受了反复筛查。在10年的研究期间，筛查组中有481人被诊断患有CRC，而未筛查的对照组中有483人。筛查组中有205人死于CRC，而对照组中有249人死亡。筛查组的CRC死亡率，包括因CRC治疗并发症导致的死亡，显著低于对照组（死亡率比0.82[95%CI 0.68 - 0.99]）（p = 0.03）。
我们的研究结果表明，通过FOB检测进行两年一次的筛查可降低CRC死亡率。本研究正在继续进行，以提高其统计效力，并评估与对照组相比，筛查组参与者切除更多癌前腺瘤对CRC发病率的影响。
