论文部分内容阅读
背景结肠直肠癌是居世界第3位的癌症,且病死率高。本研究对55~64岁患者进行软式乙状结肠镜单筛查可减少结肠直肠癌发病率和病死率的假说进行检验。方法英国14家中心随机对照试验。将回馈的调查问卷表明愿意接受筛查邀请的170 432例男、女性受试者随机分组:干预组(做软式乙状结肠镜筛查)和对照组。对12个街区中心用序列号生成随机化,用试验中心、开业医生、家庭类型层化。主要结果为结肠直肠癌发生率,包括筛查时发现患病病例和结肠直肠癌病死率。做意向治疗分析和完成治疗分析。发现对照组113 195例,干预组57 237例,分别有112 939例和57 099例受试者进入最后分析。40 674例(71%)做了软式乙状结肠镜检查。筛查和跟踪中位时间11.2年(IQR 10.7~11.9)中,有2 524受试者诊断为结肠直肠癌(对照组1 818例,干预组706例)及20 543例死亡(13 768例和6 775例;727例证实死于结肠直肠癌)。意向治疗分析,干预组结肠直肠癌发生率减少23%,病死率减少31%。完成治疗(PP)分析,干预组校正自我选择偏倚,经筛查后结肠直肠癌发病率减少33%,病死率减少43%。远端结肠直肠癌(直肠和乙状结肠)减少50%(次级结果)。至研究末,为预防某结肠直肠癌诊断或死亡,需做筛查的数目分别为191和489。解释对55~64岁者采用软式乙状结肠镜单筛查是安全和实用的方法,也是获益的重要和长效途径。
Background Colorectal cancer is the third most cancer in the world and has a high case fatality rate. This study examined the hypothesis that soft sigmoidoscopy alone in 55-64-year-old patients reduced colorectal cancer morbidity and mortality. Methods 14 centers in the United Kingdom randomized controlled trials. The questionnaire to be fed back showed that a total of 170,432 male and female subjects who were willing to accept the screening invitation were randomly assigned to intervention group (screening with soft sigmoidoscopy) and control group. Generate randomization for serial number of 12 block centers, stratification by experiment center, doctor, family type. The main outcome is the incidence of colorectal cancer, including the prevalence of cases and colorectal cancer mortality at screening. Intent to do the analysis and treatment analysis. 113 195 cases in the control group and 57 237 cases in the intervention group were found, with 112 939 cases and 57 099 cases respectively entering into the final analysis. 40 674 (71%) performed flexible sigmoidoscopy. Of the 12.24 years (IQR 10.7 to 11.9) who were screened and followed up, 2 524 subjects were diagnosed with colorectal cancer (control group, 1818 interventions, 706 interventions) and 20 543 deaths (13 768 and 6 775 cases; 727 confirmed death from colorectal cancer). Intent-to-treat analysis showed that the incidence of colorectal cancer in the intervention group decreased by 23% and the mortality rate decreased by 31%. Completion of treatment (PP) analysis, intervention group corrected self-selection bias, after screening, the incidence of colorectal cancer decreased by 33%, the mortality rate decreased by 43%. Distal colorectal cancer (rectum and sigmoid colon) reduced by 50% (secondary outcome). To the end of the study, the number of screening required to prevent the diagnosis or death of a colorectal cancer was 191 and 489, respectively. Interpretation A single screen for flexible sigmoidoscopy for 55-64 years is a safe and practical way to benefit, as well as an important and long-term benefit.