大肠癌序贯筛检方案在人群中应用的前瞻性评估

Randomized controlled trial of sequence mass screening program for colorectal cancer

目的 建立并验证大肠癌序贯筛检方案在我国人群中应用的效果。方法 以大肠癌高发区嘉善县 1989年 30岁及以上者作为目标人群 ,采用随机分组空白对照研究设计 ,以免疫法粪便潜血试验结合个体危险度隶属度函数 (AD值 )为初筛手段 ,纤维肠镜为复筛的序贯筛检方案。结果经筛检后筛检人群与对照人群的大肠癌 8年累积发病率分别为 3.95‰ (95 %CI为 3.81～ 4.10 )和4.0 1‰ (95 %CI为 3 .86～ 4.16 ) ,两者差异无显著性 ;而大肠癌的累积死亡率则分别为 2 .0 8‰ (95 %CI为 1.96～ 2 .18)和 2 .44‰ (95 %CI为 2 .33～ 2 .5 5 ) ,筛检人群较对照人群约下降了 15 %左右。其中直肠癌累积死亡率下降达 31% ,经生存分析筛检区直肠癌的生存率显著高于对照区 (log rank =9.0 1,P =0 .0 0 2 7)。结论 粪便潜血试验和个体危险度AD值的序贯筛检方案在人群中实施 。

Objective In order to assess the effectiveness of mass screening program for colorectal cancer, a sequence mass screening program based on RPHA FOBT and individual quantitative risk assessment model (attributive degree value, AD) was used and evaluated on its effectiveness in a randomized controlled trial. Methods The residents of Jiashan county aged 30 years and over were randomized to either screening or control groups in 1989. Participants in screening group were asked to fill in a questionnaire and to submit one paper slide with stool. Participants who tested positive underwent diagnostic evaluations including flexible sigmiodscopy and colonoscopy. Results According to the cancer registry of Jiashan, after initial mass screening in 1989, the 8 year cumulative incidence per 1 000 of colorectal cancer in screening and control groups appeared to be 3.95 ( 95%CI 3.81 4.10 ) and 4.01 (95% CI 3.86 4.16 ) respectively. There was no significant statistieal difference between two groups ( P > 0.05 ). Nevertheless, the 8 year cumulative mortality for colorectal cancer in screening group ( 2.08 per 1 000 ; 95%CI 1.96 2.18 ) was reduced 14.7 % comparing with the control group ( 2.44 per 1 000 ; 95%CI 2.33 2.55 ). In particular, the cumulative mortality of rectal cancer was significantly ( 31.7 %) lower than that in control group. Log rank test showed that survival rate of rectal cancer in screening group was higher than that in controls (log rank= 9.01 , P = 0.002 7 ). Conclusions The sequential mass screening program which based on RPHA FOBT and ADV might reduce the mortality for colorectal cancer in the Chinese population.