目的评价连续3轮次年度粪便免疫化学试验(FIT)在中国人群结直肠癌筛查中的参与率和结直肠病变检出情况。
方法基于2018年5月至2021年5月在全国6个中心开展的一项人群结直肠癌筛查研究,共纳入了7 793例50~74岁符合研究条件的受试者,为其提供免费的FIT检测和结肠镜检查(仅针对FIT初筛阳性者)。在基线时,所有受试者均受邀接受FIT筛查。在后续轮次筛查中,仅邀请FIT阳性但未接受结肠镜检查者或FIT阴性者进行重复FIT筛查。FIT阳性者推荐接受结肠镜和病理检查(如结肠镜下有异常发现)。研究共计开展了3轮次每年1次的FIT筛查,主要研究结局为FIT参与率、FIT阳性者的结肠镜检查参与率以及结直肠肿瘤的检出率。
结果7 793例受试者中男3 310人(42.5%),年龄为(60.50±6.49)岁。第1轮、第2轮和第3轮FIT筛查的参与率分别为94.0%(7 327/7 793)、86.8%(6 048/6 968)和91.3%(6 113/6 693)。在7 793例参与者中,99.3%(7 742/7 793)参加了至少1轮筛查,66.3%(5 163/7 793)参加了全部3轮筛查。第1轮筛查人群的FIT阳性率(14.6%,1 071/7 327)高于第2轮(5.6%,341/6 048)和第3轮(5.5%,339/6 113)筛查(均 P<0.001)。FIT阳性受试者结肠镜检查依从率在3轮筛查中均达到70%以上,分别为76.3%(817/1 071)、75.7%(258/341)和71.7%(243/339)。logistic多因素回归分析显示,性别和吸烟状态是影响FIT筛查参与率的影响因素,男性和不吸烟者的FIT筛查参与率较高。此外,年龄与FIT阳性者的结肠镜检查依从率呈负相关。经过3轮筛查,进展期肿瘤(结直肠癌+进展期腺瘤)的检出率逐轮下降[第1轮:1.15%(90/7 793);第2轮:0.57%(40/6 968);第3轮:0.58%(39/6 693)],但进展期肿瘤的阳性预测值逐轮增加,分别为11.02%、15.50%和16.05%。在各轮次筛查中,男性病变检出率均高于女性,且检出率均随着年龄增长而增加。
结论每年1次的重复FIT筛查在中国人群中具有较好的接受度以及较高的病变检出率。为了优化和提升人群结直肠癌筛查效果,应在保证人群筛查参与率的条件下推行多轮次重复FIT筛检。
ObjectiveTo evaluate the participation rate and detection of colorectal neoplasms based on annual fecal immunochemical testing (FIT) for three consecutive years in a population-based colorectal cancer screening program in China.
MethodsBased on a population-based colorectal cancer screening program conducted from May 2018 to May 2021 in 6 centers in China, 7 793 eligible participants aged 50-74 were included and offered free FIT and colonoscopy (for those who were FIT-positive on initial screening). At baseline, all participants were invited to receive FIT. In subsequent screening rounds, only FIT-positive participants who did not undergo colonoscopy or FIT-negative participants were invited to have repeated FIT screening. FIT-positive participants were recommended to undertake colonoscopy and pathological examination (if abnormalities were found during colonoscopy). An overall of three rounds of annual FIT screening were conducted. The primary outcomes of the study were the participation rate of FIT screening, the compliance rate of colonoscopy for FIT-positive participants, and the detection rate of colorectal neoplasms.
ResultsAmong the 7 793 participants included in this study, 3 310 (42.5%) were male, with age of (60.50±6.49) years. The overall participation rates for the first, second and third round of FIT screening were 94.0%(7 327/7 793), 86.8% (6 048/6 968) and 91.3% (6 113/6 693), respectively. Overall, 7 742 out of 7 793 participants (99.3%) attended at least one round of screening, and 5 163 out of 7 793 participants (66.3%) attended all three rounds of screening. The positivity rate was significantly higher in the first (14.6%, 1 071/7 327) round compared with the second (5.6%, 3 41/6 048) and third (5.5%, 3 39/6 113) screening rounds ( P<0.001). The overall compliance rates of colonoscopy examination among FIT-positive subjects were over 70% in three rounds, which were 76.3% (817/1 071), 75.7% (258/341) and 71.7% (243/339), respectively. In a multivariate logistic regression model considering factors including sex, education background, smoking, alcohol drinking, previous colonoscopy examination, colonic polyp history and family history of colorectal cancer among first-degree relatives, gender and smoking status were related factors affecting the participation rate of FIT screening, with higher rate in males and non-smokers. In addition, logistic regression analysis also found that age was negatively correlated with the compliance rate of colonoscopy in FIT positive patients. The detection rate of advanced tumors (colorectal cancer + advanced adenoma) declined from the first round to subsequent rounds [1st round: 1.15% (90/7 793); 2nd round: 0.57% (40/6 968); and 3rd round: 0.58% (39/6 693)], however, the positive predictive value for advanced neoplasms increased round by round, and was 11.02% in the first screening round, 15.50% in the second screening round, and 16.05 % in the third screening round. In each screening round, the detection rate for advanced neoplasms was higher in men than that in women, and increased with age.
ConclusionsAnnual repeated FIT screening has high acceptance and satisfying detection rates in the Chinese population. To optimize and improve the effectiveness of colorectal cancer screening, multi-round repeated FIT screening should be implemented while ensuring high participation rates.
李娜,周月阳,卢明,等. 多轮次免疫法粪便潜血试验用于中国人群结直肠癌筛查的参与率与病变检出情况分析[J]. 中华肿瘤杂志,2023,45(12):1041-1050.
DOI:10.3760/cma.j.cn112152-20230221-00073版权归中华医学会所有。
未经授权,不得转载、摘编本刊文章,不得使用本刊的版式设计。
除非特别声明,本刊刊出的所有文章不代表中华医学会和本刊编委会的观点。
基本特征 | 例数(%) |
---|---|
性别 | |
男 | 3 310(42.5) |
女 | 4 483(57.5) |
年龄(岁) | |
50~54 | 1 825(23.4) |
55~59 | 1 603(20.6) |
60~64 | 1 924(24.7) |
65~69 | 1 729(22.2) |
70~74 | 712(9.1) |
受教育程度 a | |
初中及以下 | 5 605(71.9) |
高中 | 1 542(19.8) |
大专及以上 | 621(8.0) |
吸烟情况 a | |
不吸烟 | 6 269(80.4) |
既往吸烟 | 282(3.6) |
吸烟 | 1 217(15.6) |
饮酒情况 a | |
经常 | 999(12.8) |
偶尔 | 1 047(13.4) |
不饮酒 | 5 722(73.4) |
既往结肠镜检查 a | |
无 | 7 517(96.5) |
有 | 251(3.2) |
息肉检出史 a | |
无 | 7 543(96.8) |
有 | 94(1.2) |
慢性结肠炎史 a | |
有 | 172(2.2) |
无 | 7 465(95.8) |
一级亲属结直肠癌家族史 a | |
有 | 335(4.3) |
无 | 7 277(93.4) |
不清楚/未知 | 156(2.0) |
注: a有缺失数据
注:FIT:粪便免疫化学试验;T0:第1轮筛查;T1:第2轮筛查;T2:第3轮筛查
组别 | 第1轮筛查 | 第2轮筛查 | 第3轮筛查 | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
总人数 | 完成人数 | 参与率(%) | P值 | 总人数 | 完成人数 | 参与率(%) | P值 | 总人数 | 完成人数 | 参与率(%) | P值 | |
全组 | 7 793 | 7 327 | 94.0(93.5~94.5) | - | 6 968 | 6 048 | 86.8(86.0~87.6) | - | 6 693 | 6 113 | 91.3(90.6~92.0) | - |
分性别组 | 0.890 | 0.699 | 0.865 | |||||||||
男 | 3 310 | 3 114 | 94.1(93.2~94.8) | 2 900 | 2 523 | 87.0(85.7~88.2) | 2 753 | 2 512 | 91.2(90.1~92.2) | |||
女 | 4 483 | 4 213 | 94.0(93.2~94.6) | 4 068 | 3 525 | 86.7(85.6~87.7) | 3 940 | 3 601 | 91.4(90.5~92.2) | |||
年龄组(岁) | <0.001 | 0.598 | 0.083 | |||||||||
50~54 | 1 825 | 1 738 | 95.2(94.2~96.1) | 1 613 | 1 406 | 87.2(85.4~88.7) | 1 547 | 1 393 | 90.0(88.5~91.4) | |||
55~59 | 1 603 | 1 526 | 95.2(94.0~96.1) | 1 448 | 1 264 | 87.3(85.5~88.9) | 1 387 | 1 268 | 91.4(89.8~92.8) | |||
60~64 | 1 924 | 1 780 | 92.5(91.2~93.6) | 1 725 | 1 481 | 85.9(84.1~87.4) | 1 668 | 1 519 | 91.1(89.6~92.3) | |||
≥65 | 2 441 | 2 283 | 93.5(92.5~94.4) | 2 182 | 1 897 | 86.9(85.5~88.3) | 2 091 | 1 933 | 92.4(91.2~93.5) | |||
地区分组 | <0.001 | <0.001 | <0.001 | |||||||||
浙江省温岭市 | 981 | 954 | 97.2(96.0~98.1) | 874 | 787 | 90.0(87.9~91.9) | 772 | 639 | 82.8(79.9~85.3) | |||
浙江省兰溪市 | 1 064 | 1 056 | 99.2(98.5~99.6) | 932 | 854 | 91.6(89.7~93.2) | 837 | 769 | 91.9(89.8~93.5) | |||
湖南省长沙市 | 1 675 | 1 633 | 97.5(96.6~98.1) | 1 465 | 1 400 | 95.6(94.4~96.5) | 1 450 | 1 406 | 97.0(96.0~97.7) | |||
安徽省合肥市 | 1 517 | 1 453 | 95.8(94.6~96.7) | 1 300 | 1 072 | 82.5(80.3~84.4) | 1 262 | 1 223 | 96.9(95.8~97.7) | |||
云南省昆明市 | 836 | 813 | 97.2(95.9~98.2) | 757 | 591 | 78.1(75.0~80.9) | 754 | 503 | 66.7(63.3~70.0) | |||
江苏省徐州市 | 1 720 | 1 418 | 82.4(80.6~84.2) | 1 640 | 1 344 | 82.0(80.0~83.7) | 1 618 | 1 573 | 97.2(96.4~98.0) |
注:-为无数据;( )内为95% CI
组别 | 至少参加1轮次筛查 | 参加过1轮次筛查 | 参加过2轮次筛查 | 参加过3轮次筛查 | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
总人数 | 完成人数 | 参与率(%) | 总人数 | 完成人数 | 参与率(%) | 总人数 | 完成人数 | 参与率(%) | 总人数 | 完成人数 | 参与率(%) | |
全组 | 7 793 | 7 742 | 99.3(99.1~99.5) | 7 793 | 1 148 | 14.7(13.9~15.5) | 7 793 | 1 431 | 18.4(17.5~19.2) | 7 793 | 5 163 | 66.3(65.2~67.3) |
分性别组 | ||||||||||||
男 | 3 310 | 3 291 | 99.4(99.1~99.7) | 3 310 | 547 | 16.5(15.3~17.8) | 3 310 | 624 | 18.9(17.5~20.2) | 3 310 | 2 120 | 64.0(62.4~65.7) |
女 | 4 483 | 4 451 | 99.3(99.0~99.5) | 4 483 | 601 | 13.4(12.4~14.4) | 4 483 | 807 | 18.0(16.9~19.2) | 4 483 | 3 043 | 67.9(66.5~69.2) |
年龄组(岁) | ||||||||||||
50~54 | 1 825 | 1 815 | 99.5(99.0~99.7) | 1 825 | 275 | 15.1(13.5~16.8) | 1 825 | 355 | 19.5(17.7~21.3) | 1 825 | 1 185 | 64.9(62.7~67.1) |
55~59 | 1 603 | 1 596 | 99.6(99.1~99.8) | 1 603 | 221 | 13.8(12.1~15.6) | 1 603 | 286 | 17.8(16.0~19.8) | 1 603 | 1 089 | 67.9(65.6~70.2) |
60~64 | 1 924 | 1 904 | 99.0(98.4~99.4) | 1 924 | 284 | 14.8(13.2~16.4) | 1 924 | 362 | 18.8(17.1~20.6) | 1 924 | 1 258 | 65.4(63.2~67.5) |
≥65 | 2 441 | 2 427 | 99.4(99.0~99.7) | 2 441 | 368 | 15.1(13.7~16.6) | 2 441 | 428 | 17.5(16.0~19.1) | 2 441 | 1 631 | 66.8(64.9~68.7) |
地区分组 | ||||||||||||
浙江省温岭市 | 981 | 976 | 99.5(98.8~99.8) | 981 | 149 | 15.2(12.6~16.9) | 981 | 250 | 25.5(22.8~28.3) | 981 | 577 | 58.8(55.7~61.9) |
浙江省兰溪市 | 1 064 | 1 062 | 99.8(99.3~99.9) | 1 064 | 156 | 14.7(12.6~16.9) | 1 064 | 195 | 18.3(16.1~20.8) | 1 064 | 711 | 66.8(63.9~69.6) |
湖南省长沙市 | 1 675 | 1 671 | 99.8(99.4~99.9) | 1 675 | 225 | 13.4(11.8~15.2) | 1 675 | 122 | 7.3(6.1~8.6) | 1 675 | 1 324 | 79.0(77.1~81.0) |
安徽省合肥市 | 1 517 | 1 513 | 99.7(99.3~99.9) | 1 517 | 255 | 16.8(11.8~15.2) | 1 517 | 275 | 18.1(16.2~20.2) | 1 517 | 983 | 64.8(62.3~67.2) |
云南省昆明市 | 836 | 829 | 99.2(98.3~99.7) | 836 | 172 | 20.6(17.9~23.5) | 836 | 236 | 28.2(25.2~31.4) | 836 | 421 | 50.4(46.9~53.8) |
江苏省徐州市 | 1 720 | 1 691 | 98.3(97.6~98.9) | 1 720 | 191 | 11.1(9.7~12.7) | 1 720 | 353 | 20.5(18.6~22.5) | 1 720 | 1 147 | 66.7(64.4~68.9) |
注:( )内为95% CI
影响因素 | 第1轮筛查 | 第2轮筛查 | 第3轮筛查 | ||||||
---|---|---|---|---|---|---|---|---|---|
OR a | 95% CI | P值 | OR a | 95% CI | P值 | OR a | 95% CI | P值 | |
性别 | |||||||||
女 | 1 | 1 | 1 | ||||||
男 | 1.18 | 0.92~1.51 | 0.191 | 1.26 | 1.05~1.52 | 0.013 | 1.26 | 1.05~1.52 | 0.015 |
年龄(岁) | |||||||||
≥65 | 1 | 1 | 1 | ||||||
50~54 | 1.11 | 0.83~1.50 | 0.481 | 0.88 | 0.72~1.08 | 0.205 | 0.87 | 0.71~1.07 | 0.185 |
55~59 | 1.30 | 0.96~1.77 | 0.088 | 0.92 | 0.75~1.14 | 0.444 | 0.91 | 0.74~1.23 | 0.393 |
60~64 | 0.78 | 0.60~1.01 | 0.055 | 0.86 | 0.71~1.04 | 0.112 | 0.86 | 0.71~1.05 | 0.136 |
受教育程度 | |||||||||
初中及以下 | 1 | 1 | 1 | ||||||
高中 | 0.62 | 0.49~0.79 | <0.001 | 1.11 | 0.92~1.36 | 0.270 | 1.11 | 0.91~1.35 | 0.304 |
大专及以上 | 0.88 | 0.62~1.28 | 0.490 | 1.12 | 0.86~1.48 | 0.410 | 1.13 | 0.87~1.50 | 0.374 |
吸烟 | |||||||||
吸烟者 | 1 | 1 | 1 | ||||||
不吸烟者 | 1.14 | 0.79~1.63 | 0.473 | 1.57 | 1.23~2.01 | <0.001 | 1.58 | 1.24~2.02 | <0.001 |
既往吸烟者 | 0.90 | 0.50~1.72 | 0.741 | 1.01 | 0.69~1.49 | 0.971 | 1.02 | 0.69~1.52 | 0.938 |
饮酒 | |||||||||
经常 | 1 | 1 | 1 | ||||||
偶尔 | 1.75 | 1.12~2.76 | 0.015 | 0.99 | 0.74~1.31 | 0.924 | 1.02 | 0.77~1.37 | 0.879 |
不饮酒 | 1.25 | 0.84~1.82 | 0.265 | 1.03 | 0.79~1.32 | 0.839 | 1.05 | 0.81~1.36 | 0.705 |
既往结肠镜检查 | |||||||||
无 | 1 | 1 | 1 | ||||||
有 | 1.59 | 0.80~1.63 | 0.217 | 0.77 | 0.51~1.19 | 0.219 | 0.76 | 0.50~1.18 | 0.204 |
息肉检出史 | |||||||||
无 | 1 | 1 | 1 | ||||||
有 | 0.55 | 0.22~1.70 | 0.249 | 0.67 | 0.36~1.34 | 0.249 | 0.66 | 0.34~1.32 | 0.218 |
慢性结肠炎史 | |||||||||
无 | 1 | 1 | 1 | ||||||
有 | 0.97 | 0.50~2.08 | 0.941 | 0.97 | 0.58~1.72 | 0.237 | 1.00 | 0.60~1.77 | 0.999 |
一级亲属结直肠癌家族史 | |||||||||
无 | 1 | 1 | 1 | ||||||
有 | 1.47 | 0.81~2.97 | 0.242 | 1.11 | 0.75~1.73 | 0.919 | 1.01 | 0.67~1.57 | 0.961 |
不清楚/未知 | 0.40 | 0.21~0.83 | 0.009 | 1.11 | 0.61~2.21 | 0.745 | 1.09 | 0.59~2.17 | 0.799 |
注: alogistic回归分析校正了地区因素
注:FIT:粪便免疫化学试验;T0:第1轮筛查;T1:第2轮筛查;T2:第3轮筛查
筛查轮次 | 参检人数 | 阳性人数 | 完成结肠镜人数 | 阳性率(%) | 结肠镜依从率(%) |
---|---|---|---|---|---|
第1轮 | 7 327 | 1 071 | 817 | 14.6(13.8~15.4) | 76.3(73.6~78.7) |
第2轮 | 6 048 | 341 | 258 | 5.6(5.1~6.2) | 75.7(70.9~79.9) |
第3轮 | 6 113 | 339 | 243 | 5.5(5.0~6.1) | 71.7(66.7~76.2) |
注:( )内为95% CI
筛查结果和组别 | 第1轮筛查 | |||
---|---|---|---|---|
总人数 | 病变检出人数 | 检出率(%) | PPV(%) | |
进展期肿瘤(结直肠癌+进展期腺瘤) | ||||
总人群 | 7 793 | 90 | 1.15(0.94~1.42) | 11.02(9.05~13.35) |
男性组 | 3 310 | 62 | 1.87(1.46~2.39) a | 15.27(12.10~19.09) |
女性组 | 4 483 | 28 | 0.62(0.43~0.90) | 6.81(4.76~9.67) |
50~54岁组 | 1 825 | 22 | 1.21(0.80~1.82) | 10.43(6.99~15.28) |
55~59岁组 | 1 603 | 9 | 0.56(0.30~1.06) | 5.88(3.13~10.80) |
60~64岁组 | 1 924 | 24 | 1.25(0.84~1.85) | 12.24(8.37~17.57) |
≥65岁组 | 2 441 | 35 | 1.43(1.03~1.99) | 13.62(9.96~18.35) |
任意肿瘤(结直肠癌+进展期腺瘤+非进展期腺瘤) | ||||
总人群 | 7 793 | 256 | 3.28(2.91~3.70) | 31.33(28.25~34.60) |
男性组 | 3 310 | 164 | 4.95(4.27~5.75) a | 40.39(35.73~45.24) |
女性组 | 4 483 | 92 | 2.05(1.68~2.51) | 22.38(18.62~26.66) |
50~54岁组 | 1 825 | 56 | 3.07(2.37~3.96) | 26.54(21.04~32.88) |
55~59岁组 | 1 603 | 38 | 2.37(1.73~3.24) | 24.84(18.66~32.24) |
60~64岁组 | 1 924 | 68 | 3.53(2.80~4.46) | 34.69(28.38~41.59) |
≥65岁组 | 2 441 | 94 | 3.85(3.16~4.69) | 36.58(30.93~42.62) |
筛查结果和组别 | 第2轮筛查 | |||
---|---|---|---|---|
总人数 | 病变检出人数 | 检出率(%) | PPV(%) | |
进展期肿瘤(结直肠癌+进展期腺瘤) | ||||
总人群 | 6 968 | 40 | 0.57(0.42~0.78) | 15.50(11.60~10.42) |
男性组 | 2 900 | 25 | 0.86(0.58~1.27) a | 18.80(13.07~26.28) |
女性组 | 4 068 | 15 | 0.37(0.22~0.61) | 12.00(7.41~18.86) |
50~54岁组 | 1 613 | 4 | 0.25(0.10~0.64) | 6.25(2.46~15.00) |
55~59岁组 | 1 448 | 10 | 0.69(0.38~1.27) | 17.24(9.64~28.91) |
60~64岁组 | 1 725 | 10 | 0.58(0.32~1.06) | 18.87(10.59~31.36) |
≥65岁组 | 2 182 | 16 | 0.73(0.45~1.19) | 19.28(12.23~29.04) |
任意肿瘤(结直肠癌+进展期腺瘤+非进展期腺瘤) | ||||
总人群 | 6 968 | 87 | 1.25(1.01~1.54) | 33.72(28.23~39.69) |
男性组 | 2 900 | 50 | 1.72(1.31~2.27) a | 37.59(29.82~46.07) |
女性组 | 4 068 | 37 | 0.91(0.66~1.25) | 29.60(22.30~38.11) |
50~54岁组 | 1 613 | 18 | 1.12(0.71~1.76) | 28.13(18.59~40.13) |
55~59岁组 | 1 448 | 20 | 1.38(0.90~2.12) | 34.48(23.56~47.33) |
60~64岁组 | 1 725 | 20 | 1.16(0.75~1.78) | 37.74(25.94~51.19) |
≥65岁组 | 2 182 | 29 | 1.33(0.93~1.90) | 34.94(25.56~45.66) |
筛查结果和组别 | 第3轮筛查 | |||
---|---|---|---|---|
总人数 | 病变检出人数 | 检出率(%) | PPV(%) | |
进展期肿瘤(结直肠癌+进展期腺瘤) | ||||
总人群 | 6 693 | 39 | 0.58(0.43~0.80) | 16.05(11.97~21.19) |
男性组 | 2 753 | 16 | 0.58(0.36~0.94) | 14.55(9.16~22.33) |
女性组 | 3 940 | 23 | 0.58(0.39~0.87) | 17.29(11.81~24.61) |
50~54岁组 | 1 547 | 4 | 0.26(0.10~0.66) | 7.55(2.97~17.86) |
55~59岁组 | 1 387 | 6 | 0.43(0.20~0.94) | 11.11(5.19~22.19) |
60~64岁组 | 1 668 | 14 | 0.84(0.50~1.40) | 16.47(10.07~25.77) |
≥65岁组 | 2 091 | 15 | 0.72(0.44~1.18) | 29.41(18.71~43.00) |
任意肿瘤(结直肠癌+进展期腺瘤+非进展期腺瘤) | ||||
总人群 | 6 693 | 91 | 1.36(1.11~1.67) | 37.45(31.60~43.68) |
男性组 | 2 753 | 41 | 1.49(1.10~2.01) | 37.27(28.81~46.59) |
女性组 | 3 940 | 50 | 1.27(0.96~1.67) | 37.59(29.82~46.07) |
50~54岁组 | 1 547 | 15 | 0.97(0.59~1.59) | 28.30(17.97~41.57) |
55~59岁组 | 1 387 | 19 | 1.37(0.88~2.13) | 35.19(23.82~48.52) |
60~64岁组 | 1 668 | 32 | 1.92(1.36~2.70) | 37.65(28.09~48.27) |
≥65岁组 | 2 091 | 25 | 1.20(0.91~1.76) | 49.01(35.86~62.32) |
注:FIT:粪便免疫化学试验;PPV:阳性预测值;( )内为95% CI; a与女性人群比较, P<0.05
李娜:统计学分析、论文撰写;周月阳、卢明、蔡洁、张愉涵、陆斌、骆晨雨、骆家辉:数据整理,论文修改;陈宏达、代敏:研究指导、论文修改、经费支持

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