数值化便潜血试验对结直肠癌及其他胃肠道疾病诊断价值的研究
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摘要
[目的]探讨数值化便潜血试验(quantitative immunochemical fecal occult blood test, QIFOBT)对结直肠癌(colorectal cancer,CRC)及其他胃肠道疾病的诊断价值。
【方法】(1)对2008年11月～2010年2月在我院门诊内镜中心接受胃肠镜检查的患者和我院普外科住院的CRC患者进行了数值化便潜血试验(QIFOBT)和免疫胶体金法便潜血试验(colloidal gold immunochromatographic,CGIFOBT)的检测；共检测标本502例,其中门诊病人420例,住院病人82例；共有101例最终诊断为CRC(住院82例,门诊19例)；我们对比分析了两种方法对CRC及其他胃肠道疾病的诊断价值；(2)比较了QIFOBT与腹部CT检查、气钡双重造影(double-contrast barium enema,DCBE)及血清肿瘤标记物CEA (carcinoembryonic antigen)对结直肠癌的诊断符合率；(3)分析了QIFOBT与CRC Dukes分期及肿瘤大小的相关性；(4)初步观察了QIFOBT不同阳性阈值对诊断CRC阳性率的影响。
【结果】(1)本组502例受检患者,QIFOBT和CGIFOBT的总阳性率分别为35%和21%(P<0.05),假阳性率分别为1.9%和3.7%(P>0.05)；两种方法对所有101例CRC的阳性率分别为93.4%和63.2%(P<0.05)；两种方法对门诊420例患者总阳性率分别为16.1%和7.2%(P<0.05),两种方法对所检出的各病种(息肉、炎性肠病等)的各自阳性率比较均无显著性差异(P>0.05)。QIFOBT对CRC和非CRC疾病总阳性率分别为92.1%和15.4%(P＜0.05); QIFOBT对门诊病人上、下消化道疾病的阳性检出率分别为13.1%和26.8%(P<0.05)；QIFOBT对≥1cm和<1cm结直肠息肉的阳性率分别为29.4%和5.3%(P<0.05)。(2)QIFOBT和腹部CT对CRC的阳性检出率分别为97.3%和97.3%(P>0.05)；QIFOBT和DCBE对CRC的阳性检出率分别为84.6%和100%(P>0.05)；QIFOBT和血清肿瘤标记物CEA对CRC的阳性率分别为93.8%和73.4%(P<0.05)。(3)QIFOBT与CRC Dukes分期无相关性(P>0.05)；而QIFOBT与CRC肿瘤大小成正相关(P<0.05)。(4)与本实验所设定的QIFOBT阳性阈值100ng/mL相比较,当阳性阈值下调为50 ng/mL时CRC的QIFOBT阳性检出率增加2%,此时,结肠镜检查正常组QIFOBT阳性检出率亦增加一倍(4.6%)；当阈值上调为150ng／mL时,CRC的QIFOBT阳性检出率减少3%,结肠镜检查正常组阳性检出率减少0.9%；当阈值上调为200 ng/mL时,CRC的QIFOBT阳性检出率减少5%,此时,结肠镜检查正常组阳性检出率亦减少0.9%。
【结论】(1)数值化便潜血试验对结直肠癌有很高的诊断阳性率,可达90%以上；与腹部CT、气钡双重造影有相近的诊断符合率；其诊断敏感性显著高于免疫胶体金法便潜血试验和血清肿瘤标记物CEA检测；(2)数值化便潜血试验对下消化道疾病的诊断阳性率显著高于对上消化道疾病；其对结直肠息肉的检出率与息肉大小相关；(3)数值化便潜血试验的阳性阈值对结直肠癌的诊断阳性率有一定影响,阳性阈值设定为100 ng/mL时对结直肠癌的诊断具有最适阳性检出率和假阳性率；(4)数值化便潜血试验与结直肠癌大小(肿瘤粘膜面最大直径)成正相关,但与Dukes病理分期的相关性有待进一步验证。
[Objectives] To investigate the clinical value of the quantitative immunochemical fecal occult blood test(QIFOBT) for colorectal cancer(CRC) and other gastrointestinal diseases.
[Matheds] Outpatients (from November 2008 to February 2010) who were going to undergo gastroscopy and colonoscopy and inpatients with final diagnosis of CRC who were going to undergo surgical operation simultaneously accepted the QIFOBT and the colloidal gold immunochromatographic FOBT(CGIFOBT) for research purposes. (1) The total number of samples was 502 including 101 patients with CRC(82 inpatients and 19 outpatients) and 401 outpatients with non-colorectal cancer. The diagnosis value in CRC and non-colorectal cancer of the two methods were compared and evaluated. (2) We compared the diagnosis rates of the QIFOBT with CT scan and DCBE(double-contrast barium enema) and CEA(carcinoembryonic antigen). (3) We investigated whether the QIFOBT was associated with the Dukes Staging or the size of CRC. (4) We performed a preliminary analysis of the diagnositic positive rates of the QIFOBT for CRC at different positive threshold.
[Results] (1) The total positive rates of the QIFOBT and the CQIFOBT in all the 502 patients were 35% and 21%(P<0.05) respectively, while the false positive rates were 1.9% and 3.7%(P>0.05), and the positive rates in CRC were 93.4% and 63.2% (P<0.05) respectively. The total positive rates of the QIFOBT and the GIFOBT for the 420 outpatients were 16.1% and 7.2%(P<0.05). No statistical differences were found between the QIFOBT and the CGIFOBT in each disease of the outpatients (P>0.05). The positive rates of the QIFOBT for CRC and non-colorectal cancer were 92.1% and 15.4%(P<0.05) respectively. The positive rates of the QIFOBT for the upper gastrointestinal diseases and lower gastrointestinal diseases were 13.1% and 26.8%(P＜0.05), and for the colorectal polyps with≥1cm and＜1cm were 29.4% and 5.3%(P<0.05) respectively. (2) The positive rates of the QIFOBT and CEA for the colorectal cancer were 93.8% and 73.4% respectively (P＜0.05). The positive rates of the QIFOBT and DCBE were 84.6% and 100%(P>0.05), and CT scan were 97.3% and 97.3%, respectively (P>0.05). (3) The QIFOBT was not significantly associated with the Dukes Staging of the CRC (P>0.05), whereas has direct correlation with the size of CRC (P<0.05). (4) Compared with 100 ng/mL, the positive rates of CRC and the normal large intestine(normal appearance of colorectal mucosa) will increase by 2% and 4.6% when the positive threshold of the QIFOBT is at 50 ng/mL, and it will decrease by 3% and 0.9% at 150ng/mL, by 5% and 0.9% at 200ng/mL, respectively.
[Conclusions] (1) Compared with the CGIFOBT and serum tumor markers (such as CEA), the QIFOBT has a significantly higher positive rate (>90%) and a comparable diagnosis value with CT scan and DCBE for CRC. (2) The QIFOBT has more high sensibility in the diagnosis of the lower gastrointestinal diseases than that of the upper gastrointestinal diseases, and the positive rate of the QIFOBT for CRC is associated with the size of the colorectal polyp. (3) The positive threshold of the QIFOBT can affect the detection rate in the diagonsis of CRC, and the threshold at 100 ng/mL has the most optimum positive rate and false positive rate for the diagnosis of CRC. (4) The QIFOBT has a direct correlation with the size of the CRC, while the correlation between the QIFOBT and the Dukes Staging of the CRC should be further determined.
【方法】(1)对2008年11月～2010年2月在我院门诊内镜中心接受胃肠镜检查的患者和我院普外科住院的CRC患者进行了数值化便潜血试验(QIFOBT)和免疫胶体金法便潜血试验(colloidal gold immunochromatographic,CGIFOBT)的检测；共检测标本502例,其中门诊病人420例,住院病人82例；共有101例最终诊断为CRC(住院82例,门诊19例)；我们对比分析了两种方法对CRC及其他胃肠道疾病的诊断价值；(2)比较了QIFOBT与腹部CT检查、气钡双重造影(double-contrast barium enema,DCBE)及血清肿瘤标记物CEA (carcinoembryonic antigen)对结直肠癌的诊断符合率；(3)分析了QIFOBT与CRC Dukes分期及肿瘤大小的相关性；(4)初步观察了QIFOBT不同阳性阈值对诊断CRC阳性率的影响。
【结果】(1)本组502例受检患者,QIFOBT和CGIFOBT的总阳性率分别为35%和21%(P<0.05),假阳性率分别为1.9%和3.7%(P>0.05)；两种方法对所有101例CRC的阳性率分别为93.4%和63.2%(P<0.05)；两种方法对门诊420例患者总阳性率分别为16.1%和7.2%(P<0.05),两种方法对所检出的各病种(息肉、炎性肠病等)的各自阳性率比较均无显著性差异(P>0.05)。QIFOBT对CRC和非CRC疾病总阳性率分别为92.1%和15.4%(P＜0.05); QIFOBT对门诊病人上、下消化道疾病的阳性检出率分别为13.1%和26.8%(P<0.05)；QIFOBT对≥1cm和<1cm结直肠息肉的阳性率分别为29.4%和5.3%(P<0.05)。(2)QIFOBT和腹部CT对CRC的阳性检出率分别为97.3%和97.3%(P>0.05)；QIFOBT和DCBE对CRC的阳性检出率分别为84.6%和100%(P>0.05)；QIFOBT和血清肿瘤标记物CEA对CRC的阳性率分别为93.8%和73.4%(P<0.05)。(3)QIFOBT与CRC Dukes分期无相关性(P>0.05)；而QIFOBT与CRC肿瘤大小成正相关(P<0.05)。(4)与本实验所设定的QIFOBT阳性阈值100ng/mL相比较,当阳性阈值下调为50 ng/mL时CRC的QIFOBT阳性检出率增加2%,此时,结肠镜检查正常组QIFOBT阳性检出率亦增加一倍(4.6%)；当阈值上调为150ng／mL时,CRC的QIFOBT阳性检出率减少3%,结肠镜检查正常组阳性检出率减少0.9%；当阈值上调为200 ng/mL时,CRC的QIFOBT阳性检出率减少5%,此时,结肠镜检查正常组阳性检出率亦减少0.9%。
【结论】(1)数值化便潜血试验对结直肠癌有很高的诊断阳性率,可达90%以上；与腹部CT、气钡双重造影有相近的诊断符合率；其诊断敏感性显著高于免疫胶体金法便潜血试验和血清肿瘤标记物CEA检测；(2)数值化便潜血试验对下消化道疾病的诊断阳性率显著高于对上消化道疾病；其对结直肠息肉的检出率与息肉大小相关；(3)数值化便潜血试验的阳性阈值对结直肠癌的诊断阳性率有一定影响,阳性阈值设定为100 ng/mL时对结直肠癌的诊断具有最适阳性检出率和假阳性率；(4)数值化便潜血试验与结直肠癌大小(肿瘤粘膜面最大直径)成正相关,但与Dukes病理分期的相关性有待进一步验证。
[Objectives] To investigate the clinical value of the quantitative immunochemical fecal occult blood test(QIFOBT) for colorectal cancer(CRC) and other gastrointestinal diseases.
[Matheds] Outpatients (from November 2008 to February 2010) who were going to undergo gastroscopy and colonoscopy and inpatients with final diagnosis of CRC who were going to undergo surgical operation simultaneously accepted the QIFOBT and the colloidal gold immunochromatographic FOBT(CGIFOBT) for research purposes. (1) The total number of samples was 502 including 101 patients with CRC(82 inpatients and 19 outpatients) and 401 outpatients with non-colorectal cancer. The diagnosis value in CRC and non-colorectal cancer of the two methods were compared and evaluated. (2) We compared the diagnosis rates of the QIFOBT with CT scan and DCBE(double-contrast barium enema) and CEA(carcinoembryonic antigen). (3) We investigated whether the QIFOBT was associated with the Dukes Staging or the size of CRC. (4) We performed a preliminary analysis of the diagnositic positive rates of the QIFOBT for CRC at different positive threshold.
[Results] (1) The total positive rates of the QIFOBT and the CQIFOBT in all the 502 patients were 35% and 21%(P<0.05) respectively, while the false positive rates were 1.9% and 3.7%(P>0.05), and the positive rates in CRC were 93.4% and 63.2% (P<0.05) respectively. The total positive rates of the QIFOBT and the GIFOBT for the 420 outpatients were 16.1% and 7.2%(P<0.05). No statistical differences were found between the QIFOBT and the CGIFOBT in each disease of the outpatients (P>0.05). The positive rates of the QIFOBT for CRC and non-colorectal cancer were 92.1% and 15.4%(P<0.05) respectively. The positive rates of the QIFOBT for the upper gastrointestinal diseases and lower gastrointestinal diseases were 13.1% and 26.8%(P＜0.05), and for the colorectal polyps with≥1cm and＜1cm were 29.4% and 5.3%(P<0.05) respectively. (2) The positive rates of the QIFOBT and CEA for the colorectal cancer were 93.8% and 73.4% respectively (P＜0.05). The positive rates of the QIFOBT and DCBE were 84.6% and 100%(P>0.05), and CT scan were 97.3% and 97.3%, respectively (P>0.05). (3) The QIFOBT was not significantly associated with the Dukes Staging of the CRC (P>0.05), whereas has direct correlation with the size of CRC (P<0.05). (4) Compared with 100 ng/mL, the positive rates of CRC and the normal large intestine(normal appearance of colorectal mucosa) will increase by 2% and 4.6% when the positive threshold of the QIFOBT is at 50 ng/mL, and it will decrease by 3% and 0.9% at 150ng/mL, by 5% and 0.9% at 200ng/mL, respectively.
[Conclusions] (1) Compared with the CGIFOBT and serum tumor markers (such as CEA), the QIFOBT has a significantly higher positive rate (>90%) and a comparable diagnosis value with CT scan and DCBE for CRC. (2) The QIFOBT has more high sensibility in the diagnosis of the lower gastrointestinal diseases than that of the upper gastrointestinal diseases, and the positive rate of the QIFOBT for CRC is associated with the size of the colorectal polyp. (3) The positive threshold of the QIFOBT can affect the detection rate in the diagonsis of CRC, and the threshold at 100 ng/mL has the most optimum positive rate and false positive rate for the diagnosis of CRC. (4) The QIFOBT has a direct correlation with the size of the CRC, while the correlation between the QIFOBT and the Dukes Staging of the CRC should be further determined.
引文
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