液基薄层宫颈刷片细胞学检查结合二代杂交捕获法人乳头瘤病毒筛查宫颈癌的前瞻性队列研究

Prospective Cohort Research on Cervical Carcinoma Screening of Thinprep Cytological Test Combined With Human Papilloma Virus Hybrid Capture Ⅱ.

目的探讨液基薄层宫颈刷片细胞学检查（thinprep cytological test，TCT）结合二代杂交捕获法（hybrid capture Ⅱ，HC-Ⅱ）人乳头瘤病毒（human papilloma virus，HPV）检测，对宫颈癌筛查的价值。方法2003年1月至2005年1月，本院妇科对435例志愿者病例行前瞻性队列研究（本研究遵循的程序符合本院人体试验委员会所制定的伦理学标准，得到该委员会批准，取得受试对象的知情同意，并与受试患者签署临床研究知情同意书），采用液基薄层宫颈刷片细胞学检查方法结合二代杂交捕获法检测人乳头瘤病毒。根据检测结果，将纳入病例分为4组，①HPV呈阴性、TCT呈阴性组[HPV（-），TCT（-）组]；②HPV呈阳性、TCT呈阴性组[HPV（＋），TCT（-）组]；③HPV呈阴性、TCT呈阳性组[HPV（-），TCT（＋）组]；④HPV呈阳性、TCT呈阳性组[HPV（＋），TCT（＋）组]。不同组别病例按不同间隔时间进行液基薄层宫颈刷片细胞学检查和人乳头瘤病毒二代杂交捕获法复查，必要时行阴道镜、活体病理学检查及宫颈管诊断性刮宫（endocervical curettage，ECC），随访3年，直到观察病例出现宫颈病变或研究终止。本研究数据采用Logistic回归分析评估、复查宫颈癌细胞学发生的决定因素。结果液基薄层宫颈刷片细胞学检查和二代杂交捕获法检测人乳头瘤病毒的灵敏度、特异度、一致率、阳性预测值、阴性预测值、Knppa值分别为85．9％，96．2％，94．7％，79．7％，97．5％，0．7959和92．2％，80．1％，81．8％，44．4％，98．3％，0．4996。与HPV（-）、TCT（-）组相比，HPV（＋）、TCT（-）组及HPV（-）、TCT（＋）组患宫颈癌癌前病变的风险度增高（RR=45．033，95％CI 17．140～118．313；RR=235．886，95％CI 70．694～487．088）；HPV（＋）、TCT（＋）组患宫颈癌癌前病变的风险度明显增高（RR=464．400，95％CI 105．162～950．806）。结论液基薄层宫颈刷片细胞学检查结合二代杂交捕获法检测人乳头瘤病毒检测的敏感度和特异度比较理想，二者结合能满足筛查早期宫颈癌及癌前病变筛查的需要，是比较适合本地区经济状况的筛查方案。

Objective To investigate the screening value of the thinprep cytological test （TCT） detection combined with human papilloma virus（HPV） hybrid capture Ⅱ （HC-Ⅱ ） for cervical carcinoma. Methods From January 2003 to January 2005, the thinprep cytological test and hybrid captureⅡ were applied to screen cervical carcinoma in 435 cases in the Department of Obstetrics and Gynecology in Hexian Memorial Hospital. The thinprep cytological test was applied to detect cervical carcinoma cytology, and hybrid captureⅡ was applied to detect human papilloma virus. According to the detection results, all cases were divided into4 groups, group of HPV（-）, TCT（-）, group of HPV（＋）, TCT（- ）, group of HPV （-）, TCT（＋）, group of HPV（＋）,TCT（＋）. A follow-up of 3 years had been carried out, and different groups were checked by the thinprep cytological test and human papilloma virus hybrid capture Ⅱ at different interval times, and colpomieroscope, biopsy and endocervical curettage （ECC） would also be used if necessary. Determinant elements of cytology occurrence were evaluated by the Logistic regression analysis. Results The sensitivity, specificity, efficiency, positive predictive value （PPV）, negative predictive value（NPV）, Kappa values of the thinprep cytological test and human papilloma virus hybrid capture Ⅱwere 85.9%, 96. 2%, 94. 7%, 79. 7%, 97. 5%, 0. 7959, and 92. 2%, 80. 1%, 81. 8%, 44.4%, 98.3%, 0. 4996. The group of HPV（＋）,TCT（-）, and the group of HPV（-）,TCT（＋） had higher risk of pathological changes of cervical carcinoma （RR = 45. 033, 95 % CI 17. 140- 118. 313;RR= 235. 886, 95% CI 70. 694-487. 088） compared with the group of HPV（-）,TCT（-）, and the group of HPV（＋） ,TCT（＋） had distinct risks （RR=464. 400, 95% CI 105. 162-950. 806）. Conclusion The detection of sensitivity and specificity by the combination of the thinprep cytological test with human papilloma virus hybrid capture Ⅱ can be enhanced, which could meet the requirement of screening the early stage of cervical carcinomas and precancerous changes.