初筛首选 (30岁及以上女性)

为什么使用digene HPV 检测对30岁及以上女性进行筛查?

  • 流行病学数据显示，女性随着年龄增长，HPV感染率降低，但宫颈癌的发病率是呈增加趋势。

  • HPV感染率与宫颈癌发病率的交叉点对应的年龄是在30岁左右，因此建议对30岁及以上的女性进行宫颈癌的筛查（HPV+细胞学）。

  • 该年龄组群的高危型HPV检测结果阳性，提示存在持续感染，其发展为宫颈高度病变的风险较高。

  • 事实上，研究显示，大于30岁以上的女性，细胞学结果正常但HPV阳性者，与细胞学和HPV结果都正常者相比，其发展为高度宫颈病变的风险高出116倍。 1

     

    HPV 感染率和宫颈癌发病率与年龄的关系
    国家癌症研究机构SEER 1990-1994的数据和Melkert et al., 1993. Int J Canc 53:919.

  • digene HPV 检测帮助临床医生更加客观地评判女性发生宫颈癌的风险。

  • 单独使用细胞学进行筛查，其漏诊率最高可以达到35％。但是，digene HPV 检测联合细胞学，不论是传统的巴氏亦或改良的液基细胞学，检测出宫颈高度病变和宫颈癌的敏感度几乎都是100％——避免了假阴性结果。 6 

  • 美国一项大规模研究发现，digene HPV 检测与细胞学的联合筛查方法，对CIN3和宫颈癌的阴性预测值可以达到99.21％。3

  • 持续感染高危型HPV的女性，发生宫颈高度病变的风险比未感染者高300倍。5 

     

    digene HPV检测和细胞学结果都是阴性的女性，在三年内发生宫颈高度病变或宫颈癌的风险几乎为零。

    大量的临床研究数据都证实了上述结论，并得到了专业权威机构ACOG, ACS, AMWA, NPWH 和 ARHP的认同。

  • digene HPV 检测联合细胞学，与单独使用细胞学相比，临床敏感度和阴性预测值都大大提高。

  • 很多研究都证实了这种联合筛查方案对评估宫颈病变风险的准确性与可靠性。7,8,9

 

参考文献：

1 Melkert PW, Hopman E, van den Brule AJ, et al. Prevalence of HPV in cytomorphologically normal cervical smears, as determined by the polymerase chain reaction, is aged–dependent. Int J Cancer 1993; 53: 919–23.
2 ACOG Practice Bulletin No. 45, "Cervical Cytology Screening. Clinical Management Guidelines for Obstetrician–Gynecologists." August 2003.
3 Sherman ME, Lorincz A, Scott DR, et al. Baseline Cytology, Human Papillomavirus Testing, and Risk for Cervical Neoplasia: A 10–Year Cohort Analysis. J Nat Cancer Inst, 2003; 95 (1): 46–52.
4 Bory JP, Cucherousset J, Lorenzato M, et al. Recurrent Human Papillomavirus Infection, Detected with the Hybrid Capture II Assay, Selects Women With Normal Cervical Smears at Risk for Developing High Grade Cervical Lesions. A Longitudinal Study of 3,091 Women. Int J Cancer, 2002; 102, 519–525.
5 Clavel C, Masure M, Bory J–P, et al. Human papillomavirus testing in primary screening for the detection of high–grade cervical lesions: a study of 7932 women. Brit J Cancer, 2001; 89 (12): 1616–1623.
6 Saslow D, Runowicz C, Solomon D, et al. American Cancer Society Guideline for the Early Detection of Cervical Neoplasia and Cancer. CA Cancer J Clin, 2002; 52: 342–362.
7 Sherman ME, Lorincz A, Scott DR, et al. Baseline Cytology, Human Papillomavirus Testing, and risk for Cervical Neoplasia: A 10–Year Cohort Analysis. J Nat Cancer Inst, 2003; 95 (1): 46–52
8 Clavel C, et al. Negative human papillomavirus testing in normal smears selects a population at low risk for developing high–grade cervical lesions. Brit J Cancer. 2004; 90:1803–1808.
9 Cuzick J, et al. Management of women who test positive for high–risk types of human papillomavirus: the HART study. LANCET. 2003; 362:1871–1876
10 Mayrand MH, Duarte-Franco E, Rodrigues I, Walter SD, Hanley J, Ferenczy A, Ratnam S, Coutlée F, Franco EL, Human Papillomavirus DNA versus Pananicolaou Screening Tests for Cervical Cancer. N. Engl. J. Med. 357(16):1579-88 (2007)
11 Ronco G, Segnan N, Giorgi-Rossi P, Zappa M, Casadei GP, Carozzi F, Dalla Palma P, Del Mistro A, Folicaldi S, Gillio-Tos A, Nardo G, Naldoni C, Schincaglia P, Zorzi M, Confortini M, Cuzick J. Human papillomavirus testing and liquid-based cytology: results at recruitment from the new technologies for cervical cancer randomized controlled trial. J Natl Cancer Inst. 98(11):765-74 (2006)
12 Cytyc package insert; ThinPrep® Imaging System Table 2.
13 Biscotti CV, Dawson AE, Dziura B, et al. Assisted primary screening using the automated ThinPrep imaging system.Am J Clin Pathol. 2005;123:281-287.


* 经美国FDA和欧洲CE认证的 "digene HPV Test" ，就是被临床医生和实验室所熟知的 "digene HC2 HPV DNA Test®".