人類乳頭狀病毒檢測診斷宮頸癌前病變的價值：隨機對照研究的系統評價_《中國循證醫學雜志》

作者：

李克敏 ¹ ,  尹如鐵 ¹ , 康德英 ² , 伍偉偉 ³ , 文進 ²

1. 四川大學華西第二醫院婦科（成都?610041）；2. 四川大學華西臨床醫學院循證醫學與臨床流行病學教研室（成都?610041）；3. 四川大學華西第二醫院病理科（成都?610041）;

關鍵詞：

宮頸癌前病變人類乳頭狀病毒系統評價 Meta分析隨機對照試驗

DOI：

10.7507/1672-2531.20110154

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目的　系統評價人類乳頭狀病毒檢測對宮頸癌前病變的診斷價值。
方法　計算機檢索CBM、CNKI、MEDLINE、PubMed、EMbase（均從建庫至2010年6月），Cochrane臨床對照試驗中心注冊庫（2010年第2期），并手工檢索相關雜志和納入研究的參考文獻。由兩位評價員按照納入與排除標準獨立選擇文獻、提取資料和評價質量后，采用Meta Disc 1.4軟件進行Meta分析，并用RevMan 5.0軟件繪制森林圖和SROC曲線。
結果　共納入7個隨機對照研究，合計171 604例受試者。Meta分析結果顯示：與傳統的宮頸細胞學檢查比較，人類乳頭狀病毒（HPV）檢測能明顯提高對宮頸癌前病變診斷的敏感性，其中HPV聯合宮頸細胞學篩查診斷宮頸上皮內瘤變2級及以上病變時，與傳統的宮頸細胞學檢查比較差異有統計學意義（P lt;0.000 01）；但HPV檢測卻明顯降低了對其診斷的特異性；只檢測HPV，同時檢測HPV和宮頸細胞學和先檢測HPV。再以細胞學分流的方法診斷宮頸上皮內瘤變，與傳統宮頸細胞學檢查比較，除了第三種方法診斷宮頸上皮內瘤變1級及以上病變無統計學差異外（P=0.41），其余兩種方法與之比較均有明顯的統計學差異（P lt;0.01）。
結論　現有循證醫學證據顯示，與傳統的宮頸細胞學篩查相比，HPV檢測聯合宮頸細胞學篩查可以明顯提高診斷宮頸上皮內瘤變2級及以上病變的敏感性，但HPV檢測并不能提高診斷宮頸癌前病變的特異性；應用HPV檢測篩查宮頸癌前病變有待進一步研究。

引用本文： 李克敏,尹如鐵,康德英,伍偉偉,文進. 人類乳頭狀病毒檢測診斷宮頸癌前病變的價值：隨機對照研究的系統評價. 中國循證醫學雜志, 2011, 11(8): 910-918. doi: 10.7507/1672-2531.20110154 復制

1.	1 Reeves WC, Quiroz E. Prevalence of sexually transmitted diseases in high-risk women in the Republic of Panama. Sex Transm Dis , 1987, 14(2): 69-74.
2.	Morrison EA, Ho GY, Vermund SH, et al . Human papillomavirus infection and other risk factors for cervical neoplasia: case-control study. Int J Cancer , 1991, 49(1): 6-13.
3.	Bosch FX, Muñoz N, de Sanjosé S, et al . Risk factors for cervical cancer in Colombia and Spain. Int J Cance r, 1992, 52(5): 750-758.
4.	Bosch FX, Manos MM, Muñoz N, et al . Prevalence of human papillomavirus in cervical cancer: a worldwide perspective. International biological study on cervical cancer (IBSCC) Study Group. J Natl Cancer Inst , 1995, 87(11): 796-802.
5.	Yamakawa Y, Forslund O, Teshima H, et al . Human papillomavirus DNA in adenocarcinoma and adenosquamous carcinoma of the uterine cervix detected by polymerase chain reaction (PCR). Gynecol Oncol , 1994, 53(2): 190-195.
6.	Blumenthal PD, Gaffikin L, Chirenje ZM, et al . Adjunctive testing for cervical cancer in low resource settings with visual inspection, HPV, and the Pap smear. Int J Gynaecol Obstet , 2001, 72(1): 47-53.
7.	Costa S, SideriM, Syrjanen K, et al . Combined Pap smear, cervicography and HPV DNA testing in the detection of cervical intraepithelial neoplasia and cancer. Acta Cytol , 2000, 44(3): 310-318.
8.	Cuzick J, Szarewski A, Terry G, et al . Human papillomavirus testing in primary cervical screening. Lancet , 1995, 345(8964): 1533-1536.
9.	Sherman ME, Lorincz AT, Scott DR, et al . Baseline cytology, human papillomavirus testing, and risk for cervical neoplasia: a 10-year cohort analysis. J Natl Cancer Inst , 2003, 95(1), 46-52.
10.	Wu D, Ding L, Wu JH, et al . Application of liquid-based cytology and high-risk human papillomavirus DNA detection in cervical lesion screening. J South Med Nniv , 2007, 27(9): 1421-1423.
11.	Arbyn M, Buntinx F, Van Ranst M, et al . Cytologic versus virologic triage of women with equivocal Pap smears: a meta-analysis of the accuracy to detect high-grade intraepithelial neoplasia. J Natl Cancer Inst , 2004, 96(4): 280-293.
12.	Solomon D, Schiffman M. Have we resolved how to triage equivocal cervical cytology? J Natl Cancer Inst , 2004, 96(4): 250-251.
13.	Paraskevaidis E, Arbyn M, Sotiriadis A, et al . The role of HPV testing in the follow up period after treatment for CIN: a systematic review of the literature. Cancer Treat Rev , 2004, 30(2): 205-211.
14.	Arbyn M, Paraskevaidis E, Martin-Hirsch P, et al . Clinical utility of HPV DNA detection: triage of minor cervical lesions, follow-up of women treated for high-grade CIN. An update of pooled evidence. Gynecol Oncol , 2005, 99(Suppl 3): 7-11.
15.	Solomon D, Davey D, Kurman R, et al . The 2001 Bethesda System: terminology for reporting results of cervical cytology. JAMA , 2002, 287(16): 2114-2119.
16.	Richart RM. Cervical intraepithelial neoplasia. Pathol Annu , 1973, 8: 301-328.
17.	de Vet HCW, Eisinga A, Riphagen II, et al . Searching for studies//Deeks JJ, Bossuyt PM, Gatsonis C. Cochrane Handbook for Diagnostic Test Accuracy Version 1.0.0. The Cochrane Collaboration 2008. Available from: URL: http://srdta.cochrane.org.
18.	Smidt N, Deeks J, Moore T. Guide to the contents of a Cochrane review and protocol for Diagnostic Test Accuracy version 1.0.1 (updated February 2008). The Conchrane Collaboration 2008. Available from: URL: http://srdta.cochrane.org.
19.	Whiting P, Rutjes AW, Reitsma JB, et al . The development of QUADAS: a tool for the quality assessment of studies of diagnostic accuracy included in systematic reviews. BMC Med Res Methodol 2003. Available from: URL: http://www.biomedcentral.com/1471-2288/3/25.
20.	Whiting PF, Weswood ME, Rutjes AW, et al . Evaluation of QUADAS, a tool for the quality assessment of diagnostic accuracy studies. BMC Med Res Methodol 2006. Available from: URL: http://www.biomedcentral.com/1471-2288/6/9.
21.	Cochran WG. The combination of estimates from different experiments. Biometrics , 1954, 10(6): 101-129.
22.	Higgins JP, Thompson SG, Deeks JJ, et al . Measuring inconsistency in meta-analyses. BMJ , 2003, 327(7414): 557-560.
23.	Lytwyn A, Sellors JW, Mahony JB, et al . Comparison of human papillomavirus DNA testing and repeat Papanicolaou test in women with low-grade cervical cytologic abnormalities: a randomized trial. CMAJ , 2000, 163(6): 701-707.
24.	Lytwyn A, Sellors JW, Mahony JB, et al . Adjunctive human papillomavirus testing in the 2-year follow-up of women with low-grade cervical cytologic abnormalities: a randomized trial and economic evaluation. Arch Pathol Lab Med , 2003, 127(9): 1169-1175.
25.	Sankaranarayanan R, Nene BM, Dinshaw KA, et al . A cluster randomized controlled trial of visual, cytology and human papillomavirus screening for cancer of the cervix in rural India. Int J Cancer , 2005, 116(4): 617-623.
26.	Kotaniemi-Talonen L, Nieminen P, Anttila1 A, et al . Cervical screening with primary HPV testing and cytology triage protocol in a randomized setting. British Journal of Cancer , 2005, 93(8): 862-867.
27.	Kotaniemi-Talonen L, Anttila A, Malila N, et al . Screening with a primary human papillomavirus test does not increase detection of cervical cancer and intraepithelial neoplasia 3. Eur J Cancer , 2008, 44(4): 565-571.
28.	Ronco G, Giorgi-Rossi P, Carozzi F, et al . Results at recruitment from a randomized controlled trial comparing human papillomavirus testing alone with conventional cytology as the primary cervical cancer screening test. J Natl Cancer Inst , 2008, 100(7): 492-501.
29.	Bjerre P, Silfverdal L, Dillner L, et al . A randomized trial of basing treatment on human papillomavirus and/or cytology results in low-grade cervical lesion triage. Am J Obstet Gynecol , 2008, 199(1): 24.e1-7.
30.	Giorgi-Rossi P, Segnan N, Zappa M, et al . The impact of new technologies in cervical cancer screening: results of the recruitment phase of a large randomised controlled trial from a public health perspective. Int J Cancer , 2007, 121(12): 2729-2734.
31.	Ronco G, Segnan N, Giorgi-Rossi P, et al . Human Papillomavirus testing and liquid-based cytology: results at recruitment from the new technologies for cervical cancer randomized controlled trial. J Natl Cancer Inst , 2006, 98(11): 765-774.
32.	Giorgi-Rossi P, Segnan N, Zappa M, et al . The impact of new technologies in cervical cancer screening: results of the recruitment phase of a large randomized controlled trial from a public health perspective. Int J Cancer , 2007, 121(12): 2729-2734.
33.	Disaia PJ, Creasman WT. Preinvasive disease of the cervix. Disaia PJCreasman WT editor. Clinical gynecologic oncology. 6th ed. Health Science Asia, Elsevier Science, 2002: 1-33.
34.	Edward E, Abu-Rustum N, Susan M, et al . Cervical Cancer Screening. V.1.2010. NCCN Clinical Practice Guidelines in Oncology. Available from: URL: http://www.nccn.org.
35.	Kitchener HC, Almonte M, Thomson C. HPV testing in combination with liquid-based cytology in primary cervical screening (ARTISTIC): a randomized controlled trial. Lancet Oncol , 2009, 10(7): 672-682.
36.	Kitchener HC, Almonte M, Gilham C. ARTISTIC: a randomised trial of human papillomavirus (HPV)testing in primary cervical screening. Health Technol Assess , 2009, 13(51): 1-150, iii-iv.

1. 1 Reeves WC, Quiroz E. Prevalence of sexually transmitted diseases in high-risk women in the Republic of Panama. Sex Transm Dis , 1987, 14(2): 69-74.
2. Morrison EA, Ho GY, Vermund SH, et al . Human papillomavirus infection and other risk factors for cervical neoplasia: case-control study. Int J Cancer , 1991, 49(1): 6-13.
3. Bosch FX, Muñoz N, de Sanjosé S, et al . Risk factors for cervical cancer in Colombia and Spain. Int J Cance r, 1992, 52(5): 750-758.
4. Bosch FX, Manos MM, Muñoz N, et al . Prevalence of human papillomavirus in cervical cancer: a worldwide perspective. International biological study on cervical cancer (IBSCC) Study Group. J Natl Cancer Inst , 1995, 87(11): 796-802.
5. Yamakawa Y, Forslund O, Teshima H, et al . Human papillomavirus DNA in adenocarcinoma and adenosquamous carcinoma of the uterine cervix detected by polymerase chain reaction (PCR). Gynecol Oncol , 1994, 53(2): 190-195.
6. Blumenthal PD, Gaffikin L, Chirenje ZM, et al . Adjunctive testing for cervical cancer in low resource settings with visual inspection, HPV, and the Pap smear. Int J Gynaecol Obstet , 2001, 72(1): 47-53.
7. Costa S, SideriM, Syrjanen K, et al . Combined Pap smear, cervicography and HPV DNA testing in the detection of cervical intraepithelial neoplasia and cancer. Acta Cytol , 2000, 44(3): 310-318.
8. Cuzick J, Szarewski A, Terry G, et al . Human papillomavirus testing in primary cervical screening. Lancet , 1995, 345(8964): 1533-1536.
9. Sherman ME, Lorincz AT, Scott DR, et al . Baseline cytology, human papillomavirus testing, and risk for cervical neoplasia: a 10-year cohort analysis. J Natl Cancer Inst , 2003, 95(1), 46-52.
10. Wu D, Ding L, Wu JH, et al . Application of liquid-based cytology and high-risk human papillomavirus DNA detection in cervical lesion screening. J South Med Nniv , 2007, 27(9): 1421-1423.
11. Arbyn M, Buntinx F, Van Ranst M, et al . Cytologic versus virologic triage of women with equivocal Pap smears: a meta-analysis of the accuracy to detect high-grade intraepithelial neoplasia. J Natl Cancer Inst , 2004, 96(4): 280-293.
12. Solomon D, Schiffman M. Have we resolved how to triage equivocal cervical cytology? J Natl Cancer Inst , 2004, 96(4): 250-251.
13. Paraskevaidis E, Arbyn M, Sotiriadis A, et al . The role of HPV testing in the follow up period after treatment for CIN: a systematic review of the literature. Cancer Treat Rev , 2004, 30(2): 205-211.
14. Arbyn M, Paraskevaidis E, Martin-Hirsch P, et al . Clinical utility of HPV DNA detection: triage of minor cervical lesions, follow-up of women treated for high-grade CIN. An update of pooled evidence. Gynecol Oncol , 2005, 99(Suppl 3): 7-11.
15. Solomon D, Davey D, Kurman R, et al . The 2001 Bethesda System: terminology for reporting results of cervical cytology. JAMA , 2002, 287(16): 2114-2119.
16. Richart RM. Cervical intraepithelial neoplasia. Pathol Annu , 1973, 8: 301-328.
17. de Vet HCW, Eisinga A, Riphagen II, et al . Searching for studies//Deeks JJ, Bossuyt PM, Gatsonis C. Cochrane Handbook for Diagnostic Test Accuracy Version 1.0.0. The Cochrane Collaboration 2008. Available from: URL: http://srdta.cochrane.org.
18. Smidt N, Deeks J, Moore T. Guide to the contents of a Cochrane review and protocol for Diagnostic Test Accuracy version 1.0.1 (updated February 2008). The Conchrane Collaboration 2008. Available from: URL: http://srdta.cochrane.org.
19. Whiting P, Rutjes AW, Reitsma JB, et al . The development of QUADAS: a tool for the quality assessment of studies of diagnostic accuracy included in systematic reviews. BMC Med Res Methodol 2003. Available from: URL: http://www.biomedcentral.com/1471-2288/3/25.
20. Whiting PF, Weswood ME, Rutjes AW, et al . Evaluation of QUADAS, a tool for the quality assessment of diagnostic accuracy studies. BMC Med Res Methodol 2006. Available from: URL: http://www.biomedcentral.com/1471-2288/6/9.
21. Cochran WG. The combination of estimates from different experiments. Biometrics , 1954, 10(6): 101-129.
22. Higgins JP, Thompson SG, Deeks JJ, et al . Measuring inconsistency in meta-analyses. BMJ , 2003, 327(7414): 557-560.
23. Lytwyn A, Sellors JW, Mahony JB, et al . Comparison of human papillomavirus DNA testing and repeat Papanicolaou test in women with low-grade cervical cytologic abnormalities: a randomized trial. CMAJ , 2000, 163(6): 701-707.
24. Lytwyn A, Sellors JW, Mahony JB, et al . Adjunctive human papillomavirus testing in the 2-year follow-up of women with low-grade cervical cytologic abnormalities: a randomized trial and economic evaluation. Arch Pathol Lab Med , 2003, 127(9): 1169-1175.
25. Sankaranarayanan R, Nene BM, Dinshaw KA, et al . A cluster randomized controlled trial of visual, cytology and human papillomavirus screening for cancer of the cervix in rural India. Int J Cancer , 2005, 116(4): 617-623.
26. Kotaniemi-Talonen L, Nieminen P, Anttila1 A, et al . Cervical screening with primary HPV testing and cytology triage protocol in a randomized setting. British Journal of Cancer , 2005, 93(8): 862-867.
27. Kotaniemi-Talonen L, Anttila A, Malila N, et al . Screening with a primary human papillomavirus test does not increase detection of cervical cancer and intraepithelial neoplasia 3. Eur J Cancer , 2008, 44(4): 565-571.
28. Ronco G, Giorgi-Rossi P, Carozzi F, et al . Results at recruitment from a randomized controlled trial comparing human papillomavirus testing alone with conventional cytology as the primary cervical cancer screening test. J Natl Cancer Inst , 2008, 100(7): 492-501.
29. Bjerre P, Silfverdal L, Dillner L, et al . A randomized trial of basing treatment on human papillomavirus and/or cytology results in low-grade cervical lesion triage. Am J Obstet Gynecol , 2008, 199(1): 24.e1-7.
30. Giorgi-Rossi P, Segnan N, Zappa M, et al . The impact of new technologies in cervical cancer screening: results of the recruitment phase of a large randomised controlled trial from a public health perspective. Int J Cancer , 2007, 121(12): 2729-2734.
31. Ronco G, Segnan N, Giorgi-Rossi P, et al . Human Papillomavirus testing and liquid-based cytology: results at recruitment from the new technologies for cervical cancer randomized controlled trial. J Natl Cancer Inst , 2006, 98(11): 765-774.
32. Giorgi-Rossi P, Segnan N, Zappa M, et al . The impact of new technologies in cervical cancer screening: results of the recruitment phase of a large randomized controlled trial from a public health perspective. Int J Cancer , 2007, 121(12): 2729-2734.
33. Disaia PJ, Creasman WT. Preinvasive disease of the cervix. Disaia PJCreasman WT editor. Clinical gynecologic oncology. 6th ed. Health Science Asia, Elsevier Science, 2002: 1-33.
34. Edward E, Abu-Rustum N, Susan M, et al . Cervical Cancer Screening. V.1.2010. NCCN Clinical Practice Guidelines in Oncology. Available from: URL: http://www.nccn.org.
35. Kitchener HC, Almonte M, Thomson C. HPV testing in combination with liquid-based cytology in primary cervical screening (ARTISTIC): a randomized controlled trial. Lancet Oncol , 2009, 10(7): 672-682.
36. Kitchener HC, Almonte M, Gilham C. ARTISTIC: a randomised trial of human papillomavirus (HPV)testing in primary cervical screening. Health Technol Assess , 2009, 13(51): 1-150, iii-iv.

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人類乳頭狀病毒檢測診斷宮頸癌前病變的價值：隨機對照研究的系統評價

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《中國循證醫學雜志》

人類乳頭狀病毒檢測診斷宮頸癌前病變的價值：隨機對照研究的系統評價

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