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30岁以上女性宫颈癌筛查中,初级人乳头瘤病毒检测、细胞学检查及联合检测的成本效益分析

Cost-Effectiveness of Primary HPV Testing, Cytology and Co-testing as Cervical Cancer Screening for Women Above Age 30 Years.

作者信息

Jin Xian Wen, Lipold Laura, Foucher Julie, Sikon Andrea, Brainard Jennifer, Belinson Jerome, Schramm Sarah, Nottingham Kelly, Hu Bo, Rothberg Michael B

机构信息

Department of Internal Medicine, Cleveland Clinic, Cleveland, OH, USA.

Department of Family Medicine, Cleveland Clinic, Cleveland, OH, USA.

出版信息

J Gen Intern Med. 2016 Nov;31(11):1338-1344. doi: 10.1007/s11606-016-3772-5. Epub 2016 Jul 14.

Abstract

BACKGROUND

Cervical cancer screening guidelines for women aged ≥30 years allow for co-testing or primary cytology testing. Our objective was to determine the test characteristics and costs associated with Cytology, HPV and Co-testing screening strategies.

MAIN METHODS

Retrospective cohort study of women undergoing cervical cancer screening with both cytology and HPV (Hybrid Capture 2) testing from 2004 to 2010 in an integrated health system. The electronic health record was used to identify women aged ≥30 years who had co-testing. Unsatisfactory or unavailable test results and incorrectly ordered tests were excluded. The main outcome was biopsy-proven cervical intraepithelial neoplasia grade 3 or higher (CIN3+).

KEY RESULTS

The final cohort consisted of 99,549 women. Subjects were mostly white (78.4 %), married (70.7 %), never smokers (61.3 %) and with private insurance (86.1 %). Overall, 5121 (5.1 %) tested positive for HPV and 6115 (6.1 %) had cytology ≥ ASCUS; 1681 had both and underwent colposcopy and 310 (0.3 %) had CIN3+. Sensitivity for CIN3+ was 91.9 % for Primary Cytology, 99.4 % for Co-testing, and 94.8 % for Primary HPV; specificity was 97.3 % for Co-testing and Primary Cytology and 97.9 % for Primary HPV. Over a 3-year screening interval, Primary HPV detected more cases of CIN3+ and was less expensive than Primary Cytology. Co-testing detected 14 more cases of CIN3+ than Primary HPV, but required an additional 100,277 cytology tests and 566 colposcopies at an added cost of $2.38 million, or $170,096 per additional case detected.

CONCLUSIONS

Primary HPV was more effective and less expensive than Primary Cytology. Primary HPV screening appears to represent a cost-effective alternative to Co-testing.

摘要

背景

针对30岁及以上女性的宫颈癌筛查指南允许联合检测或采用单纯细胞学检测。我们的目标是确定与细胞学、人乳头瘤病毒(HPV)检测及联合检测筛查策略相关的检测特征和成本。

主要方法

对2004年至2010年在一个综合卫生系统中同时接受细胞学和HPV(杂交捕获2代)检测的宫颈癌筛查女性进行回顾性队列研究。利用电子健康记录识别接受联合检测的30岁及以上女性。排除不满意或无法获得的检测结果以及检测医嘱错误的情况。主要结局是经活检证实的宫颈上皮内瘤变3级或更高级别(CIN3+)。

关键结果

最终队列包括99549名女性。研究对象大多为白人(78.4%)、已婚(70.7%)、从不吸烟(61.3%)且拥有私人保险(86.1%)。总体而言,5121人(5.1%)HPV检测呈阳性,6115人(6.1%)细胞学检查结果≥非典型鳞状细胞不能明确意义(ASCUS);1681人两者均有并接受了阴道镜检查,310人(0.3%)患有CIN3+。CIN3+的敏感度在单纯细胞学检测中为91.9%,联合检测中为99.4%,单纯HPV检测中为94.8%;联合检测和单纯细胞学检测的特异度为97.3%,单纯HPV检测的特异度为97.9%。在3年的筛查间隔期内,单纯HPV检测发现的CIN3+病例更多,且成本低于单纯细胞学检测。联合检测比单纯HPV检测多发现14例CIN3+病例,但需要额外进行100277次细胞学检查和566次阴道镜检查,额外成本为238万美元,即每多发现一例病例需增加成本170096美元。

结论

单纯HPV检测比单纯细胞学检测更有效且成本更低。单纯HPV筛查似乎是联合检测的一种具有成本效益的替代方案。

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