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[宫颈癌筛查中高危型人乳头瘤病毒检测分诊的结果与成本评估:皮埃蒙特(意大利西北部)的一项试点研究]

[Results and cost evaluation of triage with high risk HPV test in cervical cancer screening. A pilot study in Piedmont (North-West Italy)].

作者信息

Magnani Corrado, Gillio Tos Anna, De Marco Laura, Calvia Maria, Cipelletti Angela, Bestagini Piero, Pagano Eva, Segnan Nereo, Ronco Guglielmo

机构信息

SCDU epidemiologia dei tumori, CPO Piemonte, AOU Maggiore di Novara e Università del Piemonte orientale, Novara, Italy.

出版信息

Epidemiol Prev. 2012 Mar-Apr;36(2):88-94.

Abstract

OBJECTIVE

causal relation between high risk Papilloma virus and cervical carcinoma is definitely ascertained. HPV test is suggested both as primary screening test and as triage test for selecting women who should undergo colposcopy examination. Evidence is clear for triage after ASC-US cytology. A recent study suggested the implementation after LSIL cytology in women 35 or older but the issue is controversial.We present a pilot study on the implementation of HPV test triage in the framework of cervical cancer screening. The study was conducted in respect to: participation, predictive value, and cost analysis, separately for ASC-US and LSIL cytology.

DESIGN

HPV test was offered to women with Pap test result ASC-US or LSIL (35 and over), as an add-on to the "Prevenzione serena Screening Program" protocol. All samples were analyzed in the same specialized laboratory. HPV positive women were invited to colposcopy, negative will be invited at the scheduled interval for negative screening tests.

SETTING AND PARTICIPANTS

Piedmont (NW Italy), LHAs of Novara and Verbano. In the 1-year study period 15,614 Pap tests were performed: 153 women were eligible for the triage.

MAIN OUTCOME MEASURES

Participation at HPV test, HPV test results, costs.

RESULTS

ninety two percent of women invited to HPV test actually participated: 66.9% of them were positive (52.8% after ASC-US and 82.8% after LSIL). Regarding colposcopy and histological results, CIN2+ were 9.4% of positive HPV tests in ASC-US group and 17.1% in LSIL group. Cost analysis showed limited differences between triage (offered after ASC-US and LSIL cytology) and traditional protocol. Triage is economically convenient when limited to women with ASC-US cytology.

CONCLUSION

the pilot study demonstrated the feasibility of adding a triage phase with HPV test in cervical cancer screening protocol. Additional cost is balanced by the saving due to the reduction in the number of colposcopy exams: the process is economically convenient when limited to women with ASC-US cytology. When extended to LSIL cytology the marginal cost increases because of the higher prevalence of HPV positive results and total cost of triage with HPV test is close to the cost of immediate colposcopy referral.

摘要

目的

明确高危型乳头瘤病毒与宫颈癌之间的因果关系。人乳头瘤病毒(HPV)检测既被建议作为初步筛查检测,也被用作分流检测,以筛选出应接受阴道镜检查的女性。对于非典型鳞状细胞不能明确意义(ASC-US)细胞学检查后的分流,证据确凿。最近一项研究建议在35岁及以上女性的低度鳞状上皮内病变(LSIL)细胞学检查后进行HPV检测分流,但这个问题存在争议。我们开展了一项关于在宫颈癌筛查框架内实施HPV检测分流的试点研究。该研究分别针对ASC-US和LSIL细胞学检查的参与情况、预测价值和成本分析进行。

设计

将HPV检测提供给巴氏试验结果为ASC-US或LSIL(35岁及以上)的女性,作为“宁静预防筛查计划”方案的补充。所有样本均在同一专业实验室进行分析。HPV检测呈阳性的女性被邀请进行阴道镜检查,阴性者将按预定间隔被邀请进行阴性筛查检测。

地点和参与者

意大利西北部皮埃蒙特地区诺瓦拉和韦尔巴诺的地方卫生机构。在为期1年的研究期间,共进行了15614次巴氏试验:153名女性符合分流检测条件。

主要观察指标

HPV检测的参与情况、HPV检测结果、成本。

结果

受邀进行HPV检测的女性中有92%实际参与:其中66.9%检测呈阳性(ASC-US检查后为52.8%,LSIL检查后为82.8%)。关于阴道镜检查和组织学结果,ASC-US组中HPV检测呈阳性者的高级别鳞状上皮内病变(CIN2+)占9.4%,LSIL组中占17.1%。成本分析显示,分流检测(ASC-US和LSIL细胞学检查后进行)与传统方案之间差异有限。当仅限于ASC-US细胞学检查的女性时,分流检测在经济上是可行的。

结论

试点研究证明了在宫颈癌筛查方案中增加HPV检测分流阶段的可行性。由于阴道镜检查次数减少所节省的费用平衡了额外成本:当仅限于ASC-US细胞学检查的女性时,该过程在经济上是可行的。当扩展到LSIL细胞学检查时,由于HPV阳性结果的患病率较高,边际成本增加,且HPV检测分流的总成本接近直接转诊进行阴道镜检查的成本。

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