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基于意义不明确的非典型鳞状细胞/低级别鳞状上皮内病变分流研究(ALTS)的成本效益分析。

Cost-effectiveness analysis based on the atypical squamous cells of undetermined significance/low-grade squamous intraepithelial lesion Triage Study (ALTS).

作者信息

Kulasingam Shalini L, Kim Jane J, Lawrence William F, Mandelblatt Jeanne S, Myers Evan R, Schiffman Mark, Solomon Diane, Goldie Sue J

机构信息

Department of Obstetrics and Gynecology, Duke University, Durham, NC, USA.

出版信息

J Natl Cancer Inst. 2006 Jan 18;98(2):92-100. doi: 10.1093/jnci/djj009.

Abstract

BACKGROUND

The ALTS (atypical squamous cells of undetermined significance [ASCUS] and low-grade squamous intraepithelial lesion [LSIL] Triage Study) suggests that, for women diagnosed with ASCUS, human papillomavirus (HPV) DNA testing followed by referral to colposcopy of only those women with oncogenic HPV (i.e., HPV DNA testing) is as effective at detecting cervical intraepithelial neoplasia (CIN) 3 or cancer (CIN3+) as referring all women with ASCUS for immediate colposcopy. We conducted a cost-effectiveness analysis of the ALTS trial to determine whether HPV DNA testing is a cost-effective alternative to immediate colposcopy or conservative management with up to three cytology examinations.

METHODS

Data from the ALTS trial were used in conjunction with medical care costs in a short-term decision model. The model compared the incremental costs per case of CIN3+ detected as measured by the incremental cost-effectiveness ratio (ICER) for the following management strategies for women with ASCUS: immediate colposcopy, HPV DNA testing, and conservative management with up to three cytology examinations.

RESULTS

The least costly and least sensitive strategy was conservative management with one repeat cytology examination using a threshold of high-grade squamous intraepithelial lesion (HSIL) for referral to colposcopy. Compared with this strategy, triage to colposcopy based on a positive HPV DNA test result had an ICER of 3517 dollars per case of CIN3+ detected. Immediate colposcopy and conservative management with up to three repeat cytology visits detected fewer cases of CIN3+ and were more costly than HPV DNA testing. Immediate colposcopy became cost-effective at 20,370 dollars compared with HPV DNA testing only if colposcopy and biopsy were assumed to be 100% sensitive.

CONCLUSIONS

HPV DNA testing is an economically viable strategy for triage of ASCUS cytology. The less than perfect sensitivity of colposcopy and biopsy needs to be accounted for in future clinical guidelines and policy analyses.

摘要

背景

非典型鳞状细胞意义不明确(ASCUS)和低度鳞状上皮内病变(LSIL)分流研究(ALTS)表明,对于诊断为ASCUS的女性,人乳头瘤病毒(HPV)DNA检测后仅将致癌性HPV阳性的女性(即HPV DNA检测阳性者)转诊至阴道镜检查,在检测宫颈上皮内瘤变(CIN)3级或癌症(CIN3+)方面与将所有ASCUS女性直接转诊至阴道镜检查同样有效。我们对ALTS试验进行了成本效益分析,以确定HPV DNA检测相对于直接阴道镜检查或进行最多三次细胞学检查的保守管理而言是否为具有成本效益的替代方案。

方法

在一个短期决策模型中,将ALTS试验的数据与医疗费用相结合。该模型比较了ASCUS女性以下管理策略每检测出一例CIN3+的增量成本,增量成本通过增量成本效益比(ICER)来衡量:直接阴道镜检查、HPV DNA检测以及进行最多三次细胞学检查的保守管理。

结果

成本最低且敏感性最低的策略是进行一次重复细胞学检查的保守管理,使用高级别鳞状上皮内病变(HSIL)阈值来转诊至阴道镜检查。与该策略相比,基于HPV DNA检测阳性结果分流至阴道镜检查每检测出一例CIN3+的ICER为3517美元。直接阴道镜检查以及进行最多三次重复细胞学检查的保守管理检测出的CIN3+病例较少,且成本高于HPV DNA检测。仅当假设阴道镜检查和活检的敏感性为100%时,直接阴道镜检查与HPV DNA检测相比在成本效益方面才达到20370美元。

结论

HPV DNA检测是对ASCUS细胞学进行分流的一种经济可行的策略。阴道镜检查和活检的敏感性并非完美,这一点在未来的临床指南和政策分析中需要予以考虑。

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