Division of Laboratory Medicine and the Preventive Gynecology Unit, European Institute of Oncology IRCCS, the Clinical Analysis Laboratory, Humanitas Research Hospital, Rozzano, and ASST-Monza, University of Milano-Bicocca, Milan, Italy; and Becton, Dickinson and Company, BD Life Sciences-Diagnostic Systems, Sparks, Maryland.
Obstet Gynecol. 2019 Sep;134(3):452-462. doi: 10.1097/AOG.0000000000003409.
To systematically examine human papillomavirus (HPV) genotyping compared with qualitative high-risk HPV result during follow-up after treatment of high-grade cervical intraepithelial neoplasia (CIN), for risk estimation of posttreatment high-grade CIN.
MEDLINE, Cochrane, and ClinicalTrials.gov were searched from January 2000 to April 2019 for prospective studies of women and retrospective studies of residual specimens from women, tested using HPV assays with genotype reporting.
The primary outcome was posttreatment high-grade CIN after treatment of high-grade CIN. Risk of bias (individual study quality) was evaluated with a modified Newcastle-Ottawa Scale. Overall quality of evidence for the risk estimate outcomes was evaluated using modified GRADE methodology for observational diagnostic studies.
TABULATION, INTEGRATION, AND RESULTS: Of the 233 identified abstracts, 33 full-text articles were retrieved, and seven studies were included in the synthesis. The risk of bias was deemed to be low. Either a positive qualitative HPV test result or a positive test result for the same genotype that was present pretreatment have a sensitivity for predicting posttreatment high-grade CIN that approaches 100%. However, the positive predictive value (PPV) for the same genotype result pretreatment and posttreatment (median 44.4%) is about double the PPV (median 22.2%) for qualitative HPV results. The PPV of a new HPV infection posttreatment approximates zero. Human papillomavirus genotyping discriminated risk of posttreatment high-grade CIN to a clinically significant degree for women after treatment procedures for high-grade CIN lesions, when same-genotype persistence was compared with new genotype infection.
There is moderately high-quality evidence to support the improved clinical utility of HPV genotyping compared with qualitative HPV positivity to follow-up after treatment of high-grade CIN.
PROSPERO: CRD42018091095.
Becton, Dickinson and Company, BD Life Sciences-Diagnostic Systems.
系统评估人乳头瘤病毒（HPV）基因分型与高级别宫颈上皮内瘤变（CIN）治疗后随访中定性高危型 HPV 结果相比，对治疗后高级别 CIN 的风险估计。
从 2000 年 1 月到 2019 年 4 月，检索 MEDLINE、Cochrane 和 ClinicalTrials.gov，以寻找关于女性的前瞻性研究和关于女性残留标本的回顾性研究，这些研究均使用可报告基因型的 HPV 检测方法进行检测。
主要结局是治疗高级别 CIN 后发生治疗后高级别 CIN。使用改良的 Newcastle-Ottawa 量表评估个体研究质量的偏倚风险（个体研究质量）。使用改良的 GRADE 方法评估观察性诊断研究中风险估计结果的总体证据质量。
列表、综合和结果：在 233 篇摘要中，有 33 篇全文文章被检索到，其中有 7 项研究被纳入综合分析。偏倚风险被认为是低的。无论是定性 HPV 检测阳性结果还是治疗前存在的相同基因型阳性检测结果，其预测治疗后高级别 CIN 的敏感性均接近 100%。然而，治疗前和治疗后相同基因型结果的阳性预测值（PPV）（中位数为 44.4%）约为定性 HPV 结果的阳性预测值（中位数为 22.2%）的两倍。治疗后新发 HPV 感染的 PPV 接近零。HPV 基因分型在高级别 CIN 病变治疗后随访中，与新基因型感染相比，对相同基因型持续存在的情况下，对高级别 CIN 女性的风险评估具有重要的临床意义。
有中等质量的证据支持 HPV 基因分型在高级别 CIN 治疗后随访中的临床应用优于定性 HPV 阳性检测。
PROSPERO：CRD42018091095。
Becton，Dickinson and Company，BD Life Sciences-Diagnostic Systems。
