结合我国子宫颈癌前病变和子宫颈癌发病情况以及全球子宫颈癌筛查策略,为实现消除子宫颈癌的目标,我国七个学(协)会专家共同制定了子宫颈癌筛查指南(二).本指南重点在于规范子宫颈癌筛查结果异常的分流方法,其目的是通过精细化管理,避免过度诊断与漏诊.高危型人乳头瘤病毒(high-risk human papillomavirus,HR-HPV)检测初筛阳性人群以子宫颈细胞学检查为主要分流方法;子宫颈细胞学初筛阳性人群以其结果的不同风险进行管理.此外,p16/Ki-67双重染色用于HR-HPV初筛不分型检测阳性或非HPV16/18的其他12种HR-HPV检测(简称12 HR-HPV)阳性的分流,也可用于联合筛查中HR-HPV不分型检测阳性或12 HR-HPV阳性,同时细胞学检查为未见上皮内病变或恶性细胞(negative for intraepithelial lesion or malignancy,NILM);未明确诊断意义的不典型鳞状细胞(atypical squa-mous cells of undetermined significance,ASC-US)和低级别鳞状上皮内病变(low-grade squamous intraepithe-lial lesion,LSIL)的分流;甲基化检测可用于12 HR-HPV阳性人群的分流.根据目前我国研究结果,HPV基因整合检测也可用于HR-HPV初筛阳性的分流.以上新的检测方法均需选择经国内外权威机构认可、临床试验验证有相关适应证的试剂.HPV拓展分型或HPV载量等其他方法还需积累更多的临床证据.
Guidelines for cervical cancer screening in China Ⅱ
In response to the incidence of cervical intraepithelial neoplasia and cervical cancer in China and global screening strategies,a collaborative effort was undertaken by seven Chinese medical societies to de-velop this guideline Ⅱ for cervical cancer screening.This guide focuses on standardizing methods for triaging abnormal cervical cancer screening results,with the aim of reducing overdiagnosis and missed diagnosis through refined management.Cervical cytology is currently the main triage method for individuals with positive high-risk human papillomavirus(HR-HPV)detection.Primary screening with cytology is managed based on the different risks of their results.In addition,p16/Ki-67 dual stain(DS)is acceptable for triage HPV-positive test results without genotyping or those positive for other(non-16/18)HR-HPV types(12 HR-HPV).It can also be used for triage in co-testing with HPV-positive results(no genotyping or 12 HR-HPV)when the cytology result shows NILM,ASC-US and LSIL.Methylation is acceptable for triage of individuals testing 12 HR-HPV-positive.HPV gene integration testing could be used for the triage of HR-HPV positive individuals based on current research results in China.All these new testing methods must utilize reagents that have been approved by authoritative in-stitutions and clinically validated for relevant indications.Additional clinical evidence is required for other meth-ods such as HPV extended genotyping or HPV viral load,etc.
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