Chen Cheng-Chieh, Huang Lee-Wen, Bai Chyi-Huey, Lee Chin-Cheng
Dr. Chin-Cheng Lee, Department of Pathology and Laboratory Medicine,, Shin Kong Wu Ho-Su Memorial Hospital,, No. 95, Wen Change Road, Shih Lin District,, Taipei City, Taipei, 111 Taiwan, T: 886-2-28332211 ext. 2121,, F: 886-2-28389360,
Ann Saudi Med. 2016 Jul-Aug;36(4):245-51. doi: 10.5144/0256-4947.2016.245.
The Papanicolaou (Pap) test is one screening strategy used to prevent cervical cancer in developed countries. The p16/Ki-67 immunocytochemistry is a triage test performed on Pap smears in women with atypical squamous cells of undetermined significance (ASCUS) or low grade squamous intraepithelial lesion.
Our objective was to review studies investigating the diagnostic performance of p16/Ki-67 dual stain for triage of women with abnormal Pap tests.
We conducted a systematic review and meta-analysis of diagnostic test accuracy studies.
We followed the protocol of systematic review of diagnostic accuracy studies.
We searched PubMed, The Cochrane Library, BioMed Central, and ClinicalTrials.gov for relevant studies. We included research that assessed the accuracy of p16/Ki-67 dual stain and high risk human papillomavirus testing for triage of abnormal Pap smears. Review articles and studies that provided insufficient data to construct 2.2 tables were excluded. Data synthesis was conducted using a random-effects model.
Sensitivity and specificity.
In seven studies encompassing 2628 patients, the pooled sensitivity and specificity of p16/Ki-67 for triage of abnormal Pap smear results were 0.91 (95% CI, 0.89 to 0.93) and 0.64 (95% CI, 0.62 to 0.66), respectively. No study used a case-control design. A subgroup analysis involving liquid-based cytology showed a sensitivity of 0.91 (95%CI, 0.89 to 0.93) and specificity of 0.64 (95%CI, 0.61 to 0.66).
Our meta-analysis of p16/Ki-67 dual stain studies showed that the test achieved high sensitivity and moderate specificity for p16/Ki-67 immunocytochemistry for high-grade squamous intraepi.thelial lesion and cervical cancer. We suggest that p16/Ki-67 dual stain might be a reliable ancillary method identifying high-grade squamous intraepithelial lesions in women with abnormal Pap tests.
No study in the meta-analysis examined the accuracy of the p16/Ki-67 dual stain for inter.pretation of glandular neoplasms.
巴氏涂片检查是发达国家用于预防宫颈癌的一种筛查策略。p16/Ki-67免疫细胞化学检测是对意义不明确的非典型鳞状细胞（ASCUS）或低级别鳞状上皮内病变的女性进行巴氏涂片检查时所做的分流检测。
我们的目的是回顾研究p16/Ki-67双重染色对异常巴氏涂片检查女性进行分流的诊断性能。
我们对诊断试验准确性研究进行了系统评价和荟萃分析。
我们遵循诊断准确性研究系统评价的方案。
我们在PubMed、Cochrane图书馆、BioMed Central和ClinicalTrials.gov上搜索相关研究。我们纳入了评估p16/Ki-67双重染色和高危人乳头瘤病毒检测对异常巴氏涂片检查进行分流准确性的研究。排除了综述文章和提供的数据不足以构建2×2表格的研究。使用随机效应模型进行数据合成。
敏感性和特异性。
在纳入2628例患者的7项研究中，p16/Ki-67对异常巴氏涂片检查结果进行分流的合并敏感性和特异性分别为0.91（95%CI，0.89至0.93）和0.64（95%CI，0.62至0.66）。没有研究采用病例对照设计。一项涉及液基细胞学的亚组分析显示敏感性为0.91（95%CI，0.89至0.93），特异性为0.64（95%CI，0.61至0.66）。
我们对p16/Ki-67双重染色研究的荟萃分析表明，该检测对p16/Ki-67免疫细胞化学检测高级别鳞状上皮内病变和宫颈癌具有高敏感性和中度特异性。我们建议p16/Ki-67双重染色可能是一种可靠的辅助方法，用于识别巴氏涂片检查异常的女性中的高级别鳞状上皮内病变。
荟萃分析中没有研究检验p16/Ki-67双重染色对腺性肿瘤判读的准确性。
