Ziemke P, Griesser H
, Kutscherweg 2, 14469, Potsdam, Deutschland.
FB Pathologie und Zytologie, Labor Wisplinghoff, Classen-Kappelmann-Str. 24, 50931, Köln, Deutschland.
Pathologe. 2017 Feb;38(1):38-44. doi: 10.1007/s00292-016-0262-9.
The p16/Ki-67 immunocytochemistry has been used for more than five years in cervical cytology to detect transforming HPV infections.
Based on findings in the study presented here and data in the literature, practically relevant indications for this test are to be determined. The clinical course of 1109 patients with varying primary cytology results and simultaneous immunocytochemistry is analyzed. Short-term observations considering currently present lesions and long-term follow-up evaluation aimed at the prognostic evaluation are studied separately and compared with the literature.
The p16/Ki-67 immunocytochemistry effectiveness is described by the relative risk (RR) for the positive endpoint CIN2+. For short-term observations (n = 409) a RR of 3.79 (CI 95% 2.15 to 6.67) and for long-term follow-up (n = 700) after an average 34.7 months a RR of 8.72 (CI 95% 5.77 to 13.17) was found. The highest RR of 6.32 (CI 95% 3.71 to 10.76) was determined for the group IIID1/LSIL, followed by 3.98 (95% CI 1.45 to 10.91) for the group III-p (ASC-H).
Regardless of the study designs and significant differences of the resulting statistics in the literature, there is consensus concerning the significantly higher specificity and positive prediction of the p16/Ki-67 immunocytochemistry compared to cytology or HPV DNA test results. Therefore, p16/Ki-67 immunocytochemistry is useful in cases of persistent group IIID1/LSIL and equivocal cytological findings (group III-p/ASC-H). Especially in the former group, the frequency of colposcopic examinations can be reduced. In this respect, adding p16/Ki-67 immunochemistry likely improves patient management. However, an indication for treatment solely based upon a positive immunocytochemical finding is unjustified.
p16/Ki-67免疫细胞化学已在宫颈细胞学中应用超过五年，用于检测转化型人乳头瘤病毒（HPV）感染。
基于本研究结果及文献数据，确定该检测的实际相关指征。分析了1109例初筛细胞学结果各异且同时进行免疫细胞化学检测患者的临床病程。分别研究了考虑当前病变的短期观察结果以及旨在进行预后评估的长期随访评估结果，并与文献进行比较。
p16/Ki-67免疫细胞化学有效性通过阳性终点CIN2+的相对风险（RR）来描述。短期观察（n = 409）时RR为3.79（95%可信区间2.15至6.67），平均34.7个月的长期随访（n = 700）时RR为8.72（95%可信区间5.77至13.17）。IIID1/LSIL组的RR最高，为6.32（95%可信区间3.71至10.76），其次是III-p（ASC-H）组，为3.98（95%可信区间1.45至10.91）。
无论文献中的研究设计及所得统计数据的显著差异如何，与细胞学或HPV DNA检测结果相比，p16/Ki-67免疫细胞化学具有显著更高的特异性和阳性预测值，这一点已达成共识。因此，p16/Ki-67免疫细胞化学在持续性IIID1/LSIL及细胞学结果不明确（III-p/ASC-H组）的病例中有用。特别是在前一组中，可减少阴道镜检查的频率。在这方面，增加p16/Ki-67免疫化学检测可能改善患者管理。然而，仅基于免疫细胞化学检测阳性结果进行治疗的指征是不合理的。
