Carpenter A B, Davey D D
Department of Pathology and Laboratory Medicine, University of Kentucky Chandler Medical Center, Lexington, USA.
Cancer. 1999 Jun 25;87(3):105-12. doi: 10.1002/(sici)1097-0142(19990625)87:3<105::aid-cncr2>3.0.co;2-z.
The ThinPrep Pap Test (TP), a liquid-based cervical cytology preparation, was approved for use in the U.S. in 1996. The purpose of this study was to compare TP performance and biopsy follow-up studies with a similar population of high risk patients sampled by conventional Papanicolaou (Pap) smear (CS).
Diagnostic and specimen adequacy interpretations for 2727 TP direct-to-vial Pap tests from a high risk university hospital practice were compared with 5000 CS preparations from the same physicians taken 1 year previously. Biopsy follow-up studies for the categories of squamous intraepithelial lesion (SIL), carcinoma, and atypical squamous cells of undetermined significance (ASCUS) for each time period and technique were contrasted.
The SIL/carcinoma detection rate increased from 7.7% to 10.5% (P < 0.01) and the ASCUS rate decreased from 12.5% to 6.9% (P < 0.01); the percentage of satisfactory but limited specimens decreased from 19.4% to 10.5% (P < 0.01). Low grade SIL cases increased by 57% (P < 0.01) whereas the 26% increase in high grade SIL cases was not statistically significant. Greater than 90% of ungraded SIL, high grade SIL, and carcinoma cases had abnormal biopsies by both the TP and CS methods. The number of biopsy-confirmed high grade dysplasias and carcinomas was similar in the two groups. A low grade SIL detected by TP was less likely to have an abnormal biopsy (70% vs. 85% for CS). Nevertheless, the 57% increase in low grade SIL diagnoses by TP resulted in more TP patients with dysplastic biopsy diagnoses. Follow-up studies for ASCUS cases diagnosed by either TP or CS were similar, and 21-24% of patients eventually were found to have dysplasia.
The TP technique appears to lead to the increased detection of low grade SIL lesions, decreased satisfactory but limited samples, and fewer equivocal specimens. No increase in biopsy-confirmed high grade dysplasias and carcinomas was found. Follow-up studies for the ASCUS category were nearly identical to those for CS.
薄层液基宫颈细胞学检测（ThinPrep Pap Test，TP）是一种液基宫颈细胞学制片方法，于1996年在美国获得批准使用。本研究的目的是比较TP检测性能以及活检随访研究结果与采用传统巴氏涂片（conventional Papanicolaou smear，CS）对相似高危患者群体进行采样的情况。
将一所高危大学医院的2727例TP直接制片的巴氏检测的诊断及标本充足性解读，与同一批医生一年前采集的5000例CS制片进行比较。对每个时间段和技术的鳞状上皮内病变（squamous intraepithelial lesion，SIL）、癌以及意义不明确的非典型鳞状细胞（atypical squamous cells of undetermined significance，ASCUS）类别进行活检随访研究对比。
SIL/癌的检出率从7.7%增至10.5%（P<0.01），ASCUS率从12.5%降至6.9%（P<0.01）；满意但有限标本的比例从19.4%降至10.5%（P<0.01）。低级别SIL病例增加了57%（P<0.01），而高级别SIL病例增加26%，差异无统计学意义。超过90%的未分级SIL、高级别SIL和癌病例，TP和CS方法的活检结果均异常。两组活检确诊的高级别发育异常和癌的数量相似。TP检测出的低级别SIL进行活检结果异常的可能性较小（CS为85%，TP为70%）。然而，TP检测出的低级别SIL诊断增加了57%，导致更多TP患者活检诊断为发育异常。TP或CS诊断的ASCUS病例的随访研究结果相似，最终21%-24%的患者被发现有发育异常。
TP技术似乎能增加低级别SIL病变的检出率，减少满意但有限的样本以及可疑标本数量。活检确诊的高级别发育异常和癌的数量未增加。ASCUS类别的随访研究结果与CS几乎相同。
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