Does liquid-based technology really improve detection of cervical neoplasia? A prospective, randomized trial comparing the ThinPrep Pap Test with the conventional Pap Test, including follow-up of HSIL cases
Does liquid-based technology really improve detection of cervical neoplasia? A prospective, randomized trial comparing the ThinPrep Pap Test with the conventional Pap Test, including follow-up of HSIL cases
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DOI：
10.1159/000328292
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发表时间：
2001-09-01
期刊：
影响因子：
1.8
通讯作者：
Brack, S
中科院分区：
文献类型：
--
作者：
Obwegeser, JH;Brack, S
目的：为了比较敏感性，特异性和标本充分的ThinPrep巴氏试验（TP）与传统的巴氏试验（CV）在低风险人群与随后的后续HSIL cases.Study设计：一个前瞻性的，随机的，对照设计被选择来比较TP与CV。评价细胞学诊断和标本充分性，并与组织学资料比较，在高度鳞状上皮内病变（HSIL）病例。15名接受过阴道镜检查培训的私人执业妇科医生参加了试验，比较两组细胞学诊断HSIL病例的细胞学诊断、标本充足性和随访情况。总共纳入了1，999例患者，TP组997例，CV组1，002例。在细胞学病例报告表上指定随机分配，并将其置于缩放信封中。每个信封有一个顺序的随机化号码在外面，以允许跟踪和认证的随机assigns.RESULTS：CV和TP之间的结果比较显示，在所有的诊断类别，从“正常范围内”HSIL没有统计学上的显着差异。然而，CV的标本充分性优于上级（P < .001）。HSIL的细胞学诊断与组织学诊断在91%的TP组和100%的CV group.CONCLUSION：因为没有统计学上的显着差异，两种技术的敏感性和特异性，改善宫颈异常的检测和更好的标本充分性可能不是一个后果，利用液体为基础的制剂，但一个更好的采样技术。在采集细胞样本之前，用纤维素拭子清除宫颈表面的粘液和细胞碎片。使用适当的采样装置，可以获得相同的灵敏度和样本充足性，并且比液基技术便宜得多。
OBJECTIVE: To compare the sensitivity, specificity and specimen adequacy of the ThinPrep Pap Test (TP) with the conventional Pap Test (CV) in a low-risk population with subsequent follow-up of HSIL cases.STUDY DESIGN: A prospective, randomized, controlled design was chosen to compare the TP with CV. Cytologic diagnosis and specimen adequacy were evaluated and compared with histology data ill high grade squamous intraepithelial lesion (HSIL) cases. Fifteen gynecologists in private practice, all trained in colposcopy, participated hi the trial, Cytologic diagnosis, specimen adequacy and follow-up of the cytologic HSIL cases were compared in the two groups. In total, 1,999 patients were included, 997 in the TP group and 1,002 in the CV group. Randomization assignments were designated on cytology case report forms, which were placed in scaled envelopes. Each envelope had a sequential randomization number on the outside to allow tracking and authentication of randomization assignments.RESULTS: Comparison of results between CVs and TPs revealed no statistically significant differences in all diagnostic categories, ranging from "within normal limits" to HSIL. Specimen adequacy, however, was superior with CVs (P < .001). The cytologic diagnosis of HSIL correlated with the histologic diagnosis in 91 % of the TP group and 100% of the CV group.CONCLUSION: Because there was no statistically significant difference in sensitivity and specificity of the two techniques, improved detection of cervical abnormalities and better specimen adequacy might not be a consequence of utilizing liquid-based preparations but of a better sampling technique. Removing mucus and cellular debris from the cervical surface with a cellulose swab before sampling cells With a proper Sampling device results in the same sensitivity and specimen adequacy and is much less expensive than the liquid-based technique.