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宫颈病变可疑女性行宫颈管取样:诊断试验准确性研究的系统评价和荟萃分析。

Endocervical sampling in women with suspected cervical neoplasia: a systematic review and meta-analysis of diagnostic test accuracy studies.

机构信息

Department of Gynecology and Obstetrics, Amager and Hvidovre Hospital, Copenhagen University, Hvidovre, Denmark.

Department of Gynecology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.

出版信息

Am J Obstet Gynecol. 2022 Dec;227(6):839-848.e4. doi: 10.1016/j.ajog.2022.07.036. Epub 2022 Aug 4.

DOI:10.1016/j.ajog.2022.07.036
PMID:35934116
Abstract

OBJECTIVE

Endocervical sampling in women with suspected cervical neoplasia can be performed by either endocervical brush or endocervical curettage. This study aimed to estimate the diagnostic accuracy, discomfort, and number of inadequate samples with either test.

DATA SOURCES

Four bibliographic databases were searched on June 9, 2022, with no date or language restrictions.

STUDY ELIGIBILITY CRITERIA

We included all diagnostic studies and randomized clinical trials that compared the endocervical brush with endocervical curettage in women with an indication for colposcopy.

METHODS

The review protocol was registered on the International Prospective Register of Systematic Reviews (PROSPERO) (CRD42021222406). Two authors independently screened studies, extracted data, performed the risk-of-bias assessment (Quality Assessment of Diagnostic Accuracy Studies-2), and rated the certainty of the evidence using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology. A meta-analysis of diagnostic test accuracy was performed using a bivariate random-effects model.

RESULTS

We included 7 studies: 4 diagnostic cohort studies and 3 randomized clinical trials. The reference standard was conization or hysterectomy. Risk of bias and concern about applicability were high for some of the studies in patient selection and flow and timing. Overall pooled sensitivity was 81% (95% confidence interval, 48-95; 799 women; 7 studies; low quality of evidence) for endocervical brush and 70% (95% confidence interval, 42-89; 761 women; 7 studies; low quality of evidence) for endocervical curettage. Overall pooled specificity was 73% (95% confidence interval, 36-93; 799 women; 7 studies; low quality of evidence) for endocervical brush and 81% (95% confidence interval, 56-94; 761 women; 7 studies; low quality of evidence) for endocervical curettage. The risk ratio for inadequate samples with endocervical curettage compared with endocervical brush was 2.53 (95% confidence interval, 0.58-11.0; P=.215; low-certainty evidence). Two studies reported on patient discomfort; one found less discomfort in the endocervical brush group, and the other found no difference.

CONCLUSION

No difference was found between endocervical brush and endocervical curettage in diagnostic accuracy, inadequate sampling rate, and adverse effects based on low-quality of evidence. Variation in the characteristics of women and the resulting diagnostic pathways make the external validity limited.

摘要

目的

对于疑似宫颈癌前病变的女性,可通过宫颈刷或宫颈刮匙进行宫颈内取样。本研究旨在评估这两种检测方法的诊断准确性、不适程度和样本不足的数量。

资料来源

于 2022 年 6 月 9 日检索了四个文献数据库,未设置日期或语言限制。

研究入选标准

纳入了所有比较宫颈刷和宫颈刮匙在有阴道镜适应证的女性中应用的诊断性研究和随机临床试验。

方法

本综述方案已在国际前瞻性系统评价注册库(PROSPERO)(CRD42021222406)进行了注册。两名作者独立筛选研究、提取数据、进行诊断准确性研究质量评估(QUADAS-2),并使用推荐评估、制定与评价(GRADE)方法评估证据质量。使用双变量随机效应模型进行诊断试验准确性的荟萃分析。

结果

我们纳入了 7 项研究:4 项诊断性队列研究和 3 项随机临床试验。参考标准为子宫颈锥形切除术或子宫切除术。一些研究在患者选择、流程和时间方面存在较高的偏倚风险和适用性担忧。宫颈刷的总体汇总敏感性为 81%(95%置信区间,48-95;799 名女性;7 项研究;低质量证据),宫颈刮匙的总体汇总敏感性为 70%(95%置信区间,42-89;761 名女性;7 项研究;低质量证据)。宫颈刷的总体汇总特异性为 73%(95%置信区间,36-93;799 名女性;7 项研究;低质量证据),宫颈刮匙的总体汇总特异性为 81%(95%置信区间,56-94;761 名女性;7 项研究;低质量证据)。与宫颈刷相比,宫颈刮匙的样本不足风险比为 2.53(95%置信区间,0.58-11.0;P=.215;低质量证据)。有两项研究报告了患者不适情况,其中一项研究发现宫颈刷组的不适程度较低,另一项研究则未发现差异。

结论

基于低质量证据,宫颈刷和宫颈刮匙在诊断准确性、样本不足率和不良影响方面无差异。女性特征的差异和由此产生的诊断途径使外部有效性受限。

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