HPV DNA和HPV E6/E7 mRNA检测在宫颈病变诊治中应用价值的比较

doi:10.12280/gjfckx.20201209

摘要/Abstract

摘要：

目的: 比较人乳头瘤病毒（human papillomavirus,HPV）E6/E7 mRNA检测和HPV DNA检测在宫颈病变诊治中的应用价值。方法: 选取2018年1月—2019年9月在石家庄市妇幼保健院行宫颈液基薄层细胞学检查（thin-prep cytology test,TCT）的患者共33 496例,其中符合纳入标准的诊断意义不明的非典型鳞状上皮细胞（atypical squamous cells of undetermined significance,ASCUS）患者共3 190例,将其随机分为2组,各1 595例,分别进行HPV DNA检测（对照组）及HPV E6/E7 mRNA检测（观察组）,再对每组的阳性患者进行阴道镜下活检及病理组织学检测,比较2种方法对宫颈病变的检出率。从对照组和观察组阳性的患者中随机各抽取184例,共368例,分别进行HPV E6/E7 mRNA和HPV DNA检测,比较2种方法的诊断效能。结果: 对照组高级别宫颈上皮内病变患者的检出率为4.8%（77/1 595）,观察组为4.1%（66/1 595）,差异无统计学意义（χ²=0.886,P=0.347）。但与HPV DNA检测相比,HPV E6/E7 mRNA检测具有较高的敏感度（87.50%）、特异度（71.79%）、阳性预测值（49.36%）、阴性预测值（94.81%）、约登指数（0.593）和较低的阴道镜转诊率（42.4%,P<0.05）。结论: 对于高级别宫颈上皮内病变,HPV E6/E7 mRNA检测比HPV DNA检测具有更高的诊断效能,可以作为ASCUS患者分流的新方法。

关键词: 宫颈疾病, 人乳头状瘤病毒DNA检测, DNA, RNA,信使, 乳头状瘤病毒科, 诊断, HPV E6/E7 mRNA检测

Abstract:

Objective: To compare the application value of high risk human papillomavirus (HPV) E6/E7 mRNA and HPV DNA detection in the diagnosis and treatment of cervical cancer. Methods: From January 2018 to September 2019, a total of 33 496 patients received cervical liquid-based thin-prep cytology test (TCT) in Shi Jia Zhuang Maternal & Child Healthcare Hospital. Among them, 3 190 patients who met inclusion criteria (ASCUS) were randomly divided into control group and observation group, with 1 595 cases in each group. Control group received HPV DNA test and the other group received HPV E6/E7mRNA test. Then, cervical biopsy under colposcopy and histopathological examination were performed for positive patients in each group. The detection rate of cervical lesions was compared between the two methods. Then, 184 patients were randomly selected from the control group with positive result to receive HPV E6/E7 mRNA test. The other 184 patients were randomly selected from the observation group with positive result for HPV DNA detection. The diagnostic efficacy of the two methods was compared in 368 cases. Results: The detection rate of high-grade Cervical intraepithetial neoplasia was 77/1 595 (4.8%) in the control group and 66/1 595 (4.1%) in the observation group, with no statistically significant difference ( χ ²=0.886,P=0.347). However, compared with HPV DNA test, HPV E6/E7 mRNA test had higher sensitivity (87.50%), specificity (71.79%), positive predictive value (49.36%), negative predictive value (94.81%) and lower colposcopy referral rate (42.4%). The difference was statistically significant (P<0.05). Conclusions: The diagnostic value of HPV E6/E7 mRNA test is higher than that of HPV DNA test for high-grade cervical lesions. It could be used as a new method to triage patients with ASCUS.

Key words: Uterine cervical diseases, Human papillomavirus DNA tests, DNA, RNA,messenger, Papillomaviridae, Diagnosis, HPV E6/E7 mRNA test

刘晓旭, 梁建梅, 苏学艳, 王素娟, 赵会娟, 秦丽欣, 卢雪景, 王亚凡. HPV DNA和HPV E6/E7 mRNA检测在宫颈病变诊治中应用价值的比较[J]. 国际妇产科学杂志, 2021, 48(4): 462-466.

LIU Xiao-xu, LIANG Jian-mei, SU Xue-yan, WANG Su-juan, ZHAO Hui-juan, QIN Li-xin, LU Xue-jing, WANG Ya-fan. Comparison of the Application Value of HPV E6/E7 mRNA and HPV DNA Detection in the Diagnosis and Treatment of Cervical Lesions[J]. Journal of International Obstetrics and Gynecology, 2021, 48(4): 462-466.

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年龄	例	构成比（%）
20~29岁	646	20.25
30~39岁	999	31.32
40~49岁	865	27.12
50~59岁	510	15.99
60~65岁	170	5.32
合计	3 190	100.00

年龄	例	构成比（%）
20~29岁	646	20.25
30~39岁	999	31.32
40~49岁	865	27.12
50~59岁	510	15.99
60~65岁	170	5.32
合计	3 190	100.00

组别	n	检测结果阳性	病理检查结果
组别	n	检测结果阳性	宫颈炎	CINⅠ	CINⅡ	CINⅢ	宫颈癌
对照组	1 595	417	144	196	33	38	6
观察组	1 595	402	152	184	27	35	4

组别	n	检测结果阳性	病理检查结果
组别	n	检测结果阳性	宫颈炎	CINⅠ	CINⅡ	CINⅢ	宫颈癌
对照组	1 595	417	144	196	33	38	6
观察组	1 595	402	152	184	27	35	4

组别	n	<CINⅡ	≥CINⅡ
HPV18阳性	44	42（95.5）	2（4.5）
HPV16阳性	205	152（74.1）	53（25.9）
其他HPV亚型阳性	168	146（86.9）	22（13.1）
χ²		16.313
P		0.000