Influencing Factors of HPV 16/18 Cervical Cancer Detection Rate and Application Effect of Vaginal In Vitro Qualitative HPV-DNA Detection Screening Model
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摘要:目的
探讨人乳头瘤病毒(human papillomavirus,HPV)宫颈癌检出率影响因素及阴道体外定性HPV-DNA检测在HPV16/18分流筛查中的应用。
方法采用分层整群随机抽样的横断面调查方法对5 217例体外定性HPV-DNA核酸检测患者检测结果进行分析。记录患者临床资料,分析影响HPV宫颈癌阳性检出率的危险因素。基于危险因素构建列线图模型并利用受试工作者(receiver operating characteristic,ROC)曲线和校准曲线评价模型的应用效果。
结果5 217例患者经阴道体外定性HPV宫颈癌筛查并经阴道镜病理诊断检查,结果显示,HPV真阳性2 187例,真阴性2 248例,假阳性495例,假阴性287例;准确性为85.01%,敏感性为88.40%,特异性为81.95%,阳性预测值为81.54%,阴性预测值为88.68%。年龄 > 45岁,伴有糖尿病、高血压、高血脂、子宫内膜炎、乳腺增生、阴道炎、卵巢囊肿、乳腺炎的阳性检出率较高,是HPV-DNA宫颈癌结果阳性检出率的影响因素。ROC曲线下和校准曲线显示模型应用效果良好。
结论阴道体外定性阴道体外定性HPV-DNA宫颈癌筛查具有较高的准确性,可应用于分流筛查HPV16/18分型。
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关键词:
- 阴道体外定性 /
- HPV-DNA宫颈癌筛查 /
- HPV16/18分流筛查
Abstract:ObjectiveTo explore the factors influencing the detection rate of human papillomavirus (HPV) cervical cancer and the application of in vitro qualitative HPV-DNA test in HPV16/18 shunt screening.
MethodsThe results of 5 217 patients with in vitro qualitative HPV-DNA nucleic acid testing were analyzed by stratified cluster random sampling cross-sectional investigation. The clinical data of patients were recorded and the risk factors affecting the positive detection rate of HPV cervical cancer were analyzed. The nomogram model was constructed based on the risk factors, and the application effect of the model was evaluated by the receiver operating characteristic (ROC) curve and calibration curve.
ResultsA total of 5 217 patients were screened by vaginal in vitro qualitative HPV cervical cancer screening mode and pathological diagnosis by colposcopy. The results showed that there were 2 187 true positive cases, 2 248 true negative cases, 495 false positive cases, and 287 false negative cases. The accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of HPV were 85.01%, 88.40%, 81.95%, 81.54%, and 88.68%, respectively. Age > 45 years, diabetes mellitus, hypertension, hyperlipidemia, endometritis, mammary hyperplasia, vaginitis, ovarian cysts, and mastitis influenced the positive detection rate of HPV-DNA cervical cancer. The ROC curve and calibration curve showed that the model had a good application effect.
ConclusionsIn vitro vaginal HPV DNA cervical cancer screening has high accuracy and can be used in shunt screening for HPV16/18 types.
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宫颈癌是女性最常见的恶性肿瘤之一,人乳头瘤病毒(human papillomavirus,HPV)[1]是其主要致病因子。大多数宫颈癌在癌变期间并无明显临床特征,不易被发现,晚期常表现为阴道流血、浸润、转移,若能在疾病进展到晚期前及时发现,将可通过治疗的方式防止其向宫颈癌进展。宫颈癌筛查计划提出,有效降低了宫颈癌的死亡率,具有划时代的意义[2]。近年来,宫颈癌的筛查覆盖率及方式的下降,导致发病率有缓慢上升趋势[3]。目前地区间医疗水平发展不均衡、目标人群覆盖率低、取样方式复杂等问题均是筛查工作的影响因素,也是当今筛查工作需解决的问题。阴道体外定性HPV-DNA检查具有便利性,可重复性且操作简单,有效改善筛查的覆盖率,进而患者可及时治疗,降低该病的发病率和死亡率[4-5]。研究报道,约超过30%的女性HPV宫颈癌是HPV16、18亚型[6],因此,分析HPV宫颈癌检出率影响因素及阴道体外定性HPV-DNA检测在HPV16/18分流筛查中的应用对宫颈癌的普及筛查具有重要指导意义,现报道如下。
1. 资料与方法
1.1 研究对象
回顾性选取2019年1月至2021年1月于中国人民解放军联勤保障部队第九〇八医院健康体检中心通过体外定性HPV-DNA核酸检测法进行宫颈癌筛查的5 217例健康患者作为研究对象,排除妊娠期患者。
1.2 方法
1.2.1 一般资料收集
通过医院电子档案收集患者一般资料,包括年龄、糖尿病、高血压、高血脂、吸烟、饮酒、子宫内膜炎、乳腺增生、阴道炎、卵巢囊肿、乳腺炎。
1.2.2 阴道体外定性HPV-DNA检测宫颈癌
HPV-DNA检测:采用HPV核酸杂交捕获-化学发光法DNA检测(杭州德同生物技术有限公司)检测14种HPV亚型,包括HPV16、18、31、33、35、39、45、51、52、56、58、59、66、68型;HPV检测中设立内质控,如提示检测失败,定义为取样不合格,即联系患者重新取样。
1.3 诊断标准
HPV-DNA检测[7]:光亮度数≥1.0判断为阳性。阴道镜活检病理检测[8]:子宫颈上皮不典型增生(cervical epithelial atypical hyperplasia,CIN)Ⅰ、CIN Ⅱ、CIN Ⅲ、宫颈鳞状细胞癌(squamous cell carcinoma,SCC)判断为阳性。
1.4 统计学处理
采用SPSS 22.0软件进行统计分析。计量资料以(x ± s)表示,计数资料以率表示,采用χ2检验进行比较。多因素logistic回归分析影响HPV宫颈癌检出率的独立危险因素;采用R软件根据独立危险因素构建列线图模型,受试工作者特征(receiver operating characteristic curve,ROC)曲线和校准曲线评价模型的应用效果。P < 0.05为差异有统计学意义。
2. 结果
2.1 不同临床特征HPV宫颈癌阳性结果比较
不同临床特征患者HPV宫颈癌阳性检出率存在明显差异,年龄 > 45岁,伴有糖尿病、高血压、高血脂、子宫内膜炎、阴道炎、卵巢囊肿、乳腺炎的患者的阳性检出率较高(P < 0.05),见表 1。
表 1 不同临床特征HPV宫颈癌阳性结果比较Table 1. Comparison of positive results of HPV cervical cancer with different clinical featuresVariables n Colposcopically positive(n=2 474) Positive detection rate/(%) χ2 P Age 4.908 0.027 > 45 year 3 478 1 687 48.50 ≤45 year 1 739 787 45.26 Diabetes 48.686 0.000 Yes 1 206 678 56.22 No 4 011 1 796 44.78 Hypertension 10.015 0.002 Yes 1 165 600 51.50 No 4 052 1 874 46.25 Hyperlipidemia 19.804 0.000 Yes 1 126 600 53.29 No 4 091 1 874 45.81 Smoking history 0.947 0.331 Yes 2 325 1 120 48.17 No 2 892 1 354 46.82 Alcohol used 1.702 0.192 Yes 2 020 935 46.29 No 3 197 1 539 48.14 Endometritis 24.894 0.000 Yes 1 267 678 53.51 No 3 950 1 796 45.47 Mammary glands 0.155 0.694 Yes 1 934 924 47.78 No 3 283 1 550 47.21 Vaginitis 10.153 0.001 Yes 1 522 774 50.85 No 3 695 1 700 46.01 Ovarian cyst 30.471 0.000 Yes 1 325 715 53.96 No 3 892 1 759 45.20 Mastitis 18.675 0.000 Yes 2 064 1 055 51.11 No 3 153 1 419 45.00 2.2 多因素logistic回归分析影响HPV宫颈癌检出率的危险因素
年龄 > 45岁,伴有糖尿病、高血压、高血脂、子宫内膜炎、阴道炎、卵巢囊肿、乳腺炎是影响HPV宫颈癌检出率的危险因素(P < 0.05),见表 2。
表 2 多因素logistic回归分析影响HPV宫颈癌结果准确性的危险因素Table 2. Risk factors affecting the accuracy of HPV cervical cancer results in multivariate logistic regression analysisVariables β SE Wald χ2 95%Cl OR P Age > 45 year 0.443 0.102 18.897 1.025~3.281 1.558 0.001 Diabetes 0.523 0.158 10.955 1.065~3.699 1.687 0.000 Hypertension 0.313 0.126 6.185 1.025~3.999 1.368 0.003 Hyperlipidemia 0.424 0.122 12.076 1.112~3.697 1.528 0.000 Endometritis 0.700 0.164 18.199 1.265~4.016 2.013 0.000 Vaginitis 0.672 0.189 12.639 1.654~4.297 1.958 0.002 Ovarian cyst 0.797 0.122 42.635 1.524~4.667 2.218 0.000 Mastitis 0.861 0.137 39.516 1.264~4.873 2.366 0.001 缩写:SE,标准误;CI,可信区间。
Abbreviated:SE,stander error;CI,confidence interval.2.3 构建预测影响HPV宫颈癌检出率的列线图模型
将2.2中独立危险因素纳入并构建列线图模型,见图 1,通过自变量回归系数计算各指标对应得分,分别为62分(年龄 > 45岁)、37分(糖尿病)、48分(高血压)、33分(高血脂)、58分(子宫内膜炎)、54分(阴道炎)、42分(卵巢囊肿)、74分(乳腺炎),将各个变量的单项得分相加获得对应总分,总分对应预测HPV宫颈癌阳性检出率。
2.4 模型评价观测值预测值
应用ROC曲线和校准曲线对列线图模型进行评价,结果显示,曲线下面积为0.869[95%可信区间(confidence interval,CI)0.774~0.902,P=0.001],灵敏度为82.4%,特异度为83.3%,约登指数为0.657,校准曲线显示模型拟合度良好,见图 2。
2.5 阴道体外定性HPV-DNA检测结果
5 217例患者经阴道体外定性HPV-DNA宫颈癌筛查模式筛查,以阴道镜病理诊断作为金标准,结果显示,阴性2 743例,CIN Ⅰ为772例,CIN Ⅱ为632例,CIN Ⅲ为748例,SCC为322例。HPV-DNA检测结果显示,阴性2 535例,阳性2 682例。HPV-DNA诊断宫颈癌的准确性为85.01%(4 435/5 217),敏感性为88.40%(2 187/2 474),特异性为81.95%(2 248/2 743),阳性预测值为81.54%(2 187/2 682),阴性预测值为88.68%(2 248/2 535),详见表 3。
表 3 阴道体外定性HPV-DNA与病理诊断结果分布Table 3. Distribution of qualitative HPV-DNA and pathological diagnosis in vitro of vaginaHPV-DNA diagnose Pathological diagnosis Total Negative CINⅠ CINⅡ CINⅢ SCC Negative 2 248 87 90 70 40 2 535 Positive 495 685 542 678 282 2 682 Total 2 743 772 632 748 322 5 217 2.6 体外定性HPV-DNA宫颈癌筛查在HPV16/18分流筛查中的应用
分流筛查的结果显示,HPV亚型主要是16、18分型,16、18、其他(包括31、33、35、39、45、51、52、56、58、59、66、68)分型分别有2 729例、2 102例、386例,灵敏度分别为80.84%、68.91%、61.32%;特异度分别为65.71%、75.85%、67.50%;阳性预测值分别为67.17%、75.80%、41.67%;阴性预测值分别为79.80%、63.18%、82.17%;准确率分别为72.74%、72.22%、65.80%,见表 4。
表 4 体外定性HPV-DNA宫颈癌筛查模式在HPV16/18分流筛查中的应用Table 4. Application of in vitro qualitative HPV-DNA cervical cancer screening mode in HPV16/18 shunt screeningHPV subtype HPV-DNA result Colposcopy screening results Sensitivity Specificity Positive predictive value Negative predictive value Accuracy Positive Negative 16 Positive 1 526 1 025 501 80.84% 65.71% 67.17% 79.80% 72.74% Negative 1 203 243 960 18 Positive 1 000 758 242 68.91% 75.85% 75.80% 63.18% 72.22% Negative 1 102 342 760 Others Positive 156 65 91 61.32% 67.50% 41.67% 82.17% 65.80% Negative 230 41 189 3. 讨论
宫颈癌发病率近年来居高不下,严重威胁女性的身体健康。在中低收入地区,由于医疗条件不完善,HPV宫颈癌检出率明显降低[9-11]。另外,取样方式复杂不便等因素也可以导致筛查检出率低等情况,研究表明[12],体外定性HPV-DNA检查具有便利性,可重复性且操作简单,有效改善筛查的覆盖率,进而患者可及时治疗,降低该病的发病率和死亡率[13]。本研究选取了收治于我院的5 217例患者经阴道体外定性HPV宫颈癌筛查模式筛查,结果显示,HPV阳性2 682例,并进一步阴道镜检查,其中,真阳性2 187例,真阴性2 248例,假阳性495例,假阴性287例;准确性为85.01%,敏感性为88.40%,特异性为81.95%,阳性预测值为81.54%,阴性预测值为88.68%。说明体外定性HPV-DNA宫颈癌筛查模式具有较高的准确度,有必要进行相关医疗知识的普及工作,促进更为标准规范的HPV-DNA宫颈癌筛查,如果进展顺利,就可以降低筛查成本,提高筛查率及检出率,降低发病率,使得患者能够得到及时有效的治疗。
本研究结果显示,不同临床特征HPV宫颈癌患者阳性检出率存在明显差异,年龄 > 45岁,伴有糖尿病、高血压、高血脂、子宫内膜炎、阴道炎、卵巢囊肿、乳腺炎的患者的HPV-DNA阳性率较高,经多因素logistic回归分析,上述因素是HPV-DNA宫颈癌阳性检出率的危险因素。有数据显示[14],我国女性的更年期年龄大部分在45~55岁之间,有70%的女性在此年龄段有各种生理问题,加上部分女性平时生活作息不规律,内分泌激素水平紊乱[15],很容易导致各种妇科疾病。另一方面可能是因为年龄 < 45岁的女性处于性活跃期和生育年龄高峰阶段,在经历妊娠、分娩、避孕等过程中,于医院妇科门诊就诊机会较多,故可能导致宫颈癌阳性潜在患者较少。年龄较大的患者多合并糖尿病、高血压和高血脂等基础疾病,故可能导致伴有糖尿病、高血压、高血脂的患者阳性检出率较高。子宫内膜炎、阴道炎患者大多伴有阴道微生态失衡,部分厌氧菌在机体免疫力下降时,在体内大量繁殖,导致该类患者感染HPV的概率显著增大,这与吴鸿滨[16]的研究一致。卵巢囊肿、乳腺炎的患者的阳性检出率较高可能与不良的生活习惯以及身体的各项病变均可以使得机体内部生理生化指标出现异常,加重HPV的感染程度,使得宫颈癌的病情加重。因此,如能尽早进行阴道体外定性HPV-DNA宫颈癌筛查,且确定不同的危险因素[17],对患者进行适时合理的干预措施,做到早期发现,诊断和治疗,也可以降低筛查的成本,降低HPV宫颈癌的发病率。
HPV主要亚型有16分型和18分型,对于HPV感染患者的筛查,能够做到分流筛查,确定HPV亚型,从而进行有针对性的治疗至关重要[18]。本研究分流筛查的结果显示,HPV亚型主要是16、18分型,16、18、其他(包括31、33、35、39、45、51、52、56、58、59、66、68)分型分别有2 729例、2 102例、386例,灵敏度分别为80.84%、68.91%、61.32%;特异度分别为65.71%、75.85%、67.50%;阳性预测值分别为67.17%、75.80%、41.67%;阴性预测值分别为79.80%、63.18%、82.17%;准确率分别为72.74%、72.22%、65.80%。说明阴道体外定性HPV-DNA宫颈癌筛查模式对于筛查HPV的主要分型具有较高的准确度,本文不足之处在于,样本量较少且研究对象均来自于我院,较为单一,可能导致实验结果出现偏倚,后续还需多中心大样本的深入研究。
综上,阴道体外定性阴道体外定性HPV-DNA宫颈癌筛查具有较高的准确性,可应用于分流筛查HPV16/18分型。
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表 1 不同临床特征HPV宫颈癌阳性结果比较
Table 1 Comparison of positive results of HPV cervical cancer with different clinical features
Variables n Colposcopically positive(n=2 474) Positive detection rate/(%) χ2 P Age 4.908 0.027 > 45 year 3 478 1 687 48.50 ≤45 year 1 739 787 45.26 Diabetes 48.686 0.000 Yes 1 206 678 56.22 No 4 011 1 796 44.78 Hypertension 10.015 0.002 Yes 1 165 600 51.50 No 4 052 1 874 46.25 Hyperlipidemia 19.804 0.000 Yes 1 126 600 53.29 No 4 091 1 874 45.81 Smoking history 0.947 0.331 Yes 2 325 1 120 48.17 No 2 892 1 354 46.82 Alcohol used 1.702 0.192 Yes 2 020 935 46.29 No 3 197 1 539 48.14 Endometritis 24.894 0.000 Yes 1 267 678 53.51 No 3 950 1 796 45.47 Mammary glands 0.155 0.694 Yes 1 934 924 47.78 No 3 283 1 550 47.21 Vaginitis 10.153 0.001 Yes 1 522 774 50.85 No 3 695 1 700 46.01 Ovarian cyst 30.471 0.000 Yes 1 325 715 53.96 No 3 892 1 759 45.20 Mastitis 18.675 0.000 Yes 2 064 1 055 51.11 No 3 153 1 419 45.00 表 2 多因素logistic回归分析影响HPV宫颈癌结果准确性的危险因素
Table 2 Risk factors affecting the accuracy of HPV cervical cancer results in multivariate logistic regression analysis
Variables β SE Wald χ2 95%Cl OR P Age > 45 year 0.443 0.102 18.897 1.025~3.281 1.558 0.001 Diabetes 0.523 0.158 10.955 1.065~3.699 1.687 0.000 Hypertension 0.313 0.126 6.185 1.025~3.999 1.368 0.003 Hyperlipidemia 0.424 0.122 12.076 1.112~3.697 1.528 0.000 Endometritis 0.700 0.164 18.199 1.265~4.016 2.013 0.000 Vaginitis 0.672 0.189 12.639 1.654~4.297 1.958 0.002 Ovarian cyst 0.797 0.122 42.635 1.524~4.667 2.218 0.000 Mastitis 0.861 0.137 39.516 1.264~4.873 2.366 0.001 缩写:SE,标准误;CI,可信区间。
Abbreviated:SE,stander error;CI,confidence interval.表 3 阴道体外定性HPV-DNA与病理诊断结果分布
Table 3 Distribution of qualitative HPV-DNA and pathological diagnosis in vitro of vagina
HPV-DNA diagnose Pathological diagnosis Total Negative CINⅠ CINⅡ CINⅢ SCC Negative 2 248 87 90 70 40 2 535 Positive 495 685 542 678 282 2 682 Total 2 743 772 632 748 322 5 217 表 4 体外定性HPV-DNA宫颈癌筛查模式在HPV16/18分流筛查中的应用
Table 4 Application of in vitro qualitative HPV-DNA cervical cancer screening mode in HPV16/18 shunt screening
HPV subtype HPV-DNA result Colposcopy screening results Sensitivity Specificity Positive predictive value Negative predictive value Accuracy Positive Negative 16 Positive 1 526 1 025 501 80.84% 65.71% 67.17% 79.80% 72.74% Negative 1 203 243 960 18 Positive 1 000 758 242 68.91% 75.85% 75.80% 63.18% 72.22% Negative 1 102 342 760 Others Positive 156 65 91 61.32% 67.50% 41.67% 82.17% 65.80% Negative 230 41 189 -
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