中国PCR反向斑点杂交人乳头瘤病毒基因分型检测在预测治疗后患者残留/复发性CIN 2+中的应用评估
Evaluation of PCR-Reverse Dot Blot Human Papillomavirus Genotyping Test in Predicting Residual/Recurrent CIN 2+ in Posttreatment Patients in China.
作者信息
Zhang Qiaoyu, Dong Binhua, Chen Lihua, Lin Tingting, Tong Yao, Lin Wenyu, Lin Haifeng, Gao Yuqin, Lin Fen, Sun Pengming
机构信息
Laboratory of Gynecologic Oncology, Fujian Provincial Maternity and Children's Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, People's Republic of China.
Department of Gynecology, The First Affiliated Hospital of Xiamen University, Xiamen, People's Republic of China.
出版信息
Cancer Manag Res. 2020 Apr 1;12:2369-2379. doi: 10.2147/CMAR.S237490. eCollection 2020.
OBJECTIVE
To assess the clinical value of the PCR-reverse dot blot human papillomavirus genotyping test during follow-up of patients with CIN grade 2 or worse (CIN 2+).
METHODS
Four hundred patients with CIN 2+ receiving treatment from January 2008 to January 2017 were included in our study. Postoperative follow-up procedures comprised HPV examination and cervical cytology every 3-6 months for the first 2 years and then followed up every 6-12 months. A pathology examination was performed when there was a positive funding for HPV 16/18 or an abnormal ThinPrep cytology test (TCT) with or without positive for HR-HPV according to the American Society for Coloscopy and Cervical Pathology (ASCCP) guidelines.
RESULTS
The median follow-up period was 27.10±12.47 months (ranging from 3 to 50 months). During follow-up, 12.00% (48/400) of the women developed residual/recurrent disease. The highest risk in CIN 2+ and CIN 3+ residual/recurrence was HPV-16/-18 (hazard ratio (HR)=12.898, 95% CI= 6.849-24.289; HR= 20.726, 95% CI= 9.64-44.562, respectively). Among the different follow-up methods, type-specific (TP) HR-HPV persistent infection showed the highest cumulative incidence risk (CIR) (84.62%, 95% CI=73.29-95.94) and HR (5.38, 95% CI= 2.596-11.149) during the 4-year follow-up period. At the CIN 2+ and CIN 3+ endpoints, TP-HPV testing had relatively high sensitivity (84.62%, 95% CI=73.29-95.94 and 89.28%, 95% CI= 77.83-100.00, respectively) and specificity (78.07%, 95% CI= 72.70-83.44 and 75.73%, 95% CI= 70.30-81.17, respectively). However, at the CIN 2+/CIN 3+ endpoint, TCT follow-up had a sensitivity of 60.42%/62.16% (95% CI=46.58-72.25/46.54-77.79) and specificity of 90.18%/88.72% (95% CI=86.95-93.41/85.35-92.10).
CONCLUSION
TP HR-HPV follow-up can provide a reliable and sensitive clinical reference for CIN 2+ postoperative patients.
目的
评估聚合酶链反应-反向斑点杂交人乳头瘤病毒基因分型检测在2级或更高级别宫颈上皮内瘤变（CIN 2+）患者随访中的临床价值。
方法
纳入2008年1月至2017年1月接受治疗的400例CIN 2+患者。术后随访程序包括在前2年每3 - 6个月进行一次HPV检测和宫颈细胞学检查，之后每6 - 12个月进行一次随访。根据美国阴道镜及宫颈病理学会（ASCCP）指南，当HPV 16/18检测呈阳性或薄层液基细胞学检测（TCT）异常（无论HR-HPV是否呈阳性）时，进行病理检查。
结果
中位随访期为27.10±12.47个月（范围为3至50个月）。随访期间，12.00%（48/400）的女性出现残留/复发性疾病。CIN 2+和CIN 3+残留/复发的最高风险是HPV-16/-18（风险比（HR）=12.898，95%置信区间（CI）=6.849 - 24.289；HR = 20.726，95% CI = 9.64 - 44.562）。在不同的随访方法中，型特异性（TP）HR-HPV持续感染在4年随访期内显示出最高的累积发病率风险（CIR）（84.62%，95% CI = 73.29 - 95.94）和HR（5.38，95% CI = 2.596 - 11.149）。在CIN 2+和CIN 3+终点时，TP-HPV检测具有相对较高的敏感性（分别为84.62%，95% CI = 73.29 - 95.94和89.28%，95% CI = 77.83 - 100.00）和特异性（分别为78.07%，95% CI = 72.70 - 83.44和75.73%，95% CI = 70.30 - 81.17）。然而，在CIN 2+/CIN 3+终点时，TCT随访的敏感性为60.42%/62.16%（95% CI = 46.58 - 72.25/46.54 - 77.79），特异性为90.18%/88.72%（95% CI = 86.95 - 93.41/85.35 - 92.10）。
结论
TP HR-HPV随访可为CIN 2+术后患者提供可靠且敏感的临床参考。
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