Department of Obstetrics and Gynecology, Klinikum Wolfsburg, Wolfsburg, Germany.
Institute for Medical Epidemiology, Biometrics, and Informatics, Martin-Luther-University Halle-Wittenberg, Halle, Germany.
BMC Cancer. 2018 Mar 23;18(1):318. doi: 10.1186/s12885-018-4225-9.
The primary objective was to determine human papilloma virus (HPV) clearance rate after cervical biopsy among women with persistent high-risk HPV infection compared with spontaneous HPV clearance rate in the absence of biopsy.
We collected data from a dedicated screening program of women aged 30-70 years old. Inclusion criteria for the baseline non-interventional cohort were a positive HPV test (hybrid capture 2, HC2) and normal cytology. In the baseline cohort women were followed with approximately yearly HPV-tests and cytology until HPV regressed (one negative HPV test) or interventions in the form of diagnostic biopsies or therapy. Women who had a diagnostic biopsy were included in the biopsy cohort and followed until HPV regression or therapy. Observed HPV regression rates and time to HPV regression were compared between baseline and biopsy cohorts. For the comparison, we used Fisher's exact test for the HPV regression rates and interval-censored, accelerated failure time model for time to HPV regression.
Among the 1079 women included in the baseline cohort, 499 (46.3%) had HPV clearance and 475 were referred for colposcopy with biopsy. The biopsy cohort comprised all women who were not treated and had at least one HC2 test after biopsy (201/475; 42.3%). Of those, 138 (68.7%) experienced HPV regression. In the biopsy cohort, time to clearance of HPV infection was approximately halved (0.46, 95% CI 0.38-0.56) compared with the baseline cohort. This result was robust in a wide range of sensitivity analyses.
A higher proportion of women cleared their HPV infection, and time to HPV clearance was shorter in the biopsy cohort than in the baseline cohort. It is reassuring for clinicians to know that conservative management of patients with HPV persistency is successful when colposcopy with biopsies excludes high-grade disease.
本研究的主要目的是比较持续性高危型人乳头瘤病毒（HPV）感染女性行宫颈活检后的 HPV 清除率与未经活检的自然 HPV 清除率。
我们收集了一项针对 30-70 岁女性的专门筛查计划的数据。该基础非干预队列的纳入标准为 HPV 检测（杂交捕获 2 法，HC2）阳性且细胞学正常。在基线队列中，女性每大约 1 年进行一次 HPV 检测和细胞学检查，直到 HPV 消退（一次 HPV 检测阴性）或接受诊断性活检或治疗的干预。行诊断性活检的女性纳入活检队列，并随访至 HPV 消退或治疗。比较基线队列和活检队列的 HPV 消退率和 HPV 消退时间。HPV 消退率比较采用 Fisher 确切概率法，HPV 消退时间比较采用间隔 censored 加速失效时间模型。
在纳入基线队列的 1079 名女性中，499 名（46.3%）HPV 得以清除，475 名接受阴道镜检查并进行活检。活检队列包括所有未接受治疗且在活检后至少进行了一次 HC2 检测的女性（475 名中有 201 名，占 42.3%）。其中，138 名（68.7%）发生 HPV 消退。在活检队列中，HPV 感染的清除时间大约缩短了一半（0.46，95%CI 0.38-0.56）。这一结果在广泛的敏感性分析中是稳健的。
活检队列中 HPV 清除的女性比例更高，HPV 清除时间更短。当阴道镜检查和活检排除高级别病变时，对 HPV 持续性患者进行保守管理是成功的，这让临床医生感到安心。
