Merck Research Laboratories, North Wales, PA 19454-10099, USA.
Cancer Epidemiol Biomarkers Prev. 2010 Jun;19(6):1585-94. doi: 10.1158/1055-9965.EPI-09-1235.
We describe the incidence and duration of cervical human papillomavirus (HPV) infection episodes along with the risk of infection reappearance following a period of nondetection.
Women (1,788) ages 16 to 23 years underwent cytologic testing and PCR-based testing of cervical swab samples for HPV DNA (HPV-16/18/31/33/35/45/52/58/59) at approximately 6-month intervals for up to 4 years in the context of a phase 3 clinical trial (placebo arm). HPV type-specific incidence rates were estimated per 100 person-years. Duration of type-specific cervical infection episodes and risk of reappearance following a period of nondetection were estimated using Kaplan-Meier methods.
HPV-16 exhibited the highest (5.9), and HPV-35 and HPV-33 exhibited the lowest (1.0) incidence rates per 100 person-years. Mean cervical infection durations ranged from 13 months for HPV-59 to 20 months for HPV-16 and 58 (with ongoing infections censored at the time of treatment, if done). The risk of cervical infection reappearance within approximately 3 years following a period of nondetection ranged from 0% to 16% across HPV types, with a mean of 8%. Limited evidence was found for a role of false-positive HPV tests, missed infections that were above the threshold for detection, or new acquisition of infection in accounting for patterns of infection reappearance.
Incidence of high-risk cervical infection was observed to vary considerably more across HPV types than infection duration. A nontrivial proportion of women exhibited infection reappearance following a period of nondetection, with a potential explanation for many such events observed within this analysis being a return to detectable levels of a previously acquired infection.
The risk of HPV infection reappearance following a period of nondetection has not been previously reported for individual HPV types, and this study finds that a nontrivial proportion of infected women exhibit reappearances. Future studies could ascertain subject-level factors that potentially modify the risk of infection reappearance.
我们描述了宫颈人乳头瘤病毒(HPV)感染发作的发生率和持续时间,以及在一段时间未检出后再次感染的风险。
在一项 3 期临床试验(安慰剂组)中,年龄在 16 至 23 岁的女性每 6 个月左右进行细胞学检测和宫颈拭子样本 HPV DNA(HPV-16/18/31/33/35/45/52/58/59)的基于 PCR 的检测,最长可达 4 年。HPV 型别特异性发生率以每 100 人年为单位计算。使用 Kaplan-Meier 方法估计特定 HPV 型别宫颈感染的持续时间以及在未检出后的再次出现风险。
HPV-16 的发生率最高(5.9),HPV-35 和 HPV-33 的发生率最低(1.0),每 100 人年。HPV-59 的宫颈感染持续时间平均为 13 个月,HPV-16 和 58 的持续时间平均为 20 个月(如果在治疗时已进行治疗,持续感染则被删失)。在大约 3 年内未检出后的宫颈再次感染风险在 HPV 型别之间的范围为 0%至 16%,平均为 8%。在解释感染再次出现的模式方面,仅有有限的证据表明 HPV 检测的假阳性、检测阈值以上的漏检感染或新获得的感染在起作用。
高危型宫颈感染的发生率在 HPV 型别之间观察到的差异显著大于感染持续时间。相当一部分女性在未检出后出现感染再次出现,在本分析中观察到的许多此类事件的一个可能解释是先前获得的感染重新达到可检测水平。
个体 HPV 型别的未检出后 HPV 感染再次出现的风险以前从未报道过,本研究发现,相当一部分受感染的女性会出现再次出现。未来的研究可以确定潜在的个体因素,这些因素可能会改变感染再次出现的风险。