Human Papillomavirus-Based Cervical Cancer Prevention: Long-term Results of a Randomized Screening Trial
Human Papillomavirus-Based Cervical Cancer Prevention: Long-term Results of a Randomized Screening Trial
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DOI：
10.1093/jnci/djq342
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发表时间：
2010-10-01
影响因子：
10.3
通讯作者：
Wright, Thomas C., Jr.
中科院分区：
文献类型：
--
作者：
Denny, Lynette;Kuhn, Louise;Wright, Thomas C., Jr.
背景宫颈癌预防的筛查和治疗方法对于低资源环境是一个有吸引力的选择，但缺乏关于其长期疗效的数据。我们通过随机试验对两种筛查和治疗方法的有效性进行了评估。方法对6637名年龄在35-65岁的未筛查的南非妇女进行了宫颈样本中高危人乳头瘤病毒(HPV)DNA的检测，并使用醋酸染色和HIV血清试验进行了宫颈目视检查。其中6555人被随机分配到三个研究组：1)HPV+治疗组，所有HPV DNA检测阳性的女性都接受冷冻治疗；2)目视检查+治疗组，所有视力检查阳性的女性都接受冷冻治疗；或3)对照组，进一步评估或治疗推迟6个月。所有妇女在6个月时都接受了阴道镜检查和活检。所有登记时HPV DNA或肉眼检查呈阳性的女性，以及所有其他女性的子组，通过每年一次的阴道镜检查，延长了36个月的随访时间(n=3639)。终点-宫颈上皮内瘤变2级或更严重(CIN2+)-使用精算寿命表方法进行分析。结果36个月后，HPV加治疗组CIN2+累积检测率持续显著低于对照组(1.5%vs5.6%，差异=4.1%，95%可信区间[CI]=2.8%~5.3%，P<；.001)。视力检查和治疗组CIN2+累积检测值与对照组相比差异较小(3.8%比5.6%，差异=1.8%，95%CI=0.4%~3.2%，P=0.002)。与对照组(1.0%，95%CI=0.5%~1.7%)或目视检查治疗组(1.3%，95%CI=0.8%~2.1%)相比，HPV+治疗组CIN2+的发生率(0.3%，95%CI=0.05%~1.02%)较低。使用HPV DNA检测的筛查和治疗方法识别并治疗了CIN2+的流行病例，似乎减少了冷冻治疗后12个月以上发生的CIN2+病例的数量。
Background Screen-and-treat approaches to cervical cancer prevention are an attractive option for low-resource settings, but data on their long-term efficacy are lacking. We evaluated the efficacy of two screen-and-treat approaches through 36 months of follow-up in a randomized trial.Methods A total of 6637 unscreened South African women aged 35-65 years who were tested for the presence of high-risk human papillomavirus (HPV) DNA in cervical samples underwent visual inspection of the cervix using acetic acid staining and HIV serotesting. Of these, 6555 were randomly assigned to three study arms: 1) HPV-and-treat, in which all women with a positive HPV DNA test result underwent cryotherapy; 2) visual inspection-and-treat, in which all women with a positive visual inspection test result underwent cryotherapy; or 3) control, in which further evaluation or treatment was delayed for 6 months. All women underwent colposcopy with biopsy at 6 months. All women who were HPV DNA-or visual inspection-positive at enrollment, and a subset of all other women had extended follow-up to 36 months (n = 3639) with yearly colposcopy. The endpoint-cervical intraepithelial neoplasia grade 2 or worse (CIN2+)-was analyzed using actuarial life-table methods. All statistical tests were two-sided.Results After 36 months, there was a sustained statistically significant decrease in the cumulative detection of CIN2+ in the HPV-and-treat arm compared with the control arm (1.5% vs 5.6%, difference = 4.1%, 95% confidence interval [CI] = 2.8% to 5.3%, P < .001). The difference in the cumulative detection of CIN2+ in the visual inspection-and-treat arm compared with the control was less (3.8% vs 5.6%, difference = 1.8%, 95% CI = 0.4% to 3.2%, P = .002). Incident cases of CIN2+ (identified more than 12 months after enrollment) were less common in the HPV-and-treat arm (0.3%, 95% CI = 0.05% to 1.02%) than in the control (1.0%, 95% CI = 0.5% to 1.7%) or visual inspection-and-treat (1.3%, 95% CI = 0.8% to 2.1%) arms.Conclusions In this trial, a screen-and-treat approach using HPV DNA testing identified and treated prevalent cases of CIN2+ and appeared to reduce the number of incident cases of CIN2+ that developed more than 12 months after cryotherapy.