Risk of Cervical Precancer and Cancer Among HIV-Infected Women With Normal Cervical Cytology and No Evidence of Oncogenic HPV Infection
Risk of Cervical Precancer and Cancer Among HIV-Infected Women With Normal Cervical Cytology and No Evidence of Oncogenic HPV Infection
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DOI：
10.1001/jama.2012.5664
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发表时间：
2012-07-25
影响因子：
120.7
通讯作者：
Strickler, Howard D.
中科院分区：
文献类型：
--
作者：
Keller, Marla J.;Burk, Robert D.;Strickler, Howard D.
美国针对 30 岁或以上未感染人类免疫缺陷病毒 (HIV) 的女性的宫颈癌筛查指南最近进行了修订，对于宫颈细胞学 (Pap 检测) 结果正常且致癌人乳头瘤病毒 (HPV) 检测呈阴性的女性，建议的巴氏 (Pap) 检测间隔时间从 3 年延长至 5 年。对于细胞学正常且致癌性 HPV 阴性的 HIV 感染女性，是否可以采用 3 年或 5 年的筛查间隔尚不清楚。 目的 确定 HIV 感染女性中以细胞学（高级鳞状上皮内病变或更大 [HSIL+]）或组织学（宫颈上皮内瘤变 2 或更大 [CIN-2+]）定义的宫颈癌前病变或癌症的风险，作为 2 个独立的终点设计、设置和参与者 参与者包括 420 名 HIV 感染妇女和 279 名宫颈细胞学正常的未感染 HIV 的妇女，她们在 2001 年 10 月 1 日至 2002 年 9 月 30 日期间参加美国多机构妇女机构间 HIV 研究队列，随访至 4 月2011 年 12 月 30 日。每半年在 6 个临床中心进行一次访视，包括巴氏涂片检查以及宫颈活检（如有指征）。使用聚合酶链反应对入组的宫颈阴道灌洗标本进行 HPV DNA 检测。主要分析在 5 年随访时被截断。 主要结果指标 宫颈癌前病变和癌症的五年累积发病率。 结果 在 369 名 (88%[95% CI, 84%-91%]) 感染 HIV 的女性和 255 名 (91% [95% CI, 88%-94%]) 宫颈细胞学检查正常的未感染 HIV 的女性中，未检测到致癌 HPV。招生。在这些致癌 HPV 阴性女性中，观察到 2 例 HSIL+；未感染 HIV 的女性和 CD4 细胞计数为 500 个细胞/μL 或更高的 HIV 感染女性。组织学数据从 6 个临床部位中的 4 个部位获得。 145 名未感染 HIV 的女性中有 6 例 CIN-2+（累积发生率，5% [95% CI, 1%-8%]），219 名 HIV 感染女性中有 9 例（累积发生率，5% [95% CI, 2%-8%]）。其中包括 44 名致癌 HPV 阴性 HIV 感染女性中的 1 例 CIN-2+，CD4 细胞计数低于 350 个细胞/μL（累积发生率，2% [95% CI，0%-7%]），47 名女性中的 1 例 CD4 细胞计数为 350 至 499 个细胞/μL（累积发生率，2% [95% CI，0%-7%]）（累积发生率，2% [95% CI，0%-7%]）。 0%-7%]），128 名女性中有 7 例 CD4 细胞计数为 500 个细胞/μL 或更高（累积发生率，6% [95% CI，2%-10%]）。一名 HIV 感染者和 1 名未感染 HIV 的女性患有 CIN-3，但没有人罹患癌症。 结论 在入组时细胞学正常且致癌 HPV 阴性的 HIV 感染女性和未感染 HIV 女性中 HSIL+ 和 CIN-2+ 的 5 年累积发病率相似。
Context US cervical cancer screening guidelines for human immunodeficiency virus (HIV)-uninfected women 30 years or older have recently been revised, increasing the suggested interval between Papanicolaou (Pap) tests from 3 years to 5 years among those with normal cervical cytology (Pap test) results who test negative for oncogenic human papillomavirus (HPV). Whether a 3- year or 5-year screening interval could be used in HIV-infected women who are cytologically normal and oncogenic HPV-negative is unknown.Objective To determine the risk of cervical precancer or cancer defined cytologically (high-grade squamous intraepithelial lesions or greater [HSIL+]) or histologically (cervical intraepithelial neoplasia 2 or greater [CIN-2+]), as 2 separate end points, in HIV-infected women and HIV-uninfected women who at baseline had a normal Pap test result and were negative for oncogenic HPV.Design, Setting, and Participants Participants included 420 HIV-infected women and 279 HIV-uninfected women with normal cervical cytology at their enrollment in a multi-institutional US cohort of the Women's Interagency HIV Study, between October 1, 2001, and September 30, 2002, with follow-up through April 30, 2011. Semiannual visits at 6 clinical sites included Pap testing and, if indicated, cervical biopsy. Cervicovaginal lavage specimens from enrollment were tested for HPV DNA using polymerase chain reaction. The primary analysis was truncated at 5 years of follow-up.Main Outcome Measure Five-year cumulative incidence of cervical precancer and cancer.Results No oncogenic HPV was detected in 369 (88%[95% CI, 84%-91%]) HIV-infected women and 255 (91% [95% CI, 88%-94%]) HIV-uninfected women with normal cervical cytology at enrollment. Among these oncogenic HPV-negative women, 2 cases of HSIL+ were observed; an HIV-uninfected woman and an HIV-infected woman with a CD4 cell count of 500 cells/mu L or greater. Histologic data were obtained from 4 of the 6 clinical sites. There were 6 cases of CIN-2+ in 145 HIV-uninfected women(cumulative incidence, 5% [95% CI, 1%-8%]) and 9 cases in 219 HIV-infected women (cumulative incidence, 5% [95% CI, 2%-8%]). This included 1 case of CIN-2+ in 44 oncogenic HPV-negative HIV-infected women with CD4 cell count less than 350 cells/mu L (cumulative incidence, 2% [95% CI, 0%-7%]), 1 case in 47 women with CD4 cell count of 350 to 499 cells/mu L (cumulative incidence, 2% [95% CI, 0%-7%]), and 7 cases in 128 women with CD4 cell count of 500 cells/mu L or greater (cumulative incidence, 6% [95% CI, 2%-10%]). One HIV-infected and 1 HIV-uninfected woman had CIN-3, but none had cancer.Conclusion The 5-year cumulative incidence of HSIL+ and CIN-2+ was similar in HIV-infected women and HIV-uninfected women who were cytologically normal and oncogenic HPV-negative at enrollment.