冷冻疗法可降低南非感染艾滋病毒妇女的宫颈上皮内瘤变1级进展：一项随机对照试验

Cryotherapy Reduces Progression of Cervical Intraepithelial Neoplasia Grade 1 in South African HIV-Infected Women: A Randomized, Controlled Trial.

作者信息

Firnhaber Cynthia, Swarts Avril, Goeieman Bridgette, Rakhombe Ntombi, Mulongo Masangu, Williamson Anna-Lise, Michelow Pam, Ramotshela Sibongile, Faesen Mark, Levin Simon, Wilkin Timothy

机构信息

*Cervical Cancer Screening and Treatment Research Department, Right to Care, Johannesburg, South Africa; †Clinical HIV Research Unit, Faculty of Health Sciences, Department of Clinical Medicine University of the Witwatersrand, Johannesburg, South Africa; ‡Division of Medical Virology, Department of Pathology, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa; §National Health Laboratory Service, Groote Schuur Hospital, Cape Town, South Africa; ‖Cytology Unit, Department of Anatomical Pathology, Faculty of Health Sciences, University of the Witwatersrand and National Health Laboratory Service, Johannesburg, South Africa; and ¶Division of Infectious Diseases, Weill Cornell Medicine, New York, NY.

出版信息

J Acquir Immune Defic Syndr. 2017 Dec 15;76(5):532-538. doi: 10.1097/QAI.0000000000001539.

DOI:10.1097/QAI.0000000000001539

PMID:28902073

Abstract

BACKGROUND

HIV-infected women are at an increased risk of cervical cancer, especially in resource-limited countries. Cervical cancer prevention strategies focus treating cervical high-grade squamous intraepithelial lesions (HSIL). The management of low-grade squamous intraepithelial lesions (LSIL) in HIV-infected women is unknown.

SETTING

HIV treatment clinic in Johannesburg, South Africa.

METHODS

We randomized HIV-infected women with histologic cervical LSIL to cervical cryotherapy vs. no treatment (standard of care). Cervical high-risk human papillomavirus testing (hrHPV) was performed at baseline. All women underwent cervical cytology and colposcopic biopsies 12 months after enrollment. The primary end point was HSIL on histology at month 12. Chi-square was used to compare arms.

RESULTS

Overall, 220 HIV-infected women were randomized to cryotherapy (n = 112) or no treatment (n = 108). Median age was 38 years, 94% were receiving antiretroviral therapy; median CD4 was 499 cells per cubic millimeter, and 59% were hrHPV positive. Cryotherapy reduced progression to HSIL: 2/99 (2%) in the cryotherapy arm and 15/103 (15%) in the no treatment arm developed HSIL, 86% reduction (95% confidence interval: 41% to 97%; P = 0.002). Among 17 HSIL end points, 16 were hrHPV+ at baseline. When restricting the analysis to hrHPV+ women, HSIL occurred in 2/61 (3%) in the cryotherapy arm vs. 14/54 (26%) in the no treatment arm, 87% reduction (95% confidence interval: 47% to 97%; P = 0.0004). Participants in the cryotherapy arm experienced greater regression to normal histology and improved cytologic outcomes.

CONCLUSIONS

Treatment of cervical LSIL with cryotherapy decreased progression to HSIL among HIV-infected women especially if hrHPV positive. These results support treatment of LSIL in human papillomavirus test-and-treat approaches for cervical cancer prevention in resource-constrained settings.

摘要

背景

感染艾滋病毒的女性患宫颈癌的风险增加，尤其是在资源有限的国家。宫颈癌预防策略侧重于治疗宫颈高级别鳞状上皮内病变（HSIL）。感染艾滋病毒女性的低级别鳞状上皮内病变（LSIL）的管理尚不明确。

地点

南非约翰内斯堡的艾滋病毒治疗诊所。

方法

我们将组织学诊断为宫颈LSIL的感染艾滋病毒女性随机分为宫颈冷冻治疗组和不治疗组（护理标准）。在基线时进行宫颈高危型人乳头瘤病毒检测（hrHPV）。所有女性在入组12个月后接受宫颈细胞学检查和阴道镜活检。主要终点是第12个月时组织学诊断为HSIL。采用卡方检验比较两组。

结果

总体而言，220名感染艾滋病毒的女性被随机分为冷冻治疗组（n = 112）或不治疗组（n = 108）。中位年龄为38岁，94%的女性正在接受抗逆转录病毒治疗；中位CD4细胞计数为每立方毫米499个细胞，59%的女性hrHPV呈阳性。冷冻治疗降低了进展为HSIL的风险：冷冻治疗组99名中有2名（2%）进展为HSIL，不治疗组103名中有15名（15%）进展为HSIL，降低了86%（95%置信区间：41%至97%；P = 0.002）。在17例HSIL终点病例中，16例在基线时hrHPV呈阳性。将分析限于hrHPV阳性女性时，冷冻治疗组61名中有2名（3%）发生HSIL，不治疗组54名中有14名（26%）发生HSIL，降低了87%（95%置信区间：47%至97%；P = 0.0004）。冷冻治疗组的参与者组织学回归正常的情况更好，细胞学结果也有所改善。