Sankaranarayanan Rengaswamy, Nene Bhagwan M, Shastri Surendra S, Jayant Kasturi, Muwonge Richard, Budukh Atul M, Hingmire Sanjay, Malvi Sylla G, Thorat Ranjit, Kothari Ashok, Chinoy Roshan, Kelkar Rohini, Kane Shubhada, Desai Sangeetha, Keskar Vijay R, Rajeshwarkar Raghevendra, Panse Nandkumar, Dinshaw Ketayun A
International Agency for Research on Cancer, Lyon, France.
N Engl J Med. 2009 Apr 2;360(14):1385-94. doi: 10.1056/NEJMoa0808516.
In October 1999, we began to measure the effect of a single round of screening by testing for human papillomavirus (HPV), cytologic testing, or visual inspection of the cervix with acetic acid (VIA) on the incidence of cervical cancer and the associated rates of death in the Osmanabad district in India.
In this cluster-randomized trial, 52 clusters of villages, with a total of 131,746 healthy women between the ages of 30 and 59 years, were randomly assigned to four groups of 13 clusters each. The groups were randomly assigned to undergo screening by HPV testing (34,126 women), cytologic testing (32,058), or VIA (34,074) or to receive standard care (31,488, control group). Women who had positive results on screening underwent colposcopy and directed biopsies, and those with cervical precancerous lesions or cancer received appropriate treatment.
In the HPV-testing group, cervical cancer was diagnosed in 127 subjects (of whom 39 had stage II or higher), as compared with 118 subjects (of whom 82 had advanced disease) in the control group (hazard ratio for the detection of advanced cancer in the HPV-testing group, 0.47; 95% confidence interval [CI], 0.32 to 0.69). There were 34 deaths from cancer in the HPV-testing group, as compared with 64 in the control group (hazard ratio, 0.52; 95% CI, 0.33 to 0.83). No significant reductions in the numbers of advanced cancers or deaths were observed in the cytologic-testing group or in the VIA group, as compared with the control group. Mild adverse events were reported in 0.1% of screened women.
In a low-resource setting, a single round of HPV testing was associated with a significant reduction in the numbers of advanced cervical cancers and deaths from cervical cancer.
1999年10月，我们开始通过检测人乳头瘤病毒（HPV）、细胞学检测或用醋酸对宫颈进行视诊检查（VIA）来评估一轮筛查对印度奥斯曼阿巴德地区宫颈癌发病率及相关死亡率的影响。
在这项整群随机试验中，52个村庄群，共有131746名年龄在30至59岁之间的健康女性，被随机分为四组，每组13个村庄群。这些组被随机分配接受HPV检测筛查（34126名女性）、细胞学检测（32058名）或VIA筛查（34074名），或接受标准护理（31488名，对照组）。筛查结果呈阳性的女性接受阴道镜检查和定向活检，患有宫颈癌前病变或癌症的女性接受适当治疗。
在HPV检测组中，诊断出127例宫颈癌患者（其中39例为II期或更高期），而对照组中有118例患者（其中82例为晚期疾病）（HPV检测组中晚期癌症检测的风险比为0.47；95%置信区间[CI]，0.32至0.69）。HPV检测组有34例癌症死亡，而对照组有64例（风险比，0.52；95%CI，0.33至0.83）。与对照组相比，细胞学检测组或VIA组在晚期癌症数量或死亡人数上没有显著减少。0.1%的接受筛查的女性报告了轻微不良事件。
在资源匮乏的环境中，一轮HPV检测与晚期宫颈癌数量和宫颈癌死亡人数的显著减少相关。
