Sankaranarayanan Rengaswamy, Esmy Pulikkottil Okkuru, Rajkumar Rajamanickam, Muwonge Richard, Swaminathan Rajaraman, Shanthakumari Sivanandam, Fayette Jean-Marie, Cherian Jacob
Screening Group, International Agency for Research on Cancer, Lyon, France.
Lancet. 2007 Aug 4;370(9585):398-406. doi: 10.1016/S0140-6736(07)61195-7.
Cervical cancer is the most common cancer among women in developing countries. We assessed the effect of screening using visual inspection with 4% acetic acid (VIA) on cervical cancer incidence and mortality in a cluster randomised controlled trial in India.
Of the 114 study clusters in Dindigul district, India, 57 were randomised to one round of VIA by trained nurses, and 57 to a control group. Healthy women aged 30 to 59 years were eligible for the study. Screen-positive women had colposcopy, directed biopsies, and, where appropriate, cryotherapy by nurses during the screening visit. Those with larger precancerous lesions or invasive cancers were referred for appropriate investigations and treatment. Cervical cancer incidence and mortality in the study groups were analysed and compared using Cox regression taking the cluster design into account, and analysis was by intention to treat. The primary outcome measures were cervical cancer incidence and mortality.
Of the 49,311 eligible women in the intervention group, 31,343 (63.6%) were screened during 2000-03; 30,958 control women received the standard care. Of the 3088 (9.9%) screened positive, 3052 had colposcopy, and 2539 directed biopsy. Of the 1874 women with precancerous lesions in the intervention group, 72% received treatment. In the intervention group, 274,430 person years, 167 cervical cancer cases, and 83 cervical cancer deaths were accrued compared with 178,781 person-years, 158 cases, and 92 deaths and in the control group during 2000-06 (incidence hazard ratio 0.75 [95% CI 0.55-0.95] and mortality hazard ratio 0.65 [0.47-0.89]).
VIA screening, in the presence of good training and sustained quality assurance, is an effective method to prevent cervical cancer in developing countries.
宫颈癌是发展中国家女性中最常见的癌症。我们在印度的一项整群随机对照试验中评估了使用4%醋酸肉眼观察法（VIA）进行筛查对宫颈癌发病率和死亡率的影响。
在印度丁迪古尔区的114个研究群组中，57个被随机分配给经过培训的护士进行一轮VIA筛查，57个被分配到对照组。年龄在30至59岁的健康女性符合研究条件。筛查呈阳性的女性在筛查就诊期间由护士进行阴道镜检查、定向活检，并在适当情况下进行冷冻治疗。那些患有较大癌前病变或浸润性癌症的患者被转诊进行适当的检查和治疗。使用Cox回归分析并比较研究组中的宫颈癌发病率和死亡率，同时考虑群组设计，分析采用意向性分析。主要结局指标为宫颈癌发病率和死亡率。
干预组的49311名符合条件的女性中，31343名（63.6%）在2000 - 2003年期间接受了筛查；30958名对照女性接受了标准护理。在3088名（9.9%）筛查呈阳性的女性中，3052名进行了阴道镜检查，2539名进行了定向活检。干预组中1874名患有癌前病变的女性中，72%接受了治疗。在2000 - 2006年期间，干预组累积了274430人年，167例宫颈癌病例和83例宫颈癌死亡，而对照组分别为178781人年、158例和92例死亡（发病率风险比0.75 [95%可信区间0.55 - 0.95]，死亡率风险比0.65 [0.47 - 0.89]）。
在具备良好培训和持续质量保证的情况下，VIA筛查是发展中国家预防宫颈癌的有效方法。
