Effect of screening on oral cancer mortality in Kerala, India: a cluster-randomised controlled trial
Effect of screening on oral cancer mortality in Kerala, India: a cluster-randomised controlled trial
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DOI：
10.1016/s0140-6736(05)66658-5
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发表时间：
2005-06-04
期刊：
影响因子：
168.9
通讯作者：
Rajan, B
中科院分区：
文献类型：
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作者：
Sankaranarayanan, R;Ramadas, K;Rajan, B
背景口腔癌在发展中国家的男性中很常见，吸烟和饮酒会增加口腔癌的发病率。方法在印度喀拉拉邦Trivandrum区，选取13组受试者，其中7组每隔3年由训练有素的卫生工作者进行三轮口腔视觉检查，6组随机分配给对照组。年龄在35岁及以上的健康参与者有资格参加这项研究。筛查阳性者由医生转介进行临床检查、活检和治疗。结果指标为存活率、病死率和口腔癌死亡率。用聚类分析方法对研究组的口腔癌死亡率进行分析和比较。在96 517名符合条件的干预组参与者中，87655人(91%)至少进行了一次筛查，53312人(55%)进行了两次筛查，29102人(30%)进行了三次筛查。在5145名筛查呈阳性的人中，3218人(63%)遵守了转介。对照组95 356名符合条件的参与者接受标准护理。干预组有205例口腔癌和77例口腔癌死亡，而对照组有158例和87例死亡(死亡率比0.79[95%CI 0.51~1.22])。在干预组中，吸烟和/或饮酒的使用者发生了70例口腔癌死亡，而对照组为85例(0.66[0.45-0.95])。男性烟酒使用者的死亡率比为0.57(0.35~0.93)，女性使用者为0.78(0.43~1.42)。解释：口腔视觉筛查可以降低高危人群的死亡率，并有可能在全球范围内预防至少37000例口腔癌死亡。
Background Oral cancer is common in men from developing countries, and is increased by tobacco and alcohol use. We aimed to assess the effect of visual screening on oral cancer mortality in a cluster-randomised controlled trial in India.Methods Of the 13 clusters chosen for the study, seven were randomised to three rounds of oral visual inspection by trained health workers at 3-year intervals and six to a control group during 1996-2004, in Trivandrum district, Kerala, India. Healthy participants aged 35 years and older were eligible for the study. Screen-positive people were referred for clinical examination by doctors, biopsy, and treatment. Outcome measures were survival, case fatality, and oral cancer mortality. Oral cancer mortality in the study groups was analysed and compared by use of cluster analysis. Analysis was by intention to treat.Findings Of the 96 517 eligible participants in the intervention group, 87 655 (91%) were screened at least once, 53 312 (55%) twice, and 29 102 (30%) three times. Of the 5145 individuals who screened positive, 3218 (63%) complied with referral. 95 356 eligible participants in the control group received standard care. 205 oral cancer cases and 77 oral cancer deaths were recorded in the intervention group compared with 158 cases and 87 deaths in the control group (mortality rate ratio 0.79 [95% Cl 0.51-1.22]). 70 oral cancer deaths took place in users of tobacco or alcohol, or both, in the intervention group, compared with 85 in controls (0.66 [0.45-0.95]). The mortality rate ratio was 0.57 (0.35-0.93) in male tobacco or alcohol users and 0.78 (0.43-1.42) in female users.Interpretation: Oral visual screening can reduce mortality in high-risk individuals and has the potential of preventing at least 37 000 oral cancer deaths worldwide.