[Effect evaluation of the primary screening strategy for liver cancer in rural areas of China].

Objective: To estimate the effectiveness of the primary screening strategy for liver cancer in rural areas to provide basic information for the optimization and perfection of the technical program for the early detection and treatment of liver cancer. Methods: Residents including males aged 35-64 and females aged 45-64 from 9 counties in rural China between 2013 and 2015 were selected as the target population. The participant was classified into a high-risk and non-high-risk group based on the standardized questionnaire or HBsAg, and the Chi-squared test was applied to compare differences between the two groups. The Cox proportional hazard regression models were applied to assess hazard ratio (HR) and its 95% confidence interval (CI). Results: 358 348 participants were recruited from 2013 to 2015. 1 196 individuals were identified with liver cancer until December 31, 2021, with an incidence density of 52.0/10(5) person-years. Of the participants, 54 650 were assessed as high risk (15.3%) based on the questionnaire and the status of HBsAg. The high-risk population had a higher incidence density (168.3/10(5) person-years vs 31.5/10(5) person-years) and higher risk of developing liver cancer (HR=2.98, 95% CI=2.64-3.35), compared to the non-high-risk group. Based on the questionnaire-based high-risk assessment system, 47 884 (13.4%) individuals were identified as high risk, who showed statistical differences in terms of incidence density and incidence risk, in comparison to the low-risk population (all P<0.05). HBsAg can screen out a higher proportion of high-risk individuals who are women, non-smokers, non-drinkers, and individuals without a family history of liver cancer (all P<0.05). The sensitivity analysis of the effectiveness of the whole primary screening method is stable, and high-risk individuals still had a higher risk of liver cancer. Conclusions: The primary screening method of the questionnaire-based risk assessment system and HBsAg can achieve satisfactory effectiveness. The questionnaire-based risk assessment system could identify high-risk individuals to some extent, however, it still needs to be improved to meet the actual requirements.目的： 评估中国农村地区肝癌初筛方案的效果，为改善肝癌早诊早治技术方案提供基础信息。 方法： 本研究是以人群为基础的多中心前瞻性队列研究，研究对象为2013—2015年中国农村地区9个县或区参加肝癌筛查的35~64岁男性和45~64岁女性，根据标准化的风险评估量表和HBsAg检测结果将队列人群分为高风险组和低风险组，采用χ(2)检验比较组间差异，采用Cox比例风险回归模型计算两组人群发生肝癌的风险比(HR)和95% CI。 结果： 2013—2015年共纳入基线人群358 348人，截至2021年12月31日共确诊肝癌1 196例，发病密度为52.0/10万人年。根据量表结合HBsAg检测的初筛方案，判定54 650人(15.3%)为肝癌高风险组。与低风险组比较，高风险组具有更高的发病密度(分别为168.3/10万人年和31.5/10万人年，P<0.001)和发病风险(HR＝2.98，95% CI：2.64~3.35)。若以风险评估量表单独判定，则47 884人(13.4%)为高风险组，与低风险组的发病密度和发病风险差异仍具有统计学意义(均P<0.05)。而HBsAg检测在量表基础上筛选出了更高比例的女性、不吸烟、不饮酒和无肝癌家族史的高风险人群(均P<0.001)。敏感性分析显示，初筛方案效果稳健，高风险组仍具有更高的肝癌发病风险。 结论： 量表结合HBsAg检测的肝癌初筛方案可以达到较优的效果，单独的风险评估量表能够对高风险人群起到一定的筛选作用，但量表仍需改善以满足实际需求。.