Screening for liver cancer: results of a randomised controlled trial in Qidong, China
Screening for liver cancer: results of a randomised controlled trial in Qidong, China
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DOI：
10.1258/096914103771773320
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发表时间：
2003-01-01
影响因子：
2.9
通讯作者：
Zhu, YR
中科院分区：
文献类型：
--
作者：
Chen, JG;Parkin, DM;Zhu, YR
目的：探讨肝癌筛查在降低高危人群死亡率中的作用。方法：对江苏省启东县1989~1995年间30~69岁慢性乙肝病毒携带者(HBs Ag阳性)进行随机对照研究。方法：通过人群筛查，将5581名HBs Ag携带者随机分为筛查组(A组，3712人)和对照组(B组，1869人)。筛查计划是每月六次甲胎蛋白检测，并对检测异常(大于或等于20µg/L)的受试者进行随访。结果：该方案的总体敏感性和特异性分别为55.3%和86.5%，在符合所有筛查试验的受试者中分别为80.0%和80.9%。本文报告了374例原发性肝癌的诊断。A组I期病例比例(29.6%)明显高于B组(6.0%)。A组1、3、5年相对生存率分别为23.7%、7.0%、4.0%，B组分别为9.7%、4.0%、4.1%，两组5年生存率差异无统计学意义。筛查组死亡率(1138/10万人年)与对照组(1114/10万人年)无显著差异。Poisson回归模型显示，筛查组的死亡概率(比率比)为0.83(95%CI 0.68~1.03)。结论：AFP筛查可使肝癌得到更早的诊断，但由于筛查发现的患者的治疗无效，提前时间的增加并不能导致死亡率的总体下降。指出了使用改进的筛查、诊断和治疗方法进行的进一步研究。
Objectives: To investigate the effectiveness of screening for liver cancer in reducing mortality from the disease in a high-risk population in China.Setting: A randomised controlled trial was carried out among men aged 30-69 who were chronic carriers of hepatitis-B virus (HBsAg positive) during the period 1989-1995 in Qidong county, Jiangsu Province, China.Methods: 5581 HBsAg carriers were identified by population screening and randomly assigned to a screening group (group A, 3712 men), and controls (group B, 1869 men). Screening was planned to be six monthly alpha-fetoprotein (AFP) assays, with follow-up of subjects having an abnormal (greater than or equal to 20 mug/l) test. All subjects were followed up for liver cancer and/or death until 3 1 December 1995.Results: The overall sensitivity and specificity of the programme was 55.3% and 86.5%, respectively; in subjects who complied with all scheduled screening tests, the values were 80.0% and 80.9%. Three hundred and seventy-four primary liver cancer (PLC) cases were diagnosed. The percentage of cases in stage I was significantly higher in group A (29.6%) than in group B (6.0%). The one-, three-, and five-year relative survival rates were 23.7%, 7.0%, and 4.0% in group A, and 9.7%, 4.0%, and 4.1 % in group B respectively, with no difference in five-year survival between the groups. The mortality rate in the screened group (1138 per 100,000 person-years) was not significantly different from that in the controls (I 114 per 100,000). A Poisson regression model showed that the probability of death (rate ratio) in the screening group was 0.83 (95% Cl 0.68-1.03) relative to the control group.Conclusions: Screening with AFP resulted in earlier diagnosis of liver cancer, but the gain in lead time did not result in any overall reduction in mortality, because therapy for the patients found by screening was ineffective. Further studies using improved methods of screening, diagnosis and treatment are indicated.