肝癌筛查：中国启东一项随机对照试验的结果

Screening for liver cancer: results of a randomised controlled trial in Qidong, China.

作者信息

Chen J-G, Parkin D M, Chen Q-G, Lu J-H, Shen Q-J, Zhang B-C, Zhu Y-R

机构信息

Qidong Liver Cancer Institute, Qidong, Jiangsu, China.

出版信息

J Med Screen. 2003;10(4):204-9. doi: 10.1258/096914103771773320.

DOI:10.1258/096914103771773320

PMID:14738659

Abstract

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 (>/=20 micrograms/l) test. All subjects were followed up for liver cancer and/or death until 31 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 (1114 per 100,000). A Poisson regression model showed that the probability of death (rate ratio) in the screening group was 0.83 (95% CI 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.

摘要

目的

在中国高危人群中研究肝癌筛查在降低该疾病死亡率方面的有效性。

背景

1989年至1995年期间，在中国江苏省启东县对年龄在30 - 69岁的慢性乙肝病毒携带者（乙肝表面抗原阳性）男性进行了一项随机对照试验。

方法

通过人群筛查确定了5581名乙肝表面抗原携带者，并将其随机分为筛查组（A组，3712名男性）和对照组（B组，1869名男性）。计划每六个月进行一次甲胎蛋白（AFP）检测，对检测结果异常（≥20微克/升）的受试者进行随访。所有受试者均随访至1995年12月31日，观察是否患肝癌和/或死亡情况。

结果

该筛查方案的总体灵敏度和特异度分别为55.3%和86.5%；在完全遵守所有预定筛查检测的受试者中，这两个值分别为80.0%和80.9%。共诊断出374例原发性肝癌（PLC）病例。A组I期病例的百分比（29.6%）显著高于B组（6.0%）。A组的1年、3年和5年相对生存率分别为23.7%、7.0%和4.0%，B组分别为9.7%、4.0%和4.1%，两组的5年生存率无差异。筛查组的死亡率（每10万人年1138例）与对照组（每10万人年1114例）无显著差异。泊松回归模型显示，相对于对照组，筛查组的死亡概率（率比）为0.83（95%置信区间0.68 - 1.03）。