原发性肝癌二级预防的随机分组前瞻性研究

Randomized controlled prospective study of secondary prevention for primary liver cancer

目的 评价原发性肝癌二级预防的效果。方法 将 3 5～5 5岁的乙型病毒性肝炎 (简称乙肝 )抗原抗体阳性或有慢性肝炎史的 18816名上海市民随机分为筛查组 ( 93 73人 )与对照组 ( 94 43人)。筛查组每 6个月作 1次AFP与实时超声检查 ,检出的可疑病例即以放射免疫法复查AFP及作CT或MRI检查 ,一旦确诊 ,且有手术指征者皆积极动员作手术切除治疗 ;对照组不作任何主动检查 ,但自行发病的肝癌病人亦同样为之争取手术切除或其他积极的治疗 ,并随访其生存期。结果 经过5年的筛查和 6年的随访 ,筛查组共筛查 2 2 63 1 5人年 ,检出肝癌 86例。对照组共观察 3 2 94 4人年 ,发现肝癌 5 1例。两组肝癌病例相比 ,筛查组I期肝癌占 60 5 % ,对照组为 0 (P <0 0 1)。筛查组小肝癌占 4 5 3 % ,对照组为 0 (P <0 0 1)。说明筛查确能检出早期肝癌。筛查组能作手术切除的占4 6 5 % ,而对照组为 7 8% ,差异有非常显著意义 (P <0 0 1)。筛查组肝癌的 1～ 5年生存率分别为60 5 %、60 5 %、5 2 7%、5 2 7%和 5 2 7% ,而对照组为 3 0 0 %、6 5 %、0、0和 0。结论 本研究结果说明筛查确能检出早期肝癌。通过积极治疗 ,筛查组肝癌的远期生存率显著高于对照组。亦即证明了肝癌二级预防确能降低肝癌的死亡率。

Objective To evaluated the effectiveness of secondary prevention for primary liver cancer (PLC) Methods This is a randomized controlled study 18 816 Shanghai urban residents, aged 35～55, with serum evidence of HBV infection or chronic hepatitis were randomly assigned into the screening group (9 373) or the control group (9 443) In the screening group, participants were tested with serum AFP and real time ultrasound every 6 months, while in the control group, participants were not informed about the study and received no screening Participants with positive results underwent a diagnostic evaluation, and all patients diagnosed as PLC were treated appropriately and followed up Results After 5 years of study, there were 22 631 5 person years screened. 86 patients with PLC were detected 51 patients were detected in the control group within 32 944 person years In the screened group, 60 5% (52/86) of patients were in stage I, and 45 3% (40/86) with small liver cancer However, there were no patients in stage I or with small liver cancer in the control group The resection rates were 46 5% in the screened group, and 7 8% in the control group The 1 to 5 years survival rates of PLC patients in the screening group were 65 0%, 65 0%, 52 7%, 52 7% and 52 7%, respectively, and in the control group were 30 0%, 6 5%, 0%, 0% and 0%, respectively Conclusion Screening can detect PLC in the early stage, and improve the prognosis of PLC, indicating that secondary prevention can decrease the mortality of PLC