孕中期唐氏综合征血清学筛查的经济效益评价

Economic benefit evaluation of prenatal screening for Down’s Syndrome in second trimester

目的从临床及卫生经济学的角度探讨孕中期唐氏综合征产前筛查的意义。方法采用酶联免疫吸附试验(ELISA)检测12720名孕龄为14～20周的中国孕妇的血清甲胎蛋白(AFP)、绒毛膜促性腺激素(β-hCG)水平,结合孕妇的年龄、孕周等关键参数,计算唐氏综合征的风险系数,并对高危人群进行产前诊断。结果761例唐氏综合征筛查高危妊娠妇女中,诊断唐氏综合征患儿7例;11959例唐氏综合征筛查低危妊娠妇女中,诊断唐氏综合征2例。筛查成本为495023元,安全指数为0.28。结论采用ELISA法检测孕妇血清AFP和β-hCG的方法成本低、安全性高,是适合中国国情的唐氏综合征产前筛查方案。

Objective To discuss the clinical significance and health economics of prenatal screening for Down’s syndrome during second trimester. Methods Using enzyme-linked immunosorbent assay（ELISA）, we examined the AFP and β-HCG in 12,720 Chinese pregnant women between at 14-20 weeks of gestation. The risk index of Down’s syndrome was calculated while considering the age and gestation weeks of those women. Prenatal diagnosis was done in high risk subjects. Results Seven Down’s syndrome cases were diagnosed among 761 of screening positive subjects. Two Down’s syndrome cases were diagnosed among 11,959 of screening negative subjects. The screening cost was 495,023 RMB and the safety index was 0.28. Conclusion ELISA examination of maternal serum AFP and β-hCG is safe and cost-effective, and it is suitable for prenatal screening of Down’s syndrome.