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中国唐氏综合征产前筛查和诊断策略的卫生经济学评价

Health economics evaluation of prenatal screening and diagnostic strategy for Down syndrome in China

  • 摘要: 目的 从社会角度对中国5种唐氏综合征(Down syndrome,DS)产前筛查和诊断策略进行卫生经济学评价,为卫生部门决策提供循证依据。方法 本研究采用方便抽样法在我国7个省各选择1家开展产前筛查/诊断服务的二级以上医疗机构进行现场调查,孕产妇调查样本量共为7 200例。根据现场调查和相关文献,本研究建立了5种DS产前筛诊策略,并使用决策树模型进行了各策略的成本效果分析和成本效益分析。其中,各筛诊策略的直接医疗成本来源于机构问卷调查,直接非医疗和间接成本来源于孕产妇问卷调查。模型的效果指标为避免出生的DS胎儿例数,安全性指标为每避免1例DS胎儿出生所造成的正常胎儿的流产数。结果 无创产前基因检测(non-invasive prenatal testing,NIPT)全筛查策略(所有孕妇均接受NIPT,筛查高风险的孕妇进行产前诊断)的效果最好,避免DS出生率为69.86%。而NIPT条件筛查策略(≥35岁孕妇接受NIPT,高风险孕妇接受产前诊断;<35岁孕妇先接受传统血清学筛查,高风险后再先后接受NIPT和产前诊断)的经济学价值最高。该策略每避免1例DS患儿出生所需要的社会成本最低(90.85万元/人),每投入1元所带来的项目回报最高(2.79元)。结论 相对于其他策略,NIPT条件筛查策略的经济学效益最优,NIPT全筛查策略在当前NIPT价格水平下成本仍较高,而现行国家推行的策略可能会导致较多不必要的产前诊断。

     

    Abstract: Objective To conduct a health economic evaluation of five prenatal screening and diagnostic strategies for Down syndrome(DS) in China from a social perspective so as to provide evidence for health policy making.Methods Seven provinces were selected through convenience sampling. In each province, a secondary or tertiary hospital providing prenatal screening or diagnostic services was chosen as research site. The sample size of pregnant women was 7 200. Based on field investigation and literature review,five DS prenatal screening and diagnostic strategies were established. The decision tree model was used to conduct cost-effectiveness analysis and cost-benefit analysis. The direct medical cost was calculated through institutional questionnaires, and the direct nonmedical and indirect costs through questionnaire survey from pregnant women. The outcome indicator was the number of DS fetuses prevented, and the safety indicator was the number of abortions of normal fetuses divided by the number of DS fetuses prevented.Results The effectiveness of the full non-invasive prenatal testing(NIPT) screening strategy(providing NIPT for all pregnant women, then high-risk women undergoing prenatal diagnosis) was the best, with the DS avoidance rate being 69. 86%. The economic value of conditional NIPT screening strategy was the highest(providing NIPT for pregnant women ≥35-year-old, then high-risk women undergoing prenatal diagnosis; providing traditional maternal serum screening for women < 35-year-old, then high-risk women undergoing NIPT and prenatal diagnosis). This strategy had the lowest cost-effectiveness ratio(908 500 RMB per person), and the highest benefit-cost ratio(2. 79 RMB).Conclusion Compared with other strategies, the economic value of conditional NIPT screening strategy is the best. The full NIPT screening strategy remains costly at current NIPT prices. And the current national strategy may lead to unnecessary prenatal diagnosis.

     

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