中国唐氏综合征产前筛查和诊断策略的敏感性分析与优化研究

Study of sensitivity and optimization of the prenatal screening and diagnosis strategies for Down syndrome in China

目的对中国5种唐氏综合征(Down syndrome, DS)产前筛诊策略的经济学价值进行敏感性分析,提出针对中国DS产前筛诊策略的优化方案。方法本研究对我国7家产前筛查/诊断机构进行现场调查,并使用成本效果分析的方法评价现有的5种DS产前筛诊策略的经济学价值。研究使用敏感性分析的方法评价成本以及临床参数的不确定性对卫生经济学评价结果的影响。结果当≥35岁孕妇占比和无创产前基因检测(non-invasive prenatal testing, NIPT)接受率上升时,成本效果比最低的策略始终为NIPT条件筛查策略。当NIPT的价格低于476元时,NIPT全筛查策略的成本效果比最低。NIPT条件筛查策略在各个调查现场的成本效果比均最低。结论我国应推广NIPT条件筛查策略,并健全孕产妇全孕期管理网络。此外,我国应在保障孕妇知情选择权的基础上,为产前筛查项目提供定额补贴,并加强对孕妇的健康宣教。

Objective To conduct sensitivity analysis from the perspective of health economic on 5 kinds of Down syndrome(DS)prenatal screening and diagnosis strategies, so as to provide optimal suggestion in China.Methods Based on the field investigation of seven prenatal screening and diagnostic agency, cost effectiveness analysis was used to assess the economic value of 5 DS prenatal screening and diagnosis strategies in China. Besides, sensitivity analysis was carried out to evaluate the impact of cost and clinical parameters’ uncertainty on the results of health economics evaluation.Results When the proportion of women over 35 years and the up-taken rate of non-invasive prenatal testing(NIPT) increased, the strategy with the lowest cost-effectiveness ratio was always the conditional NIPT screening strategy. When the price of NIPT was lower than 476 Yuan, the cost-effectiveness ratio of the full NIPT screening strategy was the lowest. The conditional NIPT screening strategy had the lowest cost-effectiveness ratio at each study site.Conclusion The conditional NIPT screening strategy should be promoted and the full-cycle pregnancy management network should be well constructed. Pregnant women’s right of informed choices should be guaranteed in China. In addition, fixed subsidies should be provided for prenatal screening, and health education for pregnant women should be reinforced.