子痫前期标志物sFlt-1与PLGF的检验性能及临床预测能力评估

The Experimental and Clinical Validation of the Preeclampsia Markers sFlt-1 and PLGF

目的研究能够预测子痫前期(preeclampsia)发生的检验指标胎盘生长因子(PLGF)和可溶性fms样酪氨酸激酶-1(sFlt-1)的检验性能及临床预测能力。方法利用商品化试剂进行检验项目的性能评估;运用统计学方法,对2018年1月至2019年5月期间,在北京妇产医院孕期体检并伴有子痫前期高危因素的孕妇血清共336例,进行临床预测能力评估。结果 PLGF和sFlt-1的检验性能评估结果合格;在有子痫前期高危因素的孕妇中,有66例最终确诊为子痫前期,270例直至生产也未发生子痫。其中最终确诊子痫前期的66例孕妇中,有5例为入组后1周内发病,12例为入组后4周内发病。入组1周发病率为1.5%,入组4周发病率为3.6%。另外孕妇均是在出现高危因素的情况下进行检测,1周内发生子痫的检测结果,与1周内未发病的检测结果进行比较,PLGF的一组数据和sFlt-1/PLGF的一组数据,差异有统计学意义,P<0.05;4周内发生子痫的检测结果,与4周内未发病的检测结果进行比较,PLGF的一组数据、sFlt-1的一组数据和sFlt-1/PLGF的一组数据,差异有统计学意义,P<0.05。结论测定sFlt-1/PLGF、PLGF、sFlt-1预测子痫前期的发生是有一定的现实作用。若以sFlt-1/PLGF比值38作为的cutoff值判断,可以比较好地排除子痫前期的指标,却不能用来预测子痫前期的发生。所以还需要找到适合本地区人群的cutoff值进行诊疗。

Objective Preeclampsia(PE)is clinically significant to maternal health.Its diagnosis relies on the profound changes of blood pressure and the presence of proteinuria.Being the only available predictive PE markers,the experimental and clinical performance of the placental growth factor(PLGF)and the soluble fms-like tyrosine kinase-1(sFlt-1)needs to be validated.Methods The experimental performance was validated for precision,accuracy,and linearity.From Jan,2018 to May,2019,the pregnant women with singleton pregnancies and suspected PE were recruited in our study.Whether the sFlt-1/PLGF ratios could predict the presence or the absence of PE in 4 weeks was evaluated.Results The experimental performance of PLGF and sFlt-1 was acceptable.Of the 336 pregnant women with suspected PE,66 were diagnosed with PE before delivery.However,only 5 of the 66 patients developed PE within 1 week and 12 developed PE within 4 weeks.Conclusion The current recommended sFlt-1/PLGF ratio of 38 is able to predict the absence of PE with over 95% negative predictive value.