对10488例中国孕妇母体血清筛查妊娠结局的探讨

Exploration on Outcome of Maternal Serum Screening in 10488 Chinese Women

目的通过回顾性研究,探讨应用外国软件IMMULATE 2000和ACCESS 2进行母体血清筛查对中国妇女的适用性。方法对来自北京的分别进行IMMULATE 2000和ACCESS 2检查的5668例和4820例两组孕妇进行回顾性分析,检测孕中期母体血清中AFP(MSAFP)和人绒毛膜促性腺激素含量(human chorionic gonadotropin,MShCG)。结果IMMULATE 2000的阳性预测值(positive predictive value,PPV)是5.88%,检出率(detection rate,DR)是5.56%,假阳性率(false positive rate,FPR)是5.11%,假阴性率(false negative rate,FNR)是10.00%。ACCESS 2的阳性预测值(PPV)是5.26%,检出率(DR)是7.84%,假阳性率(FPR)是5.78%,假阴性率(FNR)是51.61%。采用SPSS统计软件对两种方法的FNR、DR、FNR进行比较分析,本研究中ACCESS 2的DR和FNR明显高于IMMULATE 2000(P<0.01),而两仪器间的FPR差异无统计学意义(P=0.983,P>0.05)。结论用外国软件进行中国母体血清筛查时应使用校正公式。

Objective To explore the applicability of IMMULATE 2000 and ACCESS 2 with foreign maternal screening software on Chinese women through retrospective research. Methods Retrospective analysis were performed on two groups of 5668 and 4820 pregnancies in Beijing China using IMMULATE 2000 and ACCESS 2 respectively. Second-trimester maternal serum α-fetoprotein （MSAFP） and human chorionic gonadotropin （MShCG） were measured. Results For IMMULATE 2000, the positive predictive value （PPV）, the detection rate （DR）, the false positive rate （FPR） and the false negative rate （FNR） were 5.88%, 5.56%, 5.10%, and 10.00% respectively. For ACCESS 2, the PPV, DR, FPR and FNR were 5.26%, 7.84%, 5.78%, and 51.61% respectively. After comparison by SPSS, DR and FNR of ACCESS 2 were significantly higher than those of IMMULATE 2000 （ P 〈 0.01 ）, while there were no statistical differences on FPR（P =0. 983, P 〉 0.05 ）. Conclusion Corrections in Chinese population should be applied when using foreign screening software.